Southern Implants PEEK Abutments

Abutment, Implant, Dental, Endosseous

Southern Implants (Pty) Ltd

The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Southern Implants Peek Abutments.

Pre-market Notification Details

• Device ID: K172160
• 510k Number: K172160
• Device Name: Southern Implants PEEK Abutments
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Southern Implants (Pty) Ltd 1 Albert Street Irene, ZA 0062
• Contact: Lauranda Breytenbach
• Correspondent: Kevin Walls; Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-18
• Decision Date: 2018-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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