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

Device, anti-snoring (LRK) (8) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (1) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (1)

Premarket Exempt

Yes No

Clear

ACE Surgical - D745MUS00140 Catalog Number : MUS0014

Device Description : ACE Surgical INTERNAL HEX Prosthetic Screw

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE Surgical - D745MUS00430 Catalog Number : MUS0043

Device Description : ACE Surgical TRI-CAM Prosthetic Screw Unigrip

Device Class : 1

Duns Number: 021228671

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Silent Nite - D745SILNT0 Catalog Number : SILNT

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

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHG0 Catalog Number : SNGLHG

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGADJ0 Catalog Number : SNGLHGADJ

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Adjust

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGHL0 Catalog Number : SNGLHGHL

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Half Lower

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGHU0 Catalog Number : SNGLHGHU

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Half Upper

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGXP0 Catalog Number : SNGLHGXP

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Original Parts

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGXPHL0 Catalog Number : SNGLHGXPHL

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Original Part Lower

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Silent Nite Sleep Appliance with Glidewell Hinge - D745SNGLHGXPHU0 Catalog Number : SNGLHGXPHU

Device Description : Silent Nite Sleep Appliance with Glidewell Hinge Original Part Upper

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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