510(k) · Cleared
ClearedBlue Sky Bio CAD-CAM Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Sky Bio, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 18, 2020 as substantially equivalent to K191986 (Terrats Medical SL, 2019) after a 149-day review. Its family tree reaches back 18 generations to 1996. 11 later devices descend from it.
- Decided
- Dec 18, 2020
- Review
- 149 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K960026 (1996). 321 ancestors in all, the oldest K781060 (1978). 11 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- Descendant · cites it directly · 9 of its ownK212108 Dynamic TiBaseTalladium España, SL · 2021
- Descendant · 2 generations on · 5 of its ownK221966 Dynamic TiBaseTalladium Espana, SL · 2022
- Descendant · 3 generations on · 2 of its ownK232151 Dynamic TiBaseTalladium España, SL · 2023
- Descendant · 3 generations on · 1 of its ownK231559 Multi-Unit DAS SystemTalladium España, SL · 2023
- Descendant · 2 generations on · 1 of its ownK221673 Bonafix TiBaseZentek Medical, LLC · 2023
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K212108Dynamic TiBaseTalladium España, SL · 2021 · cites it directly9descendants
- K221966Dynamic TiBaseTalladium Espana, SL · 2022 · 2 generations on5descendants
- K232151Dynamic TiBaseTalladium España, SL · 2023 · 3 generations on2descendants
- K231559Multi-Unit DAS SystemTalladium España, SL · 2023 · 3 generations on1descendant
- K221673Bonafix TiBaseZentek Medical, LLC · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −1 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| 0 (this device) | K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 | — |
| +1 | K212108 | Dynamic TiBase | Talladium España, SL | 2021 | — |
| +2 | K221966 | Dynamic TiBase | Talladium Espana, SL | 2022 | — |
| +3 | K232151 | Dynamic TiBase | Talladium España, SL | 2023 | — |
| +3 | K231559 | Multi-Unit DAS System | Talladium España, SL | 2023 | — |
| +2 | K221673 | Bonafix TiBase | Zentek Medical, LLC | 2023 | — |
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 | 24 | 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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 30.7 · 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 |
|---|---|---|---|
| * | K191986 | DESS Dental Smart SolutionsSummary page 4…spiratory, ENT and Dental Devices) Reviewing Division Division of Health Technology 1B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K180536, Neodent Implant System - GM Line, JJGC Indústria e C… | 2019 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K102034 | Blue Sky Bio Dental Implant System | 2011 |
| † | K060957 | Modification to Blue Sky Bio Dental Implant System | 2006 |
| † | K051507 | Modification to Blue Sky Bio Dental Implant System | 2005 |
| † | K183518 | Preat Abutments | 2019 |
| † | K151984 | Thommen Milling Abutment for CAD/CAM | 2016 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 44 of the 321 ancestors have a recall of any class.
- Of its descendants, K212108 (Talladium España, SL, 2021) has gone furthest, with 9 descendants of its own.
- 8 other devices also cite its predicate K191986.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202026 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202026: Blue Sky Bio CAD-CAM Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202026
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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