510(k) · Cleared
ClearedDrill for Blue Sky Bio Dental 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 Mar 29, 2007 after a 90-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Mar 29, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK063874 Drill for Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC · 2007
- Descendant · cites it directly · 4 of its ownK102034 Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · 2 generations on · 1 of its ownK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK190491 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC · 2011 · cites it directly4descendants
- K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · 2 generations on1descendant
- K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016 · 2 generations on1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 3 generations on0descendants
- K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063874 | Drill for Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | 2007 | — |
| +1 | K102034 | Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | 2011 | — |
| +2 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +2 | K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016 | — |
| +3 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
| +3 | K190491 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102034 | Blue Sky Bio Dental Implant System | 2011 | 4 |
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?
- Of its descendants, K102034 (Blue Sky Bio, LLC, 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis For single stage or two stage surgical procedure One piece implants for single stage procedure only For immediate placement and immediate…
Read the full statement (123 words)
For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
For single tooth or multiple unit prosthesis
For single stage or two stage surgical procedure
One piece implants for single stage procedure only
For immediate placement and immediate function when multiple units are splinted and for single units when adequate initial stability is achieved in type I or type 11 bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063874: Drill for Blue Sky Bio Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063874
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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