510(k) · Cleared
ClearedBti Dental Implant 5.5-6.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.T.I. Biotechnology Institute, Sl. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 22, 2010 as substantially equivalent to K022258 (B.T.I. Biotechnology Institute, Sl., 2003) and 2 other predicates after a 256-day review. Its family tree reaches back 4 generations to 1995. 6 later devices descend from it.
- Decided
- Jan 22, 2010
- Review
- 256 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935544 (1995). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 3 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 2 generations backK022258 B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2003
- 1 generation backK053355 Bti Interna Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2006
- This deviceK091387 Bti Dental Implant 5.5-6.5B.T.I. Biotechnology Institute, Sl. · 2010
- Descendant · cites it directly · 5 of its ownK151391 BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016
- Descendant · 2 generations on · 1 of its ownK211952 BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · 2 generations on · 0 of its ownK233137 Ticare Dental Implant SystemsMozograu S.A. · 2024
- Descendant · 3 generations on · 0 of its ownK232750 BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023
- Descendant · 2 generations on · 0 of its ownK202825 BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151391BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016 · cites it directly5descendants
- K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022 · 2 generations on1descendant
- K233137Ticare Dental Implant SystemsMozograu S.A. · 2024 · 2 generations on0descendants
- K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023 · 3 generations on0descendants
- K202825BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −3 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −2 | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2003 | — |
| −1 | K053355 | Bti Interna Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| 0 (this device) | K091387 | Bti Dental Implant 5.5-6.5 | B.T.I. Biotechnology Institute, Sl. | 2010 | — |
| +1 | K151391 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2016 | — |
| +2 | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +2 | K233137 | Ticare Dental Implant Systems | Mozograu S.A. | 2024 | — |
| +3 | K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
| +2 | K202825 | BTI Extra-Short Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant SystemSummary page 1…Date Prepared: May 08, 2009 Device Trade Name: BTI Dental implant 5.5-6.5 Common Name: IMPLANT, ENDOSSEOUS, ROOT-FORM Substantial Equivalence: K022258 BTI Dental Implant System K053355 BTI Interna Dental Implant System K063779… | 2003 |
| * | K053355 | Bti Interna Dental Implant SystemSummary page 1…ental implant 5.5-6.5 Common Name: IMPLANT, ENDOSSEOUS, ROOT-FORM Substantial Equivalence: K022258 BTI Dental Implant System K053355 BTI Interna Dental Implant System K063779 OsseoSpeedTM 4.0S - 6mm Device Description: The BTI… | 2006 |
| * | K063779 | Osseospeed 4.0S-6MM, Model 24619Summary page 1…, ROOT-FORM Substantial Equivalence: K022258 BTI Dental Implant System K053355 BTI Interna Dental Implant System K063779 OsseoSpeedTM 4.0S - 6mm Device Description: The BTI Dental Implant 5.5-6.5 is a self tapping, threaded… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151391 | BTI Dental Implant System UnicCa | 2016 | 5 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K151391 (B.T.I. Biotechnology Institute, Sl., 2016) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K022258.
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?
BTI Dental implants 5.5 - 6.5 mnm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.
These implants are not indicated for immediate loading.
These implants are not indicated to support removable resilient retained restorations or angled abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091387: Bti Dental Implant 5.5-6.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091387
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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