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Essentials by 3D Dental 1

by 3D Dental Designs and Development, LLC 8 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 Number00810126505651 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  • Withdrawn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
Essentials by 3D Dental
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Ref / Catalog
1, ELM3-BK
Primary DI / UDI-DI
00810126505651
FDA Product Code
FXX
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
878.4040
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
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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