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Starter Pack B4U Starter-Pack-B4U.

by Sweden & Martina 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7702707123 UDI-DI Date26 Sep 2025ListedStatusListed 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  • Withdrawn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
Starter Pack B4U
Generic Name
Synthetic gutta-percha
Model / Ref / Catalog
STARTER-PACK-B4U.
Primary DI / UDI-DI
D7702707123
FDA Product Code
EKM
GMDN Term
Synthetic gutta-percha
Device Class
Class I
Regulation Number
872.3850
GUDID distribution status
In Commercial Distribution

Other devices from Sweden & Martina Inc

See all devices from Sweden & Martina Inc →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (8)

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