Blue Sky Bio Computerized Orthodontic Bracket System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182338 FDA 510(k)
- FDA Product Code
- DYW 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)
The Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended to assist in orthodontic treatment planning for correcting malocclusions in orthodontic patients. It is designed for use by dental professionals trained in orthodontic treatment and is compatible with commercially available brackets used in standard orthodontic procedures.
The system provides indirect bonding trays for dental professionals to place multiple brackets simultaneously. The device is regulated under FDA 510(k) clearance (K182338) and falls under the medical specialty of dental care. It is not specified whether the device is single-use or reusable, nor are details about sterility, storage, or MRI safety provided.
Frequently asked questions
What is the Blue Sky Bio Computerized Orthodontic Bracket System used for?
The system is intended to assist dental professionals in the orthodontic treatment planning process for correcting malocclusions. It also provides indirect bonding trays that allow for the simultaneous placement of multiple brackets.
Who is the intended user for this device?
The device is designed for use by dental professionals who have been trained in orthodontic treatment procedures.
Is the system compatible with standard orthodontic procedures?
Yes, the system is compatible with commercially available brackets used in standard orthodontic procedures.
What regulatory clearance does the device have?
The device is regulated under FDA 510(k) clearance with the specific number K182338.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 33.2 Computerised Orthodontic Bracket System | Blue Sky Bio Digital, Blue Sky Bio Computerized Orthodontic Bracket System, Blue Sky Bio Computerized Orthodontic Bracket System by Blue Sky Bio ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182338 | Class II | Active |
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Manufacturer
- Manufacturer
- Blue Sky Bio, Llc
- FDA Applicant
- Blue Sky Bio
Sources (1)
- FDA 510(k) K182338 24 fields · synced Oct 1, 2026