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A-Silicone for Bite Registration Dispenser-Mix Normal Set

by Shandong Huge Dental Material Corporation

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 Number06909412313194 UDI-DI Date26 Oct 2025ListedStatusListed 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  • Withdrawn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
A-Silicone for Bite Registration
Generic Name
Silicone dental impression material
Model / Ref / Catalog
Dispenser-Mix Normal Set, W-VCS 50ml*2+Mixer(White)*6
Primary DI / UDI-DI
06909412313194
510(k) Number
FDA Product Code
ELW
GMDN Term
Silicone dental impression material
Device Class
Class II
Regulation Number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201684)

Other devices from Shandong Huge Dental Material Corporation

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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