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AdDent OraBlu

by Addent, Inc.

AdDent OraBlu (112001) is a Class II device made by Addent, Inc., cleared under FDA 510(k) K121282 on 24 Jul 2012 and listed in FDA GUDID since 1 Jun 2017 (UDI-DI D8691120010), active as of 22 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 22 Oct 2026

Documents

510(k) K121282

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD8691120010 UDI-DI Date1 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121282 Date24 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121282 decided 24 Jul 2012 Active
  • FDA GUDID UDI-DI D8691120010 listed 1 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121282
  2. Listed FDA GUDID D8691120010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AdDent
Generic name
Toluidine blue O solution IVD
Model / Ref / Catalog
OraBlu, 112001
Primary DI / UDI-DI
D8691120010
510(k) Number
FDA product code
NXV
GMDN term
Toluidine blue O solution IVD
Device class
Class II
Regulation number
872.6350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Toluidine blue O solution IVD

Similar devices

Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).

Other devices from Addent, Inc.

See all devices from Addent, Inc. →

Properties

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