510(k) · Cleared
ClearedTsi; Eri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oco Biomedical · DZE Implant, Endosseous, Root-Form
Cleared on Sep 14, 2009 as substantially equivalent to K033392 (O Co., Inc., 2003) and 2 other predicates after a 234-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 14, 2009
- Review
- 234 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K944964 (1995). 64 ancestors in all, the oldest K820013 (1982). 4 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 1 generation backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- This deviceK090174 Tsi; EriOco Biomedical · 2009
- Descendant · cites it directly · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · cites it directly · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142846 BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
Most influential descendants
Showing 4 of 4 · See all- K110337Universal Maxillary MolarOco Biomedical · 2012 · cites it directly1descendant
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · cites it directly0descendants
- K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016 · cites it directly0descendants
- K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −1 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| 0 (this device) | K090174 | Tsi; Eri | Oco Biomedical | 2009 | — |
| +1 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +1 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
| +1 | K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | 2016 | — |
| +1 | K122198 | 6.00MM X 6.00MM Macro External Implant System | Oco Biomedical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K033392 | Immediate Stabilizing Implant (Isi)Summary page 1…Dental Implant Classification Name: Dental Implant Endosseous, Root-Form Substantial Equivalence to: Immediate Stabilizing Implant (151) K033392 (Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) MeggaGen ExFeel… | 2003 |
| * | K023336 | Oco Dental Implant (5.0MM Diameter)Summary page 1…l Equivalence to: Immediate Stabilizing Implant (151) K033392 (Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) MeggaGen ExFeel K052369 (Cleared 1/10/06) Description of Dev… | 2002 |
| * | K052369 | Exfeel Implant SystemSummary page 1…(Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) MeggaGen ExFeel K052369 (Cleared 1/10/06) Description of Device: The TS I & ERI implants are self-tapping, commercially pure. CP Titanium or Ti… | 2006 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 64 ancestors have a recall of any class.
- Of its descendants, K110337 (Oco Biomedical, 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K033392.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes.
Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090174: Tsi; Eri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090174
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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