510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KLCClass I

Chair, Dental, With Operative Unit

21 CFR 872.6250 / Dental
FDA source (opens on fda.gov)

KLC is the FDA product code for Chair, Dental, With Operative Unit, a class I device type, regulated under 21 CFR 872.6250. As of , FDA records hold 63 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
KLC
Device name
Chair, Dental, With Operative Unit
Regulation
21 CFR 872.6250
Device class
Class I
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
63
Ingested recalls
7

Clearances, product code KLC

By decision year
63 clearances under product code KLC with a decision year between 1976 and 2024, 1993 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code KLC by decision year
YearClearances
19763
19771
19781
19803
19821
19831
19842
19864
19883
198911
19903
19912
19925
199313
19944
19951
19961
19971
20071
20161
20241

Applicants with the most clearances

Product code KLC
Applicants holding the most 510(k) clearances under product code KLC
ApplicantClearances
A-dec, Inc.18
Oriola OY Finndent7
Alpine Dental Equipment Co.4
Chayes Virginia, Inc.2
Den-Tal-Ez Mfg Co., Inc.2
Healthpak, Inc.2
KaVo Dental Technologies, LLC2
Planmeca U.S.A. Inc2
Ritter GmbH2
Atlantic Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order