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3D Dental EN27H

by 3D Dental Designs and Development, LLC

3D Dental EN27H is a dental irrigation/aspiration syringe (FDA Class I; FDA product code EIC, Syringe, Periodontic, Endodontic, Irrigating) made by 3D Dental Designs and Development, LLC, listed in FDA GUDID since 16 Dec 2022 (UDI-DI 00817169024330), 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 Number00817169024330 UDI-DI Date16 Dec 2022ListedStatusListed 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  • Withdrawn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

Trade name
3D Dental
Generic name
Dental irrigation/aspiration syringe
Model / Ref / Catalog
EN27H
Primary DI / UDI-DI
00817169024330
FDA product code
EIC
GMDN term
Dental irrigation/aspiration syringe
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental irrigation/aspiration syringe

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Other devices filed under Dental irrigation/aspiration syringe.

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Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)