YOUNG DENTAL MANUFACTURING I, LLC

Address:13705 Shoreline Ct E,EARTH CITY,MO,63045,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Disinfectant, medical devices (LRJ) (4) Handpiece, contra- and right-angle attachment, dental (EGS) (3) Evacuator, oral cavity (EHZ) (2) AGENT, POLISHING, ABRASIVE, ORAL CAVITY (EJR) (1)

Premarket Exempt

No Yes

Clear

Young - 00302730000009 Catalog Number : 296248

Device Description : Young Vera DPA Splatter Guard Elite, Latex Free, Soft, Short, Web Purple Cup

Device Class :

Duns Number: 006309355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

Biotrol - 00302730000030 Catalog Number : DOCW06-100

Device Description : OPTI-CIDE WIPES, 100 ct - Disinfectant (BIOTROL)

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Biotrol - 00302730000047 Catalog Number : DOCS12-024

Device Description : OPTI-CIDE 24OZ Solution - Disinfectant (BIOTROL)

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Biotrol - 00302730000054 Catalog Number : DOCP04-128

Device Description : OPTI-CIDE 1 GAL Solution - RTU Disinfectant (BIOTROL)

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Biotrol - 00302730000061 Catalog Number : DOCP02-320

Device Description : OPTI-CIDE 2 x 2.5 GAL Solution - RTU Disinfectant (BIOTROL)

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Biotrol - 00302730000078 Catalog Number : SE125SWH

Device Description : Biotrol Surgical Evacuation Tips, White, .16? (4mm), Autoclavable Aspiration Instrument

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : Yes

Device Count : 1

Biotrol - 00302730000085 Catalog Number : SE250MGR

Device Description : Biotrol Surgical Evacuation Tips, Green, .25? (6.4mm), Autoclavable Aspiration Instrument

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : Yes

Device Count : 1

Young - 00302730000092 Catalog Number : 296249

Device Description : Young Vera DPA Splatter Guard Elite, Latex Free, Soft, Short, Web Purple Cup

Device Class :

Duns Number: 006309355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

Young - 00302730000108 Catalog Number : 296250

Device Description : Young Vera DPA Splatterguard Classic, Latex Free, Soft, Short, Web Purple Cup

Device Class :

Duns Number: 006309355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

Biotrol - 00302730000115 Catalog Number : PGC103CM

Device Description : First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Cool Mint

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : Yes

Device Count : 1

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