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Southern Implants, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Southern Implants, Inc. makes

Southern Implants, Inc. manufactures endosseous dental implant systems and standalone endosseous dental implants, designed for dental restoration and osseointegration in oral and maxillofacial applications.

The company’s products are classified as Class II medical devices under US regulations and are listed via the FDA’s 510(k) pathway. The portfolio is regulated in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Southern Implants, Inc., the earliest on 2013-09-13 and the most recent on 2015-01-23. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 23 Jan 2015 Z-1265-2015 Class II Terminated Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa. Distribution: US Nationwide Distribution. Submission number: K071161

  • 2013

    • 13 Sep 2013 Z-0382-2014 Class II Terminated Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5). Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Guatemala, Taiwan. Submission number: K070905

Frequently asked questions

How many devices does Southern Implants, Inc. have in the registry?

The registry currently lists 5 devices for Southern Implants, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Southern Implants, Inc.'s devices?

Among its 5 most recently registered devices, Southern Implants, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Southern Implants, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Southern Implants, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Southern Implants, Inc.?

FDA recall records list 2 recalls initiated by Southern Implants, Inc., the most recent initiated on 23 Jan 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Southern Implants, Inc. in the registry?

The most recently registered devices listed for Southern Implants, Inc. include ENDOSSEOUS DENTAL IMPLANT SYSTEM and ENDOSSEOUS DENTAL IMPLANT.

Generated automatically from registry data and not verified by a human reviewer.