FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP

K Number: K932990 · Decision Sep 29, 1993
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
8
Review Days
103

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Basic Information

Device Name
ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
K Number
K932990
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4200
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Oral-B Laboratories
Date Received
June 18, 1993
Decision Date
September 29, 1993
Product Code
EFB
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EFB Handpiece, Air-Powered, Dental

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K Number Device Name
K942633 ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
K943157 ORAL-B ULTRAFLOSS WITH FLLUORIDE
K943182 ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K925409 ORAL-B DENTAL FLOSS WITH FLUORIDE
K925408 ORAL-B DENTAL TAPE WITH FLUORIDE
K913603 FIBRETWINS
K883024 ORAL-B FLOSSERS