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) (8) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (2)

Premarket Exempt

No Yes

Clear

ACE Surgical - D7453043600 Catalog Number : 304360

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 4.3 x 6 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453043MU170 Catalog Number : 3043MU17

Device Description : ACE Surgical TRI-CAM 17° Multi-Unit Abutment 3 mmH for 4.3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453043MU300 Catalog Number : 3043MU30

Device Description : ACE Surgical TRI-CAM 30° Multi-Unit Abutment 4 mmH for 4.3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453043MUA0 Catalog Number : 3043MUA

Device Description : ACE Surgical TRI-CAM Multi-Unit Abutment 2 mmH for 4.3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453043MUS0 Catalog Number : 3043MUS

Device Description : ACE Surgical TRI-CAM Multi-Unit Angled Abutment Screw for 4.3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D745305030 Catalog Number : 30503

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 5.0 x 3 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453050600 Catalog Number : 305060

Device Description : ACE Surgical TRI-CAM Titanium Base Abutment 5.0 x 6 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453050MUA0 Catalog Number : 3050MUA

Device Description : ACE Surgical TRI-CAM Multi-Unit Abutment 2 mmH for 5.0 mm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7453073550 Catalog Number : 307355

Device Description : ACE Surgical TRI-CAM Implant Analog for 3.5 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ACE Surgical - D7453074350 Catalog Number : 307435

Device Description : ACE Surgical TRI-CAM Implant Analog for 4.3 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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