510(k) · Cleared
ClearedTIB Abutment System
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 Oct 27, 2020 as substantially equivalent to K180899 (Nobel Biocare AB, 2018) and 6 other predicates after a 357-day review. Its family tree reaches back 14 generations to 1993. 3 later devices descend from it.
- Decided
- Oct 27, 2020
- Review
- 357 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K925765 (1993). 273 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations between
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- This deviceK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK230873 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222469 TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 13 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 12 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 11 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 10 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 9 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 8 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 7 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 5 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 4 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- This deviceK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023 · cites it directly0descendants
- K222469TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −14 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −13 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −12 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −11 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −10 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −9 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −8 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −7 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −5 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −4 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −3 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −2 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| −1 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| 0 (this device) | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +1 | K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +1 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 6 | 0 |
| 1990 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 15 | 0 |
| 1994 | 13 | 0 |
| 1995 | 15 | 0 |
| 1996 | 14 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 5 | 0 |
| 2001 | 15 | 0 |
| 2002 | 16 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 14 | 0 |
| 2007 | 14 | 0 |
| 2008 | 11 | 0 |
| 2009 | 12 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K180899 | Universal Base AbutmentSummary page 4…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455… | 2018 |
| * | K181359 | InterActive SMARTBase AbutmentsSummary page 4…viewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455… | 2018 |
| * | K111421 | Sirona Dental Cad/Cam SystemSummary page 4…ranch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455 Pa… | 2012 |
| * | K163634 | External Hex ImplantsSummary page 4…Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455 Page 1 of 7… | 2017 |
| * | K130991 | Nexxzr (TM)T and Nexxzr (TM)SSummary page 4…Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455 Page 1 of 7 === Pag… | 2014 |
| * | K130436 | Multilink Hybrid Abutment CementSummary page 4…Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455 Page 1 of 7 5… | 2013 |
| * | K151455 | 3Shape Abutment Designer SoftwareSummary page 4…Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K180899 The reference predicate devices are K181359, K111421, K163634, K130991, K130436 and K151455 Page 1 of 7 510(k) Summar… | 2016 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 35 of the 273 ancestors have a recall of any class.
- Of its descendants, K230873 (Southern Implants (Pty), Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K180899.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193084: TIB Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193084
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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