Product code EBE— Dental

FDA has cleared 3 devices under product code EBE between 1979 and 1983, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19832 clearances
• 19791 clearance

• Richardson Merrel, Inc.1 clearance
• Johnson & Johnson Professionals, Inc.1 clearance
• Chema-Scutum, Inc.1 clearance

• K832500 — CS-11Chema-Scutum, Inc.·1983-10-27
• K830491 — JOHNSON & JOHNSON OPAQUE COLOR MODIFIJohnson & Johnson Professionals, Inc.·1983-03-17
• K790339 — CONCEPT IIRichardson Merrel, Inc.·1979-07-17