FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

ENDOBRUSH

K Number: K870177 · Decision Feb 19, 1987
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
1
Review Days
35

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Basic Information

Device Name
ENDOBRUSH
K Number
K870177
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4565
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
C & S Microinstruments , Ltd.
Date Received
January 15, 1987
Decision Date
February 19, 1987
Product Code
EKS
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
EKS File, Pulp Canal, Endodontic

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