FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTIBACTERIAL GUTTA PERCHA
K Number: K971641
·
Decision Jul 21, 1997
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- ANTIBACTERIAL GUTTA PERCHA
- K Number
- K971641
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dr. Howard Martin, P.A.
- Date Received
- May 2, 1997
- Decision Date
- July 21, 1997
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
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