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iSmile 45-0001

by Ismile Dental Products Inc.

iSmile 45-0001 is a Class II device made by Ismile Dental Products Inc., cleared under FDA 510(k) K190484 on 10 Sep 2019 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419021945), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K190484

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816419021945 UDI-DI Date21 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190484 Date10 Sep 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190484 decided 10 Sep 2019 Active
  • FDA GUDID UDI-DI 00816419021945 listed 21 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190484
  2. Listed FDA GUDID 00816419021945

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iSmile
Generic name
Medical equipment/instrument drape, single-use
Model / Ref / Catalog
45-0001
Primary DI / UDI-DI
00816419021945
510(k) Number
FDA product code
PEM
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K190484)

and 8 more cleared under K190484

Similar devices in this category

Other devices filed under Medical equipment/instrument drape, single-use.

Other devices from Ismile Dental Products Inc.

  • iSmile 25-3004

    Class I

  • iSmile 45-1540

    Class II

  • iSmile 45-2503

    Class II

  • iSmile 65-6015

    Class II

See all devices from Ismile Dental Products Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)