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DD Basic Shade D3

by Dental Direkt GmbH 2 variants

DD Basic Shade D3 (LBS30D3) is a Class II device made by Dental Direkt GmbH, cleared under FDA 510(k) K150196 on 26 Mar 2015 and listed in FDA GUDID since 8 Nov 2016 (UDI-DI EDDILBS30D31), 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) K150196

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 NumberEDDILBS30D31 UDI-DI Date8 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK150196 Date26 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150196 decided 26 Mar 2015 Active
  • FDA GUDID UDI-DI EDDILBS30D31 listed 8 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150196
  2. Listed FDA GUDID EDDILBS30D31

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DD Basic Shade
Generic name
Dental prosthesis dye
Model / Ref / Catalog
D3, LBS30D3
Primary DI / UDI-DI
EDDILBS30D31
510(k) Number
FDA product code
EIH
GMDN term
Dental prosthesis dye
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Related devices

Category: Dental prosthesis dye

Cleared under the same submission (K150196)

and 8 more cleared under K150196

Other devices from Dental Direkt GmbH

See all devices from Dental Direkt GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)