iSmile 45-2503

• FDA 510(k) K172280 decided 3 Aug 2018 Active
• FDA GUDID UDI-DI 00816419020351 listed 21 Jun 2023 Listed

1. 3 Aug 2018 Cleared FDA 510(k) K172280
2. 21 Jun 2023 Listed FDA GUDID 00816419020351

Trade name

iSmile

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

45-2503

Primary DI / UDI-DI

00816419020351

510(k) Number

K172280 ↗

FDA product code

FRG

GMDN term

Sterilization packaging, single-use

Device class

Class II

Regulation number

880.6850

GUDID distribution status

In Commercial Distribution

Category: Sterilization packaging, single-use

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

• SINGLE BASIN SET by Packaging Technologies, Inc.
• INSTRUTAINER by Intrumed, Inc.
• Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators by Safe Secure Packaging Co., Ltd.
• CENTRAL LINE DRESSING CHANGE TRAY by Clinical Resources, Inc.
• Steriking® LT-Blueline Pouches with Tyvek® by Wipak Oy
• Chex-All Sterilization Pouches and Tubes by Propper Manufacturing Co., Inc.
• APTIMAX™ 011077 by Advanced Sterilization Products, Inc.
• OR/CS WRAP by American Threshold Industries, Inc.
• SIGMA Sterilization Pouch and Roll by Sigma Medical Supplies Corp.
• Gemini Sterilization Wrap by MEDLINE INDUSTRIES, INC.

• iSmile 25-3004

  Class I

  GUDID on market

• iSmile 45-0001

  Class II

  FDA 510(k) K190484 Active Cleared 10 Sep 2019 GUDID on market

• iSmile 45-1540

  Class II

  FDA 510(k) K133070 Active Cleared 22 Jun 2015 GUDID on market

• iSmile 65-6015

  Class II

  FDA 510(k) K190484 Active Cleared 10 Sep 2019 GUDID on market

See all devices from Ismile Dental Products Inc. →