OT EQUATOR

Abutment, Implant, Dental, Endosseous

RHEIN'83 SRL

The following data is part of a premarket notification filed by Rhein'83 Srl with the FDA for Ot Equator.

Pre-market Notification Details

• Device ID: K160382
• 510k Number: K160382
• Device Name: OT EQUATOR
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: RHEIN'83 SRL VIA E. ZAGO 10/ABC Bologna, IT 40128
• Contact: Claudia Nardi
• Correspondent: Claudia Nardi; RHEIN'83 SRL VIA E. ZAGO 10/ABC Bologna, IT 40128
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-10
• Decision Date: 2016-08-11
• Summary: summary