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

CDB FLIP-SIDE-CLIP BRACKET

K Number: K091702 · Decision Aug 7, 2009
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
6
Review Days
58

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Basic Information

Device Name
CDB FLIP-SIDE-CLIP BRACKET
K Number
K091702
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.5470
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Cdb Corporation
Date Received
June 10, 2009
Decision Date
August 7, 2009
Product Code
NJM
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
NJM Bracket, Ceramic, Orthodontic

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Other Clearances by Cdb Corporation

K Number Device Name
K212173 HDH Treatment Planning System
K210613 HIT Clear Aligner
K191823 Clear-Aligners
K160957 CDB Self Ligating Bracket 8F
K080906 CDB CLIP