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Mizzy Millennium 6010040

by Keystone Industries

Mizzy Millennium 6010040 is a Class II device made by Keystone Industries, cleared under FDA 510(k) K983876 on 16 Dec 1998 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI H66860100401), 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) K983876

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 NumberH66860100401 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983876 Date16 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983876 decided 16 Dec 1998 Active
  • FDA GUDID UDI-DI H66860100401 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983876
  2. Listed FDA GUDID H66860100401

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mizzy Millennium
Generic name
Denture repair kit, professional
Model / Ref / Catalog
6010040
Primary DI / UDI-DI
H66860100401
510(k) Number
FDA product code
EBI
GMDN term
Denture repair kit, professional
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING).

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

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