Atlas FDA

KLC

63 FDA 510(k) clearances · Product code

85 daysmedian time to decision
414 days90th percentile
63clearances measured

FDA profile

Official device name
Chair, Dental, With Operative Unit
Device class
Class I (low risk)
Regulation
21 CFR 872.6250
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 1 · 1996: 6 · 1997: 14 · 1998: 2 · 2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Luvis Chair (LC700C) (K233921)Dentis Co., Ltd.2024-09-06
DCI Edge Dental Chair with Operative Unit (K151987)Dci2016-06-01
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (K071353)Shanghai Foshion Medical Instruments Co., Ltd.2007-12-14
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (K971063)King Dental Corp.1997-06-03
PROSTYLE COMPACT (K963209)Planmeca Oy1996-10-24
ULTIMA 2 DENTAL CHAIR (K942870)Dentech Corp.1995-02-27
KAVO SYSTEMATICA 1060 (K940950)Kavo America1994-12-29
E 4000 DENTAL OPERATING CHAIR (K925567)Dentalez Group1994-03-10
A-DEC 1040 CHAIR (K925119)A-Dec, Inc.1994-01-31
PM2002 PROLINE (K923534)Planmeca USA, Inc.1994-01-31
A-DEC 2185 DOCTOR'S UNIT (K925325)A-Dec, Inc.1993-12-09
A-DEC 2183 DUO UNIT, CUSP (K925323)A-Dec, Inc.1993-12-09
A-DEC 2145 DUO UNIT, CUSP (K925320)A-Dec, Inc.1993-12-09
A-DEC 2172 DOCTOR'S UNIT (K925316)A-Dec, Inc.1993-12-09
A-DEC 2181 DUO UNIT (K925318)A-Dec, Inc.1993-12-09
A-DEC 2182 DOCTOR'S UNIT (K925319)A-Dec, Inc.1993-12-09
A-DEC 2146 DUO UNIT (K925321)A-Dec, Inc.1993-12-09
A-DEC 2180 DUO UNIT, CUSP (K925317)A-Dec, Inc.1993-12-09
A-DEC 2184 DUO UNIT (K925324)A-Dec, Inc.1993-12-09
A-DEC 2170 DUO UNIT CUSP (K925314)A-Dec, Inc.1993-12-09
A-DEC 2147 DOCTOR'S UNIT (K925322)A-Dec, Inc.1993-12-09
A-DEC 2171 DUO UNIT (K925315)A-Dec, Inc.1993-12-09
MDT DENTAL CHAIR (K931169)Mdt Corp., Inc.1993-05-20
PM2002 PROLINE, PM2002 PROLINE EC (K923461)Planmeca USA, Inc.1992-12-21
HEALTHPAK CHAIR SOX BARRIERS (K922175)Healthpak, Inc.1992-08-06
HEALTHPAK UTILITY SOX BARRIERS (K923306)Healthpak, Inc.1992-08-05
IMPROVED DENTAL OPERATING LIGHT (K920017)Den-Tal-Ez Mfg Co., Inc.1992-03-02
IMPROVED DENTAL CHAIR (K920016)Den-Tal-Ez Mfg Co., Inc.1992-03-02
A-DEC DECADE 1020 CHAIR (K913535)A-Dec, Inc.1991-10-09
A-DEC KNEEBREAK 1030 CHAIR (K913059)A-Dec, Inc.1991-10-08
A-DEC DECADE 1010 CHAIR (K903454)A-Dec, Inc.1990-10-24
A-DEC DECADE 1015 CHAIR (K903450)A-Dec, Inc.1990-10-24
FD5000 DENTAL CHAIR (K896602)Oriola OY Finndent1990-02-14
ESSE QUATTRO/ESSE UNO (K894060)Eurodent, Inc.1989-09-07
FD 300 DENTAL STOOL (K893944)Oriola OY Finndent1989-08-15
FD4500 (DENTAL CHAIR) (K893890)Oriola OY Finndent1989-08-15
FD3500 (DENTAL CHAIR) (K893889)Oriola OY Finndent1989-08-15
FD 200 DENTAL STOOL (K893943)Oriola OY Finndent1989-08-15
FD 350 DENTAL STOOL (K893945)Oriola OY Finndent1989-08-11
FD 400 DENTAL STOOL (K893946)Oriola OY Finndent1989-08-08
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD (K893454)Atlantic Industries, Inc.1989-07-25
A-DEC PRIORITY 1005 CHAIR (K893045)A-Dec, Inc.1989-07-14
ORTHO PATIENT CHAIR (K884304)Halton Furniture Mfg.1989-04-25
DENTAL CHAIR F1 (K884830)Fimet OY1989-02-10
DENTAL CHAIR (K883437)E.F. Brewer Co.1988-10-12
AREA (DENTAL CHAIR) (K880474)Alpine Dental Equipment Co.1988-09-23
SKEMA (DENTAL UNIT) (K880475)Alpine Dental Equipment Co.1988-09-23
DENTATUS L SET (K863016)Sds Dental, Inc.1986-10-01
SIEMENS SIRONA(R) DENTAL CHAIR (K863484)Pelton & Crane Co.1986-09-19
POLO DENTAL UNIT (K854647)Alpine Dental Equipment Co.1986-06-05
MANTA DENTAL CHAIR (K854644)Alpine Dental Equipment Co.1986-01-23
ANATOM SYSTEM (K843233)Lic-Orthion1984-10-25
DENTAL CHAIR (K843436)Swedish Dental Products, Inc.1984-09-27
HERPES-IHA KIT (K822095)Hillcrest Biologicals1983-04-05
K30000 DENTAL CHAIR (K822740)Kaycor Intl., Ltd.1982-09-28
RITTER MODEL H COMPANION STOOL (K800276)Sybron Corp.1980-03-17
SIROPORT (K800172)Siemens Corp.1980-02-05
RITTER MODEL J DENTAL CHAIR (K800084)Ritter Co.1980-01-29
DENTAL CHAIR, VANGUARD (K772300)Ritter Co.1978-01-03
VISION SERIES DENTAL CHAIR (K771873)Chayes Virginia, Inc.1977-10-25
DENTAL CHAIRS (K760599)Chayes Virginia, Inc.1976-09-15
BI-CENTRIC SYSTEM (K760404)Pelton & Crane Co.1976-08-23
CHAIR, ATTACHED INSTRUMENT DEL. SYS. (K760322)The S. S. White Co.1976-08-03

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