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 - 00850031761414 Catalog Number : OBEV0068

Device Description : Short Rail

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761421 Catalog Number : OBEV0069

Device Description : Rail Slider for Cross

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761438 Catalog Number : OBEV0070

Device Description : Magnetic Bases (Disposables)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761445 Catalog Number : OBHV006

Device Description : Horizontal and vertical bar (6)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761452 Catalog Number : OBHV024

Device Description : Horizontal and vertical bar (24)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761469 Catalog Number : OBA006

Device Description : OneBite Arches (6)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761476 Catalog Number : OBA024

Device Description : OneBite Arches (24)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761483 Catalog Number : OBEV0065

Device Description : OneBite Evolution Stylus Base

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761490 Catalog Number : OBEV0063

Device Description : OneBite Evolution Stylus Arm

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761506 Catalog Number : OBEV0062

Device Description : OneBite Evolution Stylus Shaft

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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