FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M ESPE LAVA CHAIRSIDE ORAL SCANNER
K Number: K073199
·
Decision Dec 21, 2007
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
4
Applicant Total
2
Review Days
38
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Basic Information
- Device Name
- 3M ESPE LAVA CHAIRSIDE ORAL SCANNER
- K Number
- K073199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3661
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brontes Technologies
- Date Received
- November 13, 2007
- Decision Date
- December 21, 2007
- Product Code
- NOF
- 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 |
|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | FDA class 2 | Dental |
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Other Clearances by Brontes Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K081961 | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Sep 5, 2008 | Substantially Equivalent |