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

POWDER, PORCELAIN (EIH) (8) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (2)

Premarket Exempt

No Yes

Clear

ACE Surgical - D7453075050 Catalog Number : 307505

Device Description : ACE Surgical TRI-CAM Implant Analog for 5.0 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

ACE Surgical - D7453076060 Catalog Number : 307606

Device Description : ACE Surgical TRI-CAM Implant Analog for 6.0 mm

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

BruxZir - D74544000680 Catalog Number : 4400068

Device Description : BruxZir Spray Glaze Powder

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : No

Device Count : 1

BruxZir - D74544001681 Catalog Number : 4400168

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 A1 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001691 Catalog Number : 4400169

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 A2 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001701 Catalog Number : 4400170

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 A3 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001711 Catalog Number : 4400171

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 A3.5 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001721 Catalog Number : 4400172

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 A4 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001731 Catalog Number : 4400173

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 B1 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

BruxZir - D74544001741 Catalog Number : 4400174

Device Description : BruxZir Shaded-16 CAD/CAM 20x19 B2 5-Pack

Device Class :

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 5

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