FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RINSENDO
K Number: K052271
·
Decision May 26, 2006
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
18
Review Days
280
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Basic Information
- Device Name
- RINSENDO
- K Number
- K052271
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Air Techniques, Inc.
- Date Received
- August 19, 2005
- Decision Date
- May 26, 2006
- Product Code
- NYL
- 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 |
|---|---|---|---|
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | FDA class 1 | Dental |
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