Metal-Lined Transcend Ceramic Bracket

Q: What is the product code of K944286?

The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.

FDA 510(k) K944286 · Unitek Corp.

Substantially Equivalent

510(k) numberK944286

Submission

Device name: Metal-Lined Transcend Ceramic Bracket
Applicant: Unitek Corp.
Monrovia, CA, US
Received: September 2, 1994
Decision date: November 29, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: DYW – Bracket, Plastic, Orthodontic
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.5470
Specialty: Dental

Other 510(k)s with product code DYW

510(k)	Device	Applicant	Decision
K252760	Carriere® Motion Pro® Clear Bite CorrectorDYW · Traditional	Ortho Organizers, Inc.	11/27/2025SE
K251196	Composite Orthodontic Brackets and ButtonsDYW · Traditional	Ec Certification Service GmbH	04/21/2025SE
K201940	Braces on Demand BracketDYW · Traditional	Braces on Demand, Inc.	12/03/2020SE
K182338	Blue Sky Bio Computerized Orthodontic Bracket SystemDYW · Traditional	Blue Sky Bio	11/09/2018SE
K180718	Orthodontic Plastic Brackets and AccessoriesDYW · Traditional	Tomy, Inc.	10/30/2018SE
K160720	Carriere Motion Clear Class IIDYW · Traditional	Ortho Organizers, Inc.	11/28/2016SE
K150830	CompleClear Plastic Orthodontic Bracket and Wire ApplianceDYW · Traditional	Oracrew	08/26/2016SE
K150702	Exceed TxDYW · Traditional	Great Lakes Orthodontics, Ltd.	03/24/2016SE
K140807	Composite Orthodontic BracketsDYW · Traditional	Ortho Specialties	11/12/2014SE
K123118	Insignia DigicastDYW · Traditional	Ormco Corp.	03/26/2013SE

More from Ormco Corp.

510(k)	Device	Decision
K933501	AlastikEJF · Traditional	04/28/1994SE
K940165	AlastikECI · Traditional	03/07/1994SE
K923999	Alastik NSECI · Traditional	06/24/1993SE
K924645	Transcend Series 6000 Debonding InstrumentsJEX · Traditional	11/25/1992SE
K924295	Debracketing InstrumentJEX · Traditional	11/23/1992SE
K923432	German Mini DynalockEJF · Traditional	10/30/1992SE
K911271	Adhesive Precoated BracketsDYH · Traditional	05/29/1991SE
K910288	Nonstaining AlastiksEJF · Traditional	03/29/1991SE
K890529	AlastigardEJF · Traditional	03/09/1989SE
K880392	Ortholux Visible Light Curing UnitEBZ · Traditional	04/07/1988SE

Questions and answers

When was Metal-Lined Transcend Ceramic Bracket cleared by the FDA?

Metal-Lined Transcend Ceramic Bracket (K944286) received a 510(k) decision of Substantially Equivalent on November 29, 1994, 88 days after the submission was received.

What is the product code of K944286?

The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.