510(k) · Cleared
ClearedRevois Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curasan AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 11, 2007 as substantially equivalent to K013867 (Friadent GmbH, 2002) and 6 other predicates after a 243-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Jun 11, 2007
- Review
- 243 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K925765 (1993). 72 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 6 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 5 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 4 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 3 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 2 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK061629 Certain Prevail Dental ImplantImplant Innovations, Inc. · 2007
- This deviceK063106 Revois Implant SystemCurasan AG · 2007
- Descendant · cites it directly · 0 of its ownK113539 Revois Pro Implant StsyemRiemser Arzneimittel AG · 2013
- Descendant · cites it directly · 0 of its ownK113042 Revois Implant SystemRiemser Arzneimittel AG · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −7 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −6 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −5 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −4 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −3 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −2 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K061629 | Certain Prevail Dental Implant | Implant Innovations, Inc. | 2007 | — |
| 0 (this device) | K063106 | Revois Implant System | Curasan AG | 2007 | — |
| +1 | K113539 | Revois Pro Implant Stsyem | Riemser Arzneimittel AG | 2013 | — |
| +1 | K113042 | Revois Implant System | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K013867 | Xive Dental Implant SystemSummary page 2…ment [RevisionO2 MAY07] 5 -1 3. PREDICATE DEVICES XiVE® Dental Implant System: K013867, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System:… | 2002 |
| * | K021318 | Xive Dental Implant SystemSummary page 2…[RevisionO2 MAY07] 5 -1 3. PREDICATE DEVICES XiVE® Dental Implant System: K013867, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System: KOl 1245… | 2002 |
| * | K024004 | Xive Transgingival Dental Implant SystemSummary page 2…5 -1 3. PREDICATE DEVICES XiVE® Dental Implant System: K013867, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System: KOl 1245 Certain® PREVAILTM Implants: K061629 4. INTE… | 2003 |
| * | K032284 | Xive TG Dental Implant SystemSummary page 2…5 -1 3. PREDICATE DEVICES XiVE® Dental Implant System: K013867, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System: KOl 1245 Certain® PREVAILTM Implants: K061629 4. INTENDED USE… | 2003 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 2…ge 2 === 3. PREDICATE DEVICES XiVE® Dental Implant System: K013867, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System: KOl 1245 Certain® PREVAILTM Implants: K061629 4. INTENDED USE The REVOIS® Implant System is an imp… | 2001 |
| * | K011245 | Advent Implant System, Swiss Plus Implant System | 2001 |
| * | K061629 | Certain Prevail Dental Implant Cleared while this submission was under review Summary page 2…7, K021318 XiVE® Transgingival Dental Implant System: K024004, K032284 Tapered Screw-Vent® Implant: K013227 Advent® Implant System: KOl 1245 Certain® PREVAILTM Implants: K061629 4. INTENDED USE The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or… | 2007 |
What descends from it? (2)
2 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 14 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 9 of the 72 ancestors have a recall of any class.
- Of its descendants, K113539 (Riemser Arzneimittel AG, 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K013867.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The REVOIS® 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 when good primary stability is achieved and with appropriate occlusal loading, or…
Read the full statement (118 words)
The REVOIS® 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 when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant).
Angled abutments on small diameter implants (3.8 mm) of the REVOIS® Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063106: Revois Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063106
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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