FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOY PRIMER
K Number: K974089
·
Decision Dec 17, 1997
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
11
Review Days
49
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Basic Information
- Device Name
- ALLOY PRIMER
- K Number
- K974089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kuraray America, Inc.
- Date Received
- October 29, 1997
- Decision Date
- December 17, 1997
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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| K063593 | CLEARFIL MAJESTY FLOW | Feb 2, 2007 | Substantially Equivalent |
| K063228 | SURFACE COAT | Dec 8, 2006 | Substantially Equivalent |
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| K983361 | PANAVIA F | Nov 13, 1998 | Substantially Equivalent |
| K982259 | CHROMA ZONE COLOR STAIN | Sep 22, 1998 | Substantially Equivalent |
| K982164 | ESTENIA | Aug 10, 1998 | Substantially Equivalent |
| K974486 | CLEARFIL LINER BOND 2V | Jan 29, 1998 | Substantially Equivalent |