510(k) · Cleared
ClearedZimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
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 Sep 5, 2006 after a 29-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 5, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK062281 Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10…Zimmer Dental, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · cites it directly · 0 of its ownK133706 ZL Microdent Natural Lock Implant SystemZl Microdent-Attachment GmbH & Co. KG · 2014
- Descendant · 2 generations on · 0 of its ownK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
- Descendant · cites it directly · 0 of its ownK103577 Trinon Q & Q3 Implant SystemTrinon Titanium GmbH · 2012
- Descendant · cites it directly · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
Most influential descendants
Showing 5 of 5 · See all- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · cites it directly1descendant
- K133706ZL Microdent Natural Lock Implant SystemZl Microdent-Attachment GmbH & Co. KG · 2014 · cites it directly0descendants
- K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014 · 2 generations on0descendants
- K103577Trinon Q & Q3 Implant SystemTrinon Titanium GmbH · 2012 · cites it directly0descendants
- K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062281 | Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11… | Zimmer Dental, Inc. | 2006 | — |
| +1 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +1 | K133706 | ZL Microdent Natural Lock Implant System | Zl Microdent-Attachment GmbH & Co. KG | 2014 | — |
| +2 | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
| +1 | K103577 | Trinon Q & Q3 Implant System | Trinon Titanium GmbH | 2012 | — |
| +1 | K072917 | JJG Evolution Orthodontic Implant System | Odontit S.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | — | Zimmer® One-Piece Implant, 3.0mm, Straight Named without a submission number | |
| * | — | Zimmer® One-Piece Implant, 3.7mm, Straight Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K130140 (Intra-Lock International, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight 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/K062281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062281: Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062281
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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