510(k) · Cleared
ClearedProvide 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 May 16, 2006 as substantially equivalent to K053170 (Implant Innovations, Inc., 2006) after a 19-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- May 16, 2006
- Review
- 19 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871954 (1987). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871954 Abutment Head PostImplant Innovations International, Inc. · 1987
- 1 generation backK053170 Preformance PostsImplant Innovations, Inc. · 2006 · Recalled
- This deviceK061177 Provide Temporary CylinderImplant Innovations, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK071551 Quickbridge TM Cylinder and CapBiomet 3i, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK130310 Certain Bellatek Provisional AbutmentsBiomet 3i · 2013
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 |
|---|---|---|---|---|---|
| −2 | K871954 | Abutment Head Post | Implant Innovations International, Inc. | 1987 | — |
| −1 | K053170 | Preformance Posts | Implant Innovations, Inc. | 2006 | 3 |
| 0 (this device) | K061177 | Provide Temporary Cylinder | Implant Innovations, Inc. | 2006 | — |
| +1 | K071551 | Quickbridge TM Cylinder and Cap | Biomet 3i, Inc. | 2007 | 1 |
| +1 | K130310 | Certain Bellatek Provisional Abutments | Biomet 3i | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 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 HI Classification Dental Devices Panel 21 CFR § 872.3630 Predicate PreFormance Posts -> K053170 Devices Performance Performance standards have not been established by the F… | 2006 |
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?
- 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, K071551 (Biomet 3i, Inc., 2007) has gone furthest, with 1 descendant 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 Provide 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 cement retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061177: Provide Temporary Cylinder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061177
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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