FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACIFIC 56 (CB-40)
K Number: K964837
·
Decision Dec 20, 1996
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
31
Review Days
21
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Basic Information
- Device Name
- PACIFIC 56 (CB-40)
- K Number
- K964837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gateway Alloys, Inc.
- Date Received
- November 29, 1996
- Decision Date
- December 20, 1996
- 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 Gateway Alloys, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011659 | GPW-SF | Aug 27, 2001 | Substantially Equivalent |
| K011661 | CONCORD 88 | Aug 27, 2001 | Substantially Equivalent |
| K011626 | CONCORD 72 | Jul 16, 2001 | Substantially Equivalent |
| K011628 | CONCORD 82 | Jul 16, 2001 | Substantially Equivalent |
| K964950 | LA PLATA 28 (PM-28) | Jan 13, 1997 | Substantially Equivalent |
| K964941 | EL DORADO 40 | Jan 13, 1997 | Substantially Equivalent |
| K964940 | TAOS 28 | Jan 13, 1997 | Substantially Equivalent |
| K964948 | AURORA 52 (PM-01) | Jan 13, 1997 | Substantially Equivalent |
| K964949 | AURORA 53 | Jan 13, 1997 | Substantially Equivalent |
| K964838 | PALLADIA 85 (PM-13) | Dec 20, 1996 | Substantially Equivalent |