510(k) · Cleared
ClearedBTI Dental Implant System UnicCa
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 Aug 17, 2018 as substantially equivalent to K151391 (B.T.I. Biotechnology Institute, Sl., 2016) after a 311-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 17, 2018
- Review
- 311 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935544 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 5 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 4 generations backK022258 B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2003
- 3 generations backK053355 Bti Interna Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2006
- 2 generations backK092112 Bti Dental Implant Tiny 2.5-3.0B.T.I. Biotechnology Institute, Sl. · 2009
- 1 generation backK151391 BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2016
- This deviceK173257 BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −5 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −4 | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2003 | — |
| −3 | K053355 | Bti Interna Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K173257 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K151391 | BTI Dental Implant System UnicCaSummary page 4…seous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE III. PREDICATE DEVICE The primary predicate device is BTI Dental Implant System UnicCa®, K151391, concurrence date: May 2nd, 2016. Reference predicates are identified that encompass similar larger diameter/longer length denta… | 2016 |
| † | K142260 | NobelActive | 2015 |
| † | K100724 | Osseotite II Model Xifossxxx | 2011 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- 3 other devices also cite its predicate K151391.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated…
Read the full statement (134 words)
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.
In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173257: BTI Dental Implant System UnicCa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173257
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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