510(k) K041392
K041392 is an FDA 510(k) premarket notification submitted by CAO Group, Inc. for the device "SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US". The FDA issued a decision of Substantially Equivalent on November 8, 2004. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. CAO Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2004
- Date Received
- May 25, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heat Source For Bleaching Teeth
- Device Class
- Class I
- Regulation Number
- 872.6475
- Review Panel
- DE
- Submission Type