FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADENT PROPHY PASTE
K Number: K040661
·
Decision Jun 9, 2004
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- RADENT PROPHY PASTE
- K Number
- K040661
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pascal Co., Inc.
- Date Received
- March 12, 2004
- Decision Date
- June 9, 2004
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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