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iCEM Universal Plus T224KA

by Sun Medical Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04560227803434 UDI-DI Date9 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iCEM Universal Plus
Generic Name
Dental composite resin
Model / Ref / Catalog
T224KA, 66101218
Primary DI / UDI-DI
04560227803434
510(k) Number
FDA Product Code
EMA
GMDN Term
Dental composite resin
Device Class
Class II
Regulation Number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K254063)

Show all (12)

Other devices from Sun Medical Co., Ltd.

See all devices from Sun Medical Co., Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No