Medical Device Manufacturer · US , Newberg , OR

A-Dec, Inc. - FDA 510(k) Cleared Devices

69 submissions · 69 cleared · Since 1989

Total

Cleared

Denied

A-Dec, Inc. is a dental equipment manufacturer based in Newberg, Oregon. The company designs and produces integrated dental operatory systems, delivery equipment, handpieces, and mechanical room solutions for dental practices worldwide.

A-Dec has maintained a strong FDA 510(k) regulatory record since 1989. The company has received 69 FDA 510(k) clearances from 69 total submissions, with no denied submissions. All cleared devices fall within the Dental category, reflecting the company's specialization in dental equipment and accessories. The latest clearance on record dates to 2022.

A-Dec's cleared device portfolio includes dental chairs, delivery systems, handpiece motors and attachments, sonic scalers, air-driven handpieces, and self-contained water systems. The company's product lines-including the A-Dec 300, A-Dec 400, and A-Dec 500 series-represent core offerings in the dental operatory market.

This regulatory profile is presented as a historical record. For current product availability, clearance status, and device specifications, consult the FDA's 510(k) database or contact the manufacturer directly.

FDA 510(k) Regulatory Record - A-Dec, Inc.

69 devices

1-12 of 69