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Blu Jel

by Mdc Dental 2 variants

Blu Jel is a Class II device made by Mdc Dental, cleared under FDA 510(k) K011785 on 4 Sep 2001 and listed in FDA GUDID since 20 Jul 2026 (UDI-DI 07506338322676), 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) K011785

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 Number07506338322676 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011785 Date4 Sep 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011785 decided 4 Sep 2001 Active
  • FDA GUDID UDI-DI 07506338322676 listed 20 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011785
  2. Listed FDA GUDID 07506338322676

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Alginate dental impression material
Model / reference
BLU JEL
Primary DI / UDI-DI
07506338322676
510(k) Number
FDA product code
ELW
GMDN term
Alginate dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K011785)

and 8 more cleared under K011785

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

Other devices from Mdc Dental

See all devices from Mdc Dental →

Properties

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