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

STAINLESS STEEL ARCHES REPACKER RELABETER

K Number: K933377 · Decision Nov 16, 1993
Classifications
1
FEI Numbers
181
Registration Numbers
181
Same Product Code
29
Applicant Total
7
Review Days
130

Basic Information

Device Name
STAINLESS STEEL ARCHES REPACKER RELABETER
K Number
K933377
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.5410
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
HIGHLAND METALS
Date Received
July 9, 1993
Decision Date
November 16, 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 HIGHLAND METALS

K Number Device Name
K935638 NITINOL, NITI
K933374 NITI COIL SPRINGS
K933380 REVERSE SURVE NITI ARCH WIRE
K933378 REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER
K933376 NITI ARCH WIRE ON A SPOOL
K933379 STAINLESS STEEL ARCHES