FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
K Number: K042434
·
Decision Nov 3, 2004
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
11
Review Days
56
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Basic Information
- Device Name
- MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
- K Number
- K042434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOUVAG AG
- Date Received
- September 8, 2004
- Decision Date
- November 3, 2004
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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| K042822 | TCM ENDO V, MODEL 1534 | Dec 22, 2004 | Substantially Equivalent |
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| K981679 | TCM 3000 AND TCM ENDO | Feb 9, 1999 | Substantially Equivalent |
| K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 | Jan 16, 1996 | Substantially Equivalent |