FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
K Number: K911068
·
Decision May 15, 1991
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
14
Review Days
65
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Basic Information
- Device Name
- 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
- K Number
- K911068
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Micro Motors, Inc.
- Date Received
- March 11, 1991
- Decision Date
- May 15, 1991
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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Other Clearances by Micro Motors, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000120 | PRO-TORQ | Feb 3, 2000 | Substantially Equivalent |
| K991283 | DYNA TORQ TORQUE WRENCH, TORQUE WRENCH | Aug 18, 1999 | Substantially Equivalent |
| K963843 | ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT | Mar 31, 1997 | Substantially Equivalent |
| K970002 | STERILE WATER PUMP | Mar 5, 1997 | Substantially Equivalent |
| K942380 | MICRO ICS SONIC SCALER | Aug 7, 1995 | Substantially Equivalent |
| K935676 | MICRO RSH HIGH SPEED HANDPIECE | Mar 31, 1995 | 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 |