FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
K Number: K940288
·
Decision May 26, 1994
Classifications
1
FEI Numbers
343
Registration Numbers
344
Same Product Code
53
Applicant Total
9
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
- K Number
- K940288
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6865
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teledyne Water Pik
- Date Received
- January 21, 1994
- Decision Date
- May 26, 1994
- Product Code
- JEQ
- 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 |
|---|---|---|---|
| JEQ | Toothbrush, Powered | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEQ), ordered by most recent decision date.
Oral-B iO Test Drive Power Brush Trial Program Kit
FDA 510(k)
FDA Class 1
·Dental
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
FDA 510(k)
FDA Class 1
·Dental
ORAL-B SONIC COMPLETE
FDA 510(k)
FDA Class 1
·Dental
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
FDA 510(k)
FDA Class 1
·Dental
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
FDA 510(k)
FDA Class 1
·Dental
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
FDA 510(k)
FDA Class 1
·Dental
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 |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Sep 20, 1993 | Substantially Equivalent |
| K905188 | PERIO PIK | Feb 15, 1991 | 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 |