FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHITE MTA MATERIAL
K Number: K011009
·
Decision May 2, 2001
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
23
Review Days
28
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Basic Information
- Device Name
- WHITE MTA MATERIAL
- K Number
- K011009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International
- Date Received
- April 4, 2001
- Decision Date
- May 2, 2001
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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