510(k) · Cleared
Recalled · Class II · 2017Zimmer Dental One-Piece Implant
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 Jan 23, 2006 after a 90-day review. The FDA summary names its predicate without a number. 245 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 0
245 later devices descend from it, 10 citing it directly.
- This deviceK052997 Zimmer Dental One-Piece ImplantZimmer Dental, Inc. · 2006
- Descendant · cites it directly · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · cites it directly · 122 of its ownK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 245 · See all- K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · cites it directly141descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 3 generations on123descendants
- K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc. · 2006 · cites it directly122descendants
- K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 3 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052997 | Zimmer Dental One-Piece Implant | Zimmer Dental, Inc. | 2006 | — |
| +1 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| +2 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +3 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +1 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
| +3 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 13 | 0 |
| 2015 | 11 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 15 | 0 |
| 2020 | 15 | 0 |
| 2021 | 13 | 0 |
| 2022 | 22 | 0 |
| 2023 | 26 | 0 |
| 2024 | 31 | 0 |
| 2025 | 27 | 0 |
| 2026 | 18 | 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 Dental Inc., Screw-Vent® MTX™ Selective Surface Implant (Cat. No. SVMB13) /… Named without a submission number | |
| * | — | Nobel Biocare Inc., NobelDirect™ 3.0 (Cat. No. 31456) Named without a submission number |
What descends from it? (245)
See all 24510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081653 | Mdi Mii One-Piece Implant, 2.9MM | 2008 | 141 |
| K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 | 122 |
| K071235 | Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13 | 2007 | 47 |
| K080162 | Uno - One Piece Screw-Type Dental Implant | 2008 | 39 |
| K102034 | Blue Sky Bio Dental Implant System | 2011 | 4 |
| K213576 | Tatum Surgical Dental Implant System | 2022 | 1 |
| K130140 | Intra-Lock OP Dental Implant | 2013 | 1 |
| K133706 | ZL Microdent Natural Lock Implant System | 2014 | 0 |
| K103577 | Trinon Q & Q3 Implant System | 2012 | 0 |
| K080129 | Secure Implant System (2.5/3.0MM) | 2008 | 0 |
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?
- Of its descendants, K081653 (Imtec Corp., 2008) has gone furthest, with 141 descendants 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 3.7mm 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 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in…
Read the full statement (144 words)
Zimmer® One-Piece 3.7mm 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 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Zimmer® One-Piece 3.0mm 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 Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 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/K052997 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052997: Zimmer Dental One-Piece Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052997
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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