510(k) · Cleared
ClearedBlue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
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 Jun 30, 2022 as substantially equivalent to K190958 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2019) after a 302-day review. Its family tree reaches back 11 generations to 1993. 3 later devices descend from it.
- Decided
- Jun 30, 2022
- Review
- 302 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K925765 (1993). 73 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations between
- 3 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 2 generations backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- 1 generation backK190958 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- This deviceK212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant…Blue Sky Bio, LLC · 2022
- Descendant · cites it directly · 0 of its ownK252168 Straumann® BLC Implants - Indication WideningInstitut Straumann AG · 2026
- Descendant · cites it directly · 0 of its ownK252090 Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2025
- Descendant · cites it directly · 0 of its ownK232726 External Hex Implant SystemSouthern Implants (Pty), Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 9 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 8 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 7 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 6 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 5 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 2 generations backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- 1 generation backK190958 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- This deviceK212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant…Blue Sky Bio, LLC · 2022
Most influential descendants
Showing 3 of 3 · See all- K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG · 2026 · cites it directly0descendants
- K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2025 · cites it directly0descendants
- K232726External Hex Implant SystemSouthern Implants (Pty), Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −10 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −9 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −8 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −7 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −6 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −5 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −2 | K160119 | NobelSpeedy Groovy | Nobel Biocare AB | 2016 | — |
| −1 | K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| 0 (this device) | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue… | Blue Sky Bio, LLC | 2022 | — |
| +1 | K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026 | — |
| +1 | K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025 | — |
| +1 | K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | 2024 | — |
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 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K190958 | Neodent Implant SystemSummary page 4…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary predicate devices: K190958, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA; Reference devices: K061319, Spectra Implant Syst… | 2019 |
| † | K061319 | Spectra System | 2006 |
| † | K191250 | Southern Implants PEEK Abutments | 2019 |
| † | K163634 | External Hex Implants | 2017 |
| † | K190491 | Blue Sky Bio Zygomatic Implant System | 2019 |
| † | K153064 | Blue Sky Bio Zygomatic Implant System | 2016 |
| † | K102034 | Blue Sky Bio Dental Implant System | 2011 |
| † | K060957 | Modification to Blue Sky Bio Dental Implant System | 2006 |
| † | K160119 | NobelSpeedy Groovy | 2016 |
| † | K071235 | Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13 | 2007 |
What descends from it? (3)
3 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 29 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 73 ancestors have a recall of any class.
- Of its descendants, K252168 (Institut Straumann AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190958.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multi-unit restorations in splinted applications.…
Read the full statement (265 words)
Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multi-unit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45º angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45º angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212785
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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