510(k) · Cleared
ClearedHex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 7, 2009 as substantially equivalent to K953101 (Core-Vent Bio-Engineering, Inc., 1995) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 7, 2009
- Review
- 29 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. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK953101 Paragon Implant SystemCore-Vent Bio-Engineering, Inc. · 1995
- This deviceK090723 Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561…Zimmer Dental, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK113092 Zimmer Contour Provisional CopingZimmer Dental, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113092Zimmer Contour Provisional CopingZimmer Dental, Inc. · 2012 · cites it directly0descendants
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) | K090723 | Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short… | Zimmer Dental, Inc. | 2009 | — |
| +1 | K113092 | Zimmer Contour Provisional Coping | Zimmer Dental, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 2…on: The new devices are equivalent in design with Predicates. The new devices are dimensional modifications to the Predicates cleared in K953101 and K061043. They differs from the Predicate in that they are shorter in overall height. The materials, general struct… | 1995 |
| * | K061043 | Zimmer Contour Restorative SystemSummary page 2…The new devices are equivalent in design with Predicates. The new devices are dimensional modifications to the Predicates cleared in K953101 and K061043. They differs from the Predicate in that they are shorter in overall height. The materials, general structure, and fun… | 2006 |
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 |
|---|---|---|---|
| K113092 | Zimmer Contour Provisional Coping | 2012 | 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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.
The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.
The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional coping is not to exceed 28 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090723: Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090723
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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