FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROOF ALGINATE IMPRESSION MATERIAL
K Number: K854855
·
Decision Jan 30, 1986
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
37
Review Days
56
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Basic Information
- Device Name
- PROOF ALGINATE IMPRESSION MATERIAL
- K Number
- K854855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- December 5, 1985
- Decision Date
- January 30, 1986
- 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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|---|---|---|---|
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| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |
| K823795 | EVERBOND GLASS IONOMER CEMENT | Jan 26, 1983 | Substantially Equivalent |