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 Jul 27, 2016 as substantially equivalent to K133255 (Dentalpoint AG, 2014) after a 338-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Jul 27, 2016
- Review
- 338 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894595 (1990). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 1 generation backK133255 Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG · 2014
- This deviceK152385 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
- Descendant · cites it directly · 0 of its ownK163043 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
Most influential descendants
Showing 1 of 1 · See all- K163043Zeramex P6 Dental Implant SystemDentalpoint AG · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −1 | K133255 | Zeramex T and Zeramex Plus Dental Implant Systems | Dentalpoint AG | 2014 | — |
| 0 (this device) | K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K133255 | Zeramex T and Zeramex Plus Dental Implant SystemsSummary page 4…HA III. Predicate and Reference Devices Substantial equivalence is claimed to the following predicate device: • Zeramex® T Dental Implant System, Dentalpoint AG, K133255 The following devices are cited as reference devices: • Branemark System Dental Implant Products, Nobel Biocare AB, K02256… | 2014 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | 2004 |
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 |
|---|---|---|---|
| K163043 | Zeramex P6 Dental Implant System | 2016 | 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 26 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K163043 (Dentalpoint AG, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133255.
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 teeth in the upper jaw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152385: 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/K152385
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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