510(k) · Cleared
ClearedTSV BellaTek Express and BellaTek Flex 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 9, 2019 as substantially equivalent to K183138 (Biomet 3i, 2019) after an 87-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Dec 9, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K960026 (1996). 318 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183138 Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i · 2019
- This deviceK192522 TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC · 2019
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183138 Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i · 2019
- This deviceK192522 TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −7 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −6 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −5 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −1 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments | Biomet 3i | 2019 | — |
| 0 (this device) | K192522 | TSV BellaTek Express and BellaTek Flex Abutments | Biomet 3i, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 23 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K183138 | Certain BellaTek Express and BellaTek Flex AbutmentsSummary page 4…ranch: Dental Devices Branch VII. Predicate Devices: Primary predicate device: • Certain BellaTek Express and BellaTek Flex Abutment (K183138 / SE 07/02/2019) Reference Predicate Device: • Zimmer Zfx Titanium Base Abutment (K133551 / SE 07/18/2014) VII… | 2019 |
| † | K133551 | Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant System | 2014 |
| † | K150571 | 3i T3 Short Implants | 2015 |
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 23 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 43 of the 318 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants 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.
All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192522: TSV BellaTek Express and BellaTek Flex Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192522
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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