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

SUPERFINE DIAMONDS

K Number: K771214 · Decision Jul 15, 1977
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
26
Applicant Total
29
Review Days
10

Basic Information

Device Name
SUPERFINE DIAMONDS
K Number
K771214
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3240
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
DEN-MAT CORP.
Date Received
July 5, 1977
Decision Date
July 15, 1977
Product Code
EJL
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
EJL Bur, Dental

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