510(k) · Cleared
ClearedRevois Pro Implant Stsyem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riemser Arzneimittel AG · DZE Implant, Endosseous, Root-Form
Cleared on May 3, 2013 as substantially equivalent to K063106 (Curasan AG, 2007) after a 520-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- May 3, 2013
- Review
- 520 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K925765 (1993). 73 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK061629 Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007
- 1 generation backK063106 Revois Implant SystemCurasan AG · 2007
- This deviceK113539 Revois Pro Implant StsyemRiemser Arzneimittel AG · 2013
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK061629 Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007
- 1 generation backK063106 Revois Implant SystemCurasan AG · 2007
- This deviceK113539 Revois Pro Implant StsyemRiemser Arzneimittel AG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K061629 | Certain Prevail Dental Implant | Implant Innovations, Inc. | 2007 | — |
| −1 | K063106 | Revois Implant System | Curasan AG | 2007 | — |
| 0 (this device) | K113539 | Revois Pro Implant Stsyem | Riemser Arzneimittel AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K063106 | Revois Implant SystemSummary page 2…Section 5 510(K)-Summary - 3. PREDICATE DEVICES REVOIS® Implant System: K063 106 4. DESCRIPTION OF THE DEVICE The REVOIS® PRO Implant System is a development of the former REVOIS® Implant System. The R… | 2007 |
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 20 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 9 of the 73 ancestors have a recall of any class.
- 1 other device also cites its predicate K063106.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
REVOIS PRO Implant System is an implant system recommended for surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges, or dentures.
The titanium implant can be applied either in a one-stage surgical procedure with immediate loading (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113539: Revois Pro Implant Stsyem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113539
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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