DIPLOMAT

Unit, Operative Dental

DIPLOMAT DENTAL S.R.O.

The following data is part of a premarket notification filed by Diplomat Dental S.r.o. with the FDA for Diplomat.

Pre-market Notification Details

• Device ID: K130534
• 510k Number: K130534
• Device Name: DIPLOMAT
• Classification: Unit, Operative Dental
• Applicant: DIPLOMAT DENTAL S.R.O. 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701
• Contact: Stuart R Goldman
• Correspondent: Stuart R Goldman; DIPLOMAT DENTAL S.R.O. 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701
• Product Code: EIA
• CFR Regulation Number: 872.6640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-01
• Decision Date: 2013-10-30
• Summary: summary