510(k) · Cleared
ClearedZeramex (R) XT Dental Implant System, NobelPearl Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalpoint AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 16, 2018 as substantially equivalent to K133255 (Dentalpoint AG, 2014) after a 297-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 16, 2018
- Review
- 297 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894595 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK180184 Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG · 2018
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) | K180184 | Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | 2018 | — |
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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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 5…assification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate devices: • Zeramex® T Dental Implant System, K133255, Dentalpoint AG The following devices are referenced within the submission: • Zeramex® P6 Dental Implant System, K163043,… | 2014 |
| † | K163043 | Zeramex P6 Dental Implant System | 2016 |
| † | K152385 | Zeramex P6 Dental Implant System | 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 28 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.
- 1 other device also cites its predicate K133255.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The ZERAMEX® XT 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® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® XT dental implants are specially indicated for…
Read the full statement (164 words)
The ZERAMEX® XT 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® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® XT dental implants are specially indicated for patients with metal allergies/intolerances and chronic illnesses due to metal allergies/intolerances.
The NobelPearl 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 NobelPearl Dental Implant System can be used for single or multiple unit restorations.
NobelPearl Dental Implant System are intended for delayed loading.
NobelPearl Dental Implant System are specially indicated for patients with metal allergies/intolerances and chronic illness due to metal allergies/intolerances.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180184: Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180184
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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