510(k) · Cleared
ClearedFrialoc 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 Apr 9, 2002 as substantially equivalent to K925760 (Nobelpharma USA, Inc., 1993) and 2 other predicates after a 209-day review. Its family tree reaches back 3 generations to 1990. 568 later devices descend from it.
- Decided
- Apr 9, 2002
- Review
- 209 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K894595 (1990). 12 ancestors in all. 568 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- This deviceK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- Descendant · cites it directly · 547 of its ownK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- Descendant · 2 generations on · 542 of its ownK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- Descendant · cites it directly · 425 of its ownK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- Descendant · 2 generations on · 394 of its ownK032284 Xive TG Dental Implant SystemFriadent GmbH · 2003
- Descendant · 3 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
Showing 5 of 568 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 568 · See all- K021318Xive Dental Implant SystemFriadent GmbH · 2002 · cites it directly547descendants
- K032158Xive Dental Implant System MultipleFriadent GmbH · 2003 · 2 generations on542descendants
- K024004Xive Transgingival Dental Implant SystemFriadent GmbH · 2003 · cites it directly425descendants
- K032284Xive TG Dental Implant SystemFriadent GmbH · 2003 · 2 generations on394descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 3 generations on376descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| 0 (this device) | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| +1 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| +2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| +1 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| +2 | K032284 | Xive TG Dental Implant System | Friadent GmbH | 2003 | — |
| +3 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 12 | 0 |
| 2012 | 19 | 0 |
| 2013 | 22 | 0 |
| 2014 | 24 | 0 |
| 2015 | 31 | 0 |
| 2016 | 31 | 0 |
| 2017 | 27 | 0 |
| 2018 | 29 | 0 |
| 2019 | 27 | 0 |
| 2020 | 41 | 0 |
| 2021 | 39 | 0 |
| 2022 | 38 | 0 |
| 2023 | 50 | 0 |
| 2024 | 57 | 0 |
| 2025 | 48 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | K925760 | Branemark System Conical Self-Tapping FixtureSummary page 1…tal Implant System Endosseous Dental Implants 21 CFR 872.3640 IDENTIFICATION OF PREDICATE DEVICES Company Device Nobel BioCare Conical Mk II 510(k) No. Date Cleared K925760 10/05/93 3.75mm Fixture NobelBiocare Branemark System Implants K992937 02/29/00 FRIADENT GmbH FRIALIT-2 Dental Implant K945847… | 1993 |
| * | K992937 | Dental ImplantSummary page 1…ATION OF PREDICATE DEVICES Company Device Nobel BioCare Conical Mk II 510(k) No. Date Cleared K925760 10/05/93 3.75mm Fixture NobelBiocare Branemark System Implants K992937 02/29/00 FRIADENT GmbH FRIALIT-2 Dental Implant K945847 03/15/95 With Deep Profile Surface FRIADENT GmbH FRIALOC… | 2000 |
| * | K945847 | Frialit (R)-2 Stepped Screw with Deep Profile SurfaceSummary page 1…Conical Mk II 510(k) No. Date Cleared K925760 10/05/93 3.75mm Fixture NobelBiocare Branemark System Implants K992937 02/29/00 FRIADENT GmbH FRIALIT-2 Dental Implant K945847 03/15/95 With Deep Profile Surface FRIADENT GmbH FRIALOC® Dental Implant System Original Premarket 510(k) Notific… | 1996 |
What descends from it? (568)
See all 5682 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 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K021318 (Friadent GmbH, 2002) has gone furthest, with 547 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 FRIALOC Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for freestanding maxillary and mandibular bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants. In the edentulous maxilla, 2 minimum of four FRIALOC transgingival threaded implants are…
Read the full statement (108 words)
The FRIALOC Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for freestanding maxillary and mandibular bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants.
In the edentulous maxilla, 2 minimum of four FRIALOC transgingival threaded implants are placed in a trapezoidal distribution and rigidly splinted together.
In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.
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/K013067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013067: Frialoc Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026