FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COVER UP
K Number: K881914
·
Decision Jul 15, 1988
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
8
Review Days
67
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Basic Information
- Device Name
- COVER UP
- K Number
- K881914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parkell
- Date Received
- May 9, 1988
- Decision Date
- July 15, 1988
- 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 Parkell
| K Number | Device Name | ||
|---|---|---|---|
| K923867 | METAFIL | Oct 6, 1992 | Substantially Equivalent |
| K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL | Mar 15, 1991 | Substantially Equivalent |
| K900303 | CONNECT | Apr 12, 1990 | Substantially Equivalent |
| K896719 | PRIMER-P ADHESIVE AGENT | Feb 22, 1990 | Substantially Equivalent |
| K895750 | HEMA-PRIMER | Dec 21, 1989 | Substantially Equivalent |
| K892003 | ABRAKADABRA - DENTAL ADHESIVE SYSTEM | Jun 7, 1989 | Substantially Equivalent |
| K884918 | PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER | Feb 13, 1989 | Substantially Equivalent |