FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
K Number: K080338
·
Decision Apr 21, 2008
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
10
Review Days
74
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Basic Information
- Device Name
- CUTTERSIL ACTIVATOR UNIVERSAL PLUS
- K Number
- K080338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer,GmbH
- Date Received
- February 7, 2008
- Decision Date
- April 21, 2008
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Heraeus Kulzer,GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K083652 | IBOND TOTAL ETCH | Jan 21, 2009 | Substantially Equivalent |
| K073554 | NEUN | Feb 4, 2008 | Substantially Equivalent |
| K062515 | RETENTION FLOW OPAQUE | Nov 22, 2006 | Substantially Equivalent |
| K050085 | OSTEOPAL V | Sep 14, 2005 | Substantially Equivalent |
| K050854 | PALACOS LV+G | Jul 7, 2005 | Substantially Equivalent |
| K050855 | PALAMED G | Jul 7, 2005 | Substantially Equivalent |
| K051006 | IBOND NEXT GENERATION | Jun 7, 2005 | Substantially Equivalent |
| K042199 | TRANSLUX POWER BLUE | Sep 8, 2004 | Substantially Equivalent |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Mar 1, 2004 | Substantially Equivalent |