FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE PROPHYLAXIS ANGLE
K Number: K941189
·
Decision May 16, 1994
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
3
Review Days
63
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Basic Information
- Device Name
- DISPOSABLE PROPHYLAXIS ANGLE
- K Number
- K941189
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Team Technologies, Inc.
- Date Received
- March 14, 1994
- Decision Date
- May 16, 1994
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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