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

RHODIA BITE REGISTRATION MATERIAL

K Number: K013859 · Decision Jan 29, 2002
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
3
Review Days
69

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Basic Information

Device Name
RHODIA BITE REGISTRATION MATERIAL
K Number
K013859
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3660
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Rhodia, Inc.
Date Received
November 21, 2001
Decision Date
January 29, 2002
Product Code
ELW
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
ELW Material, Impression

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Other Clearances by Rhodia, Inc.

K Number Device Name
K013140 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013129 RHODIA DENTAL PUTTY IMPRESSION MATERIAL