FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
K Number: K080677
·
Decision Jun 6, 2008
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
- K Number
- K080677
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaltenbach & Voigt GmbH & Co.
- Date Received
- March 10, 2008
- Decision Date
- June 6, 2008
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Kaltenbach & Voigt GmbH & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K092446 | INTRA LUX HEAD 3 LDSY | Nov 3, 2009 | Substantially Equivalent |