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Brilliant Ng 1216

by Coltène/Whaledent AG

Brilliant Ng 1216 is a Class II device made by Coltène/Whaledent AG, cleared under FDA 510(k) K974465 on 9 Mar 1998 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI J00612160), 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) K974465

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 NumberJ00612160 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974465 Date9 Mar 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974465 decided 9 Mar 1998 Active
  • FDA GUDID UDI-DI J00612160 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974465
  2. Listed FDA GUDID J00612160

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Brilliant Ng
Generic name
Dental veneer, professional
Model / Ref / Catalog
1216
Primary DI / UDI-DI
J00612160
510(k) Number
FDA product code
EBF
GMDN term
Dental veneer, professional
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental veneer, professional

Cleared under the same submission (K974465)

and 8 more cleared under K974465

Similar devices

Other devices filed under FDA product code EBF (Material, Tooth Shade, Resin).

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)