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Surgical Design DEL-LUX-S3

by Surgical Design, 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 Number00810189451230 UDI-DI Date6 Jun 2026ListedStatusListed 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  • Withdrawn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
Surgical Design
Generic Name
Dental elevator, tooth/root
Model / Reference
DEL-LUX-S3
Primary DI / UDI-DI
00810189451230
FDA Product Code
EMJ
GMDN Term
Dental elevator, tooth/root
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

Other devices from Surgical Design, Inc.

See all devices from Surgical Design, Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No