510(k) · Cleared
ClearedBoneTrust Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instinct Deutschland GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Mar 11, 2019 as substantially equivalent to K150938 (Straumann USA, LLC, 2015) after a 196-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Mar 11, 2019
- Review
- 196 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 90 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 1 generation backK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015 · Recalled
- This deviceK182313 BoneTrust Implant SystemMedical Instinct Deutschland GmbH · 2019
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 11 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 10 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 8 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 7 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 6 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 5 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 4 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 3 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 1 generation backK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015 · Recalled
- This deviceK182313 BoneTrust Implant SystemMedical Instinct Deutschland GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −11 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −10 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −8 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −7 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −6 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −5 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −4 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −3 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −2 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| −1 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015 | 2 |
| 0 (this device) | K182313 | BoneTrust Implant System | Medical Instinct Deutschland GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsSummary page 5…Product Code: NHA 3. Predicate device • Primary Predicate Device Straumann Dental Implant System; Stramann USA, LLC #K150938 • Reference Devices CAMLOG Abutments; Altatec GmbH #K083496 Nobela… | 2015 |
| † | K083496 | Camlog Implant System Modified Implants and Abutments | 2009 |
| † | K072570 | Nobelactive Multi Unit Abutment | 2007 |
| † | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental Implant | 2004 |
| † | K113779 | Conelog Implant System | 2012 |
| † | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 |
| † | K173207 | SIC invent Dental Implant Systems | 2018 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
| † | K021318 | Xive Dental Implant System | 2002 |
| † | K171142 | Healing Cap Multi-Unit Titanium | 2017 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 90 ancestors have a recall of any class.
- 1 other device also cites its predicate K150938.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients’ chewing function. BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading. BoneTrust®…
Read the full statement (110 words)
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients’ chewing function.
BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.
BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only
BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182313: BoneTrust 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/K182313
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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