510(k) · Cleared
ClearedBellaTek Encode Emergence Healing Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 21, 2021 as substantially equivalent to K173374 (Biomet 3i, 2017) after a 113-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Dec 21, 2021
- Review
- 113 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072642 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK072642 Biomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. · 2007 · Recalled
- 2 generations backK170013 Eztetic BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- 1 generation backK173374 TSV BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- This deviceK212730 BellaTek Encode Emergence Healing AbutmentsBiomet 3i, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072642 | Biomet 3I Dental Abutments and Restorative Components | Biomet 3i, Inc. | 2007 | 81 |
| −2 | K170013 | Eztetic BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| −1 | K173374 | TSV BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| 0 (this device) | K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | 2021 | — |
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 30.7 · 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 |
|---|---|---|---|
| * | K173374 | TSV BellaTek Encode Healing AbutmentsSummary page 4…Class II V. Product Code: NHA VI. Predicate Devices: Primary predicate device: • TSV BellaTek Encode Healing Abutments (K173374) Reference device: • Eztetic BellaTek Encode Healing Abutments (K170013) • Certain BellaTek Encode He… | 2017 |
| † | K170013 | Eztetic BellaTek Encode Healing Abutments | 2017 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K173374.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BellaTek Encode Emergence 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/K212730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212730: BellaTek Encode Emergence Healing Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212730
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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