510(k) · Cleared
ClearedQZA and RS Dental Implant Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trinon Titanium GmbH · DZE Implant, Endosseous, Root-Form
Cleared on May 3, 2017 as substantially equivalent to K142260 (Nobel Biocare AB, 2015) and 1 other predicate after a 131-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- May 3, 2017
- Review
- 131 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K894595 (1990). 166 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 2 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 1 generation backK142260 NobelActiveNobel Biocare AB · 2015
- This deviceK163640 QZA and RS Dental Implant SystemsTrinon Titanium GmbH · 2017
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 2 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 1 generation backK142260 NobelActiveNobel Biocare AB · 2015
- This deviceK163640 QZA and RS Dental Implant SystemsTrinon Titanium GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −2 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −1 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| 0 (this device) | K163640 | QZA and RS Dental Implant Systems | Trinon Titanium GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 13 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K142260 | NobelActiveSummary page 12…Name) RS Dental Implant Dentis Co. Ltd./Dentis Dental Nobel Biocare AB/NobelActive K142260 K073486 QZA Implant Systems Dental… | 2015 |
| * | K160221 | Implance Dental Implant System, Implance Dental Abutment SystemSummary page 12…edikal Urunleri Ith. Ihr. QZA Tic. Ltd. Sti./Implance Dental Angled Implant System, Implance Abutment Dental Abutment System (Angled K160221 Abutments) AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti./Implance Dental QZ… | 2016 |
| † | K073486 | Dentis Dental Implant System | 2008 |
| † | K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 |
| † | K120954 | Nobelprocera Peek Abutments | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 16 of the 166 ancestors have a recall of any class.
- 9 other devices also cite its predicate K142260.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function. TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols…
Read the full statement (171 words)
TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.
TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors.
TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.
QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163640: QZA and RS Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163640
Report an extraction error
Are you the manufacturer?
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