Identifiers
- 510(k) Number
- K180107 FDA 510(k)
- FDA Product Code
- NXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A comprehensive overview of the Blue Sky Bio Aligner medical device, including its key features, regulatory compliance, and FAQs.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180107 | Class II | Active |
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Manufacturer
- Manufacturer
- Blue Sky Bio Llc
- FDA Applicant
- Blue Sky Bio, LLC
Sources (1)
- FDA 510(k) K180107 24 fields · synced Jul 30, 2026