510(k) · Cleared
ClearedKontact Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Dental, Sas · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2021 as substantially equivalent to K120414 (Astra Tech AB, 2012) after a 142-day review. Its family tree reaches back 12 generations to 1990. 7 later devices descend from it.
- Decided
- Jun 18, 2021
- Review
- 142 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 150 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 2 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 deviceK210220 Kontact Dental Implant SystemBiotech Dental, Sas · 2021
- Descendant · cites it directly · 5 of its ownK221966 Dynamic TiBaseTalladium Espana, SL · 2022
- Descendant · 2 generations on · 2 of its ownK232151 Dynamic TiBaseTalladium España, SL · 2023
- Descendant · 2 generations on · 1 of its ownK231559 Multi-Unit DAS SystemTalladium España, SL · 2023
- Descendant · 3 generations on · 0 of its ownK243732 Multi-Unit DAS SystemTalladium España, SL · 2026
- Descendant · 3 generations on · 0 of its ownK243530 Dynamic TiBaseTalladium España, SL · 2025
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 deviceK210220 Kontact Dental Implant SystemBiotech Dental, Sas · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221966Dynamic TiBaseTalladium Espana, SL · 2022 · cites it directly5descendants
- K232151Dynamic TiBaseTalladium España, SL · 2023 · 2 generations on2descendants
- K231559Multi-Unit DAS SystemTalladium España, SL · 2023 · 2 generations on1descendant
- K243732Multi-Unit DAS SystemTalladium España, SL · 2026 · 3 generations on0descendants
- K243530Dynamic TiBaseTalladium España, SL · 2025 · 3 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) | K210220 | Kontact Dental Implant System | Biotech Dental, Sas | 2021 | — |
| +1 | K221966 | Dynamic TiBase | Talladium Espana, SL | 2022 | — |
| +2 | K232151 | Dynamic TiBase | Talladium España, SL | 2023 | — |
| +2 | K231559 | Multi-Unit DAS System | Talladium España, SL | 2023 | — |
| +3 | K243732 | Multi-Unit DAS System | Talladium España, SL | 2026 | — |
| +3 | K243530 | Dynamic TiBase | Talladium España, SL | 2025 | — |
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 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K120414 | Osseospeed PlusSummary page 5…System Page 2 of 14 K210220 PREDICATE DEVICE INFORMATION Primary Predicate Device K120414, OsseoSpeed™ Plus, Astra Tech AB Reference Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Co., Ltd K131644, A… | 2012 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K131644 | Ankylos Syncone Abutment 5(Degree) | 2014 |
| † | K153509 | GPS Angled Abutment | 2016 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K170392 | S.I.N. Implant System | 2017 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K192347 | ST Internal Implant System | 2019 |
| † | K200992 | S.I.N. Dental Implant System | 2020 |
| † | K151328 | PURE Ceramic Implants | 2016 |
| † | K181381 | A.B. Dental Devices Dental Implants System | 2018 |
| † | K183518 | Preat Abutments | 2019 |
| † | K200386 | Z5-BL | 2020 |
| † | K152787 | ST Internal Fixture System | 2016 |
| † | K092341 | Low Profile Abutments - Internal and External Connection | 2009 |
| † | K203355 | Straumann TLX Novaloc and Cementable Abutments | 2021 |
What descends from it? (7)
2 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 31 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 150 ancestors have a recall of any class.
- Of its descendants, K221966 (Talladium Espana, SL, 2022) has gone furthest, with 5 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. 2021, 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?
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
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/K210220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210220: Kontact Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210220
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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