Who is the manufacturer of DENTO-PREP PARTICLE MICROBLASTER?

Ronvig A/S submitted the Traditional clearance for DENTO-PREP PARTICLE MICROBLASTER (K010816).

What is the FDA product code for DENTO-PREP PARTICLE MICROBLASTER?

KOJ. It is classified under 21 CFR 872.6080 as a Class 2 device in the Dental panel.

What is the regulatory pathway for DENTO-PREP PARTICLE MICROBLASTER?

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

DENTO-PREP PARTICLE MICROBLASTER

K010816 · Ronvig A/S · KOJ · May 10, 2001 · Dental

Device Facts

Record ID	K010816
Device Name	DENTO-PREP PARTICLE MICROBLASTER
Applicant	Ronvig A/S
Product Code	KOJ · Dental
Decision Date	May 10, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6080
Device Class	Class 2

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”