510(k) · Cleared
ClearedBlue Sky Bio Dental Taper Hex Implant Systems
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 Jan 27, 2012 as substantially equivalent to K080396 (Astra Tech AB, 2008) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Jan 27, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K073713 (2008). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK073713 Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC · 2008
- This deviceK112875 Blue Sky Bio Dental Taper Hex Implant SystemsBlue Sky Bio, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073713 | Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | 2008 | — |
| 0 (this device) | K112875 | Blue Sky Bio Dental Taper Hex Implant Systems | Blue Sky Bio, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K080396 | Osseospeed NarrowSummary page 2…evice Blue Sky Rio 3mm Dental Astra Tech 3mm Dental Implant System (Double Hex Implant System K080396. 3mm) MaeilCP Titanium Grade 4, PTtnu… | 2008 |
| * | K073713 | Blue Sky Bio Dental Implant SystemSummary page 3…ially available Dental Implant Systems including predicate devices Osseospeed Narrow Dental Implant System Astratech (K080396) and to Blue Sky Bio Dental Implant System (K0737 13) The technical comparison charts list the primary technical aspects and specifications that are pertinent to Dental Implant Syste… | 2008 |
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?
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K080396.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 3mm Double Hex implants are primarily intended for restoration of mandibular incisors and maxillary lateral incisors Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws Implants can be placed in immediate function on single-tooth and/or multiple tooth applications…
Read the full statement (146 words)
Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular incisors and maxillary lateral incisors
Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
Implants can be placed in immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations.
In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed Narrow abutments.
Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow Implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112875: Blue Sky Bio Dental Taper Hex Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112875
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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