iSmile 45-2505

• FDA 510(k) K172280 decided 3 Aug 2018 Active
• FDA GUDID UDI-DI 00816419020375 listed 21 Jun 2023 Listed

1. 3 Aug 2018 Cleared FDA 510(k) K172280
2. 21 Jun 2023 Listed FDA GUDID 00816419020375

Trade name

iSmile

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

45-2505

Primary DI / UDI-DI

00816419020375

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).

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• Surgical Instruments Kit by Clinical Resources, Inc.
• TSO3 Ozone Sterilization Wrap by Tso3, Inc.
• Cardinal Health Sterilization Wrap by Cardinal Health 200, LLC
• Halyard ONE-STEP Sterilization Wrap by Owens & Minor (O&M) Halyard, Inc.
• Tidi Brand Sterilization Wrap by Banta Healthcare Group, Ltd.
• Self-Seal Sterilization Pouch by Gs Medical Packaging, Inc.
• BioShield Express Sterilization Wrap by Allegiance Healthcare Corp.
• Convenience Contour Kits Redi Nurse System by Contour Fabricators of Florida, Inc.
• Guardian Sterilization Wrap by KIMBERLY-CLARK CORPORATION

• 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 45-2503

  Class II

  FDA 510(k) K172280 Active Cleared 3 Aug 2018 GUDID on market

See all devices from Ismile Dental Products Inc. →