Skip to content

3DDX Sleeve 510-415-35L

by 3D Diagnostix, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00850073333815 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Dental implantation drilling template guide-sleeve
Model / Reference
Drilling template guide-sleeve /510-415-35L
Primary DI / UDI-DI
00850073333815
FDA Product Code
NDP
GMDN Term
Dental implantation drilling template guide-sleeve
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
Not in Commercial Distribution

Other devices from 3D Diagnostix, Inc.

See all devices from 3D Diagnostix, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

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