510(k) · Cleared
ClearedCeraRoot TL Implant System (TL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceraroot SL · DZE Implant, Endosseous, Root-Form
Cleared on May 14, 2025 as substantially equivalent to K093595 (Oral Iceberg S.L., 2011) after a 302-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 14, 2025
- Review
- 302 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022562 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- 2 generations backK061971 Zirconia ImplantNobel Biocare AB · 2007
- 1 generation backK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
- This deviceK242072 CeraRoot TL Implant System (TL)Ceraroot SL · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −2 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| −1 | K093595 | Ceraroot Implant System | Oral Iceberg S.L. | 2011 | — |
| 0 (this device) | K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K093595 | Ceraroot Implant SystemSummary page 5…Device Owner/ 510(k) # Product Code Trade Name Primary CeraRoot SL / K093595 DZE (Implant, Endosseous, Predicate CeraRoot Implant System Root-Form) 3.2.R… | 2011 |
| † | K190406 | SDS2.2 dental implant | 2020 |
| † | K132881 | Z5C | 2014 |
| † | K163043 | Zeramex P6 Dental Implant System | 2016 |
| † | K180477 | Straumann PURE Ceramic Implant System | 2019 |
| † | K091019 | Speedcem | 2009 |
| † | K153493 | Clip Flow | 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 23 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- 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. 2025, 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?
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions.…
Read the full statement (130 words)
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function.
The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece).
CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242072: CeraRoot TL Implant System (TL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242072
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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