FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K Number: K875344
·
Decision Mar 18, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
31
Review Days
79
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Basic Information
- Device Name
- HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
- K Number
- K875344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kulzer, Inc.
- Date Received
- December 30, 1987
- Decision Date
- March 18, 1988
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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|---|---|---|---|
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| K905131 | DURAFILL COLOR VS | Mar 15, 1991 | Substantially Equivalent |
| K905302 | DENTHESIVE | Feb 26, 1991 | Substantially Equivalent |
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| K903317 | DENTALON PLUS | Aug 13, 1990 | Substantially Equivalent |
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