Dio Protem Implant System

by Dio Department Dsi, Inc. 510(k)

Active United States

510(k) K080126

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080126	Date11 Apr 2008Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K080126
FDA Product Code: DZE

Device Class: Class II
Regulation: 21 CFR Part 872.3640
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

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