510(k) · Cleared
ClearedSIC Abutments including CAD/CAM Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sic Invent AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 3, 2026 as substantially equivalent to K173207 (Sic Invent AG, 2018) after a 265-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jun 3, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- NHA
- 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 deviceK252904 SIC Abutments including CAD/CAM SolutionsSic Invent AG · 2026
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) | K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K173207 | SIC invent Dental Implant SystemsSummary page 5…nesthesia, Respiratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K173207, SIC invent Dental Implant Systems, SIC invent AG Reference Devices K210489, SICtapered & SICvantage tapered, SIC Invent AG K240… | 2018 |
| † | K210489 | SICtapered & SICvantage tapered | 2022 |
| † | K240208 | DESS Dental Smart Solutions | 2024 |
| † | K233316 | DESS Dental Smart Solutions | 2024 |
| † | K202026 | Blue Sky Bio CAD-CAM Abutments | 2020 |
| † | K193096 | S.I.N. Dental Implant System | 2020 |
| † | K211109 | N1 TiUltra TCC Implant System | 2021 |
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 NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
SIC CAD/CAM Products are intended for use with SIC Dental Implants for prosthetic restorations from single tooth replacements to full arch restorations with fixed or removable superstructures.
The Bonding Bases consist of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Bonding Base or Milling Blank are to be sent to an SIC invent validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252904: SIC Abutments including CAD/CAM Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252904
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026