FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BEGOPAL 300
K Number: K983081
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- BEGOPAL 300
- K Number
- K983081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
- Date Received
- September 2, 1998
- Decision Date
- October 28, 1998
- 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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