510(k) · Cleared
ClearedEztetic BellaTek Encode Healing 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 Sep 21, 2017 as substantially equivalent to K072642 (Biomet 3i, Inc., 2007) after a 261-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Sep 21, 2017
- Review
- 261 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072642 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK072642 Biomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. · 2007 · Recalled
- This deviceK170013 Eztetic BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- Descendant · cites it directly · 2 of its ownK173374 TSV BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
- Descendant · 2 generations on · 0 of its ownK212730 BellaTek Encode Emergence Healing AbutmentsBiomet 3i, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072642 | Biomet 3I Dental Abutments and Restorative Components | Biomet 3i, Inc. | 2007 | 81 |
| 0 (this device) | K170013 | Eztetic BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| +1 | K173374 | TSV BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| +2 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
| +2 | K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 4…es: Primary predicate device: • BellaTek® Encode® Healing Abutments referenced in Biomet 3i Dental Abutments and Restorative Components (K072642 / SE 12/20/2007) Reference device: • Healing Collars referenced in Zimmer 3.1mm Dental Implant System (K142082… | 2007 |
| † | K142082 | Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173374 | TSV BellaTek Encode Healing Abutments | 2017 | 2 |
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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Eztetic™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170013: Eztetic BellaTek Encode Healing Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170013
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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