FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K Number: K121698
·
Decision Aug 6, 2012
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
36
Review Days
59
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Basic Information
- Device Name
- NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
- K Number
- K121698
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International, Inc.
- Date Received
- June 8, 2012
- Decision Date
- August 6, 2012
- 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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