Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
FDA 510(k) clearance K212785 · decided 2022-06-30
Clearance details
- K-number
- K212785
- Device name
- Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
- Applicant
- Blue Sky Bio, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-09-01
- Decision date
- 2022-06-30
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Libertyville, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Adin Long Dental Implant System (K252031) | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| ZENEX Implant System_Short (R-System) (K253334) | Izenimplant Co., Ltd. | 2026-03-16 |
| Straumann® BLC Implants - Indication Widening (K252168) | Institut Straumann AG | 2026-03-10 |
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| Nobel Biocare S Series Implants (K252197) | Nobel Biocare AB | 2026-02-18 |
| BIORES Dental Implant System (K252286) | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
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Recalls involving this device
No recalls on record reference this clearance.