510(k) · Cleared
ClearedContour Healer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contour Healer, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 3, 2012 as substantially equivalent to K092377 (Zimmer Dental, Inc., 2009) after a 196-day review. Its family tree reaches back 1 generation to 2009. 21 later devices descend from it.
- Decided
- Feb 3, 2012
- Review
- 196 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092377 (2009). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK092377 Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A…Zimmer Dental, Inc. · 2009
- This deviceK112099 Contour HealerContour Healer, LLC · 2012
- Descendant · cites it directly · 19 of its ownK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- Descendant · 2 generations on · 12 of its ownK151328 PURE Ceramic ImplantsStraumann USA · 2016
- Descendant · 3 generations on · 8 of its ownK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
- Descendant · 2 generations on · 8 of its ownK132881 Z5CZ-Systems AG · 2014
- Descendant · 4 generations on · 6 of its ownK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120793Z-LOOK3 Evo SLMZ-Systems AG · 2012 · cites it directly19descendants
- K151328PURE Ceramic ImplantsStraumann USA · 2016 · 2 generations on12descendants
- K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017 · 3 generations on8descendants
- K132881Z5CZ-Systems AG · 2014 · 2 generations on8descendants
- K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S… | Zimmer Dental, Inc. | 2009 | — |
| 0 (this device) | K112099 | Contour Healer | Contour Healer, LLC | 2012 | — |
| +1 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| +2 | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
| +3 | K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017 | — |
| +2 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| +4 | K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S…Summary page 2…l Abutment Classification: Class 11, 21 CFR 872.3630; Product Code NHA Legally marketed device to which equivalence isclaimed:Zimmer Dental Plastic Temporary Abutment [K092377] Device Description The Contour Healer, LLC product line includes pre-manufactured dental abutments intended to serve… | 2009 |
What descends from it? (21)
See all 212 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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed. These abutments are designed to work with…
Read the full statement (103 words)
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed.
These abutments are designed to work with the following implant systems:
Zimmer [Screw-Vent Dental Implant System]
Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Implant, Nobel Biocare Endosseous Implants, and Groovy Implants]
BioHorizons [BioHorizons Tapered Internal Implant System].
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112099: Contour Healer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112099
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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