510(k) · Cleared
Recalled · Class II · 2015Preformance Posts and Temporary Cylinders
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 Jul 21, 2006 as substantially equivalent to K053170 (Implant Innovations, Inc., 2006) and 1 other predicate after a 9-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 21, 2006
- Review
- 9 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871954 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK871954 Abutment Head PostImplant Innovations International, Inc. · 1987
- 2 generations backK053170 Preformance PostsImplant Innovations, Inc. · 2006 · Recalled
- 1 generation backK060291 Preformance Temporary CylinderImplant Innovations, Inc. · 2006 · Recalled
- This deviceK061969 Preformance Posts and Temporary CylindersImplant Innovations, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK102467 Uta and UhaUta · 2011
Most influential descendants
Showing 1 of 1 · See all- K102467Uta and UhaUta · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871954 | Abutment Head Post | Implant Innovations International, Inc. | 1987 | — |
| −2 | K053170 | Preformance Posts | Implant Innovations, Inc. | 2006 | 3 |
| −1 | K060291 | Preformance Temporary Cylinder | Implant Innovations, Inc. | 2006 | 3 |
| 0 (this device) | K061969 | Preformance Posts and Temporary Cylinders | Implant Innovations, Inc. | 2006 | — |
| +1 | K102467 | Uta and Uha | Uta | 2011 | — |
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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K053170 | Preformance PostsSummary page 1…I Classification Dental Devices Panel 21 CFR § 872.3630 Predicate PreFormanceTM Posts -> K053 170 Devices PreFormanceTm Temporary Cylinders -> K06029 1 Performance Performance… | 2006 |
| * | K060291 | Preformance Temporary CylinderSummary page 1…21 CFR § 872.3630 Predicate PreFormanceTM Posts -> K053 170 Devices PreFormanceTm Temporary Cylinders -> K06029 1 Performance Performance standards have not been established by the FD… | 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 |
|---|---|---|---|
| K102467 | Uta and Uha | 2011 | 0 |
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-2436-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2437-2016 | Packaging | Pouches may not have been sealed during packing. |
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 5 months on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K102467 (Uta, 2011) has gone furthest, with 0 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 Abutment Posts and 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061969: Preformance Posts and Temporary Cylinders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061969
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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