510(k) · Cleared
Recalled · Class II · 2018External Hex Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants (Pty), Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 6, 2017 as substantially equivalent to K133049 (Biomet 3i, 2014) and 10 other predicates after a 319-day review. Its family tree reaches back 13 generations to 1993. 13 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2017
- Review
- 319 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 11
Its longest line of descent runs back 13 generations to K925765 (1993). 216 ancestors in all, the oldest K781060 (1978). 13 later devices descend from it, 8 citing it directly.
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations between
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Show all 13 generations
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 12 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 11 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 10 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 9 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 8 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 7 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 4 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · cites it directly3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · cites it directly2descendants
- K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023 · cites it directly1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −12 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −11 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −10 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −9 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −8 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −7 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −4 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −3 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −2 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −1 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| 0 (this device) | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | — |
| +1 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +1 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 15 | 0 |
| 1994 | 11 | 0 |
| 1995 | 15 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
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 |
|---|---|---|---|
| * | K133049 | 3I T3(R) External Hex Dental ImplantsSummary page 5…K Number Biomet 3i (Primary) 3i T3 External Hex Dental implants K133049 Reference Predicates NSI Inc Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System)… | 2014 |
| * | K003620 | Nsi Hexed and Non-Hexed Implant SystemSummary page 5…K133049 Reference Predicates NSI Inc Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) K003620 NSI Inc Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) K020617 Southern… | 2001 |
| * | K020617 | Nsi Hexed and Non-Hexed Implant SystemSummary page 5…(NSI Hexed and Non-Hexed Implant System) K003620 NSI Inc Endosseous implant and accessories (NSI Hexed and Non-Hexed Implant System) K020617 Southern Implants Inc. Endosseous implant and accessories K082651 Northern… | 2002 |
| * | K082651 | Endosseous Dental Implant SystemSummary page 5…(NSI Hexed and Non-Hexed Implant System) K020617 Southern Implants Inc. Endosseous implant and accessories K082651 Northern Implants, LLC Endosseous implant and accessories K053478 Southern… | 2008 |
| * | K053478 | Endosseous Dental Implant SystemSummary page 5…K082651 Northern Implants, LLC Endosseous implant and accessories K053478 Southern Implants Inc. Endosseous implant and accessories K070841 Southern… | 2006 |
| * | K070841 | Endosseous Dental Implant SystemSummary page 5…K053478 Southern Implants Inc. Endosseous implant and accessories K070841 Southern Implants Inc. Endosseous implant and accessories K070905 Biomet 3i… | 2007 |
| * | K070905 | Endosseous Dental Implant SystemSummary page 5…K070841 Southern Implants Inc. Endosseous implant and accessories K070905 Biomet 3i Low Profile Abutment K092341 Thommen M… | 2007 |
| * | K092341 | Low Profile Abutments - Internal and External ConnectionSummary page 5…K070905 Biomet 3i Low Profile Abutment K092341 Thommen Medical AG VARIOunite K160244 Neoss, Lt… | 2009 |
| * | K160244 | VARIOuniteSummary page 5…K092341 Thommen Medical AG VARIOunite K160244 Neoss, Ltd. Neoss TiBase and CoCr Abutments K150669 AstraTech… | 2016 |
| * | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Summary page 5…K160244 Neoss, Ltd. Neoss TiBase and CoCr Abutments K150669 AstraTech AB [Dentsply] OsseoSpeed™ Plus K120414 IND… | 2015 |
| * | K120414 | Osseospeed PlusSummary page 5…K150669 AstraTech AB [Dentsply] OsseoSpeed™ Plus K120414 INDICATIONS FOR USE Southern Implants’ External Hex Implants are intended for surgical placement in the upper or lower… | 2012 |
What descends from it? (13)
See all 138 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2018 | Class II | Z-1386-2018 | Process control | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 25 of the 216 ancestors have a recall of any class.
- Of its descendants, K193084 (Southern Implants (Pty), Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K133049.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Southern Implants’ External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Southern Implants’ External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
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/K163634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163634: External Hex Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163634
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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