510(k) · Cleared
ClearedBlue Sky Bio Zygomatic Implant System
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 Aug 12, 2019 as substantially equivalent to K153064 (Blue Sky Bio, LLC, 2016) after a 165-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Aug 12, 2019
- Review
- 165 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K960026 (1996). 146 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 2 generations backK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
- This deviceK190491 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019
Show all 15 generations
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 13 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 12 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 8 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 7 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 6 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 5 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 4 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 3 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 2 generations backK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
- This deviceK190491 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −14 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −8 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −7 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −6 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −5 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −4 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −3 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −2 | K141777 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016 | — |
| 0 (this device) | K190491 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 12 | 0 |
| 2002 | 15 | 0 |
| 2003 | 11 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K153064 | Blue Sky Bio Zygomatic Implant SystemSummary page 4…sification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device: K153064, Blue Sky Bio Zygomatic Implant System, Blue Sky Bio, LLC Reference Device: K151909, Noris Medical Zygomatic Dental Implant Syst… | 2016 |
| † | K151909 | Noris Medical Zygomatic Dental Implant System | 2016 |
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 6 companies; a new generation was cleared every 9 months on median.
- 18 of the 146 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?
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190491: Blue Sky Bio Zygomatic Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190491
Report an extraction error
Are you the manufacturer?
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