FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO
K Number: K932243
·
Decision Apr 28, 1994
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
3
Review Days
356
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Basic Information
- Device Name
- GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO
- K Number
- K932243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precious Chemicals U.S.A., Inc.
- Date Received
- May 7, 1993
- Decision Date
- April 28, 1994
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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