Cleared Traditional

K250473 - Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (FDA 510(k) Clearance)

Class I Dental device.

K250473 · Dci International, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
-
Days
Class 1
Risk

K250473 is an FDA 510(k) clearance for the Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dci International, LLC (Newberg, US). The FDA issued a Cleared decision on February 19, 2025.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dci International, LLC devices

Submission Details

510(k) Number K250473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2025
Decision Date February 19, 2025
Days to Decision -
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIA Unit, Operative Dental

All 283
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K250473.
Midmark Dental Delivery System
K251626 · Midmark Corporation · Nov 2025
K5 Cart, K5 Mount, K5 Swing
K251491 · Osstem Implant Company., Ltd. Chair Business · Jul 2025
Integral Dental Unit
K243130 · Guangdong Yadeng Medical Apparatus Co., Ltd., · Jun 2025
Integral Dental Units
K242611 · Mipont Medical Equipment Co., Ltd. · May 2025
BDC Dental Unit
K242404 · Bdc Dental Corporation , Ltd. · Feb 2025
Firstar Dental Unit
K231297 · Firstar Dental Company · Jan 2025