510(k) · Cleared
ClearedFrialit-2 Corabase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friatec AG · DZE Implant, Endosseous, Root-Form
Cleared on Sep 4, 1998 after a 198-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Sep 4, 1998
- Review
- 198 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 3 citing it directly.
- This deviceK980630 Frialit-2 CorabaseFriatec AG · 1998
- Descendant · cites it directly · 0 of its ownK072730 Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
- Descendant · cites it directly · 0 of its ownK014175 Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK014214 Sulzer Dental Ceramic System-SplineSulzer Dental, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See all- K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008 · cites it directly0descendants
- K014175Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc. · 2002 · cites it directly0descendants
- K014214Sulzer Dental Ceramic System-SplineSulzer Dental, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980630 | Frialit-2 Corabase | Friatec AG | 1998 | — |
| +1 | K072730 | Friadent Cercon and Ankylos Cercon Balance Abutments | Dentsply Intl. | 2008 | — |
| +1 | K014175 | Sulzer Dental Ceramic System-Hexlock | Sulzer Dental, Inc. | 2002 | — |
| +1 | K014214 | Sulzer Dental Ceramic System-Spline | Sulzer Dental, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2008 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K961737 | FDA’s K961737 is Cera One Abutment System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1996 |
What descends from it? (3)
3 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?
- Of its descendants, K072730 (Dentsply Intl., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 FRIALIT-2® CeraBase abutment is intended for use in the fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.
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/K980630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980630: Frialit-2 Corabase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980630
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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