FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DMC COMPOSITE
K Number: K081695
·
Decision Aug 12, 2008
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
9
Review Days
56
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Basic Information
- Device Name
- DMC COMPOSITE
- K Number
- K081695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Corp.
- Date Received
- June 17, 2008
- Decision Date
- August 12, 2008
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Kerr Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K091613 | TAKE 1 | Oct 7, 2009 | Substantially Equivalent |
| K090292 | PREMISE MODIFIED | Apr 3, 2009 | Substantially Equivalent |
| K072622 | STANDOUT 2 | Dec 4, 2007 | Substantially Equivalent |
| K042888 | DEMETRON IDS CURING LIGHT | Nov 10, 2004 | Substantially Equivalent |
| K031484 | STAND OUT | Jul 3, 2003 | Substantially Equivalent |
| K014179 | DEMETRON LC | Feb 4, 2002 | Substantially Equivalent |
| K010994 | TAKE ONE BITE MODIFIED | Apr 23, 2001 | Substantially Equivalent |
| K001655 | PERMLASTIC 2 | Aug 10, 2000 | Substantially Equivalent |