510(k) · Cleared
ClearedZeramex T and Zeramex Plus Dental Implant Systems
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 Aug 12, 2014 as substantially equivalent to K093595 (Oral Iceberg S.L., 2011) and 2 other predicates after a 293-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 12, 2014
- Review
- 293 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K894595 (1990). 15 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- This deviceK133255 Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG · 2014
- Descendant · cites it directly · 1 of its ownK152385 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
- Descendant · cites it directly · 0 of its ownK180184 Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG · 2018
- Descendant · 2 generations on · 0 of its ownK163043 Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
Most influential descendants
Showing 3 of 3 · See all- K152385Zeramex P6 Dental Implant SystemDentalpoint AG · 2016 · cites it directly1descendant
- K180184Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG · 2018 · cites it directly0descendants
- K163043Zeramex P6 Dental Implant SystemDentalpoint AG · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| 0 (this device) | K133255 | Zeramex T and Zeramex Plus Dental Implant Systems | Dentalpoint AG | 2014 | — |
| +1 | K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016 | — |
| +1 | K180184 | Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | 2018 | — |
| +2 | 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 | 2 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K093595 | Ceraroot Implant SystemSummary page 4…acturer 510(k) Number CeraRoot Implant System Oral Iceberg S.L. K093595 Z-Look3 Dental Implant System Z-Systems AG K062542 Branemark System® Nobel Biocare USA… | 2011 |
| * | K062542 | Z-LOOK3 Dental Implant System, Model Z3-XXXSummary page 4…Number CeraRoot Implant System Oral Iceberg S.L. K093595 Z-Look3 Dental Implant System Z-Systems AG K062542 Branemark System® Nobel Biocare USA Inc. K992937 Description of the Device The Zeramex® T System is an… | 2007 |
| * | K992937 | Dental ImplantSummary page 4…eberg S.L. K093595 Z-Look3 Dental Implant System Z-Systems AG K062542 Branemark System® Nobel Biocare USA Inc. K992937 Description of the Device The Zeramex® T System is an endosseous dental implant/abutment system. The Zeramex® T implants are pl… | 2000 |
What descends from it? (3)
2 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K152385 (Dentalpoint AG, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K093595.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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® T 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® T Dental Implant System can be used for single or multiple unit restorations.
Zeramex® T implants are intended for delayed loading.
The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies.
The Zeramex® T (Ø 3.5 mm) 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/K133255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133255: Zeramex T and Zeramex Plus Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133255
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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