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

Premarket Exempt

No Yes

Clear

ACE Surgical - D74520103510 Catalog Number : 2010351

Device Description : ACE Surgical INTERNAL HEX Scanning Abutment, 3.5 Platform, Posterior

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74520103520 Catalog Number : 2010352

Device Description : ACE Surgical INTERNAL HEX Scanning Abutment, 4.5 Platform, Posterior

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74520104510 Catalog Number : 2010451

Device Description : ACE Surgical INTERNAL HEX Scanning Abutment, 3.5 Platform, Anterior

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D74520104520 Catalog Number : 2010452

Device Description : ACE Surgical INTERNAL HEX Scanning Abutment, 4.5 Platform, Anterior

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACE Surgical - D745203545AS0 Catalog Number : 203545AS

Device Description : ACE Surgical INTERNAL HEX Abutment Screw (5/pack)

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452035MU170 Catalog Number : 2035MU17

Device Description : ACE Surgical INTERNAL HEX 17° Multi-Unit Abutment, 3.5 Platform x 2 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452035MU300 Catalog Number : 2035MU30

Device Description : ACE Surgical INTERNAL HEX 30° Multi-Unit Abutment, 3.5 Platform x 3 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452035MUA0 Catalog Number : 2035MUA

Device Description : ACE Surgical INTERNAL HEX Multi-Unit Abutment, 3.5 Platform x 2 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACE Surgical - D7452045MU170 Catalog Number : 2045MU17

Device Description : ACE Surgical INTERNAL HEX 17° 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 - D7452045MU300 Catalog Number : 2045MU30

Device Description : ACE Surgical INTERNAL HEX 30° Multi-Unit Abutment, 4.5 Platform x 3 mmH

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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