Precision Dental Products LLC

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 - 00850031761001 Catalog Number : OBEV0022

Device Description : Articulator Plate SAM®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761018 Catalog Number : OBEV0021

Device Description : Articulator Plate Whipmix®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761025 Catalog Number : OBEV0020

Device Description : Articulator Plate Artex®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761032 Catalog Number : OBEV0054

Device Description : Flat Occlusal Mounting Plate - Long Neck

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761049 Catalog Number : OBEV0019

Device Description : Articulator Plate Stratos®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761056 Catalog Number : OBEV0009

Device Description : Horizontal Bar

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761063 Catalog Number : OBEV0010

Device Description : Baseline Bar

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761070 Catalog Number : OBEV0012

Device Description : Trinity Screw

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761087 Catalog Number : OBEV0011

Device Description : OneBite Nut

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761100 Catalog Number : OBEV0004

Device Description : Safety Plugs

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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