FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALFALLOY
K Number: K972534
·
Decision Sep 5, 1997
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
27
Review Days
60
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Basic Information
- Device Name
- ALFALLOY
- K Number
- K972534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aalba Dent, Inc.
- Date Received
- July 7, 1997
- Decision Date
- September 5, 1997
- 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 Aalba Dent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040180 | CONTINUM V | Mar 4, 2004 | Substantially Equivalent |
| K040179 | CONTINUM | Mar 3, 2004 | Substantially Equivalent |
| K033356 | VERASOFT ES | Dec 30, 2003 | Substantially Equivalent |
| K982094 | VERABOND 2 | Jul 22, 1998 | Substantially Equivalent |
| K972971 | NPG + 2 | Jan 5, 1998 | Substantially Equivalent |
| K973265 | VERABOND 2V | Oct 16, 1997 | Substantially Equivalent |
| K972607 | PLATALLOY | Oct 10, 1997 | Substantially Equivalent |
| K972533 | VERA SOLDER | Sep 5, 1997 | Substantially Equivalent |
| K972632 | VERA PD SOLDER | Aug 15, 1997 | Substantially Equivalent |
| K972532 | AALBA GOLD SOLDER | Aug 15, 1997 | Substantially Equivalent |