510(k) · Cleared
ClearedZimmer Contour Restorative System
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 Jun 27, 2006 after a 74-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jun 27, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK061043 Zimmer Contour Restorative SystemZimmer Dental, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK090723 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061043 | Zimmer Contour Restorative System | Zimmer Dental, Inc. | 2006 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | — | Zimmer Dental Advent® Implant Extender/ Healing Collar Named without a submission number | |
| * | — | 3i EP Two Piece Healing Abutment Named without a submission number | |
| * | — | Lifecore Quick-Abutment Temporary/ Healing Cap Named without a submission number | |
| * | — | Zimmer Dental Pure Form Ceramic Coping Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090723 (Zimmer Dental, Inc., 2009) has gone furthest, with 1 descendant of its own.
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 Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.
The Zimmer® Contour Healing Cap is for use with a Hex-LockTM Contour Abutment or a Zimmer® One-Piece Implant 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 Zimmer® Contour Provisional Coping is used for fabricating a provisional restoration for a Hex-LockTM Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional coping is not to exceed 28 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061043: Zimmer Contour Restorative System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061043
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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