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Premium 11.3 KG F2

by Lang Dental Manufacturing Company, Inc.

Premium 11.3 KG F2 (0770F2) is a Class II device made by Lang Dental Manufacturing Company, Inc., listed in FDA GUDID since 12 Nov 2021 (UDI-DI D6500770F20), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD6500770F20 UDI-DI Date12 Nov 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Premium
Generic name
Dental appliance fabrication material, resin
Model / Ref / Catalog
11.3 KG F2, 0770F2
Primary DI / UDI-DI
D6500770F20
FDA product code
EBI
GMDN term
Dental appliance fabrication material, resin
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental appliance fabrication material, resin

Other devices from Lang Dental Manufacturing Company, Inc.

See all devices from Lang Dental Manufacturing Company, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)