Miscellaneous devices · 21 CFR 872 Subpart G

Dental Chair with Operative Unit

FDA device type “Chair, Dental, With Operative Unit”.

FDA codeKLCClass121 CFR872.6250Pathway510(k)CategoryDental chairs & operative units

Companies listing it: 1412 makers
Brands and models: 66
510(k) clearances: 631 in five years
FDA name: Chair, Dental, With Operative Unit

510(k) clearances per year, 1976–2026

Companies that list KLC

14 companies currently list this device type with FDA.

Company	Country	Role	Brands and models listed	Clearances	Latest
Dentis Co., Ltd.	South Korea	Maker	Luvis Chair (LC700C)	37	2026
Osstem Implant Co., Ltd.	South Korea	Maker	K5 · K5 Cart, K5 Mount, K5 Swing	68	2026
Alliage S/A Industrias Medico Odontologica	Brazil	Maker	Croma Dental Chair · D1 Dental Chair · Galla Dental Chair · New Croma Dental Chair · +22	3	2024
Lakong Medical Devices Co., Ltd.	China	Maker	Laguna 2, Mirage 2 dental chair with delivery unit operatory package	2	2026
DCI International LLC	United States	Maker	DCI Edge · Dental Delivery System Series 5 and 5 Plus · Reliance	1	2025
Jiangsu Dynamic Medical Technology Co., Ltd	China	Maker	Dental Chair with Operative Unit	1	2023
Guangdong Yadeng Medical Apparatus Co.,Ltd	China	Maker	Integral Dental Unit Model: YD-A4, AD-S1, AD-S3, AD-S6	1	2025
Mipont Medical Equipment Co., Ltd.	China	Maker	Integral Dental Units	1	2025
Beyes Dental Inc	Canada	Maker	Beyes Dental Chair With Operative Unit · Comfortek Mobile Dental System · Comfortek Portable Dental System	—	—
AC Equipamentos Medicos e Odontologicos LTDA	Brazil	Maker	1402 2HP Delivery System · 1403 2 HP Rear Mounted Delivery System · 1407 3HP Delivery Systems · 1408 3 HP Rear Mounted Delivery System · +4	—	—
Summit Dental Systems LLC.	United States	Maker	1402 2HP Delivery System · 1403 2HP Rear Mounted Delivery System · 1407 3HP Delivery System · 1408 3HP Rear Mounted Delivery System · +4	—	—
Foshan Gladent Medical Instrument Co.,Ltd.	China	Maker	Dental Chair With Operative Unit	—	—
Tpc Advanced Technology, Inc.	United States	Repacker / relabeler	Bellagio Operatory Package · Laguna Hygiene Operatory Package · Laguna Operatory Package · Laguna Orthodontic Operatory Package · +5	3	2007
DDS Dentalab	United States	Repacker / relabeler	FOSHION DENTAL CHAIR WITH OPERATIVE UNIT	—	—

510(k) clearances

Decided	510(k)	Device	Applicant
6 Sep 2024	K233921	Luvis Chair (LC700C)	Dentis Co., Ltd.
1 Jun 2016	K151987	DCI Edge Dental Chair with Operative Unit	Dci
14 Dec 2007	K071353	FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C	Shanghai Foshion Medical Instruments Co., Ltd.
3 Jun 1997	K971063	OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR	King Dental Corp.
24 Oct 1996	K963209	PROSTYLE COMPACT	Planmeca Oy
27 Feb 1995	K942870	ULTIMA 2 DENTAL CHAIR	Dentech Corp.
29 Dec 1994	K940950	KAVO SYSTEMATICA 1060	Kavo America
10 Mar 1994	K925567	E 4000 DENTAL OPERATING CHAIR	Dentalez Group
31 Jan 1994	K925119	A-DEC 1040 CHAIR	A-dec, Inc.
31 Jan 1994	K923534	PM2002 PROLINE	Planmeca USA, Inc.
9 Dec 1993	K925325	A-DEC 2185 DOCTOR'S UNIT	A-dec, Inc.
9 Dec 1993	K925324	A-DEC 2184 DUO UNIT	A-dec, Inc.
9 Dec 1993	K925323	A-DEC 2183 DUO UNIT, CUSP	A-dec, Inc.
9 Dec 1993	K925322	A-DEC 2147 DOCTOR'S UNIT	A-dec, Inc.
9 Dec 1993	K925321	A-DEC 2146 DUO UNIT	A-dec, Inc.
9 Dec 1993	K925320	A-DEC 2145 DUO UNIT, CUSP	A-dec, Inc.
9 Dec 1993	K925319	A-DEC 2182 DOCTOR'S UNIT	A-dec, Inc.
9 Dec 1993	K925318	A-DEC 2181 DUO UNIT	A-dec, Inc.
9 Dec 1993	K925317	A-DEC 2180 DUO UNIT, CUSP	A-dec, Inc.
9 Dec 1993	K925316	A-DEC 2172 DOCTOR'S UNIT	A-dec, Inc.
9 Dec 1993	K925315	A-DEC 2171 DUO UNIT	A-dec, Inc.
9 Dec 1993	K925314	A-DEC 2170 DUO UNIT CUSP	A-dec, Inc.
20 May 1993	K931169	MDT DENTAL CHAIR	Mdt Corp., Inc.
21 Dec 1992	K923461	PM2002 PROLINE, PM2002 PROLINE EC	Planmeca USA, Inc.
6 Aug 1992	K922175	HEALTHPAK CHAIR SOX BARRIERS	Healthpak, Inc.
5 Aug 1992	K923306	HEALTHPAK UTILITY SOX BARRIERS	Healthpak, Inc.
2 Mar 1992	K920017	IMPROVED DENTAL OPERATING LIGHT	Den-Tal-Ez Mfg Co., Inc.
2 Mar 1992	K920016	IMPROVED DENTAL CHAIR	Den-Tal-Ez Mfg Co., Inc.
9 Oct 1991	K913535	A-DEC DECADE 1020 CHAIR	A-dec, Inc.
8 Oct 1991	K913059	A-DEC KNEEBREAK 1030 CHAIR	A-dec, Inc.
24 Oct 1990	K903454	A-DEC DECADE 1010 CHAIR	A-dec, Inc.
24 Oct 1990	K903450	A-DEC DECADE 1015 CHAIR	A-dec, Inc.
14 Feb 1990	K896602	FD5000 DENTAL CHAIR	Oriola OY Finndent
7 Sep 1989	K894060	ESSE QUATTRO/ESSE UNO	Eurodent, Inc.
15 Aug 1989	K893944	FD 300 DENTAL STOOL	Oriola OY Finndent
15 Aug 1989	K893943	FD 200 DENTAL STOOL	Oriola OY Finndent
15 Aug 1989	K893890	FD4500 (DENTAL CHAIR)	Oriola OY Finndent
15 Aug 1989	K893889	FD3500 (DENTAL CHAIR)	Oriola OY Finndent
11 Aug 1989	K893945	FD 350 DENTAL STOOL	Oriola OY Finndent
8 Aug 1989	K893946	FD 400 DENTAL STOOL	Oriola OY Finndent
25 Jul 1989	K893454	CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD	Atlantic Industries, Inc.
14 Jul 1989	K893045	A-DEC PRIORITY 1005 CHAIR	A-dec, Inc.
25 Apr 1989	K884304	ORTHO PATIENT CHAIR	Halton Furniture Mfg.
10 Feb 1989	K884830	DENTAL CHAIR F1	Fimet OY
12 Oct 1988	K883437	DENTAL CHAIR	E.F. Brewer Co.
23 Sep 1988	K880475	SKEMA (DENTAL UNIT)	Alpine Dental Equipment Co.
23 Sep 1988	K880474	AREA (DENTAL CHAIR)	Alpine Dental Equipment Co.
1 Oct 1986	K863016	DENTATUS L SET	Sds Dental, Inc.
19 Sep 1986	K863484	SIEMENS SIRONA(R) DENTAL CHAIR	Pelton & Crane
5 Jun 1986	K854647	POLO DENTAL UNIT	Alpine Dental Equipment Co.
23 Jan 1986	K854644	MANTA DENTAL CHAIR	Alpine Dental Equipment Co.
25 Oct 1984	K843233	ANATOM SYSTEM	Lic-Orthion
27 Sep 1984	K843436	DENTAL CHAIR	Swedish Dental Products, Inc.
5 Apr 1983	K822095	HERPES-IHA KIT	Hillcrest Biologicals
28 Sep 1982	K822740	K30000 DENTAL CHAIR	Kaycor Intl., Ltd.
17 Mar 1980	K800276	RITTER MODEL H COMPANION STOOL	Sybron Corp.
5 Feb 1980	K800172	SIROPORT	Siemens AG
29 Jan 1980	K800084	RITTER MODEL J DENTAL CHAIR	Ritter Co.
3 Jan 1978	K772300	DENTAL CHAIR, VANGUARD	Ritter Co.
25 Oct 1977	K771873	VISION SERIES DENTAL CHAIR	Chayes Virginia, Inc.
15 Sep 1976	K760599	DENTAL CHAIRS	Chayes Virginia, Inc.
23 Aug 1976	K760404	BI-CENTRIC SYSTEM	Pelton & Crane
3 Aug 1976	K760322	CHAIR, ATTACHED INSTRUMENT DEL. SYS.	The S. S. White Co.

Official records: FDA product classification for KLC · 21 CFR 872.6250.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026