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TrollByte Kimera Endo 3707/2607

by Directa AB

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17310230006346 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
TrollByte
Generic name
Dental x-ray film holder, reusable
Model / Ref / Catalog
Kimera Endo 3707/2607, 1574372607
Primary DI / UDI-DI
17310230006346
FDA product code
EGZ
GMDN term
Dental x-ray film holder, reusable
Device class
Class I
Regulation number
872.1905
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental x-ray film holder, reusable

Other devices from Directa AB

See all devices from Directa AB →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No