510(k) · Cleared
ClearedPlastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
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 Nov 3, 2009 after a 90-day review. The FDA summary names its predicate without a number. 51 later devices descend from it.
- Decided
- Nov 3, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 7 citing it directly.
- This deviceK092377 Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A…Zimmer Dental, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · cites it directly · 21 of its ownK112099 Contour HealerContour Healer, LLC · 2012
- Descendant · cites it directly · 19 of its ownK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 2 generations on · 12 of its ownK151328 PURE Ceramic ImplantsStraumann USA · 2016
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K112099Contour HealerContour Healer, LLC · 2012 · cites it directly21descendants
- K120793Z-LOOK3 Evo SLMZ-Systems AG · 2012 · cites it directly19descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K151328PURE Ceramic ImplantsStraumann USA · 2016 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S… | Zimmer Dental, Inc. | 2009 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +1 | K112099 | Contour Healer | Contour Healer, LLC | 2012 | — |
| +1 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +2 | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 30.7 · 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? (3)
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 |
|---|---|---|---|
| * | — | Hex-Lock® Temporary Abutment Named without a submission number | |
| * | — | Friadent® EsthetiCap Named without a submission number | |
| * | — | PreFormance Post Named without a submission number |
What descends from it? (51)
See all 517 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K112099 | Contour Healer | 2012 | 21 |
| K120793 | Z-LOOK3 Evo SLM | 2012 | 19 |
| K161435 | Temporary Snap Abutment | 2016 | 0 |
| K142082 | Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement | 2014 | 0 |
| K122559 | Biodenta Dental Implant System - Abutments | 2013 | 0 |
| 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?
- Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 descendants 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. 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 Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092377: Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092377
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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