Who is the manufacturer of FLEXICAST?

American Dent-All, Inc. submitted the Traditional clearance for FLEXICAST (K003509).

What is the FDA product code for FLEXICAST?

EJH. It is classified under 21 CFR 872.3710 as a Class 2 device in the Dental panel.

What is the regulatory pathway for FLEXICAST?

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

FLEXICAST

K003509 · American Dent-All, Inc. · EJH · Jan 2, 2001 · Dental

Device Facts

Record ID	K003509
Device Name	FLEXICAST
Applicant	American Dent-All, Inc.
Product Code	EJH · Dental
Decision Date	Jan 2, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3710
Device Class	Class 2

Regulatory Classification

Identification

A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.