510(k) · Cleared
ClearedBti Interna Dental Implant System
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 Mar 14, 2006 as substantially equivalent to K022258 (B.T.I. Biotechnology Institute, Sl., 2003) after a 102-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it.
- Decided
- Mar 14, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935544 (1995). 5 ancestors in all. 11 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 2 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 1 generation backK022258 B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2003
- This deviceK053355 Bti Interna Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2006
- Descendant · cites it directly · 6 of its ownK091387 Bti Dental Implant 5.5-6.5B.T.I. Biotechnology Institute, Sl. · 2010
- Descendant · cites it directly · 6 of its ownK092112 Bti Dental Implant Tiny 2.5-3.0B.T.I. Biotechnology Institute, Sl. · 2009
- Descendant · cites it directly · 5 of its ownK151391 BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016
- Descendant · cites it directly · 2 of its ownK061383 Bti Sterile Dental Drills Kit, Bti Abutments and CapsB.T.I. Biotechnology Institute, Sl. · 2006
- Descendant · cites it directly · 1 of its ownK211952 BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091387Bti Dental Implant 5.5-6.5B.T.I. Biotechnology Institute, Sl. · 2010 · cites it directly6descendants
- K092112Bti Dental Implant Tiny 2.5-3.0B.T.I. Biotechnology Institute, Sl. · 2009 · cites it directly6descendants
- K151391BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016 · cites it directly5descendants
- K061383Bti Sterile Dental Drills Kit, Bti Abutments and CapsB.T.I. Biotechnology Institute, Sl. · 2006 · cites it directly2descendants
- K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −2 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −1 | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2003 | — |
| 0 (this device) | K053355 | Bti Interna Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| +1 | K091387 | Bti Dental Implant 5.5-6.5 | B.T.I. Biotechnology Institute, Sl. | 2010 | — |
| +1 | K092112 | Bti Dental Implant Tiny 2.5-3.0 | B.T.I. Biotechnology Institute, Sl. | 2009 | — |
| +1 | K151391 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2016 | — |
| +1 | K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and Caps | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| +1 | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant SystemSummary page 2…I Interna Dental Implant System is claimed to be substantially equivalent in material, design, and function to the BTI Dental Implant System cleared by FDA under 510 (k) K022258on Sep 11, 2003 DEVICE DESCRIPTION The BTI Intema Dental Implant System is designed to server as support for prosthetic devices t… | 2003 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091387 | Bti Dental Implant 5.5-6.5 | 2010 | 6 |
| K092112 | Bti Dental Implant Tiny 2.5-3.0 | 2009 | 6 |
| K151391 | BTI Dental Implant System UnicCa | 2016 | 5 |
| K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and Caps | 2006 | 2 |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | 2022 | 1 |
| K090081 | Talladium International Implantology Abutments | 2010 | 0 |
| K070533 | Bti Endosseous Dental Implant Angled Abutments | 2007 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K091387 (B.T.I. Biotechnology Institute, Sl., 2010) has gone furthest, with 6 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.
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?
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053355: Bti Interna Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053355
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