FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZYLOX
K Number: K782139
·
Decision Feb 21, 1979
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
41
Review Days
56
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Basic Information
- Device Name
- ZYLOX
- K Number
- K782139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- December 27, 1978
- Decision Date
- February 21, 1979
- 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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| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
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