510(k) · Cleared
ClearedUniversal Maxillary Molar
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 Mar 16, 2012 as substantially equivalent to K033392 (O Co., Inc., 2003) and 5 other predicates after a 406-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Mar 16, 2012
- Review
- 406 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K894595 (1990). 102 ancestors in all, the oldest K820013 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- 3 generations backK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
- 2 generations backK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
- 1 generation backK071161 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
- This deviceK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · cites it directly · 0 of its ownK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| −3 | K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | Northern Implants, LLC | 2004 | — |
| −2 | K052490 | Endosseous Dental Implant System | Northern Implants, LLC | 2005 | — |
| −1 | K071161 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | 2 |
| 0 (this device) | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +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 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 14 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K033392 | Immediate Stabilizing Implant (Isi)Summary page 1…Common Name: Dental Implant Classification Name: Dental Implant Endosseous. Root-Form Substantial Equivalence to: Immediate Stabilizing Implant (ISI) K033392 (Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) OCO Biomedical TSI & ERI… | 2003 |
| * | K023336 | Oco Dental Implant (5.0MM Diameter)Summary page 1…ndosseous. Root-Form Substantial Equivalence to: Immediate Stabilizing Implant (ISI) K033392 (Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) OCO Biomedical TSI & ERI K090 174 (Cleared 9/14/09) Mega Gen… | 2002 |
| * | K090174 | Tsi; EriSummary page 1…Implant (ISI) K033392 (Cleared 12/11/03) OCO 5.0mm Taper Implant K023336 (Cleared 10/9/02) OCO Biomedical TSI & ERI K090 174 (Cleared 9/14/09) Mega Gen K08 1302 (Cleared 8/15/08) Implant Direct… | 2009 |
| * | K081302 | Rescue External Implant SystemSummary page 1…nt K023336 (Cleared 10/9/02) OCO Biomedical TSI & ERI K090 174 (Cleared 9/14/09) Mega Gen K08 1302 (Cleared 8/15/08) Implant Direct K06 1319 (Cleared 9/29/06) Southern Implants… | 2008 |
| * | K061319 | Spectra SystemSummary page 1…RI K090 174 (Cleared 9/14/09) Mega Gen K08 1302 (Cleared 8/15/08) Implant Direct K06 1319 (Cleared 9/29/06) Southern Implants K071 161 (Cleared 11/16/07) Description of Device: The I Macro… | 2006 |
| * | K071161 | Endosseous Dental Implant SystemSummary page 1…K08 1302 (Cleared 8/15/08) Implant Direct K06 1319 (Cleared 9/29/06) Southern Implants K071 161 (Cleared 11/16/07) Description of Device: The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded sc… | 2007 |
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 |
|---|---|---|---|
| K122198 | 6.00MM X 6.00MM Macro External Implant System | 2013 | 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 22 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 102 ancestors have a recall of any class.
- Of its descendants, K122198 (Oco Biomedical, 2013) has gone furthest, with 0 descendants 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. 2012, 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 I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110337: Universal Maxillary Molar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110337
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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