FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUICKSMILE
K Number: K052040
·
Decision Oct 18, 2005
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
11
Applicant Total
2
Review Days
82
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Basic Information
- Device Name
- QUICKSMILE
- K Number
- K052040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmetic Dental Materials, Inc.
- Date Received
- July 28, 2005
- Decision Date
- October 18, 2005
- 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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Other Clearances by Cosmetic Dental Materials, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063626 | DURAFLEX | Feb 8, 2007 | Substantially Equivalent |