Product code EMI— Dental

FDA has cleared 4 devices under product code EMI between 1983 and 1992, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19921 clearance
• 19911 clearance
• 19851 clearance
• 19831 clearance

• Wilde-USA, Inc.1 clearance
• Today'S Machining & Design, Inc.1 clearance
• Biomedical Composites, Ltd.1 clearance
• Artiberia1 clearance

• K914035 — MINI-MILLBiomedical Composites, Ltd.·1992-03-02
• K912989 — PLANUSTAR AND DENS NOBILIS DENTURE TEETHWilde-USA, Inc.·1991-08-16
• K851716 — 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILESArtiberia·1985-06-11
• K823676 — DISC NEEDLE SET #TX-8220Today'S Machining & Design, Inc.·1983-01-09