Who is the manufacturer of CRYSTALLESSENCE?

Confi-Dental Products Co. submitted the Traditional clearance for CRYSTALLESSENCE (K954988).

What is the FDA product code for CRYSTALLESSENCE?

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

What is the regulatory pathway for CRYSTALLESSENCE?

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

CRYSTALLESSENCE

K954988 · Confi-Dental Products Co. · EBF · Mar 8, 1996 · Dental

Device Facts

Record ID	K954988
Device Name	CRYSTALLESSENCE
Applicant	Confi-Dental Products Co.
Product Code	EBF · Dental
Decision Date	Mar 8, 1996
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.