510(k) · Cleared
ClearedBlue 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 Apr 19, 2011 as substantially equivalent to K051507 (Blue Sky Bio, LLC, 2005) and 6 other predicates after a 274-day review. Its family tree reaches back 8 generations to 1990. 4 later devices descend from it.
- Decided
- Apr 19, 2011
- Review
- 274 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K894595 (1990). 36 ancestors in all, the oldest K894844 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK102034 Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC · 2011
- Descendant · cites it directly · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · cites it directly · 1 of its ownK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK190491 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · cites it directly1descendant
- K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016 · cites it directly1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
- K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K102034 | Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | 2011 | — |
| +1 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +1 | K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K051507 | Modification to Blue Sky Bio Dental Implant SystemSummary page 1…straight abutments Platform Predicate Square Taper Regular, Wide K05 1507 , K060957 Double Hex Narrow, Regular, Wide K05 1507 , K060957… | 2005 |
| * | K060957 | Modification to Blue Sky Bio Dental Implant SystemSummary page 1…utments Platform Predicate Square Taper Regular, Wide K05 1507 , K060957 Double Hex Narrow, Regular, Wide K05 1507 , K060957 Tap… | 2006 |
| * | K063874 | Drill for Blue Sky Bio Dental Implant SystemSummary page 4…K062129 Implant System K051507,K060957, K063874, K 73713 Material Alloy, .Titanium CP Titanium Grade 4,… | 2007 |
| * | K073713 | Blue Sky Bio Dental Implant SystemSummary page 1…Platform Angle deg. Blue Sky Rio Predicate Square Taper Angled Regular, Wide 15 K073713 Sqftare Taper Angled Regular, Wide 25 K073713 Double Hex Angled… | 2008 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 4…Blue Sky Bio Dental Dental Implant Implant System Dental Implant System System K071370. K062129 Implant System K051507,K060957,… | 2007 |
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 5…Blue Sky Bio Dental Blue Sky Bio Dental Implant Implant System Implant System System K052997 (One Piece) K051507 Material Ti-6A1-4V Ti-6A1-4V Ti-6A1… | 2006 |
| * | K062129 | P.0004 ImplantsSummary page 4…tal Implant Implant System Dental Implant System System K071370. K062129 Implant System K051507,K060957,… | 2006 |
What descends from it? (4)
2 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 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K213576 (Suncoast Dental, Inc. Dba Tatum Surgical, 2022) has gone furthest, with 1 descendant 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. 2011, 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?
Intended Use for Two-Piece Implant Systems *For implantation into any area of the fully 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 *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…
Read the full statement (242 words)
Intended Use for Two-Piece Implant Systems
*For implantation into any area of the fully 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
*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.
*Unsplinted narrow implants and angled abutments are not to be used in the posterior areas.
*Taper Hex Implant System is compatible with NobelActive implants and prosthetics
*Double Hex Implant System is compatible with Astra double hex implants and prosthetics
*Square Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics
Intended Use for One-Piece Implant System
*For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
*For single tooth or multiple unit prosthesis
*For single stage surgical procedure
*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. In edentulous cases four or more implants must be used
*Overdenture Implants are intended for support of removable prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102034: Blue Sky Bio Dental 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/K102034
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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