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TopCEM Dual Cure Resin Cement Automix

by Rizhao Huge Biomaterials Company, Ltd. 7 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970006744113 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TopCEM Dual Cure Resin Cement
Generic Name
Dental composite resin
Model / Ref / Catalog
Automix, Opaque/8g/A*10, B2*5/UltraCore
Primary DI / UDI-DI
06970006744113
510(k) Number
FDA Product Code
EBF, EMA
GMDN Term
Dental composite resin
Device Class
Class II
Regulation Number
872.3690, 872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233082)

Other devices from Rizhao Huge Biomaterials Company, Ltd.

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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