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

Bone grafting material, synthetic (LYC) (3) BONE GRAFTING MATERIAL, ANIMAL SOURCE (NPM) (3) Barrier, animal source, intraoral (NPL) (2) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (2) DRESSING, WOUND, COLLAGEN (KGN) (1) Device, anti-snoring (LRK) (1) Mouthguard, prescription (MQC) (1)

Premarket Exempt

No Yes

Clear

Newport Biologics Resorbable Collagen Membrane 34 - D74570BIO3040R340 Catalog Number : 70-BIO-3040R34

Device Description : Resorbable Collagen Membrane

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

Newport Biologics Resorbable Collagen Membrane 46 - D74570BIO3040R460 Catalog Number : 70-BIO-3040R46

Device Description : Resorbable Collagen Membrane

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP050 Catalog Number : 70-BIO-BGP05

Device Description : Bone Graft Putty Mineral Collagen Composite

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LYC, NPM

Prescription Use : Yes

Device Count : 1

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP100 Catalog Number : 70-BIO-BGP10

Device Description : Bone Graft Putty Mineral Collagen Composite

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NPM, LYC

Prescription Use : Yes

Device Count : 1

Newport Biologics Bone Graft Putty Mineral Collagen Composite - D74570BIOBGP200 Catalog Number : 70-BIO-BGP20

Device Description : Bone Graft Putty Mineral Collagen Composite

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LYC, NPM

Prescription Use : Yes

Device Count : 1

Newport Biologics Resorbable Collagen Plug - D74570BIODWD100 Catalog Number : 70-BIO-DWD10

Device Description : Resorbable Collagen Plug (10 per box)

Device Class : U

Duns Number: 021228671

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Comfort Splint - D745COMSPL0 Catalog Number : COMSPL

Device Description : Device to alleviate pain caused by bruxing or clenching of teeth

Device Class : U

Duns Number: 021228671

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

EMA - D745EMA0 Catalog Number : EMA

Device Description : Device for treatment of mild to moderate obstructive sleep apnea

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ACE Surgical - D745MU00160 Catalog Number : MU0016

Device Description : ACE Surgical Multi-Unit Abutment Analog

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ACE Surgical - D745MU00170 Catalog Number : MU0017

Device Description : ACE Surgical Multi-Unit Scan Abutment For INTERNAL HEX and TRI-CAM

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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