510(k) · Cleared
ClearedCertain Contoured Margin Ceramic Abutment
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 Mar 7, 2008 after a 100-day review. The FDA summary names its predicate without a number. 56 later devices descend from it.
- Decided
- Mar 7, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 2 citing it directly.
- This deviceK073345 Certain Contoured Margin Ceramic AbutmentBiomet 3i, Inc. · 2008
- Descendant · cites it directly · 54 of its ownK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- Descendant · 2 generations on · 39 of its ownK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- Descendant · 3 generations on · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- Descendant · 4 generations on · 13 of its ownK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- Descendant · 5 generations on · 7 of its ownK171532 TruBase STruabutment, Inc. · 2018
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012 · cites it directly54descendants
- K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013 · 2 generations on39descendants
- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC · 2015 · 3 generations on30descendants
- K151324Straumann Variobase for CERECStraumann USA, LLC · 2015 · 4 generations on13descendants
- K171532TruBase STruabutment, Inc. · 2018 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073345 | Certain Contoured Margin Ceramic Abutment | Biomet 3i, Inc. | 2008 | — |
| +1 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| +2 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| +3 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| +4 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| +5 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | — | BIOMET 3i Dental Ceramic Abutments Named without a submission number | |
| * | — | Zimmer Contour Ceramic Abutment Named without a submission number |
What descends from it? (56)
See all 562 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?
- Of its descendants, K111421 (Sirona Dental Systems GmbH, 2012) has gone furthest, with 54 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. 2008, 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 Certain® Contoured Margin Ceramic Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or totally edentulous patient. The Certain® Contoured Margin Ceramic Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is cement-retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073345: Certain Contoured Margin Ceramic Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073345
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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