Niti Arch Wire on a Spool

Q: What is the product code of K933376?

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

FDA 510(k) K933376 · Highland Metals

Substantially Equivalent

510(k) numberK933376

Submission

Device name: Niti Arch Wire on a Spool
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)	Device	Applicant	Decision
K112640	Hyperelastic WireDZC · Traditional	Ormco Corp.	11/16/2011SE
K943334	Hawley Retainer Orthodontic Applicance KitDZC · Traditional	Jay H. Geller	10/05/1994SE
K935638	Nitinol, NitiDZC · Traditional	Highland Metals	05/18/1994SE
K935140	Dentaurum Steel Ligature WiresDZC · Traditional	Dentauraum, Inc.	02/04/1994SE
K935142	Dentaurum WiresDZC · Traditional	Dentauraum, Inc.	01/31/1994SE
K934265	Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional	Flexmedics	01/21/1994SE
K933374	Niti Coil SpringsDZC · Traditional	Highland Metals	11/19/1993SE
K933377	Stainless Steel Arches Repacker RelabeterDZC · Traditional	Highland Metals	11/16/1993SE
K933380	Reverse Surve Niti Arch WireDZC · Traditional	Highland Metals	11/12/1993SE
K933379	Stainless Steel ArchesDZC · Traditional	Highland Metals	11/12/1993SE

More from Highland Metals

510(k)	Device	Decision
K935638	Nitinol, NitiDZC · Traditional	05/18/1994SE
K933374	Niti Coil SpringsDZC · Traditional	11/19/1993SE
K933377	Stainless Steel Arches Repacker RelabeterDZC · Traditional	11/16/1993SE
K933380	Reverse Surve Niti Arch WireDZC · Traditional	11/12/1993SE
K933379	Stainless Steel ArchesDZC · Traditional	11/12/1993SE
K933378	Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional	11/12/1993SE

Questions and answers

When was Niti Arch Wire on a Spool cleared by the FDA?

Niti Arch Wire on a Spool (K933376) 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 K933376?

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