FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDODONTIC ROOT CANAL PLUGGER
K Number: K860569
·
Decision Mar 26, 1986
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
5
Applicant Total
279
Review Days
43
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Basic Information
- Device Name
- ENDODONTIC ROOT CANAL PLUGGER
- K Number
- K860569
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- February 11, 1986
- Decision Date
- March 26, 1986
- Product Code
- EKR
- 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 |
|---|---|---|---|
| EKR | Plugger, Root Canal, Endodontic | FDA class 1 | Dental |
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