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iSmile 20-0592

by Ismile Dental Products Inc.

iSmile 20-0592 is a Class I device made by Ismile Dental Products Inc., listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419021426), 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 Number00816419021426 UDI-DI Date21 Jun 2023ListedStatusListed 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  • Withdrawn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
iSmile
Generic name
Dental material application tool, single-use
Model / Ref / Catalog
20-0592
Primary DI / UDI-DI
00816419021426
FDA product code
EJB
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material application tool, single-use

Other devices from Ismile Dental Products Inc.

  • iSmile 25-3004

    Class I

  • iSmile 45-0001

    Class II

  • iSmile 45-1540

    Class II

  • iSmile 45-2503

    Class II

See all devices from Ismile Dental Products Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)