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Mizzy Millennium 1014335

by Keystone Industries

Mizzy Millennium 1014335 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 H66810143351), 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 NumberH66810143351 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 H66810143351 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983876
  2. Listed FDA GUDID H66810143351

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  • Withdrawn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
Dental appliance fabrication material, resin
Model / Ref / Catalog
1014335
Primary DI / UDI-DI
H66810143351
510(k) Number
FDA product code
EBI
GMDN term
Dental appliance fabrication material, resin
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.45 Kilogram
Weight — 1 Pound

Related devices

Category: Dental appliance fabrication material, resin

Cleared under the same submission (K983876)

and 8 more cleared under K983876

Similar devices in this category

Other devices filed under Dental appliance fabrication material, resin.

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

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