Who is the manufacturer of BIOCCLUS 4?

Degussa Corp. submitted the Traditional clearance for BIOCCLUS 4 (K960104).

What is the FDA product code for BIOCCLUS 4?

EJT. It is classified under 21 CFR 872.3060 as a Class 2 device in the Dental panel.

What is the regulatory pathway for BIOCCLUS 4?

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

BIOCCLUS 4

K960104 · Degussa Corp. · EJT · Feb 6, 1996 · Dental

Device Facts

Record ID	K960104
Device Name	BIOCCLUS 4
Applicant	Degussa Corp.
Product Code	EJT · Dental
Decision Date	Feb 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3060
Device Class	Class 2

Regulatory Classification

Identification

A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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.