OSSIX PLUS

Barrier, Animal Source, Intraoral

Datum Dental Ltd.

The following data is part of a premarket notification filed by Datum Dental Ltd. with the FDA for Ossix Plus.

Pre-market Notification Details

• Device ID: K160281
• 510k Number: K160281
• Device Name: OSSIX PLUS
• Classification: Barrier, Animal Source, Intraoral
• Applicant: Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170 Lod, IL 7116003
• Contact: Arie Goldlust
• Correspondent: Janice M. Hogan; Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
• Product Code: NPL
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-02
• Decision Date: 2016-08-04
• Summary: summary