ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium

Q: What is the product code of K201309?

The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.

FDA 510(k) K201309 · Mecta Corporation

Substantially Equivalent

510(k) numberK201309

Submission

Device name: ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
Applicant: Mecta Corporation
Tualatin, OR, US
Received: May 15, 2020
Decision date: June 4, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JXL – Block, Bite
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5070
Specialty: Neurology

Other 510(k)s with product code JXL

510(k)	Device	Applicant	Decision
K221469	PATI (Protector Against Tongue Injury)JXL · Traditional	Neurovice, LLC	02/22/2023SE
K172978	SurgeoBiteJXL · Traditional	Surgovations, LLC	12/22/2017SE
K150518	Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…JXL · Traditional	Dupaco, Inc.	06/29/2015SE
K050188	EpiguardJXL · Traditional	Episafe Medical Devices, Ltd.	04/27/2005SE
K992269	Ventil-A Oral ProtectorJXL · Traditional	Somatics, Inc.	10/25/1999SE
K960663	Universal Bite BlockJXL · Traditional	B&B Medical Technologies, Inc.	05/17/1996SE
K954352	Bite BlockJXL · Traditional	United States Endoscopy Group, Inc.	01/25/1996SE
K941856	Premier Promax Bite GuardJXL · Traditional	Premier Dental Products Co.	04/05/1995SE
K924333	The Davis Disposable Protective SplintJXL · Traditional	Ora-Gard, Inc.	04/23/1993SE
K924304	Bite BlockJXL · Traditional	United States Endoscopy Group, Inc.	04/06/1993SE

More from United States Endoscopy Group, Inc.

510(k)	Device	Decision
K192834	MECTA SigmaQGH · Special	04/26/2020SE
K965070	Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.QGH · Traditional	03/06/1997SE
K960754	Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MQGH · Traditional	09/18/1996SE
K852069	Mecta Ect Device Models SR & JRQGH · Traditional	08/09/1985SE

Questions and answers

When was ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium cleared by the FDA?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (K201309) received a 510(k) decision of Substantially Equivalent on June 4, 2021, 385 days after the submission was received.

What is the product code of K201309?

The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.