Precision Dental Products LLC

Address:13925 Maple Hollow Cir,Draper,UT,84020,US

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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

Tray, Impression, Preformed (EHY) (10)

Premarket Exempt

Yes

Clear

OneBite Evolution - 00850031761117 Catalog Number : OBEV0015

Device Description : Curved Occlusal Transfer Plate (Disposable)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761124 Catalog Number : OBEV0071

Device Description : OneBite Evolution Curved Mounting Plate

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761131 Catalog Number : OBEV0018

Device Description : Articulator Plate Denar®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761148 Catalog Number : OBEV0006

Device Description : Digital OneBite Arch/Occlusal Bite Plate (Disposable)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761155 Catalog Number : OBEV0055

Device Description : Flat Occlusal Mounting Plate - Standard

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761162 Catalog Number : OBEV0007

Device Description : Midline Bar

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761179 Catalog Number : OBEV0005

Device Description : OneBite Arch/Occlusal Bite Plate (Disposable)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761186 Catalog Number : OBEV0023

Device Description : Articulator Plate Kavo®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761193 Catalog Number : OBEV0024

Device Description : Articulator Plate Panadent®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761209 Catalog Number : OBEV0030

Device Description : Analog Scanning Cube

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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