FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Y CERAMIC
K Number: K833053
·
Decision Nov 14, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
25
Review Days
68
Basic Information
- Device Name
- Y CERAMIC
- K Number
- K833053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- JENERIC IND.
- Date Received
- September 7, 1983
- Decision Date
- November 14, 1983
- 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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| K834560 | VITEX P.D.A | Feb 27, 1984 | Substantially Equivalent |
| K833774 | NATURELLE II & LITE II-N72-N74-L | Jan 24, 1984 | Substantially Equivalent |