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3D Dental Endo 1

by 3D Dental Designs and Development, LLC 3 variants

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 Number00817169029984 UDI-DI Date16 Dec 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  • Withdrawn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
3D Dental Endo
Generic Name
Endodontic obturation material distribution endpiece, single-use
Model / Ref / Catalog
1, FP2115-40
Primary DI / UDI-DI
00817169029984
FDA Product Code
EKS
GMDN Term
Endodontic obturation material distribution endpiece, single-use
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

Other devices from 3D Dental Designs and Development, LLC

See all devices from 3D Dental Designs and Development, LLC →

Properties

  • Single Use
  • Premarket Exempt

Other properties (12)

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