FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-5 PALLADIUM BASE DENTAL ALLOY
K Number: K891514
·
Decision Apr 12, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
22
Review Days
26
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Basic Information
- Device Name
- C-5 PALLADIUM BASE DENTAL ALLOY
- K Number
- K891514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Macdonald Metals and Ceramics
- Date Received
- March 17, 1989
- Decision Date
- April 12, 1989
- 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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Other Clearances by Macdonald Metals and Ceramics
| K Number | Device Name | ||
|---|---|---|---|
| K891530 | M-77 GOLD BASE DENTAL ALLOY | Apr 14, 1989 | Substantially Equivalent |
| K891516 | C-89 GOLD BASE DENTAL ALLOY | Apr 14, 1989 | Substantially Equivalent |
| K891533 | M-74 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891522 | M-4 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891534 | M-75 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891518 | C-76 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891517 | C-63 GOLD BAE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891529 | M-W SILVER PALLADIUM BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891523 | M-20 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |
| K891528 | M-65 GOLD BASE DENTAL ALLOY | Apr 12, 1989 | Substantially Equivalent |