FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

MBCP GEL

K Number: K060732 · Decision Jun 2, 2006
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
8
Review Days
74

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Basic Information

Device Name
MBCP GEL
K Number
K060732
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3930
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Biomatlante
Date Received
March 20, 2006
Decision Date
June 2, 2006
Product Code
LYC
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
LYC Bone Grafting Material, Synthetic

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Other Clearances by Biomatlante

K Number Device Name
K093122 MBCP+
K071121 TRIBONE 80
K063527 MBCP+
K051774 MBCP
K051885 MBCP
K043005 MODIFICATION TO MBCP
K032268 MBCP