510(k) K101676
K101676 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "CLEARARCH". The FDA issued a decision of Substantially Equivalent on September 13, 2010. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Ormco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2010
- Date Received
- June 15, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bracket, Plastic, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type