FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
K Number: K971319
·
Decision May 22, 1997
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
2
Review Days
42
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Basic Information
- Device Name
- NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
- K Number
- K971319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tycom Dental
- Date Received
- April 10, 1997
- Decision Date
- May 22, 1997
- Product Code
- EKS
- 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 |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | FDA class 1 | Dental |
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Other Clearances by Tycom Dental
| K Number | Device Name | ||
|---|---|---|---|
| K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Jun 4, 1996 | Substantially Equivalent |