510(k) · Cleared
ClearedFriadent Plus Dental Implant Systems
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 Oct 27, 2004 as substantially equivalent to K031674 (Friadent GmbH, 2003) and 3 other predicates after a 275-day review. Its family tree reaches back 6 generations to 1990. 84 later devices descend from it.
- Decided
- Oct 27, 2004
- Review
- 275 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K894595 (1990). 26 ancestors in all, the oldest K894844 (1990). 84 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 3 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- This deviceK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- Descendant · cites it directly · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- Descendant · 2 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 2 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · 3 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · cites it directly83descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 2 generations on45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 3 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 2 generations on30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −3 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| 0 (this device) | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| +1 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| +2 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +3 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +2 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +3 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K031674 | Modification to Frialit-2 Dental Implant System Our reading of the summary gave K031671, FDA’s number for Polaris WR (Syneron Medical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FRIALIT® Dental Implant System”. | 2003 |
| * | K032158 | Xive Dental Implant System MultipleSummary page 1…bH FRIALIT® Dental Implant K031671 08/14/2003 System XiVE® S Dental Implant K032158 08/14/2003 System XiVE® TG Dental Implant K032284… | 2003 |
| * | K032284 | Xive TG Dental Implant SystemSummary page 1…XiVE® S Dental Implant K032158 08/14/2003 System XiVE® TG Dental Implant K032284 08/14/2003 System XiVE® D 3.0 Dental Implant K032302… | 2003 |
| * | K032302 | Xive TG AbutmentsSummary page 1…XiVE® TG Dental Implant K032284 08/14/2003 System XiVE® D 3.0 Dental Implant K032302 10/02/2003 System FRIADENT® PLUS Dental Implant Systems… | 2003 |
What descends from it? (84)
See all 841 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102804 | Spi Titanium Base for Cad/Cam | 2011 | 83 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K102804 (Thommen Medical AG, 2011) has gone furthest, with 83 descendants of its own.
- 1 other device also cites its predicate K031674.
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® PLUS Dental Implant System is indicated for use in single tooth restorations, 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. The XiVE® PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and…
Read the full statement (296 words)
The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, 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.
The XiVE® PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (>1 1mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 and 10 and 23 to 26.
The XiVE® TG PLUS 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 maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (>1lmm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
FRIADENT PLUS grit-blasted and high temperature acid-etched implants display higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants. The high removal torque values of FRIADENT PLUS implants after a loading period of 5 months may be interpreted as an increase in the strength of endosseous implant integration and implant stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040170 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040170: Friadent Plus Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040170
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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