510(k) K110481

TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE by Asi Medical, Inc. — Product Code EIA

K110481 is an FDA 510(k) premarket notification submitted by Asi Medical, Inc. for the device "TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE". The FDA issued a decision of Substantially Equivalent on April 5, 2012. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Asi Medical, Inc. has at least 4 other 510(k) clearances on record.