510(k) · Cleared
ClearedZeramex P6 Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalpoint AG · DZE Implant, Endosseous, Root-Form
Cleared on Nov 30, 2016 as substantially equivalent to K152385 (Dentalpoint AG, 2016) after a 30-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 30, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894595 (1990). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 2 generations backK133255 Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG · 2014
- 1 generation backK152385 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
- This deviceK163043 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −2 | K133255 | Zeramex T and Zeramex Plus Dental Implant Systems | Dentalpoint AG | 2014 | — |
| −1 | K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016 | — |
| 0 (this device) | K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K152385 | Zeramex P6 Dental Implant SystemSummary page 4…Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: • Zeramex® P6 Dental Implant System, K152385, Dentalpoint AG IV. Device Description The Zeramex® P6 Dental Implant System is an endosseous dental implant… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 17 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163043: Zeramex P6 Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163043
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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