Dentis Co., Ltd. - FDA 510(k) Cleared Devices

Dentis Co., Ltd. is a Dental device manufacturer based in Dalseo-Gu, South Korea.

The company has received 37 FDA 510(k) clearances from 37 total submissions. All submissions focus on Dental devices, with a regulatory history spanning from 2008 to 2026. The company remains active, with recent clearances demonstrating ongoing product development and market engagement.

Dentis specializes in dental implant systems, abutments, and associated clinical equipment. Recent cleared devices include implant fixtures, abutment components, scanning and healing systems, and dental chairs, reflecting a comprehensive portfolio across implantology and clinical practice solutions.

Explore the complete list of device names, product codes, and clearance dates to review Dentis's full regulatory record.

Regulatory submissions have been managed by Withus Group, Inc., Dentis Co., Ltd. and Allura Medical Solution, Inc..