510(k) · Cleared
Recalled · Class II · 2017Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 30, 2007 as substantially equivalent to K052997 (Zimmer Dental, Inc., 2006) after a 27-day review. Its family tree reaches back 1 generation to 2006. 47 later devices descend from it. It has been recalled once.
- Decided
- May 30, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052997 (2006). 47 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK052997 Zimmer Dental One-Piece ImplantZimmer Dental, Inc. · 2006 · Recalled
- This deviceK071235 Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11…Zimmer Dental, Inc. · 2007
- Descendant · cites it directly · 42 of its ownK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · 3 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK083067 MS SystemOsstem Implant Co., Ltd. · 2009
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008 · cites it directly42descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 2 generations on30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 3 generations on8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 3 generations on7descendants
- K083067MS SystemOsstem Implant Co., Ltd. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052997 | Zimmer Dental One-Piece Implant | Zimmer Dental, Inc. | 2006 | 1 |
| 0 (this device) | K071235 | Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13 | Zimmer Dental, Inc. | 2007 | — |
| +1 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +3 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +3 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +2 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 2…e Comparison: The new device is equivalent in design with Predicate. The new device is a dimensional modification to the Predicate cleared in K052997. It differs from the Predicate in that the abutment portion of the new device is angled by 17 degrees… | 2006 |
| * | — | Zimmer® Screw Vent® Mini™ 3.3mm + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm Named without a submission number |
What descends from it? (47)
See all 474 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2017 | Class II | Z-3210-2017 | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 3.0mm One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The 3.0mm One-Piece implant must be splinted if two or more are used adjacent to each other. The 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071235
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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