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Metacem Kit 9215

by Meta Biomed Co., Ltd.

Metacem Kit 9215 is a Class II device made by Meta Biomed Co., Ltd., cleared under FDA 510(k) K081913 on 5 Sep 2008 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 08806387892151), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 Nov 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K081913

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806387892151 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081913 Date5 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081913 decided 5 Sep 2008 Active
  • FDA GUDID UDI-DI 08806387892151 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081913
  2. Listed FDA GUDID 08806387892151

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Metacem Kit
Generic name
Dental composite resin
Model / reference
9215
Primary DI / UDI-DI
08806387892151
510(k) Number
FDA product code
EMA
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3275
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code EMA (Cement, Dental).

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

Properties

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