510(k) · Cleared
ClearedDeep Conical (DC) Implants and Accessories
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 Jun 13, 2017 as substantially equivalent to K120414 (Astra Tech AB, 2012) and 5 other predicates after a 224-day review. Its family tree reaches back 12 generations to 1990. 7 later devices descend from it.
- Decided
- Jun 13, 2017
- Review
- 224 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K894595 (1990). 186 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017
- 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 · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · cites it directly2descendants
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
- K222457Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| 0 (this device) | K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
| +2 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
| +2 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
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 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 16 | 0 |
| 1994 | 11 | 0 |
| 1995 | 14 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K120414 | Osseospeed PlusSummary page 4…ces: Predicate # Manufacturer Device Name K Number Primary Astra Tech AB OsseoSpeed EV (Previously known as K120414 1 OsseoSpeed Plus) 2 Northern Implants Endosseous Implants and Accessories… | 2012 |
| * | K052490 | Endosseous Dental Implant SystemSummary page 4…d EV (Previously known as K120414 1 OsseoSpeed Plus) 2 Northern Implants Endosseous Implants and Accessories K052490 3 Southern Implants, Endosseous dental implant system K070905 Inc 4 Rhein ’… | 2005 |
| * | K070905 | Endosseous Dental Implant SystemSummary page 4…Plus) 2 Northern Implants Endosseous Implants and Accessories K052490 3 Southern Implants, Endosseous dental implant system K070905 Inc 4 Rhein ’83 Srl OT Equator K142211 5 Souther… | 2007 |
| * | K142211 | OT EquatorSummary page 4…Southern Implants, Endosseous dental implant system K070905 Inc 4 Rhein ’83 Srl OT Equator K142211 5 Southern Implants, Endosseous dental implant system K053478 Inc 6 NSI Inc… | 2015 |
| * | K053478 | Endosseous Dental Implant SystemSummary page 4…Inc 4 Rhein ’83 Srl OT Equator K142211 5 Southern Implants, Endosseous dental implant system K053478 Inc 6 NSI Inc Endosseous dental implant system K070841 Device D… | 2006 |
| * | K070841 | Endosseous Dental Implant SystemSummary page 4…Southern Implants, Endosseous dental implant system K053478 Inc 6 NSI Inc Endosseous dental implant system K070841 Device Description: Implants The Deep Conical (DC Implant) has a deep conical connection system. The implants a… | 2007 |
What descends from it? (7)
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 7 companies; a new generation was cleared every 1.2 years on median.
- 19 of the 186 ancestors have a recall of any class.
- Of its descendants, K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) has gone furthest, with 2 descendants of its own.
- 26 other devices also cite its predicate K120414.
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 Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: » replacing single and multiple missing teeth in the mandible and maxilla, « immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, + immediate loading in all indications, except in single tooth situations on implants shorter than 8mm…
Read the full statement (108 words)
Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
» replacing single and multiple missing teeth in the mandible and maxilla,
« immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
+ immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors
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/K163060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163060: Deep Conical (DC) Implants and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163060
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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