KLC · Class I · 21 CFR 872.6250

FDA Product Code KLC: Chair, Dental, With Operative Unit

Leading manufacturers include A-Dec, Inc., Mdt Corp., Inc. and Kavo America.

63
Total
63
Cleared
179d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Chair, Dental, With Operative Unit Devices (Product Code KLC)

63 devices
1–24 of 63
Cleared Sep 06, 2024
Luvis Chair (LC700C)
K233921
Dentis Co., Ltd.
Dental · 268d
Cleared Jun 01, 2016
DCI Edge Dental Chair with Operative Unit
K151987
Dci
Dental · 320d
Cleared Jun 03, 1997
OPTIMA PLUS E DENTAL CHAIR
K971063
King Dental Corp.
Dental · 71d
Cleared Oct 24, 1996
PROSTYLE COMPACT
K963209
Planmeca Oy
Dental · 69d
Cleared Dec 29, 1994
KAVO SYSTEMATICA 1060
K940950
Kavo America
Dental · 304d
Cleared Jan 31, 1994
A-DEC 1040 CHAIR
K925119
A-Dec, Inc.
Dental · 479d
Cleared Dec 09, 1993
A-DEC 2170 DUO UNIT CUSP
K925314
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2171 DUO UNIT
K925315
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2172 DOCTOR'S UNIT
K925316
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2180 DUO UNIT, CUSP
K925317
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2181 DUO UNIT
K925318
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2182 DOCTOR'S UNIT
K925319
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2145 DUO UNIT, CUSP
K925320
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2146 DUO UNIT
K925321
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2147 DOCTOR'S UNIT
K925322
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2183 DUO UNIT, CUSP
K925323
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2184 DUO UNIT
K925324
A-Dec, Inc.
Dental · 414d
Cleared Dec 09, 1993
A-DEC 2185 DOCTOR'S UNIT
K925325
A-Dec, Inc.
Dental · 414d
Cleared May 20, 1993
MDT DENTAL CHAIR
K931169
Mdt Corp., Inc.
Dental · 73d
Cleared Oct 09, 1991
A-DEC DECADE 1020 CHAIR
K913535
A-Dec, Inc.
Dental · 61d
Cleared Oct 08, 1991
A-DEC KNEEBREAK 1030 CHAIR
K913059
A-Dec, Inc.
Dental · 90d
Cleared Oct 24, 1990
A-DEC DECADE 1015 CHAIR
K903450
A-Dec, Inc.
Dental · 85d
Cleared Oct 24, 1990
A-DEC DECADE 1010 CHAIR
K903454
A-Dec, Inc.
Dental · 85d
Cleared Jul 14, 1989
A-DEC PRIORITY 1005 CHAIR
K893045
A-Dec, Inc.
Dental · 81d

About Product Code KLC - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code KLC since 1976, with 63 receiving FDA clearance (average review time: 179 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.