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OneBite Evolution OBEV0039

by Precision Dental Products, LLC

OneBite Evolution OBEV0039 is a Class I device made by Precision Dental Products, LLC, listed in FDA GUDID since 7 Apr 2022 (UDI-DI 00850031761285), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850031761285 UDI-DI Date7 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OneBite Evolution
Generic name
Facebow
Model / Ref / Catalog
OBEV0039
Primary DI / UDI-DI
00850031761285
FDA product code
EHY
GMDN term
Facebow
Device class
Class I
Regulation number
872.6880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Facebow

Similar devices in this category

Other devices filed under Facebow.

Other devices from Precision Dental Products, LLC

See all devices from Precision Dental Products, LLC →

Properties

  • Premarket exempt
Other properties (14, all answered No)