510(k) · Cleared
ClearedTicare Dental Implant Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mozograu S.A. · DZE Implant, Endosseous, Root-Form
Cleared on May 16, 2024 as substantially equivalent to K151391 (B.T.I. Biotechnology Institute, Sl., 2016) after a 232-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 16, 2024
- Review
- 232 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 deviceK233137 Ticare Dental Implant SystemsMozograu S.A. · 2024
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) | K233137 | Ticare Dental Implant Systems | Mozograu S.A. | 2024 | — |
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 5…21 CRF 872.3640 REGULATION CLASS: Class II PRIMARY PRODUCT CODE: DZE SECONDARY PRODUCT CODE: NHA PREDICATE DEVICE INFORMATION Primary Predicate: K151391 BTI Dental Implant System UnicCa® Reference Predicates: K142260 NobelActive® K111216 Biomet 3i OSSEOTITE® 2 Dental… | 2016 |
| † | K142260 | NobelActive | 2015 |
| † | K111216 | Osseotite 2 Dental Implants | 2011 |
| † | K172576 | BioHorizons Tapered Short Implants | 2017 |
| † | K142167 | Medentika Abutment System | 2015 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant System | 2003 |
| † | K161435 | Temporary Snap Abutment | 2016 |
| † | K192522 | TSV BellaTek Express and BellaTek Flex Abutments | 2019 |
| † | K210220 | Kontact Dental Implant System | 2021 |
| † | K990277 | O-Ring Abutment | 1999 |
| † | K130999 | Osseospeed Profile EV | 2013 |
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 4 companies; a new generation was cleared every 6.6 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. 2024, 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?
Ticare Dental Implant Systems are endosseous dental implants intended to be implanted in the maxilla or mandible jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate…
Read the full statement (156 words)
Ticare Dental Implant Systems are endosseous dental implants intended to be implanted in the maxilla or mandible jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro and InHex Quattro implants are indicated to support permanently fixed restorations.
Ticare Inhex and Osseous implants of 6 mm length are intended for use in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233137 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233137: Ticare Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233137
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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