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 - 00850031761216 Catalog Number : OBEV0031

Device Description : Digital Scanning Cube

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761223 Catalog Number : OBEV0033

Device Description : Articulator Slider Stratos®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761230 Catalog Number : OBEV0034

Device Description : Articulator Slider Denar®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761247 Catalog Number : OBEV0035

Device Description : Articulator Slider Kavo®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761254 Catalog Number : OBEV0036

Device Description : Articulator Slider Panadent®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761261 Catalog Number : OBEV0037

Device Description : Articulator Slider Artex®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761278 Catalog Number : OBEV0038

Device Description : Articulator Slider Sam®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761285 Catalog Number : OBEV0039

Device Description : Articulator Slider Whipmix®

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761292 Catalog Number : OBEV0050

Device Description : OneBite Arch (Analog)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

OneBite Evolution - 00850031761308 Catalog Number : OBEV0051

Device Description : OneBite Occlusal Bite Plate (Analog)

Device Class : 1

Duns Number: 081523806

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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