FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PIK POCKET (IRRIGATING TIP)
K Number: K863131
·
Decision Aug 26, 1986
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
10
Review Days
11
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Basic Information
- Device Name
- PIK POCKET (IRRIGATING TIP)
- K Number
- K863131
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Teledyne, Inc.
- Date Received
- August 15, 1986
- Decision Date
- August 26, 1986
- 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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Other Clearances by Teledyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871828 | TED MODEL 760 | Feb 4, 1988 | Substantially Equivalent |
| K862695 | FLUOR-ETCH GEL ETCHANT | Jul 31, 1986 | Substantially Equivalent |
| K854817 | INSTAPURE | Feb 28, 1986 | Substantially Equivalent |
| K840721 | PERIO PIK | Apr 25, 1984 | Substantially Equivalent |
| K810864 | WATER PIK ORAL HYGIENE CENTER | Apr 21, 1981 | Substantially Equivalent |
| K810805 | WATER PIK AUTOMATIC TOOTHBRUSH | Apr 14, 1981 | Substantially Equivalent |
| K801593 | LEBODY BY WATER PIK | Aug 20, 1980 | Substantially Equivalent |
| K800919 | ORAVIEW BY WATER PIK | May 8, 1980 | Substantially Equivalent |
| K800448 | WATER PIK TRAVELER, MODEL 79 | Mar 5, 1980 | Substantially Equivalent |