FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALCIJECT
K Number: K001050
·
Decision Jul 21, 2000
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
47
Review Days
112
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Basic Information
- Device Name
- CALCIJECT
- K Number
- K001050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Centrix, Inc.
- Date Received
- March 31, 2000
- Decision Date
- July 21, 2000
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
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