FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNA SYSTEM
K Number: K855167
·
Decision Mar 4, 1986
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
23
Applicant Total
30
Review Days
68
Basic Information
- Device Name
- DYNA SYSTEM
- K Number
- K855167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3165
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- December 26, 1985
- Decision Date
- March 4, 1986
- Product Code
- EGG
- 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 |
|---|---|---|---|
| EGG | Attachment, Precision, All | FDA class 1 | Dental |
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|---|---|---|---|
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| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent |
| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |
| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 | Substantially Equivalent |