510(k) · Cleared
ClearedModification to Frialit-2 Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friadent GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Aug 14, 2003 as substantially equivalent to K945847 (Friatec Medical Inc., USA, 1996) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1993. 391 later devices descend from it.
- Decided
- Aug 14, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925765 (1993). 4 ancestors in all. 391 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 1 generation backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- This deviceK031674 Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003
- Descendant · cites it directly · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · 2 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 3 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · 3 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- Descendant · 4 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
Showing 5 of 391 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 391 · See all- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
- K083550Straumann Dental Implant SystemStraumann USA · 2009 · 3 generations on228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 3 generations on228descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 4 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| 0 (this device) | K031674 | Modification to Frialit-2 Dental Implant System | Friadent GmbH | 2003 | — |
| +1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +3 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +3 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| +4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K945847 | Frialit (R)-2 Stepped Screw with Deep Profile SurfaceSummary page 1…OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared FRIADENT GmbH FRIALITa-2 Dental K945847 03115/1996 Implant System FRIADENT GmbH FRIALITa-2 Dental K974358… | 1996 |
| * | K974358 | Frialit -2 ScrewSummary page 1…H FRIALITa-2 Dental K945847 03115/1996 Implant System FRIADENT GmbH FRIALITa-2 Dental K974358 10/02/1998 Implant System FRIADENT GmbH FRIALITO-2 Dental K994376… | 1998 |
| * | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped…Summary page 1…H FRIALITa-2 Dental K974358 10/02/1998 Implant System FRIADENT GmbH FRIALITO-2 Dental K994376 03/24/2000 Implant System FRIADENT GmbH FRIALITCB-2 Dental Implant System Spec… | 2000 |
What descends from it? (391)
See all 3912 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 10 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K033984 (Institut Straumann AG, 2004) has gone furthest, with 376 descendants of its own.
- 1 other device also cites its predicate K945847.
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 FRIALITe2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031674: Modification to Frialit-2 Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031674
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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