Product code EMM— Dental

FDA has cleared 4 devices under product code EMM between 1976 and 1996, 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.

• 19961 clearance
• 19871 clearance
• 19851 clearance
• 19761 clearance

• Steri-Oss, Inc.1 clearance
• New England Surgical Instrument Corp.1 clearance
• Artiberia1 clearance
• American Safety Equipment Corp.1 clearance

• K963897 — STERI-OSS SINUS AUGMENTATION KITSteri-Oss, Inc.·1996-11-06
• K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.)New England Surgical Instrument Corp.·1987-02-12
• K851714 — 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURSArtiberia·1985-06-11
• K760959 — SURGICAL CHISELAmerican Safety Equipment Corp.·1976-11-15