James R. Glidewell, Dental Ceramics, Inc.

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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

IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (5) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (4) ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (1)

Premarket Exempt

No Yes

Clear

ACE Surgical - D7452045MUA0 Catalog Number : 2045MUA

Device Description : ACE Surgical INTERNAL HEX Multi-Unit Abutment, 4.5 Platform x 2 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452073530 Catalog Number : 207353

Device Description : ACE Surgical INTERNAL HEX Titanium Base Abutment, 3.5 Platform, 3 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452073550 Catalog Number : 207355

Device Description : ACE Surgical INTERNAL HEX Implant Analog 3.5 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ACE Surgical - D74520735600 Catalog Number : 2073560

Device Description : ACE Surgical INTERNAL HEX Titanium Base Abutment, 3.5 Platform, 6 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452074530 Catalog Number : 207453

Device Description : ACE Surgical INTERNAL HEX Titanium Base Abutment, 4.5 Platform, 3 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452074550 Catalog Number : 207455

Device Description : ACE Surgical INTERNAL HEX Implant Analog 4.5 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ACE Surgical - D74520745600 Catalog Number : 2074560

Device Description : ACE Surgical INTERNAL HEX Titanium Base Abutment, 4.5 Platform, 6 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74520MUS0 Catalog Number : 20MUS

Device Description : ACE Surgical INTERNAL HEX Multi-Unit Angled Abutment Screw

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530103510 Catalog Number : 3010351

Device Description : ACE Surgical TRI-CAM Scanning Abutment Anterior for 3.5 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530103520 Catalog Number : 3010352

Device Description : ACE Surgical TRI-CAM Scanning Abutment Posterior for 3.5 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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