510(k) · Cleared
ClearedSicace Dental Implant System and Sic Angled Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sic Invent AG · DZE Implant, Endosseous, Root-Form
Cleared on Aug 8, 2006 as substantially equivalent to K040757 (Sic Invent AG, 2005) and 2 other predicates after a 69-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Aug 8, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894595 (1990). 53 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 1 generation backK040757 Sic ProSic Invent AG · 2005
- This deviceK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
- Descendant · cites it directly · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
Most influential descendants
Showing 1 of 1 · See all- K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −1 | K040757 | Sic Pro | Sic Invent AG | 2005 | — |
| 0 (this device) | K061500 | Sicace Dental Implant System and Sic Angled Abutments | Sic Invent AG | 2006 | — |
| +1 | K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K040757 | Sic ProSummary page 2…e sterilized by the user by using a standardized and validated sterilization process. 2. Predicate Devices * SIC invent AG, SlCpro Dental Implant System, K040757; Institut Straumann AG, ITI®synOcta Angled Abutments, K013891 * FRIADENT GmbH, XiVE@ TG Abutment Accessory to the… | 2005 |
| * | K013891 | Synocta Angled Abutments for the Iti Wide Neck ImplantSummary page 2…ation process. 2. Predicate Devices * SIC invent AG, SlCpro Dental Implant System, K040757; Institut Straumann AG, ITI®synOcta Angled Abutments, K013891 * FRIADENT GmbH, XiVE@ TG Abutment Accessory to the XiVE@ TG Dental Implant Sys- tems, K032302. K{I1500AflSum… | 2002 |
| * | K032302 | Xive TG AbutmentsSummary page 2…Institut Straumann AG, ITI®synOcta Angled Abutments, K013891 * FRIADENT GmbH, XiVE@ TG Abutment Accessory to the XiVE@ TG Dental Implant Sys- tems, K032302. K{I1500AflSumaryvl.ll O MEDAGENT GntH &Co. KG Pag 2 of 3 Implants… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073622 | Easy Grip Dental Implant System | 2008 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 53 ancestors have a recall of any class.
- Of its descendants, K073622 (T.F.I. System S.R.L, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040757.
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 SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function. Patient's must be applicable for dental treatment with endosseous implants. In cases where the ridge is too narrow to receive a 4.0 mm or…
Read the full statement (142 words)
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061500: Sicace Dental Implant System and Sic Angled Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061500
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