510(k) K944286
K944286 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "METAL-LINED TRANSCEND CERAMIC BRACKET". The FDA issued a decision of Substantially Equivalent on November 29, 1994. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Unitek Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1994
- Date Received
- September 2, 1994
- 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