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Jmu 31501002

by Jmu Dental, Inc 2 variants

Jmu 31501002 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 19 Jul 2024 (UDI-DI D930315010020), 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) K133071

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 NumberD930315010020 UDI-DI Date19 Jul 2024ListedStatusListed 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 D930315010020 listed 19 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133071
  2. Listed FDA GUDID D930315010020

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  • Withdrawn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
31501002
Primary DI / UDI-DI
D930315010020
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

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Other devices from Jmu Dental, Inc

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Properties

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