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Surgical Guide

by 3D Diagnostix, Inc.

Surgical Guide is a Class I device made by 3D Diagnostix, Inc., listed in FDA GUDID since 10 Sep 2025 (UDI-DI 00850073333020), 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 Number00850073333020 UDI-DI Date10 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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, custom-made
Model / reference
Dental Implantation Drilling Template-Custom Made Surgical Guide
Primary DI / UDI-DI
00850073333020
FDA product code
NDP
GMDN term
Dental implantation drilling template, custom-made
Device class
Class I
Regulation number
872.3980
GUDID distribution status
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 (11, all answered No)