FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VERSADOWEL POST SYSTEM
K Number: K940680
·
Decision Mar 15, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
2
Review Days
33
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Basic Information
- Device Name
- VERSADOWEL POST SYSTEM
- K Number
- K940680
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dental Power, Inc.
- Date Received
- February 10, 1994
- Decision Date
- March 15, 1994
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
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Other Clearances by Dental Power, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Mar 28, 2001 | Substantially Equivalent |