FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
K Number: K023232
·
Decision Dec 11, 2002
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
4
Review Days
75
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Basic Information
- Device Name
- SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
- K Number
- K023232
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Smartpractice
- Date Received
- September 27, 2002
- Decision Date
- December 11, 2002
- Product Code
- EFS
- 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 |
|---|---|---|---|
| EFS | Unit, Oral Irrigation | FDA class 1 | Dental |
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