FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAVI-ZYME
K Number: K922633
·
Decision Aug 6, 1992
Classifications
1
FEI Numbers
261
Registration Numbers
261
Same Product Code
7
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- CAVI-ZYME
- K Number
- K922633
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- E&D Dental Products, Inc.
- Date Received
- May 20, 1992
- Decision Date
- August 6, 1992
- Product Code
- EJB
- 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 |
|---|---|---|---|
| EJB | Handle, Instrument, Dental | FDA class 1 | Dental |
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