FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNASURG DENTAL IRRIGATION SYSTEM
K Number: K896890
·
Decision Feb 14, 1990
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
14
Review Days
68
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Basic Information
- Device Name
- DYNASURG DENTAL IRRIGATION SYSTEM
- K Number
- K896890
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Micro Motors, Inc.
- Date Received
- December 8, 1989
- Decision Date
- February 14, 1990
- Product Code
- EFS
- 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 |
|---|---|---|---|
| EFS | Unit, Oral Irrigation | FDA class 1 | Dental |
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| K970002 | STERILE WATER PUMP | Mar 5, 1997 | Substantially Equivalent |
| K942380 | MICRO ICS SONIC SCALER | Aug 7, 1995 | Substantially Equivalent |
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| 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 |