510(k) · Cleared
ClearedCertain Bellatek Provisional Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 21, 2013 as substantially equivalent to K072642 (Biomet 3i, Inc., 2007) and 3 other predicates after a 134-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jun 21, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871954 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871954 Abutment Head PostImplant Innovations International, Inc. · 1987
- 3 generations backK053170 Preformance PostsImplant Innovations, Inc. · 2006 · Recalled
- 2 generations backK061177 Provide Temporary CylinderImplant Innovations, Inc. · 2006
- 1 generation backK071551 Quickbridge TM Cylinder and CapBiomet 3i, Inc. · 2007 · Recalled
- This deviceK130310 Certain Bellatek Provisional AbutmentsBiomet 3i · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871954 | Abutment Head Post | Implant Innovations International, Inc. | 1987 | — |
| −3 | K053170 | Preformance Posts | Implant Innovations, Inc. | 2006 | 3 |
| −2 | K061177 | Provide Temporary Cylinder | Implant Innovations, Inc. | 2006 | — |
| −1 | K071551 | Quickbridge TM Cylinder and Cap | Biomet 3i, Inc. | 2007 | 1 |
| 0 (this device) | K130310 | Certain Bellatek Provisional Abutments | Biomet 3i | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…dosseous Dental Implant Abutment Classification panel Dental Regulation 21CFR §872.3630 Product Code(s) NHA Legally marketed device(s) to which equivalence is claimed K072642 BIOMET3i™ Dental Abutments and Restorative -Components KO71551 QuickBridge® Cylinder and Cap K061177 PROVIDE® Temporary Cylinde… | 2007 |
| * | K071551 | Quickbridge TM Cylinder and Cap | 2007 |
| * | K061177 | Provide Temporary CylinderSummary page 1…) NHA Legally marketed device(s) to which equivalence is claimed K072642 BIOMET3i™ Dental Abutments and Restorative -Components KO71551 QuickBridge® Cylinder and Cap K061177 PROVIDE® Temporary Cylinder K060291 PreFormance® Temporary Cylinder Reason for 510(k) submission Addition to BIOMET 3i™ abutmen… | 2006 |
| * | K060291 | Preformance Temporary CylinderSummary page 1…which equivalence is claimed K072642 BIOMET3i™ Dental Abutments and Restorative -Components KO71551 QuickBridge® Cylinder and Cap K061177 PROVIDE® Temporary Cylinder K060291 PreFormance® Temporary Cylinder Reason for 510(k) submission Addition to BIOMET 3i™ abutment product line to include a two piec… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 11 other devices also cite its predicate K072642.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Provisional Abutments 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 a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of provisional restorations. The prosthesis will be mechanically retained to the abutment system.
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/K130310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130310: Certain Bellatek Provisional Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130310
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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