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510(k) K912430

Device
DENTAL FLOSS
Applicant
WESTONE PRODUCTS LTD.
510(k) number
K912430
Product code
JES  
Decision
Substantially Equivalent (SESE)
Decision date
1991-09-30
Date received
1991-05-31
Regulation
872.6390
Classification name
Floss, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PETER S REICHERTZ
Address
C/O Arent/Fox/Kint/Plot/Kahn 1050 Connecticut Ave., NW Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JES  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091964CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSSProcter & Gamble Co.2009-09-24
K964976FLOSSBRUSH WITH FLUORIDEFlossbrush Interdental Cleaner and Applicator1997-05-06
K963746IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORIDWhitehill Oral Technologies, Inc.1996-12-12
K944034PERIO-MED DENTAL FLOSSWhitehill Oral Technologies, Inc.1995-07-25
K952091VUTLER G.U.M. WITH FLUORIDEJohn O. Butler Co.1995-06-28
K951917JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSSJohnson & Johnson Consumer Products, Inc.1995-05-10
K942689RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDERanir/Dcp Corp.1995-04-27
K942690RANIR DENTAL TAPE MINT WAXED WITH FLUORIDERanir/Dcp Corp.1995-04-27
K943157ORAL-B ULTRAFLOSS WITH FLLUORIDEOral-B Laboratories1995-04-27
K944886COLGATE PRECISION MINT WZXED DENTAL FLOSSColgate-Palmolive Co.1995-04-27
K935440JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXEDJohnson & Johnson Consumer Products, Inc.1994-02-03
K935522RANIR DENTAL TAPE MINT WAXED WITH FLOURIDERanir/Dcp Corp.1994-01-26
K931353FLOSS PLUSFloss Plus, Inc.1993-07-27
K925408ORAL-B DENTAL TAPE WITH FLUORIDEOral-B Laboratories1993-01-28
K925409ORAL-B DENTAL FLOSS WITH FLUORIDEOral-B Laboratories1993-01-28

Legacy Summary#

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FDA Review#

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