510(k) K213932

A-dec 300, A-dec 500 by A-Dec, Inc. — Product Code EIA

K213932 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-dec 300, A-dec 500". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. A-Dec, Inc. has at least 10 other 510(k) clearances on record.