Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KLC — Predicate Candidate Screening

63 FDA 510(k) clearances under this product code; the 50 most recent screened below.

85 daysmedian FDA review time

414 days90th percentile

63clearances measured

K-number	Device	Applicant	Decided	Review days
K233921	Luvis Chair (LC700C)	Dentis Co., Ltd.	2024-09-06	268
K151987	DCI Edge Dental Chair with Operative Unit	Dci	2016-06-01	320
K071353	FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C	Shanghai Foshion Medical Instruments Co., Ltd.	2007-12-14	213
K971063	OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR	King Dental Corp.	1997-06-03	71
K963209	PROSTYLE COMPACT	Planmeca Oy	1996-10-24	69
K942870	ULTIMA 2 DENTAL CHAIR	Dentech Corp.	1995-02-27	255
K940950	KAVO SYSTEMATICA 1060	Kavo America	1994-12-29	304
K925567	E 4000 DENTAL OPERATING CHAIR	Dentalez Group	1994-03-10	492
K925119	A-DEC 1040 CHAIR	A-Dec, Inc.	1994-01-31	479
K923534	PM2002 PROLINE	Planmeca USA, Inc.	1994-01-31	564
K925325	A-DEC 2185 DOCTOR'S UNIT	A-Dec, Inc.	1993-12-09	414
K925323	A-DEC 2183 DUO UNIT, CUSP	A-Dec, Inc.	1993-12-09	414
K925320	A-DEC 2145 DUO UNIT, CUSP	A-Dec, Inc.	1993-12-09	414
K925316	A-DEC 2172 DOCTOR'S UNIT	A-Dec, Inc.	1993-12-09	414
K925318	A-DEC 2181 DUO UNIT	A-Dec, Inc.	1993-12-09	414
K925319	A-DEC 2182 DOCTOR'S UNIT	A-Dec, Inc.	1993-12-09	414
K925321	A-DEC 2146 DUO UNIT	A-Dec, Inc.	1993-12-09	414
K925317	A-DEC 2180 DUO UNIT, CUSP	A-Dec, Inc.	1993-12-09	414
K925324	A-DEC 2184 DUO UNIT	A-Dec, Inc.	1993-12-09	414
K925314	A-DEC 2170 DUO UNIT CUSP	A-Dec, Inc.	1993-12-09	414
K925322	A-DEC 2147 DOCTOR'S UNIT	A-Dec, Inc.	1993-12-09	414
K925315	A-DEC 2171 DUO UNIT	A-Dec, Inc.	1993-12-09	414
K931169	MDT DENTAL CHAIR	Mdt Corp., Inc.	1993-05-20	73
K923461	PM2002 PROLINE, PM2002 PROLINE EC	Planmeca USA, Inc.	1992-12-21	160
K922175	HEALTHPAK CHAIR SOX BARRIERS	Healthpak, Inc.	1992-08-06	90
K923306	HEALTHPAK UTILITY SOX BARRIERS	Healthpak, Inc.	1992-08-05	89
K920017	IMPROVED DENTAL OPERATING LIGHT	Den-Tal-Ez Mfg Co., Inc.	1992-03-02	60
K920016	IMPROVED DENTAL CHAIR	Den-Tal-Ez Mfg Co., Inc.	1992-03-02	60
K913535	A-DEC DECADE 1020 CHAIR	A-Dec, Inc.	1991-10-09	61
K913059	A-DEC KNEEBREAK 1030 CHAIR	A-Dec, Inc.	1991-10-08	90
K903454	A-DEC DECADE 1010 CHAIR	A-Dec, Inc.	1990-10-24	85
K903450	A-DEC DECADE 1015 CHAIR	A-Dec, Inc.	1990-10-24	85
K896602	FD5000 DENTAL CHAIR	Oriola OY Finndent	1990-02-14	85
K894060	ESSE QUATTRO/ESSE UNO	Eurodent, Inc.	1989-09-07	92
K893944	FD 300 DENTAL STOOL	Oriola OY Finndent	1989-08-15	76
K893890	FD4500 (DENTAL CHAIR)	Oriola OY Finndent	1989-08-15	77
K893889	FD3500 (DENTAL CHAIR)	Oriola OY Finndent	1989-08-15	77
K893943	FD 200 DENTAL STOOL	Oriola OY Finndent	1989-08-15	76
K893945	FD 350 DENTAL STOOL	Oriola OY Finndent	1989-08-11	72
K893946	FD 400 DENTAL STOOL	Oriola OY Finndent	1989-08-08	69
K893454	CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD	Atlantic Industries, Inc.	1989-07-25	83
K893045	A-DEC PRIORITY 1005 CHAIR	A-Dec, Inc.	1989-07-14	81
K884304	ORTHO PATIENT CHAIR	Halton Furniture Mfg.	1989-04-25	194
K884830	DENTAL CHAIR F1	Fimet OY	1989-02-10	84
K883437	DENTAL CHAIR	E.F. Brewer Co.	1988-10-12	58
K880474	AREA (DENTAL CHAIR)	Alpine Dental Equipment Co.	1988-09-23	232
K880475	SKEMA (DENTAL UNIT)	Alpine Dental Equipment Co.	1988-09-23	232
K863016	DENTATUS L SET	Sds Dental, Inc.	1986-10-01	54
K863484	SIEMENS SIRONA(R) DENTAL CHAIR	Pelton & Crane Co.	1986-09-19	10
K854647	POLO DENTAL UNIT	Alpine Dental Equipment Co.	1986-06-05	198

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda