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Essentials By 3D Dental 1

by 3D Dental Designs and Development, LLC 26 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 Number00810126506337 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  • Withdrawn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
Isolation gown, single-use
Model / Ref / Catalog
1, IG-G
Primary DI / UDI-DI
00810126506337
FDA Product Code
OEA
GMDN Term
Isolation gown, single-use
Device Class
Class I
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
  • 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