510(k) · Cleared
ClearedDefcon Tsa/TSH Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impladent, S.L. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 23, 2010 as substantially equivalent to K083550 (Straumann USA, 2009) and 4 other predicates after a 360-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jul 23, 2010
- Review
- 360 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K894595 (1990). 54 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- This deviceK092261 Defcon Tsa/TSH Dental Implant SystemImpladent, S.L. · 2010
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- This deviceK092261 Defcon Tsa/TSH Dental Implant SystemImpladent, S.L. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| 0 (this device) | K092261 | Defcon Tsa/TSH Dental Implant System | Impladent, S.L. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (5)
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 |
|---|---|---|---|
| * | K083550 | Straumann Dental Implant SystemSummary page 1…FICATION NAME: Root-form Endlosseous Dental Implant (21 CFR 872.3640) PREDICATE DEVICE(S): - Straumann Dental Implant System - Straumann Institut (K(083550) - ITI Dental Implant System - Straumann Institut (K(033984) - Nobe… | 2009 |
| * | K033984 | Straumann Dental Implant SystemSummary page 1…DEVICE(S): - Straumann Dental Implant System - Straumann Institut (K(083550) - ITI Dental Implant System - Straumann Institut (K(033984) - NobelActive 8.5 mm & 18.0 mm - Nobel Biocare (K(083205) - NobelA… | 2004 |
| * | K083205 | Nobelactive 8.5 MM & 18.0 MMSummary page 1…- ITI Dental Implant System - Straumann Institut (K(033984) - NobelActive 8.5 mm & 18.0 mm - Nobel Biocare (K(083205) - NobelActive Internal Connection Implant - Nobel Biocafe (K(071370)… | 2009 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…- NobelActive 8.5 mm & 18.0 mm - Nobel Biocare (K(083205) - NobelActive Internal Connection Implant - Nobel Biocafe (K(071370) - Various Branemark System Dental Implant Products - Nobel Biocare (K(022562) DEVICE DESCRIPTIO… | 2007 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…- NobelActive Internal Connection Implant - Nobel Biocafe (K(071370) - Various Branemark System Dental Implant Products - Nobel Biocare (K(022562) DEVICE DESCRIPTION: DEFCON TSA I TSH dental implant systems are threaded, root-form endlosseous implants of various diameters… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 54 ancestors have a recall of any class.
- 8 other devices also cite its predicate K083550.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability…
Read the full statement (138 words)
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (06.0 mm and above) implants.
Specific indications for small diameter (03.3 mm) implants:
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092261: Defcon Tsa/TSH Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092261
Report an extraction error
Are you the manufacturer?
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