510(k) · Cleared
ClearedSICtapered & SICvantage tapered
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 Mar 17, 2022 as substantially equivalent to K173207 (Sic Invent AG, 2018) after a 391-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Mar 17, 2022
- Review
- 391 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K173207 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK173207 SIC invent Dental Implant SystemsSic Invent AG · 2018
- This deviceK210489 SICtapered & SICvantage taperedSic Invent AG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K173207 | SIC invent Dental Implant Systems | Sic Invent AG | 2018 | — |
| 0 (this device) | K210489 | SICtapered & SICvantage tapered | Sic Invent AG | 2022 | — |
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.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K173207.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SICtapered SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient’s chewing function. SICtapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered…
Read the full statement (223 words)
SICtapered
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient’s chewing function. SICtapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICtapered implants with Ø 3.7 mm
Use without splinting is permissible in the anterior and premolar region. In the molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICvantage tapered
SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient’s chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICvantage tapered implants with Ø 3.0 mm
Use without splinting is permissible in the anterior region for replacement of maxillary lateral incisors and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210489 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210489: SICtapered & SICvantage tapered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210489
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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