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

VERA BOND NON PERCIOUS CERAMIC ALLOY

K Number: K851569 · Decision May 29, 1985
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
27
Review Days
42

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Basic Information

Device Name
VERA BOND NON PERCIOUS CERAMIC ALLOY
K Number
K851569
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3710
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Aalba Dent, Inc.
Date Received
April 17, 1985
Decision Date
May 29, 1985
Product Code
EJH
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
EJH Alloy, Metal, Base

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Other Clearances by Aalba Dent, Inc.

K Number Device Name
K040180 CONTINUM V
K040179 CONTINUM
K033356 VERASOFT ES
K982094 VERABOND 2
K972971 NPG + 2
K973265 VERABOND 2V
K972607 PLATALLOY
K972533 VERA SOLDER
K972534 ALFALLOY
K972632 VERA PD SOLDER
Search all 27 clearances from Aalba Dent, Inc. →