FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
K Number: K991283
·
Decision Aug 18, 1999
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
14
Review Days
125
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Basic Information
- Device Name
- DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
- K Number
- K991283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micro Motors, Inc.
- Date Received
- April 15, 1999
- Decision Date
- August 18, 1999
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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| K942380 | MICRO ICS SONIC SCALER | Aug 7, 1995 | 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 |