Skip to content

iSmile 45-2506

by Ismile Dental Products Inc.

iSmile 45-2506 is a Class II device made by Ismile Dental Products Inc., cleared under FDA 510(k) K172280 on 3 Aug 2018 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419022485), 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) K172280

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 Number00816419022485 UDI-DI Date21 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172280 Date3 Aug 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172280 decided 3 Aug 2018 Active
  • FDA GUDID UDI-DI 00816419022485 listed 21 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172280
  2. Listed FDA GUDID 00816419022485

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  • Withdrawn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
Sterilization packaging, single-use
Model / Ref / Catalog
45-2506
Primary DI / UDI-DI
00816419022485
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K172280)

and 8 more cleared under K172280

Similar devices

Other devices filed under FDA product code FRG (Wrap, Sterilization).

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