FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXI-CAST CROWN CORE SYSTEM
K Number: K896693
·
Decision Feb 14, 1990
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
17
Review Days
78
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Basic Information
- Device Name
- FLEXI-CAST CROWN CORE SYSTEM
- K Number
- K896693
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Essential Dental Systems, Inc.
- Date Received
- November 28, 1989
- Decision Date
- February 14, 1990
- 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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