PIK POCKET(R), MODEL PP-3
FDA 510(k) clearance K895259 · decided 1989-11-01
Clearance details
- K-number
- K895259
- Device name
- PIK POCKET(R), MODEL PP-3
- Applicant
- Teledyne Water Pik
- Decision
- Substantially Equivalent
- Date received
- 1989-06-02
- Decision date
- 1989-11-01
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- EFS
- Device class
- 1
- Regulation number
- 872.6510
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Fort Collins, CO, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (K023232) | Smartpractice | 2002-12-11 |
| DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493) | Air Force, Inc. | 2000-10-25 |
| AGATHA-A-H2010 (K983374) | Midian Intl. | 1998-12-23 |
| DERMADAM (K964810) | Ultradent Products, Inc. | 1997-02-10 |
| BARRIER ALL FILM (K952234) | Cottrell, Ltd. | 1995-07-31 |
| ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182) | Oral-B Laboratories | 1994-09-09 |
| PERIOFLEX TIP (K923711) | Novadent, Ltd. | 1994-05-16 |
| HYDRO FLOSS (K923937) | Hydro Floss, Inc. | 1994-02-25 |
| WATER PIK PLUS PLAQUE CONTROL SYSTEM (K931380) | Teledyne Water Pik | 1993-09-20 |
| SHOWERFLOSS (K923457) | Summit Marketing Group, Inc. | 1992-09-01 |
| SHOWERFLOSS ORAL IRRIGATION UNIT (K922307) | Showerfloss, Inc. | 1992-06-16 |
| INTERJET(TM) GINGIVAL CARE INSTRUMENT (K921999) | Bausch & Lomb, Inc. | 1992-06-03 |
Recalls involving this device
No recalls on record reference this clearance.