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 - 00850031761315 Catalog Number : OBEV0052

Device Description : OneBite Arch (Digital)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761322 Catalog Number : OBEV0053

Device Description : OneBite Occlusal Bite Plate (Digital)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761339 Catalog Number : OBEV0056

Device Description : Cube Holder Base - Clin

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761346 Catalog Number : OBEV0057

Device Description : Cube Holder Arm - Clin

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761353 Catalog Number : OBEV0058

Device Description : Screw

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761360 Catalog Number : OBEV0059

Device Description : Cube Holder Base - Tech

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761377 Catalog Number : OBEV0060

Device Description : Cube Holder Arm - Tech

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761384 Catalog Number : OBEV0064

Device Description : Replaceable Lead Tips

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761391 Catalog Number : OBEV0066

Device Description : 1mm Cross

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761407 Catalog Number : OBEV0067

Device Description : Long Rail

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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