Blue Sky Bio Computerized Orthodontic Bracket System
FDA 510(k) K182338 · Blue Sky Bio
510(k) numberK182338
Submission
- Device name
- Blue Sky Bio Computerized Orthodontic Bracket System
- Applicant
- Blue Sky Bio
Grayslake, IL, US - Received
- August 28, 2018
- Decision date
- November 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K252760 | Carriere® Motion Pro® Clear Bite CorrectorDYW · Traditional | Ortho Organizers, Inc. | 11/27/2025SE |
| K251196 | Composite Orthodontic Brackets and ButtonsDYW · Traditional | Ec Certification Service GmbH | 04/21/2025SE |
| K201940 | Braces on Demand BracketDYW · Traditional | Braces on Demand, Inc. | 12/03/2020SE |
| K180718 | Orthodontic Plastic Brackets and AccessoriesDYW · Traditional | Tomy, Inc. | 10/30/2018SE |
| K160720 | Carriere Motion Clear Class IIDYW · Traditional | Ortho Organizers, Inc. | 11/28/2016SE |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire ApplianceDYW · Traditional | Oracrew | 08/26/2016SE |
| K150702 | Exceed TxDYW · Traditional | Great Lakes Orthodontics, Ltd. | 03/24/2016SE |
| K140807 | Composite Orthodontic BracketsDYW · Traditional | Ortho Specialties | 11/12/2014SE |
| K123118 | Insignia DigicastDYW · Traditional | Ormco Corp. | 03/26/2013SE |
| K123416 | Insignia with IteroDYW · Traditional | Ormco Corp. | 03/13/2013SE |
More from Ormco Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXNXC · Traditional | 04/03/2024SE |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXC · Abbreviated | 02/24/2023SE |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…DZE · Traditional | 06/30/2022SE |
| K202026 | Blue Sky Bio CAD-CAM AbutmentsNHA · Traditional | 12/18/2020SE |
| K201919 | Blue Sky Bio TADOAT · Traditional | 12/17/2020SE |
| K190491 | Blue Sky Bio Zygomatic Implant SystemNHA · Traditional | 08/12/2019SE |
| K180107 | Blue Sky Bio AlignerNXC · Traditional | 02/09/2018SE |
| K163251 | Life Essence Universal Porcelain SystemEIH · Traditional | 08/04/2017SE |
| K153064 | Blue Sky Bio Zygomatic Implant SystemDZE · Traditional | 04/29/2016SE |
| K112875 | Blue Sky Bio Dental Taper Hex Implant SystemsDZE · Traditional | 01/27/2012SE |
Questions and answers
When was Blue Sky Bio Computerized Orthodontic Bracket System cleared by the FDA?
Blue Sky Bio Computerized Orthodontic Bracket System (K182338) received a 510(k) decision of Substantially Equivalent on November 9, 2018, 73 days after the submission was received.
What is the product code of K182338?
The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.