FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO ICS SONIC SCALER
K Number: K942380
·
Decision Aug 7, 1995
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
14
Review Days
445
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Basic Information
- Device Name
- MICRO ICS SONIC SCALER
- K Number
- K942380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Motors, Inc.
- Date Received
- May 19, 1994
- Decision Date
- August 7, 1995
- 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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Other Clearances by Micro Motors, Inc.
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| K970002 | STERILE WATER PUMP | Mar 5, 1997 | Substantially Equivalent |
| K935676 | MICRO RSH HIGH SPEED HANDPIECE | Mar 31, 1995 | Substantially Equivalent |
| K911068 | 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM | May 15, 1991 | Substantially Equivalent |
| K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | Apr 16, 1991 | Substantially Equivalent |
| K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Jan 25, 1991 | Substantially Equivalent |
| K896878 | HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) | Mar 8, 1990 | Substantially Equivalent |
| K896877 | DENTAL AIR MOTORS (SEVERAL MODELS) | Mar 7, 1990 | Substantially Equivalent |