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IMPAK Disc Clear

by Shandong Huge Dental Material Corporation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06909412314627 UDI-DIDate30 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
IMPAK Disc
Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
Clear, 98×14mm-2S
Primary DI / UDI-DI
06909412314627
510(k) Number
FDA Product Code
MQC
GMDN Term
Dental appliance fabrication material, resin
Device Class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251252)

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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
  • Expiration Date: No
  • Manufacturing Date: No