510(k) · Cleared
ClearedSlactive Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Feb 27, 2006 as substantially equivalent to K971578 (Straumann USA, 1997) and 1 other predicate after a 117-day review. Its family tree reaches back 7 generations to 1990. 295 later devices descend from it.
- Decided
- Feb 27, 2006
- Review
- 117 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894595 (1990). 35 ancestors in all, the oldest K894844 (1990). 295 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- This deviceK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · cites it directly · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · cites it directly · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- Descendant · 2 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 3 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 295 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 295 · See all- K083550Straumann Dental Implant SystemStraumann USA · 2009 · cites it directly228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · cites it directly228descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 2 generations on222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 3 generations on166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| 0 (this device) | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +1 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +1 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| +2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +3 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 21 | 0 |
| 2021 | 26 | 0 |
| 2022 | 25 | 0 |
| 2023 | 33 | 0 |
| 2024 | 37 | 0 |
| 2025 | 28 | 0 |
| 2026 | 20 | 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? (2)
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 |
|---|---|---|---|
| * | K971578 | Endosseous Dental ImplantSummary page 1…ous Dental Implant (21 CIFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Dental Implant System (K(971578, K033984) 4. Description of the Device The Straumnann solid screw dental implants are of various diameters and… | 1997 |
| * | K033984 | Straumann Dental Implant SystemSummary page 1…al Implant (21 CIFR 872.3640) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Dental Implant System (K(971578, K033984) 4. Description of the Device The Straumnann solid screw dental implants are of various diameters and leng… | 2004 |
What descends from it? (295)
See all 29510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083550 | Straumann Dental Implant System | 2009 | 228 |
| K060958 | Straumann Narrow Neck Implants | 2006 | 228 |
| K081419 | Straumann Dental Implant System | 2009 | 142 |
| K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 | 123 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
| K130222 | Straumann Dental Implant System | 2013 | 118 |
| K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | 2010 | 34 |
| K101545 | Genesis Implant System | 2010 | 15 |
| K151626 | ET III Bio-SA Fixture System | 2016 | 9 |
| K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment… | 2009 | 4 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K083550 (Straumann USA, 2009) has gone furthest, with 228 descendants of its own.
- 6 other devices also cite its predicate K971578.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and hinction on singu! tooth and/c multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053088: Slactive Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053088
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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