KLC · Class I · 21 CFR 872.6250

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

Leading manufacturers include A-Dec, Inc., Oriola OY Finndent and Alpine Dental Equipment Co..

Total

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

DCI Edge Dental Chair with Operative Unit

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

K071353

Shanghai Foshion Medical Instruments Co., Ltd.

Dental · 213d

Cleared Jun 03, 1997

OPTIMA PLUS E DENTAL CHAIR

ULTIMA 2 DENTAL CHAIR

KAVO SYSTEMATICA 1060

E 4000 DENTAL OPERATING CHAIR

A-DEC 2170 DUO UNIT CUSP

A-DEC 2172 DOCTOR'S UNIT

A-DEC 2180 DUO UNIT, CUSP

A-DEC 2182 DOCTOR'S UNIT

A-DEC 2145 DUO UNIT, CUSP

A-DEC 2147 DOCTOR'S UNIT

A-DEC 2183 DUO UNIT, CUSP

A-DEC 2185 DOCTOR'S UNIT

PM2002 PROLINE, PM2002 PROLINE EC

K923461

Planmeca USA, Inc.

Dental · 160d

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.

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

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

About Product Code KLC - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights