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Splintline Powder 454 Gram Shade 65/D3

by Lang Dental Manufacturing Company, Inc.

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

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 NumberD650203065TS0 UDI-DI Date1 Dec 2017ListedStatusListed 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  • Withdrawn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
Splintline Powder
Generic Name
Temporary dental crown/bridge resin
Model / Ref / Catalog
454 GRAM SHADE 65/D3, 203065TS
Primary DI / UDI-DI
D650203065TS0
FDA Product Code
EBG
GMDN Term
Temporary dental crown/bridge resin
Device Class
Class II
Regulation Number
872.3770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Temporary dental crown/bridge 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 (9)

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