FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTSPLY G-106 CAVITRON ULTRASONIC
K Number: K834283
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
191
Applicant Total
2
Review Days
112
Basic Information
- Device Name
- DENTSPLY G-106 CAVITRON ULTRASONIC
- K Number
- K834283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- COOPER CARE, INC.
- Date Received
- November 25, 1983
- Decision Date
- March 16, 1984
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
| K832949 | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN | Oct 4, 1983 | Substantially Equivalent |