FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GDC 3445
K Number: K925273
·
Decision Dec 21, 1992
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
46
Review Days
63
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Basic Information
- Device Name
- GDC 3445
- K Number
- K925273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deringer-Ney, Inc.
- Date Received
- October 19, 1992
- Decision Date
- December 21, 1992
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
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Other Clearances by Deringer-Ney, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933178 | GDC 3509 | Oct 14, 1993 | Substantially Equivalent |
| K930482 | DENTAL CASTING ALLOY, MODIFICATION - PF-3 | Mar 31, 1993 | Substantially Equivalent |
| K930481 | DENTAL CASTING ALLOY MODIFICATION-PF-4 | Mar 31, 1993 | Substantially Equivalent |
| K920922 | GDC 3367 | May 5, 1992 | Substantially Equivalent |
| K920060 | DENTAL SOLDER ALLOY | Apr 2, 1992 | Substantially Equivalent |
| K920887 | GDC-3338, DENTAL SOLDER ALLOY | Mar 19, 1992 | Substantially Equivalent |
| K910065 | GDC-3200 DENTAL SOLDER | Mar 15, 1991 | Substantially Equivalent |
| K904695 | GDC-1501 | Jan 2, 1991 | Substantially Equivalent |
| K904614 | GDC-1475 | Dec 19, 1990 | Substantially Equivalent |
| K901532 | GDC 3084 CASTING ALLOY | May 2, 1990 | Substantially Equivalent |