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

ORTHODONTIC ARCH WIRE

K Number: K924805 · Decision Mar 31, 1993
Classifications
1
FEI Numbers
168
Registration Numbers
168
Same Product Code
29
Applicant Total
6
Review Days
188

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Basic Information

Device Name
ORTHODONTIC ARCH WIRE
K Number
K924805
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.5410
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Ultimate Wireforms, Inc.
Date Received
September 24, 1992
Decision Date
March 31, 1993
Product Code
DZC
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
DZC Wire, Orthodontic

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Other Clearances by Ultimate Wireforms, Inc.

K Number Device Name
K960799 ORTHO-ICE
K923837 DIMPLED MULTI MODULUS ARCH WIRE
K923836 .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING
K923838 THE ULTIMATE RCS ARCH WIRE
K923839 NITINOL GENTLE TOUCH COIL SPRING