EIA · Class I · 21 CFR 872.6640

FDA Product Code EIA: Unit, Operative Dental

FDA product code EIA covers operative dental units that integrate all components needed for dental treatment at a single patient chair.

These self-contained units combine delivery systems for air, water, suction, and instrument connections with an adjustable patient chair and operator's stool, providing the complete infrastructure for dental examination and treatment in a single integrated station.

EIA devices are Class I medical devices, regulated under 21 CFR 872.6640 and reviewed by the FDA Dental panel.

Leading manufacturers include A-Dec, Inc., Aseptico, Inc. and Sds Dental, Inc..

285
Total
285
Cleared
141d
Avg days
1977
Since
Stable submission activity - 8 submissions in the last 2 years
Review times increasing: avg 288d recently vs 137d historically

FDA 510(k) Cleared Unit, Operative Dental Devices (Product Code EIA)

285 devices
1–24 of 285
Cleared Aug 07, 2026
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
K251544
Lakong Medical Devices Co., Ltd.
Dental · 444d
Cleared Nov 03, 2025
Midmark Dental Delivery System
K251626
Midmark Corporation
Dental · 159d
Cleared Jul 17, 2025
K5 Cart, K5 Mount, K5 Swing
K251491
Osstem Implant Company., Ltd. Chair Business
Dental · 64d
Cleared Jun 27, 2025
Integral Dental Unit
K243130
Guangdong Yadeng Medical Apparatus Co., Ltd.,
Dental · 270d
Cleared May 27, 2025
Integral Dental Units
K242611
Mipont Medical Equipment Co., Ltd.
Dental · 266d
Cleared Feb 19, 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473
Dci International, LLC
Dental
Cleared Feb 07, 2025
BDC Dental Unit
K242404
Bdc Dental Corporation , Ltd.
Dental · 178d
Cleared Jan 27, 2025
Firstar Dental Unit
K231297
Firstar Dental Company
Dental · 634d
Cleared Sep 03, 2024
K5
K233805
Osstem Implant Co., Ltd. Chair Business
Dental · 279d
Cleared Mar 21, 2024
N2
K240754
Megagen Implant Co., Ltd.
Dental · 1d
Cleared Feb 28, 2024
Dental unit Model: Mare
K231845
Foshan Safety Medical Equipment Co., Ltd.
Dental · 251d
Cleared May 05, 2023
ELEC Master, ELEC Master Dual
K202963
Mgnewton , Ltd.
Dental · 947d
Cleared Apr 05, 2023
N2
K211556
Megagen Implant Co., Ltd.
Dental · 686d
Cleared Apr 03, 2023
G7, Dental Operative Unit and Accessories
K213749
Shinhung Company, Ltd.
Dental · 489d
Cleared Dec 15, 2022
Perceptive electric dental motor and control unit
K220873
Lares Research
Dental · 265d
Cleared Oct 19, 2022
Infinity Pro, Logic, Quality, Sprint
K213742
Olsen Ind?stria E Com?rcio S.A.
Dental · 324d
Cleared Mar 02, 2022
A-dec 300, A-dec 500
K213932
A-Dec, Inc.
Dental · 76d
Cleared Feb 05, 2020
Infinity / Infinity Cross Flex Dental Systems
K180935
Olsen Industria E Comercio S.A.
Dental · 666d
Cleared Sep 04, 2019
K3
K183347
Osstem Implant Co., Ltd.
Dental · 275d
Cleared Jul 18, 2019
Qraypen
K183121
AIOBIO Co., Ltd.
Dental · 251d
Cleared Aug 17, 2018
Forest Dental Unit
K173608
Forest Dental Products, Inc.
Dental · 269d
Cleared Apr 26, 2018
P50 Series Dental Operative Unit and Accessories
K171872
Pelton & Crane
Dental · 307d
Cleared Apr 20, 2017
K3
K152830
Osstem Implant Co., Ltd.
Dental · 569d
Cleared Dec 09, 2016
Vanguard Dental Unit
K161734
Ritter Concept GmbH
Dental · 169d

About Product Code EIA - Regulatory Context

510(k) Submission Activity

285 total 510(k) submissions under product code EIA since 1977, with 285 receiving FDA clearance (average review time: 141 days).

Submission volume has remained relatively stable over the observed period, with 8 submissions in the last 24 months.

FDA 510(k) Review Time - EIA Product Code

Recent submissions under EIA have taken an average of 288 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.

EIA devices are reviewed by the Dental panel. Browse all Dental devices →