Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
FDA 510(k) K250015 · Ormco Corporation
510(k) numberK250015
Submission
- Device name
- Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- Applicant
- Ormco Corporation
Brea, CA, US - Received
- January 2, 2025
- Decision date
- January 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K123118 | Insignia DigicastDYW · Traditional | 03/26/2013SE |
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Questions and answers
When was Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive cleared by the FDA?
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive (K250015) received a 510(k) decision of Substantially Equivalent on January 3, 2025, 1 days after the submission was received.
What is the product code of K250015?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.