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

Barrier, animal source, intraoral (NPL) (4) AGENT, TOOTH BONDING, RESIN (KLE) (2) CEMENT, DENTAL (EMA) (2) POWDER, PORCELAIN (EIH) (1) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations (NOF) (1)

Premarket Exempt

No Yes

Clear

BruxZir Shaded 16 PLUS - D745701186BXP01220 Catalog Number : 70-1186-BXP0122

Device Description : BruxZir Shaded 16 PLUS Milling Blank B1 30mm Z

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

FinalTouch - D745701197FTD00010 Catalog Number : 70-1197-FTD0001

Device Description : FinalTouch/DesignService

Device Class : 2

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Glidewell RMGI Cement - D745701198PVC00010 Catalog Number : 70-1198-PVC00010

Device Description : Glidewell RMGI cement 1X0.4gm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Glidewell Zirconia Primer - D745701198PVC00020 Catalog Number : 70-1198-PVC00020

Device Description : Glidewell Zirconia Primer 1X0.1ml

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Glidewell RMGI Cement - D745701198PVC00031 Catalog Number : 70-1198-PVC00030

Device Description : Glidewell RMGI cement 2X0.4gm

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Glidewell Zirconia Primer - D745701198PVC00041 Catalog Number : 70-1198-PVC00040

Device Description : Glidewell Zirconia Primer 2X0.1ml

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 2

Newport Biologics Resorbable Collagen Membrane 34 - D74570BIO1520R340 Catalog Number : 70-BIO-1520R34

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 - D74570BIO1520R460 Catalog Number : 70-BIO-1520R46

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 34 - D74570BIO2030R340 Catalog Number : 70-BIO-2030R34

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 - D74570BIO2030R460 Catalog Number : 70-BIO-2030R46

Device Description : Resorbable Collagen Membrane

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

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