Skip to content

StatusBlue MixStar 999693

by DMG Chemisch-Pharmazeutische Fabrik GmbH

StatusBlue MixStar 999693 is a Class II device made by DMG Chemisch-Pharmazeutische Fabrik GmbH, cleared under FDA 510(k) K013237 on 22 Oct 2001 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI EDMG9996930), 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) K013237

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 NumberEDMG9996930 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK013237 Date22 Oct 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013237 decided 22 Oct 2001 Active
  • FDA GUDID UDI-DI EDMG9996930 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013237
  2. Listed FDA GUDID EDMG9996930

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
StatusBlue MixStar
Generic name
Silicone dental impression material
Model / Ref / Catalog
999693
Primary DI / UDI-DI
EDMG9996930
510(k) Number
FDA product code
ELW
GMDN term
Silicone dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Silicone dental impression material

Cleared under the same submission (K013237)

Other devices from DMG Chemisch-Pharmazeutische Fabrik GmbH

See all devices from DMG Chemisch-Pharmazeutische Fabrik GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (11, all answered No)