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

BEGOPAL

K Number: K983078 · Decision Oct 23, 1998
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
193
Applicant Total
7
Review Days
51

Basic Information

Device Name
BEGOPAL
K Number
K983078
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3060
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
BEGO U.S.A.
Date Received
September 2, 1998
Decision Date
October 23, 1998
Product Code
EJS
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
EJS Alloy, Other Noble Metal

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EJS), ordered by most recent decision date.

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Other Clearances by BEGO U.S.A.

K Number Device Name
K033279 GOLD DENTAL CASTING ALLOYS
K032136 WIROBOND C
K983082 BEGOCER G
K983080 AUROLLOYD KF
K983077 BIO PONTOSTAR
K983079 PLATINLLOYD 100