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

AURA CERAMIC DENTAL APPLIANCE

K Number: K902390 · Decision Aug 13, 1990
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
3
Review Days
75

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Basic Information

Device Name
AURA CERAMIC DENTAL APPLIANCE
K Number
K902390
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.5410
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Progressive Technology, Inc.
Date Received
May 30, 1990
Decision Date
August 13, 1990
Product Code
EJF
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
EJF Bracket, Metal, Orthodontic

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Other Clearances by Progressive Technology, Inc.

K Number Device Name
K142729 Chi Lites Orthodontic Sapphire Bracket
K812676 AMPLITONE-3