FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
T1 CONTROL HIGH SPEED DENTAL HANDPIECE
K Number: K965238
·
Decision Mar 19, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
15
Review Days
78
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Basic Information
- Device Name
- T1 CONTROL HIGH SPEED DENTAL HANDPIECE
- K Number
- K965238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens AG
- Date Received
- December 31, 1996
- Decision Date
- March 19, 1997
- Product Code
- EFA
- 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | FDA class 1 | Dental |
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