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: K142211
• 510k Number: K142211
• Device Name: OT EQUATOR
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Rhein '83 SRL Via Emilio Zago, 10/abc Bologna, IT 40128
• Contact: Claudia Nardi
• Correspondent: Claudia Nardi; Rhein '83 SRL Via Emilio 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: 2014-08-12
• Decision Date: 2015-11-25
• Summary: summary