FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MINIM-X 2001-CIAS & MINIM-X 2002-CIAS

K Number: K882379 · Decision Sep 9, 1988
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
41
Applicant Total
1
Review Days
92

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Basic Information

Device Name
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
K Number
K882379
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.1810
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Dentomar, Inc.
Date Received
June 9, 1988
Decision Date
September 9, 1988
Product Code
EAP
Advisory Committee
Dental
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
EAP Unit, X-Ray, Intraoral

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