Composite Orthodontic Brackets and Buttons
FDA 510(k) K251196 · Ec Certification Service GmbH
510(k) numberK251196
Submission
- Device name
- Composite Orthodontic Brackets and Buttons
- Applicant
- Ec Certification Service GmbH
Sankt Veit An Der Glan, AT - Received
- April 17, 2025
- Decision date
- April 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
| 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 |
Questions and answers
When was Composite Orthodontic Brackets and Buttons cleared by the FDA?
Composite Orthodontic Brackets and Buttons (K251196) received a 510(k) decision of Substantially Equivalent on April 21, 2025, 4 days after the submission was received.
What is the product code of K251196?
The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.