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510(k) K943182

Device
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
Applicant
ORAL-B LABORATORIES
510(k) number
K943182
Product code
EFS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-09
Date received
1994-07-01
Regulation
872.6510
Classification name
Unit, Oral Irrigation
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHARON SNYDER
Address
One Lagoon Dr. Redwood City CA US 94065 94065

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EFS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpractice2002-12-11
K001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.2000-10-25
K983374AGATHA-A-H2010Midian Intl.1998-12-23
K964810DERMADAMUltradent Products, Inc.1997-02-10
K952234BARRIER ALL FILMCottrell, Ltd.1995-07-31
K923711PERIOFLEX TIPNovadent, Ltd.1994-05-16
K923937HYDRO FLOSSHydro Floss, Inc.1994-02-25
K931380WATER PIK PLUS PLAQUE CONTROL SYSTEMTeledyne Water Pik1993-09-20
K923457SHOWERFLOSSSummit Marketing Group, Inc.1992-09-01
K922307SHOWERFLOSS ORAL IRRIGATION UNITShowerfloss, Inc.1992-06-16
K921999INTERJET(TM) GINGIVAL CARE INSTRUMENTBausch & Lomb, Inc.1992-06-03
K913030MAX-I-PROBE IRRIGATION SYSTEMSmith & Nephew, Inc.1991-09-30
K910832OXYFRESH OXYCARE 3000Oxyfresh1991-04-17
K901955PERIOGARD(R) PERIOPENColgate-Palmolive Co.1991-04-15
K905188PERIO PIKTeledyne Water Pik1991-02-15

Legacy Summary#

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FDA Review#

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