Product code EFS— Dental
PERIO PIK
- Classification name
- Unit, Oral Irrigation
- Device class
- Class 1
- Regulation
- 21 CFR 872.6510
- Advisory panel
- Dental
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code EFS
FDA has cleared devices under product code EFS between 1980 and 2002, filed by 35 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2002
- 2000
- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
Top applicants under product code EFS
Recent clearances under product code EFS
- K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
- K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
- K983374 — AGATHA-A-H2010
- K964810 — DERMADAM
- K952234 — BARRIER ALL FILM
- K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
- K923711 — PERIOFLEX TIP
- K923937 — HYDRO FLOSS
- K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM
- K923457 — SHOWERFLOSS
- K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT
- K921999 — INTERJET(TM) GINGIVAL CARE INSTRUMENT
- K913030 — MAX-I-PROBE IRRIGATION SYSTEM
- K910832 — OXYFRESH OXYCARE 3000
- K901955 — PERIOGARD(R) PERIOPEN
- K905188 — PERIO PIK
- K904850 — DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
- K897053 — L'LL SQUIRT GUM ORAL RINSE DEVICE
- K901600 — OSSEOTITE IRRIGATION UNIT
- K900547 — WATER PIK(R) W/ADD'L CLAIMS
- K900178 — ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
- K900991 — SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
- K896890 — DYNASURG DENTAL IRRIGATION SYSTEM
- K895259 — PIK POCKET(R), MODEL PP-3
- K894015 — WATER PIK(R)
- K890600 — HYDRODENT ANTIPLAQUE SYSTEM
- K884220 — AIR WATER SYRINGE TIP SHIELD
- K882759 — PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
- K875132 — PERIODONTAL SCALING SOLUTION-A
- K875149 — PERIDONTAL SCALING SOLUTION-B
- K875150 — PERIODONTAL SCALING SOLUTION-C
- K864540 — PLAK VAK - PV-10
- K863131 — PIK POCKET (IRRIGATING TIP)
- K852593 — SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
- K844339 — BRAUN DENTAL CENTER OC-3
- K844318 — ORAL IRRIGATION TIP
- K840721 — PERIO PIK
- K834545 — POCKETIP 4414
- K832222 — PRO PULSE PERIODONTAL IRRIGATOR 7618
- K832223 — PERIODONTAL IRRIGATOR #7620
- K831321 — GUM MACHINE
- K823305 — DENTO SPRAY ORAL IRRIGATOR
- K813638 — MULTI-UNIT, MULTI-PURPOSE DEVICE
- K811175 — RECOH ROOT CANAL IRRIGATOR
- K810864 — WATER PIK ORAL HYGIENE CENTER
- K802595 — ERGO IRRIGATION SYSTEM
- K800448 — WATER PIK TRAVELER, MODEL 79
Data sourced from openFDA. This site is unofficial and independent of the FDA.