FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
K Number: K004031
·
Decision Mar 28, 2001
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
- K Number
- K004031
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dental Power, Inc.
- Date Received
- December 28, 2000
- Decision Date
- March 28, 2001
- 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 Dental Power, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940680 | VERSADOWEL POST SYSTEM | Mar 15, 1994 | Substantially Equivalent |