Stainless Steel Arches

FDA 510(k) K933379 · Highland Metals

Substantially Equivalent

510(k) numberK933379

Submission

Device name
Stainless Steel Arches
Applicant
Highland Metals
San Jose, CA, US
Received
July 9, 1993
Decision date
November 12, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DZC – Wire, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Specialty
Dental

Other 510(k)s with product code DZC

510(k)DeviceApplicantDecision
K112640Hyperelastic WireDZC · Traditional Ormco Corp.11/16/2011SE
K943334Hawley Retainer Orthodontic Applicance KitDZC · Traditional Jay H. Geller10/05/1994SE
K935638Nitinol, NitiDZC · Traditional Highland Metals05/18/1994SE
K935140Dentaurum Steel Ligature WiresDZC · Traditional Dentauraum, Inc.02/04/1994SE
K935142Dentaurum WiresDZC · Traditional Dentauraum, Inc.01/31/1994SE
K934265Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional Flexmedics01/21/1994SE
K933374Niti Coil SpringsDZC · Traditional Highland Metals11/19/1993SE
K933377Stainless Steel Arches Repacker RelabeterDZC · Traditional Highland Metals11/16/1993SE
K933380Reverse Surve Niti Arch WireDZC · Traditional Highland Metals11/12/1993SE
K933378Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional Highland Metals11/12/1993SE

More from Highland Metals

510(k)DeviceDecision
K935638Nitinol, NitiDZC · Traditional 05/18/1994SE
K933374Niti Coil SpringsDZC · Traditional 11/19/1993SE
K933377Stainless Steel Arches Repacker RelabeterDZC · Traditional 11/16/1993SE
K933380Reverse Surve Niti Arch WireDZC · Traditional 11/12/1993SE
K933378Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional 11/12/1993SE
K933376Niti Arch Wire on a SpoolDZC · Traditional 11/12/1993SE

Questions and answers

When was Stainless Steel Arches cleared by the FDA?

Stainless Steel Arches (K933379) received a 510(k) decision of Substantially Equivalent on November 12, 1993, 126 days after the submission was received.

What is the product code of K933379?

The FDA product code is DZC – Wire, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.