FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABRAKADABRA - DENTAL ADHESIVE SYSTEM
K Number: K892003
·
Decision Jun 7, 1989
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
8
Review Days
71
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Basic Information
- Device Name
- ABRAKADABRA - DENTAL ADHESIVE SYSTEM
- K Number
- K892003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parkell
- Date Received
- March 28, 1989
- Decision Date
- June 7, 1989
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 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 |
| K884918 | PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER | Feb 13, 1989 | Substantially Equivalent |
| K881914 | COVER UP | Jul 15, 1988 | Substantially Equivalent |