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) (3) POWDER, PORCELAIN (EIH) (1)

Premarket Exempt

No Yes

Clear

TAP - D745TAP0 Catalog Number : TAP

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

TAP 3 - D745TAP30 Catalog Number : TAP3

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

Dream TAP - D745TAPD0 Catalog Number : TAPD

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

Obsidian - D754544002000 Catalog Number : 4400200

Device Description : Obsidian Spray Glaze

Device Class : 2

Duns Number: 021228671

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

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