510(k) K231100

Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw by Proimtech Saglik Urunleri Anonim Sirketi — Product Code DZE

K231100 is an FDA 510(k) premarket notification submitted by Proimtech Saglik Urunleri Anonim Sirketi for the device "Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw". The FDA issued a decision of Substantially Equivalent on August 23, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Proimtech Saglik Urunleri Anonim Sirketi has at least 2 other 510(k) clearances on record.