FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPREFLEX ALGINATE IMPRESSION MATERIAL
K Number: K771120
·
Decision Aug 3, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
42
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Basic Information
- Device Name
- IMPREFLEX ALGINATE IMPRESSION MATERIAL
- K Number
- K771120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Espe Dental Products
- Date Received
- June 22, 1977
- Decision Date
- August 3, 1977
- Product Code
- LEW
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LEW | Thin Layer Chromatography, Theophylline | FDA class 2 | Clinical Toxicology |
Other Clearances by Espe Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K810950 | VISIO-SEAL | Apr 29, 1981 | Substantially Equivalent |
| K802819 | KETAC-CEM IN REF. TO K802048 | Nov 24, 1980 | 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 |
| K771119 | PASTES, RESTORATIVE & TINTED, DEBTAL | Jul 15, 1977 | Substantially Equivalent |