510(k) · Cleared
ClearedFrialit-2 MH-2 Abutment
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 Apr 20, 2000 as substantially equivalent to K945849 (Friatec Medical Inc., USA, 1996) and 1 other predicate after a 132-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 20, 2000
- Review
- 132 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945398 (1995). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945398 Branemark System (R) Mkii Self-Tapping FixtureNobelpharma USA, Inc. · 1995
- 1 generation backK962130 Branemark Systems Mkii Selk-Tapping FixtureNobelpharma USA, Inc. · 1996
- This deviceK994174 Frialit-2 MH-2 AbutmentFriadent GmbH · 2000
- Descendant · cites it directly · 2 of its ownK122268 Angled Xive MP Abutment, Angled AnkylosDentsply International · 2012
- Descendant · 2 generations on · 1 of its ownK131644 Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK151439 Atlantis IsusDentsply International, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945398 | Branemark System (R) Mkii Self-Tapping Fixture | Nobelpharma USA, Inc. | 1995 | — |
| −1 | K962130 | Branemark Systems Mkii Selk-Tapping Fixture | Nobelpharma USA, Inc. | 1996 | — |
| 0 (this device) | K994174 | Frialit-2 MH-2 Abutment | Friadent GmbH | 2000 | — |
| +1 | K122268 | Angled Xive MP Abutment, Angled Ankylos | Dentsply International | 2012 | — |
| +2 | K131644 | Ankylos Syncone Abutment 5(Degree) | Dentsply International, Inc. | 2014 | — |
| +3 | K151439 | Atlantis Isus | Dentsply International, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K945849 | Frialit (R)-2 Stepped Cylinder with Frios (R) TI-CoatingSummary page 1…n Name: Endosseous Dental Implants 21 CFR 872.3640 16.3 IDENTIFICATION OF PREDICATE DEVICES Company Device S510(k) No. Date Cleared FRIADENT FRIALIT-2® Stepped Cylinder K945849 03/15/96 With FRIOS® Coating System Nobel BioCare Branemark Self-Tapping MK II K962130 07/22/96 Dental Implant System 188 ===… | 1996 |
| * | K962130 | Branemark Systems Mkii Selk-Tapping FixtureSummary page 1…ES Company Device S510(k) No. Date Cleared FRIADENT FRIALIT-2® Stepped Cylinder K945849 03/15/96 With FRIOS® Coating System Nobel BioCare Branemark Self-Tapping MK II K962130 07/22/96 Dental Implant System 188 FRIADENT GmbH FRIALIT-2® MH-2 Abutment Original Premarket 510(k) Notification… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122268 | Angled Xive MP Abutment, Angled Ankylos | 2012 | 2 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122268 (Dentsply International, 2012) has gone furthest, with 2 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® MH-2 Abutment is intended for use in multiple unit bridges and bar overdentures.
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/K994174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994174: Frialit-2 MH-2 Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994174
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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