Other products from "DEN-MAT HOLDINGS, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 D813SPD15110 SPD1511 SPD1511 PREC HVY WILD BRY ELW Material, Impression 2 Precision®
2 D813VN200ST1 VN200ST VN200ST FLX VARNISH STRAWBERRY 200PK LBH Varnish, Cavity FLUORIDEX
3 D813TEN40000 TEN4000 TEN4000 TENURE 4G BONDING SYSTEM KLE Agent, Tooth Bonding, Resin 2 Tenure®
4 D813SPD19070 SPD1907 SPD1907 SPLASH LITE REG CART 5pc ELW Material, Impression 2 Splash®
5 D813SPD15470 SPD1547 SPD1547 PRECISION JUMBO CART RFL HVY ELW Material, Impression 2 Precision®
6 D813SPD15460 SPD1546 SPD1546 PRECISION JUMBO CART RFL MED ELW Material, Impression 2 Precision®
7 D813SPD15360 SPD1536 SPD1536 PRECISION FATPAK INTRO MED ELW Material, Impression 2 Precision®
8 D813SPD15350 SPD1535 SPD1535 PRECISION FATPAK INTRO HVY ELW Material, Impression 2 Precision®
9 D813SPD15340 SPD1534 SPD1534 PRECISION FATPAK REFILL MED ELW Material, Impression 2 Precision®
10 D813SPD15330 SPD1533 SPD1533 PRECISION FATPAK REFILL HVY ELW Material, Impression 2 Precision®
11 D813SPD15170 SPD1517 SPD1517 PREC JAR PTY WILD BRY ELW Material, Impression 2 Precision®
12 D813SPD15141 SPD1514 SPD1514 PREC PTY PK WILD BRY ELW Material, Impression Precision®
13 D813SPD15100 SPD1510 SPD1510 PREC MED WILD BRY ELW Material, Impression 2 Precision®
14 D813SPD15090 SPD1509 SPD1509 PREC LITE WILD BRY ELW Material, Impression 2 Precision®
15 D813SPD15080 SPD1508 SPD1508 PREC XLITE BODY WILD BRY ELW Material, Impression 2 Precision®
16 D813325999500 032599950 032599950 U-BOND PLUS CUSTOM KIT  EMA Cement, Dental 2 Ultra-Bond®
17 D8131146B0 1146B 1146B TENURE B ADHESIVE 6mL EBF Material, Tooth Shade, Resin 2 Tenure®
18 D8131145B0 1145B 1145B TENURE A ADHESIVE 6mL EBF Material, Tooth Shade, Resin 2 Tenure®
19 D8130561007750 056100775 056100775 ORTHOCLEAR RETAINER DOUBLE DYJ Retainer, Screw Expansion, Orthodontic 1 ORTHOCLEAR
20 D8130561007500 056100750 056100750 ORTHOCLEAR RETAINER LOWER DYJ Retainer, Screw Expansion, Orthodontic 1 ORTHOCLEAR
21 D8130561007250 056100725 056100725 ORTHOCLEAR RETAINER UPPER DYJ Retainer, Screw Expansion, Orthodontic 1 ORTHOCLEAR
22 D8130561004250 056100425 056100425 ORTHOCLEAR ALIGNER UPR & LWR NXC Aligner, Sequential 2 ORTHOCLEAR
23 D8130561004000 056100400 056100400 ORTHOCLEAR ALIGNER LOWER NXC Aligner, Sequential 2 ORTHOCLEAR
24 D8130325999500 032599950 032599950 U-BOND PLUS CUSTOM KIT  EMA Cement, Dental 2 Ultra-Bond®
25 D8130325997500 032599750 032599750 U-BOND PLUS MULTI SH 6g KIT R1 EMA Cement, Dental 2 Ultra-Bond®
26 D8130325993900 032599390 032599390 UB PLUS A2 DC 6g RFL KIT EMA Cement, Dental 2 Ultra-Bond®
27 D8130325993800 032599380 032599380 UB PLUS SUP WHT DC RFL KIT R:1 EMA Cement, Dental 2 Ultra-Bond®
28 D8130325993700 032599370 032599370 UB PLUS NEU DC 6g RFL KIT R:1 EMA Cement, Dental 2 Ultra-Bond®
29 D8130325993500 032599350 032599350 UB PLUS B0 DC 6g RFL KIT EMA Cement, Dental 2 Ultra-Bond®
30 D8130325993300 032599330 032599330 UB PLUS B1 DC 6g RFL KIT EMA Cement, Dental 2 Ultra-Bond®
31 D8130325993100 032599310 032599310 UB PLUS A1 DC 6g RFL KIT R:1 EMA Cement, Dental 2 Ultra-Bond®
32 D8130325991100 032599110 032599110 U-BOND PLUS M/S INTRO KIT EMA Cement, Dental 2 Ultra-Bond®
33 D8130324921100 032492110 032492110 BLOCK OUT UBP M/S INTRO KIT EMA Cement, Dental 2 Ultra-Bond®
34 D8130324915500 032491550 032491550 BLOCK OUT UBP M/S BTO KIT      EMA Cement, Dental 2 Ultra-Bond®
35 D8130324915100 032491510 032491510 BLOCK OUT UBP M/S BONDING KIT EMA Cement, Dental 2 Ultra-Bond®
36 D8130324914100 032491410 032491410 BLOCK OUT UBP SUP WHT KT EMA Cement, Dental 2 Ultra-Bond®
37 D8130324913100 032491310 032491310 BLOCK OUT UBP B0 KIT EMA Cement, Dental 2 Ultra-Bond®
38 D8130324912100 032491210 032491210 BLOCK OUT UBP B1 KIT EMA Cement, Dental 2 Ultra-Bond®
39 D8130324911100 032491110 032491110 BLOCK OUT UBP A1 KIT EMA Cement, Dental 2 Ultra-Bond®
40 D813032245101B0 032245101B 032245101B TENURE S BND ENH 6mL R:1 KLE Agent, Tooth Bonding, Resin 2 Tenure®
41 D8130319828101 031982810 031982810 TRY-IN SUP WHT SY 4pc KIT EMA Cement, Dental Ultra-Bond®
42 D8130319827101 031982710 031982710 TRY-IN NEUTRAL SY 4pc KIT EMA Cement, Dental Ultra-Bond®
43 D8130319825101 031982510 031982510 TRY-IN A1 SY 4pc KIT EMA Cement, Dental Ultra-Bond®
44 D8130319823101 031982310 031982310 TRY-IN B1 SY 4pc KIT EMA Cement, Dental Ultra-Bond®
45 D8130319822101 031982210 031982210 TRY-IN B0 SY 4pc KIT EMA Cement, Dental Ultra-Bond®
46 D8130313475201 031347520 031347520 C-SNDR POST STRIPS UFINE 6pcSM DZN Instruments, Dental Hand 1 Ceri-Sander™
47 D8130313475101 031347510 031347510 C-SNDR POST STRIPS FINE 6pc SM DZN Instruments, Dental Hand 1 Ceri-Sander™
48 D8130313475000 031347500 031347500 CERISNDR POSTERIOR KIT w/STRPS DZN Instruments, Dental Hand 1 Ceri-Sander™
49 D8130313435500 031343550 031343550 TRY-IN MULTI-SHADE PST KIT EMA Cement, Dental 2 Ultra-Bond®
50 D8130313375201 031337520 031337520 CERISANDER STRIPS U-FINE 6pcLG DZN Instruments, Dental Hand 1 Ceri-Sander™
Other products with the same Product Code "NXC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00860006891206 K173785 Dandy Clear Aligners ORTHLY, INC.
2 00860006274368 TSCA Tru-Smile Clear Aligner Tru-Smile PHASE ORTHO, INC.
3 00860006274344 PLCA Phase Ortho Private Label Clear Aligner - Temporary Placeholder Phase Ortho Private Label PHASE ORTHO, INC.
4 00860006274320 SSCA Smile Shapers Clear Aligner - Zendura Smile Shapers PHASE ORTHO, INC.
5 00860006274306 POCA Phase Ortho Clear Aligner Phase Ortho PHASE ORTHO, INC.
6 00860005619016 X Clear Dental Aligner Straight T Clear Dental Aligner STRAIGHT-T LLC
7 00860003321751 RA1 OrthoFX Rescue aligner. Specialized purpose of bringing off track treatment back on track. OrthoFX Rescue Aligner ORTHOFX
8 00860003321706 FXTetra Updated UDI submission for Zendura material aligners. OrthoFX ORTHOFX
9 00860002380094 FG0094 The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that con The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position. uLab Systems Dental Aligner ULAB SYSTEMS, INC.
10 00860002380063 FG0094 Rev. D uLab Systems Dental Aligner ULAB SYSTEMS, INC.
11 00860002380056 FG0094 uLab Systems Dental Aligner ULAB SYSTEMS, INC.
12 00860002302355 POCA Discontinued product code. Phase Ortho DERBY DENTAL LABORATORY, INC
13 00860002302348 TSCA Clear sequential aligner / progressive orthodontic appliance system. Tru-Smile DERBY DENTAL LABORATORY, INC
14 00860002302317 SSCA Discontinued product code. Smile Shapers DERBY DENTAL LABORATORY, INC
15 00860002302300 01 Discontinued - No longer in use. Smile Shapers, Tru-Smile DERBY DENTAL LABORATORY, INC
16 00860000937801 1 Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician t Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician to treat malocclusion. The patient follows a set treatment plan designed by the provider or a third party and that produces a series of steps (or trays) that are then worn by the patient. The clinician provides periodic checkups to make sure treatment is progressing appropriately. Voodoo Clear Aligners VOODOO MANUFACTURING, INC.
17 00860000506007 PRS-0063 PRS-0063 Sequential Aligners Byte Aligner System STRAIGHT SMILE LLC
18 00856379007276 1000 ASSY-500016 SureSmile Aligner (10 hours/day) SureSmile® Aligner ORAMETRIX, INC.
19 00856379007085 7.6 SureSmile Aligner Software ORAMETRIX, INC.
20 00856379007047 3000 SureSmile attachment template ORAMETRIX, INC.
21 00856379007030 2000 SureSmile attachment template ORAMETRIX, INC.
22 00856379007023 1000 SureSmile aligner ORAMETRIX, INC.
23 00856379007016 2000 sureclear template ORAMETRIX, INC.
24 00856379007009 1000 sureclear aligner ORAMETRIX, INC.
25 00850028222003 CA0000000001 The Concinnity Aligners™ are a custom clear aligner system. They are a series of The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.Intended Use / Indications for Use:The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars). Concinnity Aligners DRAKE PRECISION DENTAL LABORATORY, INC.
26 00850017524170 NBYTETray PRS-0063 Sequential Aligners Byte Night Aligners STRAIGHT SMILE LLC
27 00850017524163 HBYTETray PRS-0063 Sequential Aligners Byte Day Alignes STRAIGHT SMILE LLC
28 00850007728144 100-0365 NIGHTTIME CLEAR ALIGNER REPLACEMENT ALIGNERS ACCESS DENTAL LAB ACCESS DENTAL LAB, LLC
29 00850007728137 100-0364 NIGHTTIME CLEAR ALIGNER - REFINEMENT CORRECTIONS ACCESS DENTAL LAB ACCESS DENTAL LAB, LLC
30 00850007728120 100-0363 NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS ACCESS DENTAL LAB ACCESS DENTAL LAB, LLC
31 00850007728113 100-0362 NIGHTTIME CLEAR ALIGNERS-SEQUENTIAL ALIGNERS ACCESS DENTAL LAB ACCESS DENTAL LAB, LLC
32 00850007728045 100-0355 REPLACEMENT ALIGNERS REPLACEMENT ALIGNERS ACCESS DENTAL LAB, LLC
33 00850007728021 100-0012 REFINEMENT CORRECTION KIT REFINEMENT CORRECTION KIT ACCESS DENTAL LAB, LLC
34 00850007728014 100-0010 MIDCOURSE CORRECTIONS KIT MIDCOURSE CORRECTIONS KIT ACCESS DENTAL LAB, LLC
35 00850007728007 100-0352 sequential aligner system sequential aligner ACCESS DENTAL LAB, LLC
36 00850004223567 FA-0001 Candid Aligner System FA-0001 Candid Aligner CANDID CARE CO.
37 00850004223222 FA-0003 Candid Aligner System FA-0003 Candid Aligner CANDID CARE CO.
38 D9393DS080 3DS08 Orthodontic plastic aligner 3D Predict 3D SMILE USA, INC
39 D918SCA0 Aligners Orthodontic appliance system, progressiveFDA PT: HJDC SureCure DIGITAL ORTHODONTIC CARE
40 D865REF00051 Aligner (Single-layer) REF-05 The ClearCorrect device is fabricated of clear thin thermoformed polyurethane pl The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. ClearCorrect System CLEARCORRECT OPERATING, LLC
41 D865REF00041 Retainer REF-04 The ClearCorrect retainer device is fabricated of clear thin thermoformed polyur The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. ClearCorrect System CLEARCORRECT OPERATING, LLC
42 D865REF00031 Aligner (Multi-layer) REF-03 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-poly The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner ClearCorrect System CLEARCORRECT OPERATING, LLC
43 D865REF00021 Engager Template REF-02 Engager template device accessory for use with the ClearCorrect System. ClearCorrect System CLEARCORRECT OPERATING, LLC
44 D865REF0002 MFG-0101 1.0 REF-02 Engager template device accessory for use with the ClearCorrect System. ClearCorrect System CLEARCORRECT OPERATING, LLC
45 D865REF00011 Aligner (Single-Layer) REF-01 The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. ClearCorrect System CLEARCORRECT OPERATING, LLC
46 D865REF0001 MFG-0100 5.0 REF-01 The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. ClearCorrect System CLEARCORRECT OPERATING, LLC
47 D8410091U1M 0091U 0091U Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray EZ-Align DYNA FLEX OF MISSOURI, L.P.
48 D8410091L1D 0091L 0091L Sequential Aligner (Lower Tray) EZ-Align DYNA FLEX OF MISSOURI, L.P.
49 D84100911Z 0091 0091 Clear Sequential Aligner System EZ-Align DYNA FLEX OF MISSOURI, L.P.
50 D819702400 70240 Clear Image Aligner SPECIALTY APPLIANCES, LLC