510(k) · Cleared
ClearedBTI Interna Narrow/Plus 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 Jul 21, 2022 as substantially equivalent to K151391 (B.T.I. Biotechnology Institute, Sl., 2016) and 5 other predicates after a 393-day review. Its family tree reaches back 13 generations to 1993. 1 later device descends from it.
- Decided
- Jul 21, 2022
- Review
- 393 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K925765 (1993). 211 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations between
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK211952 BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · cites it directly · 0 of its ownK232750 BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023
Show all 13 generations
- Root · 13 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 12 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 11 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 10 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 9 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 8 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 7 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 4 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 3 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 2 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 1 generation backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- This deviceK211952 BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
Most influential descendants
Showing 1 of 1 · See all- K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −12 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −11 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −10 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −9 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −8 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −7 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −4 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −3 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −2 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −1 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| 0 (this device) | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +1 | K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (6)
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…ntal implant abutment. Regulatory Class: II 3. PREDICATE DEVICES The primary predicate device is the BTI Dental Implant System UnicCa® Interna®, which was subject of K151391 (cleared on May 2, 2016). In addition, the following predicates/reference devices have been identified for respective implants an… | 2016 |
| * | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant SystemSummary page 4…ive implants and prosthetic components described within this premarket notification: x B.T.I. Biotechnology Institute, S.L. Dental Implant System, cleared under K022258, x BTI Interna Dental Implant System, cleared under K053355, x BTI Sterile Dental Drills Kit, BTI Abutments and C… | 2003 |
| * | K053355 | Bti Interna Dental Implant SystemSummary page 4…et notification: x B.T.I. Biotechnology Institute, S.L. Dental Implant System, cleared under K022258, x BTI Interna Dental Implant System, cleared under K053355, x BTI Sterile Dental Drills Kit, BTI Abutments and Caps, cleared under K061383, x BIOMET 3i TM, cleared under K1… | 2006 |
| * | K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and CapsSummary page 4…cleared under K022258, x BTI Interna Dental Implant System, cleared under K053355, x BTI Sterile Dental Drills Kit, BTI Abutments and Caps, cleared under K061383, x BIOMET 3i TM, cleared under K133049, x S.I.N. Dental Implant System, cleared under K170392, x Strauman… | 2006 |
| * | K133049 | 3I T3(R) External Hex Dental ImplantsSummary page 4…ntal Implant System, cleared under K053355, x BTI Sterile Dental Drills Kit, BTI Abutments and Caps, cleared under K061383, x BIOMET 3i TM, cleared under K133049, x S.I.N. Dental Implant System, cleared under K170392, x Straumann Healing Abutments, Healing Caps, and Closure… | 2014 |
| * | K170392 | S.I.N. Implant SystemSummary page 4…le Dental Drills Kit, BTI Abutments and Caps, cleared under K061383, x BIOMET 3i TM, cleared under K133049, x S.I.N. Dental Implant System, cleared under K170392, x Straumann Healing Abutments, Healing Caps, and Closure Screws, cleared under K130808. x Straumann® Variobase™… | 2017 |
| † | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 |
| † | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN… | 2014 |
| † | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw | 2014 |
| † | K161655 | On1 Concept | 2017 |
| † | K162848 | Straumann CARES Golden Ti/TiN Abutments | 2017 |
| † | K171757 | Straumann Screw Retained Abutments | 2017 |
| † | K173968 | Straumann Variobase for Bridge/Bar Cylindrical | 2018 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232750 | BTI Interna Prosthetic Components | 2023 | 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 29 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 26 of the 211 ancestors have a recall of any class.
- Of its descendants, K232750 (B.T.I. Biotechnology Institute, Sl., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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/K211952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211952
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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