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

BREVET DENTAL INSTRUMENTS

K Number: K883126 · Decision Oct 5, 1988
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
6
Review Days
71

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Basic Information

Device Name
BREVET DENTAL INSTRUMENTS
K Number
K883126
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4565
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Brevet, Inc.
Date Received
July 26, 1988
Decision Date
October 5, 1988
Product Code
EKJ
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
EKJ Burnisher, Operative

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K Number Device Name
K910794 SMALL INSTRUMENT STERILIZATION/BUR BOX
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K895959 BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
K895753 BREVET DISPOSABLE CONNECTORS
K882617 BREVET CASSETTE STERILIZATION MODULE