FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CB BUR
K Number: K863097
·
Decision Aug 26, 1986
Classifications
1
FEI Numbers
264
Registration Numbers
264
Same Product Code
26
Applicant Total
3
Review Days
12
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Basic Information
- Device Name
- CB BUR
- K Number
- K863097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3240
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Beavers Dental, Div. Sybron Canada, Ltd.
- Date Received
- August 14, 1986
- Decision Date
- August 26, 1986
- Product Code
- EJL
- 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 |
|---|---|---|---|
| EJL | Bur, Dental | FDA class 1 | Dental |
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