Who is the manufacturer of MW 8000-I?

Midwest filed the 510(k) submission for MW 8000-I (K792303).

What is the FDA product code for MW 8000-I?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for MW 8000-I?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MW 8000-I?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MW 8000-I

K792303 · Midwest · EBF · Nov 27, 1979 · Dental

Device Facts

Record ID	K792303
Device Name	MW 8000-I
Applicant	Midwest
Product Code	EBF · Dental
Decision Date	Nov 27, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

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