510(k) · Cleared
Recalled · Class II · 2015Preformance Temporary Cylinder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 27, 2006 as substantially equivalent to K053170 (Implant Innovations, Inc., 2006) after a 21-day review. Its family tree reaches back 2 generations to 1987. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 27, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871954 (1987). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK871954 Abutment Head PostImplant Innovations International, Inc. · 1987
- 1 generation backK053170 Preformance PostsImplant Innovations, Inc. · 2006 · Recalled
- This deviceK060291 Preformance Temporary CylinderImplant Innovations, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- Descendant · 2 generations on · 4 of its ownK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · 2 generations on · 3 of its ownK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
- Descendant · 2 generations on · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · 3 generations on · 1 of its ownK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013 · cites it directly9descendants
- K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016 · 2 generations on4descendants
- K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016 · 2 generations on3descendants
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · 2 generations on2descendants
- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871954 | Abutment Head Post | Implant Innovations International, Inc. | 1987 | — |
| −1 | K053170 | Preformance Posts | Implant Innovations, Inc. | 2006 | 3 |
| 0 (this device) | K060291 | Preformance Temporary Cylinder | Implant Innovations, Inc. | 2006 | — |
| +1 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| +2 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +2 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
| +2 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +3 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K053170 | Preformance PostsSummary page 1…Class 11 Classification Dental Devices Panel 21 CFR § 872.3630 Predicate PreFormance Posts -> K053170 Devices Performance Performance standards have not been established by the… | 2006 |
What descends from it? (13)
See all 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2015 | Class II | Z-2493-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2415-2016 | Packaging | Pouches may not have been sealed during packing. |
| Oct 8, 2007 | Not classified | Z-0128-2008 | Process control | Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 18.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K122988 (Soadco, S.L., 2013) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K053170.
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 PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060291: Preformance Temporary Cylinder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060291
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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