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OneBite Evolution OBEV0104

by Precision Dental Products, LLC 2 variants

OneBite Evolution OBEV0104 is a Class I device made by Precision Dental Products, LLC, listed in FDA GUDID since 19 May 2026 (UDI-DI 00850031761582), 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 Number00850031761582 UDI-DI Date19 May 2026ListedStatusListed 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  • Withdrawn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
OBEV0104
Primary DI / UDI-DI
00850031761582
FDA product code
EHY
GMDN term
Facebow
Device class
Class I
Regulation number
872.6880
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EHY (Tray, Impression, Preformed).

Other devices from Precision Dental Products, LLC

See all devices from Precision Dental Products, LLC →

Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)