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rainbowTM Paste Stain Paste Stain Kit-S

by Genoss

rainbowTM Paste Stain Paste Stain Kit-S is a Class II device made by Genoss, cleared under FDA 510(k) K151731 on 15 Apr 2016 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 08809324767901), 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) K151731

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 Number08809324767901 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151731 Date15 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151731 decided 15 Apr 2016 Active
  • FDA GUDID UDI-DI 08809324767901 listed 28 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151731
  2. Listed FDA GUDID 08809324767901

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
rainbowTM Paste Stain
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
Paste Stain Kit-S
Primary DI / UDI-DI
08809324767901
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
Weight — 664 Gram

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K151731)

and 8 more cleared under K151731

Similar devices in this category

Other devices filed under Dental appliance fabrication material, ceramic.

Other devices from Genoss

See all devices from Genoss →

Properties

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