FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNOWPOST, SNOWLIGHT
K Number: K012354
·
Decision Oct 10, 2001
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
11
Review Days
77
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Basic Information
- Device Name
- SNOWPOST, SNOWLIGHT
- K Number
- K012354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danville Materials, Inc.
- Date Received
- July 25, 2001
- Decision Date
- October 10, 2001
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
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| K040952 | PRELUDE | Jun 29, 2004 | Substantially Equivalent |
| K033215 | PREPAIR | Jan 9, 2004 | Substantially Equivalent |
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