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

DENTA PLAST

K Number: K830440 · Decision Apr 28, 1983
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
2
Review Days
77

Basic Information

Device Name
DENTA PLAST
K Number
K830440
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3275
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
DENTA, INC.
Date Received
February 10, 1983
Decision Date
April 28, 1983
Product Code
EMA
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
EMA Cement, Dental

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Other Clearances by DENTA, INC.

K Number Device Name
K830439 DENTA A-33