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

MIN-IDENTOFLEX

K Number: K873002 · Decision Aug 17, 1987
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
3
Applicant Total
47
Review Days
13

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Basic Information

Device Name
MIN-IDENTOFLEX
K Number
K873002
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6010
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Centrix, Inc.
Date Received
August 4, 1987
Decision Date
August 17, 1987
Product Code
EHJ
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
EHJ Disk, Abrasive

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K120176 SENZZZZZ AWAY
K111348 RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K092384 LIQUICORD
K091380 CORDCAP
K021131 CHLORAPREP
K021146 D/SENSE 1-STEP
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