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 Dentsply Intl., Megagen Implant Co., Ltd. and Lares Research.

284
Total
284
Cleared
140d
Avg days
1977
Since
Stable submission activity - 8 submissions in the last 2 years
Review times increasing: avg 264d recently vs 137d historically

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

284 devices
1–24 of 284
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 Oct 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904
Dentsply Intl.
Dental · 27d
Cleared Apr 13, 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112
Dentsply Intl.
Dental · 90d
Cleared Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658
KARL STORZ Endoscopy-America, Inc.
Dental · 77d

About Product Code EIA - Regulatory Context

510(k) Submission Activity

284 total 510(k) submissions under product code EIA since 1977, with 284 receiving FDA clearance (average review time: 140 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 264 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 →