510(k) · Cleared
Recalled · Class II · 2020Biomet 3I Dental Abutments and Restorative Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 20, 2007 after a 93-day review. The FDA summary names its predicate without a number. 256 later devices descend from it. It has been recalled 81 times.
- Decided
- Dec 20, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 81
- Predicates
- 0
256 later devices descend from it, 12 citing it directly.
- This deviceK072642 Biomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. · 2007
- Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 256 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 256 · See all- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072642 | Biomet 3I Dental Abutments and Restorative Components | Biomet 3i, Inc. | 2007 | — |
| +1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 23 | 0 |
| 2022 | 19 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 27 | 0 |
| 2026 | 14 | 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? (10)
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 |
|---|---|---|---|
| * | — | UCLA Named without a submission number | |
| * | — | Gingehue Named without a submission number | |
| * | — | Certain Provide Named without a submission number | |
| * | — | Pre-Angled Abutments Named without a submission number | |
| * | — | Conical Abutments Named without a submission number | |
| * | — | Tapered Abutments Named without a submission number | |
| * | — | Temporary Healing Abutments Named without a submission number | |
| * | — | Abutment Posts Named without a submission number | |
| * | — | Rocket II Abutments Named without a submission number | |
| * | — | IOL Abutments Named without a submission number |
What descends from it? (256)
See all 25612 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100152 | Sirona Cad/Cam System | 2010 | 240 |
| K111935 | TI-Base Abutment, 1 Connect Abutment | 2012 | 64 |
| K111421 | Sirona Dental Cad/Cam System | 2012 | 54 |
| K083480 | Inclusive Zirconia Abutment Blanks | 2009 | 27 |
| K170013 | Eztetic BellaTek Encode Healing Abutments | 2017 | 3 |
| K102822 | Implant-One System | 2011 | 3 |
| K073217 | Inclusive Implant Abutments | 2008 | 3 |
| K183024 | Implacil Implant System | 2020 | 2 |
| K142115 | Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant | 2014 | 2 |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2020 | Class II | Z-1366-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1378-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1375-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1371-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1368-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1384-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1385-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1386-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1379-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1382-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1373-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1388-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1387-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1367-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1369-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1374-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1372-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1370-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1377-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1380-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1383-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1381-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Jan 10, 2020 | Class II | Z-1376-2020 | Process control | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Nov 25, 2015 | Class II | Z-2499-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2486-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2464-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2515-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2450-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2506-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2445-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2494-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2456-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2468-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2524-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2418-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2466-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2409-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2412-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2439-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2476-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2449-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2417-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2407-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2507-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2406-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2503-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2413-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2512-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2474-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2509-2016 | Packaging | Pouches may not have been sealed during packing. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100152 (Sirona Dental Systems GmbH, 2010) has gone furthest, with 240 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. 2007, 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?
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. Restorative Components * Temporary Healing Abutments are intended for use to shape and maintain the soft tissue…
Read the full statement (119 words)
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
Restorative Components
* Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
* Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental prosthetics.
* Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072642: Biomet 3I Dental Abutments and Restorative Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072642
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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