FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US
K Number: K041392
·
Decision Nov 8, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
11
Applicant Total
31
Review Days
167
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Basic Information
- Device Name
- SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US
- K Number
- K041392
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CAO Group, Inc.
- Date Received
- May 25, 2004
- Decision Date
- November 8, 2004
- Product Code
- EEG
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | FDA class 1 | Dental |
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