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

DENTABOND GOLD ALLOY FOR PORCELAIN

K Number: K903833 · Decision Sep 12, 1990
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
217
Review Days
22

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Basic Information

Device Name
DENTABOND GOLD ALLOY FOR PORCELAIN
K Number
K903833
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3060
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Argen Precious Metals, Inc.
Date Received
August 21, 1990
Decision Date
September 12, 1990
Product Code
EJT
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
EJT Alloy, Gold-Based Noble Metal

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Other Clearances by Argen Precious Metals, Inc.

K Number Device Name
K965216 ARGI-SATIN OR OPTI0-STAR
K961352 285 SL
K961211 ARGELITE 52+
K961285 ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K954362 ARGISTAR 74
K954368 ARGEDENT BIO 87 PF
K954358 ARGENDENT GIO 86 FR
K954404 AUROLITE 45
K954360 ARGESOL 600
K954371 SUREFIRE S
Search all 217 clearances from Argen Precious Metals, Inc. →