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

CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM

K Number: K901782 · Decision Jun 29, 1990
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
1
Review Days
73

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Basic Information

Device Name
CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM
K Number
K901782
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3670
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Productivity Training Corp.
Date Received
April 17, 1990
Decision Date
June 29, 1990
Product Code
EBH
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
EBH Material, Impression Tray, Resin

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