Atlas FDA

ORAL-B ULTRAFLOSS WITH FLLUORIDE

FDA 510(k) clearance K943157 · decided 1995-04-27

Clearance details

K-number
K943157
Device name
ORAL-B ULTRAFLOSS WITH FLLUORIDE
Applicant
Oral-B Laboratories
Decision
Substantially Equivalent
Date received
1994-07-01
Decision date
1995-04-27
Days to decision
300 days
Clearance type
Traditional
Product code
JES
Device class
1
Regulation number
872.6390
Medical specialty
Dental
Advisory committee
Dental
Location
Redwood City, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (K091964)Procter & Gamble Co.2009-09-24
FLOSSBRUSH WITH FLUORIDE (K964976)Flossbrush Interdental Cleaner and Applicator1997-05-06
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID (K963746)Whitehill Oral Technologies, Inc.1996-12-12
PERIO-MED DENTAL FLOSS (K944034)Whitehill Oral Technologies, Inc.1995-07-25
VUTLER G.U.M. WITH FLUORIDE (K952091)John O. Butler Co.1995-06-28
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (K951917)Johnson & Johnson Consumer Products, Inc.1995-05-10
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (K942689)Ranir/Dcp Corp.1995-04-27
COLGATE PRECISION MINT WZXED DENTAL FLOSS (K944886)Colgate-Palmolive Co.1995-04-27
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690)Ranir/Dcp Corp.1995-04-27
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (K935440)Johnson & Johnson Consumer Products, Inc.1994-02-03
RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE (K935522)Ranir/Dcp Corp.1994-01-26
FLOSS PLUS (K931353)Floss Plus, Inc.1993-07-27

Recalls involving this device

No recalls on record reference this clearance.