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 · DZE Implant, Endosseous, Root-Form
Cleared on Apr 29, 2016 as substantially equivalent to K141777 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2015) and 3 other predicates after a 190-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Apr 29, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K960026 (1996). 145 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations between
- 3 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 2 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 1 generation backK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- This deviceK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
- Descendant · cites it directly · 0 of its ownK190491 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019
Show all 14 generations
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 12 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 11 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 7 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 6 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 5 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 4 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 3 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 2 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 1 generation backK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- This deviceK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
Most influential descendants
Showing 1 of 1 · See all- K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −13 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −7 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −6 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −5 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −4 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −2 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −1 | K141777 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| 0 (this device) | K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K141777 | Neodent Implant SystemSummary page 5…ant System Page 2 of 5 K153064 PREDICATE DEVICE INFORMATION Primary predicate device: K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA Reference predicate devices: K102034, Blue Sky Bio… | 2015 |
| * | K102034 | Blue Sky Bio Dental Implant SystemSummary page 5…PREDICATE DEVICE INFORMATION Primary predicate device: K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA Reference predicate devices: K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K093562, Zy… | 2011 |
| * | K060957 | Modification to Blue Sky Bio Dental Implant SystemSummary page 5…Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA Reference predicate devices: K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K093562, Zygomatic Implant System, Southern Implants, Inc. INTENDED USE B… | 2006 |
| * | K093562 | Endosseous Dental ImplantSummary page 5…Dentários SA Reference predicate devices: K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K093562, Zygomatic Implant System, Southern Implants, Inc. INTENDED USE Blue Sky Bio Zygomatic Implant System is indicated for surgical… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190491 | Blue Sky Bio Zygomatic Implant System | 2019 | 0 |
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 20 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 18 of the 145 ancestors have a recall of any class.
- Of its descendants, K190491 (Blue Sky Bio, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141777.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
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/K153064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153064: Blue Sky Bio Zygomatic Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153064
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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