FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIER ABSORBENT POINTS
K Number: K800827
·
Decision Apr 29, 1980
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
41
Review Days
15
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Basic Information
- Device Name
- PREMIER ABSORBENT POINTS
- K Number
- K800827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Premier Dental Products Co.
- Date Received
- April 14, 1980
- Decision Date
- April 29, 1980
- Product Code
- EKN
- 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 |
|---|---|---|---|
| EKN | Point, Paper, Endodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
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| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Oct 4, 2006 | Substantially Equivalent |
| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Sep 21, 2004 | Substantially Equivalent |