Device Atlas

Stainless Steel Orthodontic Products

Q: What is the product code of K931980?

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

FDA 510(k) K931980 · Ortho Organizers, Inc.

Substantially Equivalent

510(k) numberK931980

Submission

Device name: Stainless Steel Orthodontic Products
Applicant: Ortho Organizers, Inc.
San Marcos, CA, US
Received: April 22, 1993
Decision date: September 1, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DYO – Band, Material, Orthodontic
Device class: Class I (low risk)
Regulation: 21 CFR 872.5410
Specialty: Dental

Other 510(k)s with product code DYO

510(k)	Device	Applicant	Decision
K935152	Dentaurum Dentaform Bands, Dentaurum StandardDYO · Traditional	Dentauraum, Inc.	01/31/1994SE
K844034	SonocareDYO · Traditional	Echo Ultrasound	01/23/1985SE

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K061266	Ortho Organizers Temporary Orthodontic AnchorOAT · Traditional	07/31/2006SE
K923218	Nitanium Palatal ExpanderEJF · Traditional	09/13/1993SE
K931663	Nitanium Pro Form Archwires,Round,Square,RectangulEJF · Traditional	07/08/1993SE

Questions and answers

When was Stainless Steel Orthodontic Products cleared by the FDA?

Stainless Steel Orthodontic Products (K931980) received a 510(k) decision of Substantially Equivalent on September 1, 1993, 132 days after the submission was received.

What is the product code of K931980?

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