510(k) · Cleared
ClearedSulzer Dental Ceramic System-Hexlock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 20, 2002 as substantially equivalent to K953101 (Core-Vent Bio-Engineering, Inc., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 20, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953101 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953101 Paragon Implant SystemCore-Vent Bio-Engineering, Inc. · 1995
- This deviceK014175 Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953101 | Paragon Implant System | Core-Vent Bio-Engineering, Inc. | 1995 | — |
| 0 (this device) | K014175 | Sulzer Dental Ceramic System-Hexlock | Sulzer Dental, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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? (2)
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 |
|---|---|---|---|
| * | K953101 | Paragon Implant SystemSummary page 1…Name: Abutment for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-HexLock The device used for comparison in this summary is the HexLock Abutment (K953101) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use: The Sulzer Dental Ceramic System-HexLock is intended for anteri… | 1995 |
| * | K980630 | Frialit-2 CorabaseSummary page 1…Trade Name: Sulzer Dental Ceramic System-HexLock The device used for comparison in this summary is the HexLock Abutment (K953101) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use: The Sulzer Dental Ceramic System-HexLock is intended for anterior single unit restoration cases. 2. Descripti… | 1998 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K953101.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of the Sulzer Dental Ceramic System-HexLock is
for anterior single unit restoration cases. This system is intended to improve esthetics in
anterior cases by replacing the metal substructure within a restoration with a tooth color
ceramic structure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014175: Sulzer Dental Ceramic System-Hexlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014175
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026