FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERIO PIK
K Number: K905188
·
Decision Feb 15, 1991
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- PERIO PIK
- K Number
- K905188
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Teledyne Water Pik
- Date Received
- November 19, 1990
- Decision Date
- February 15, 1991
- 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 Water Pik
| K Number | Device Name | ||
|---|---|---|---|
| K970594 | KALGINATE IMPRESSION MATERIAL | Mar 31, 1997 | Substantially Equivalent |
| K952422 | ELASTIC IMPRESSION CREAM | Aug 29, 1995 | Substantially Equivalent |
| K944162 | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Nov 29, 1994 | Substantially Equivalent |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | May 26, 1994 | Substantially Equivalent |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Sep 20, 1993 | Substantially Equivalent |
| K900547 | WATER PIK(R) W/ADD'L CLAIMS | Jun 15, 1990 | Substantially Equivalent |
| K895259 | PIK POCKET(R), MODEL PP-3 | Nov 1, 1989 | Substantially Equivalent |
| K894015 | WATER PIK(R) | Aug 28, 1989 | Substantially Equivalent |