510(k) K951776
K951776 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "BAND SEATER". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code ECR (Setter, Band, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Ormco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1995
- Date Received
- April 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Setter, Band, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type