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

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (6) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (4)

Premarket Exempt

No Yes

Clear

ACE Surgical - D74530104310 Catalog Number : 3010431

Device Description : ACE Surgical TRI-CAM Scanning Abutment Anterior for 4.3 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530104320 Catalog Number : 3010432

Device Description : ACE Surgical TRI-CAM Scanning Abutment Posterior for 4.3 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530105010 Catalog Number : 3010501

Device Description : ACE Surgical TRI-CAM Scanning Abutment Anterior for 5.0 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530105020 Catalog Number : 3010502

Device Description : ACE Surgical TRI-CAM Scanning Abutment Posterior for 5.0 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D745303530 Catalog Number : 30353

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 3.5 x 3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453035600 Catalog Number : 303560

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 3.5 x 6 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453035MUA0 Catalog Number : 3035MUA

Device Description : ACE Surgical TRI-CAM Multi-Unit Abutment 2 mmH for 3.5 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453035S1 Catalog Number : 3035S

Device Description : ACE Surgical TRI-CAM Titanium Screw for 3.5 mm (5-pack)

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 5

ACE Surgical - D745304330 Catalog Number : 30433

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 4.3 x 3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74530435060S1 Catalog Number : 30435060S

Device Description : ACE Surgical TRI-CAM Titanium Screw for 4.3 mm, 5.0 mm, and 6.0 mm (5-pack)

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 5

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