FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYSTAR(TM) VINTAGE PORCELAIN
K Number: K884214
·
Decision Dec 8, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
59
Review Days
63
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Basic Information
- Device Name
- CRYSTAR(TM) VINTAGE PORCELAIN
- K Number
- K884214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Shofu Dental Corp.
- Date Received
- October 6, 1988
- Decision Date
- December 8, 1988
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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