FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VINYL POLYSILOXANE IMPRESSION MATERIAL
K Number: K800485
·
Decision Mar 18, 1980
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
331
Review Days
14
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Basic Information
- Device Name
- VINYL POLYSILOXANE IMPRESSION MATERIAL
- K Number
- K800485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- March 4, 1980
- Decision Date
- March 18, 1980
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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