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OneBite Evolution OBEV2008

by Precision Dental Products, LLC

OneBite Evolution OBEV2008 is a device made by Precision Dental Products, LLC, listed in FDA GUDID since 14 Jan 2025 (UDI-DI 00860007845765), 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 Number00860007845765 UDI-DI Date14 Jan 2025ListedStatusListed 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  • Withdrawn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
OBEV2008
Primary DI / UDI-DI
00860007845765
GMDN term
Facebow
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Facebow.

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Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)