Who is the manufacturer of VERTEX ETCHANT?

Apex Dental Materials, Inc. submitted the Traditional clearance for VERTEX ETCHANT (K010849).

What is the FDA product code for VERTEX ETCHANT?

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

What is the regulatory pathway for VERTEX ETCHANT?

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

VERTEX ETCHANT

K010849 · Apex Dental Materials, Inc. · EBF · Sep 14, 2001 · Dental

Device Facts

Record ID	K010849
Device Name	VERTEX ETCHANT
Applicant	Apex Dental Materials, Inc.
Product Code	EBF · Dental
Decision Date	Sep 14, 2001
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.