510(k) · Cleared
ClearedFrialit -2 Screw
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 Feb 10, 1998 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 392 later devices descend from it.
- Decided
- Feb 10, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
392 later devices descend from it, 1 citing it directly.
- This deviceK974358 Frialit -2 ScrewFriatec AG · 1998
- Descendant · cites it directly · 391 of its ownK031674 Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003
- Descendant · 2 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · 3 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 4 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · 4 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
Showing 5 of 392 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 392 · See all- K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003 · cites it directly391descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 3 generations on295descendants
- K083550Straumann Dental Implant SystemStraumann USA · 2009 · 4 generations on228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 4 generations on228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974358 | Frialit -2 Screw | Friatec AG | 1998 | — |
| +1 | K031674 | Modification to Frialit-2 Dental Implant System | Friadent GmbH | 2003 | — |
| +2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +4 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 12 | 0 |
| 2013 | 16 | 0 |
| 2014 | 15 | 0 |
| 2015 | 21 | 0 |
| 2016 | 18 | 0 |
| 2017 | 18 | 0 |
| 2018 | 22 | 0 |
| 2019 | 18 | 0 |
| 2020 | 28 | 0 |
| 2021 | 30 | 0 |
| 2022 | 31 | 0 |
| 2023 | 37 | 0 |
| 2024 | 41 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (392)
See all 3921 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031674 | Modification to Frialit-2 Dental Implant System | 2003 | 391 |
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, K031674 (Friadent GmbH, 2003) has gone furthest, with 391 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?
FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on span to bridgework, as distal abutments on free-end areas to be restored with fixed work, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974358: Frialit -2 Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974358
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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