510(k) · Cleared
ClearedSouthern Implants PEEK Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants (Pty), Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 5, 2019 as substantially equivalent to K172160 (Southern Implants (Pty), Ltd., 2018) after a 210-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Dec 5, 2019
- Review
- 210 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K891615 (1989). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 4 generations backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- 3 generations backK043195 Neo Implant SystemNeoss, Ltd. · 2005
- 2 generations backK120954 Nobelprocera Peek AbutmentsNobel Biocare AB · 2013
- 1 generation backK172160 Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd. · 2018
- This deviceK191250 Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222457Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −4 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| −3 | K043195 | Neo Implant System | Neoss, Ltd. | 2005 | — |
| −2 | K120954 | Nobelprocera Peek Abutments | Nobel Biocare AB | 2013 | — |
| −1 | K172160 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | 2018 | — |
| 0 (this device) | K191250 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | 2019 | — |
| +1 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172160 | Southern Implants PEEK AbutmentsSummary page 4…Predicate Devices: Predicate # Manufacturer Device Name K Number Primary Southern Implants Southern Implants PEEK abutments K172160 Predicate (Pty) Ltd 1 === Page… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222457 | Provata Implant System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K222457 (Southern Implants (Pty), Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191250: Southern Implants PEEK Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191250
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026