FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XR PRIMER 2
K Number: K020303
·
Decision Apr 19, 2002
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
17
Review Days
80
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Basic Information
- Device Name
- XR PRIMER 2
- K Number
- K020303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Dental Materials Center
- Date Received
- January 29, 2002
- Decision Date
- April 19, 2002
- 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 Kerr Dental Materials Center
| K Number | Device Name | ||
|---|---|---|---|
| K050984 | BIOPLANT | Aug 11, 2005 | Substantially Equivalent |
| K031444 | OPTIBOND FL | Jul 2, 2003 | Substantially Equivalent |
| K030646 | BELLEGLASS POINT 4 | May 6, 2003 | Substantially Equivalent |
| K020178 | BELLEGLASS HP MODELING GEL | Mar 15, 2002 | Substantially Equivalent |
| K014027 | OPTIBOND SOLO PLUS 4 | Feb 22, 2002 | Substantially Equivalent |
| K020092 | TEMPHASE | Feb 22, 2002 | Substantially Equivalent |
| K013375 | BELLEGLASS HP OPAQUE 2 | Oct 29, 2001 | Substantially Equivalent |
| K013325 | POINT 4 FLOWABLE 2 | Oct 23, 2001 | Substantially Equivalent |
| K011908 | OPTIBOND SOLO PLUS 3 | Sep 6, 2001 | Substantially Equivalent |
| K000357 | EZ CONNECT RESIN | Apr 28, 2000 | Substantially Equivalent |