FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K Number: K033675
·
Decision Jan 15, 2004
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
42
Review Days
52
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Basic Information
- Device Name
- PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
- K Number
- K033675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sirona Dental Systems GmbH
- Date Received
- November 24, 2003
- Decision Date
- January 15, 2004
- Product Code
- KOJ
- 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 |
|---|---|---|---|
| KOJ | Airbrush | FDA class 2 | Dental |
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