Composite Orthodontic Brackets
FDA 510(k) K140807 · Ortho Specialties
510(k) numberK140807
Submission
- Device name
- Composite Orthodontic Brackets
- Applicant
- Ortho Specialties
Gurnee, IL, US - Received
- April 1, 2014
- Decision date
- November 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DYW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket SystemDYW · Traditional | Blue Sky Bio | 11/09/2018SE |
| 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 |
| 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 |
|---|---|---|
| K936243 | Regency TubeDZD · Traditional | 02/02/1994SE |
Questions and answers
When was Composite Orthodontic Brackets cleared by the FDA?
Composite Orthodontic Brackets (K140807) received a 510(k) decision of Substantially Equivalent on November 12, 2014, 225 days after the submission was received.
What is the product code of K140807?
The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.