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Jmu 32113003

by Jmu Dental, Inc 2 variants

Jmu 32113003 is a Class II device made by Jmu Dental, Inc, cleared under FDA 510(k) K171823 on 22 Feb 2018 and listed in FDA GUDID since 14 May 2024 (UDI-DI D930321130030), 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) K171823

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 NumberD930321130030 UDI-DI Date14 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171823 Date22 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171823 decided 22 Feb 2018 Active
  • FDA GUDID UDI-DI D930321130030 listed 14 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171823
  2. Listed FDA GUDID D930321130030

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  • Withdrawn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
Chemical/physical sterilization process indicator
Model / reference
32113003
Primary DI / UDI-DI
D930321130030
FDA product code
JOJ
GMDN term
Chemical/physical sterilization process indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

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Properties

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