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Pointech Normal 1X453G

by Major Prodotti Dentari SpA

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08056640083561 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pointech Normal
Generic Name
Alginate dental impression material
Model / Ref / Catalog
1X453G, A8014
Primary DI / UDI-DI
08056640083561
510(k) Number
FDA Product Code
ELW
GMDN Term
Alginate dental impression material
Device Class
Class II
Regulation Number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K963205)

Other devices from Major Prodotti Dentari SpA

See all devices from Major Prodotti Dentari SpA →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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