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Jmu 31501001

by Jmu Dental, Inc 2 variants

Jmu 31501001 is a Class II device made by Jmu Dental, Inc, cleared under FDA 510(k) K133071 on 28 May 2014 and listed in FDA GUDID since 11 Dec 2025 (UDI-DI 00840456200100), 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) K133071

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 Number00840456200100 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133071 Date28 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133071 decided 28 May 2014 Active
  • FDA GUDID UDI-DI 00840456200100 listed 11 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133071
  2. Listed FDA GUDID 00840456200100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jmu
Generic name
Silicone dental impression material
Model / reference
31501001
Primary DI / UDI-DI
00840456200100
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

Cleared under the same submission (K133071)

and 8 more cleared under K133071

Similar devices

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

Other devices from Jmu Dental, Inc

See all devices from Jmu Dental, Inc →

Properties

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