Dimpled Multi Modulus Arch Wire

Q: What is the product code of K923837?

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

FDA 510(k) K923837 · Ultimate Wireforms, Inc.

Substantially Equivalent

510(k) numberK923837

Submission

Device name: Dimpled Multi Modulus Arch Wire
Applicant: Ultimate Wireforms, Inc.
Terryville, CT, US
Received: July 30, 1992
Decision date: March 31, 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
K960799	Ortho-IceEAT · Traditional	05/09/1996SE
K924805	Orthodontic Arch WireDZC · Traditional	03/31/1993SE
K923836	.016' X .016 Nickel Titanium Uprighting SpringDZC · Traditional	12/23/1992SE
K923838	The Ultimate RCS Arch WireDZC · Traditional	12/04/1992SE
K923839	Nitinol Gentle Touch Coil SpringDZC · Traditional	10/15/1992SE

Questions and answers

When was Dimpled Multi Modulus Arch Wire cleared by the FDA?

Dimpled Multi Modulus Arch Wire (K923837) received a 510(k) decision of Substantially Equivalent on March 31, 1993, 244 days after the submission was received.

What is the product code of K923837?

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