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rainbow Trans TTCB9812W

by Genoss

rainbow Trans TTCB9812W is a Class II device made by Genoss, cleared under FDA 510(k) K151723 on 28 Oct 2015 and listed in FDA GUDID since 17 Dec 2016 (UDI-DI 08809324768540), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151723

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809324768540 UDI-DI Date17 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151723 Date28 Oct 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151723 decided 28 Oct 2015 Active
  • FDA GUDID UDI-DI 08809324768540 listed 17 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151723
  2. Listed FDA GUDID 08809324768540

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
rainbow Trans
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
TTCB9812W
Primary DI / UDI-DI
08809324768540
510(k) Number
FDA product code
EIH
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution
Size
Width — 98 Millimeter

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (9, all answered No)