FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KETAC-CEM IN REF. TO K802048
K Number: K802819
·
Decision Nov 24, 1980
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
8
Review Days
17
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Basic Information
- Device Name
- KETAC-CEM IN REF. TO K802048
- K Number
- K802819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe Dental Products
- Date Received
- November 7, 1980
- Decision Date
- November 24, 1980
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Espe Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K810950 | VISIO-SEAL | Apr 29, 1981 | Substantially Equivalent |
| K802049 | NIMETIC-DISPERS | Sep 16, 1980 | Substantially Equivalent |
| K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION | Feb 5, 1980 | Substantially Equivalent |
| K771889 | UNIOLITE | Oct 20, 1977 | Substantially Equivalent |
| K771901 | CAPMIX | Oct 20, 1977 | Substantially Equivalent |
| K771120 | IMPREFLEX ALGINATE IMPRESSION MATERIAL | Aug 3, 1977 | Substantially Equivalent |
| K771119 | PASTES, RESTORATIVE & TINTED, DEBTAL | Jul 15, 1977 | Substantially Equivalent |