Product code KLC
- Device name
- Chair, Dental, With Operative Unit
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6250
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | 2024-09-06 |
| K151987 | DCI Edge Dental Chair with Operative Unit | Dci | 2016-06-01 |
| K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | 2007-12-14 |
| K971063 | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | King Dental Corp. | 1997-06-03 |
| K963209 | PROSTYLE COMPACT | Planmeca Oy | 1996-10-24 |
| K942870 | ULTIMA 2 DENTAL CHAIR | Dentech Corp. | 1995-02-27 |
| K940950 | KAVO SYSTEMATICA 1060 | Kavo America | 1994-12-29 |
| K925567 | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | 1994-03-10 |
| K923534 | PM2002 PROLINE | Planmeca USA, Inc. | 1994-01-31 |
| K925119 | A-DEC 1040 CHAIR | A-Dec, Inc. | 1994-01-31 |
| K925319 | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K925314 | A-DEC 2170 DUO UNIT CUSP | A-Dec, Inc. | 1993-12-09 |
| K925315 | A-DEC 2171 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
| K925316 | A-DEC 2172 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K925317 | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 |
| K925318 | A-DEC 2181 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
| K925320 | A-DEC 2145 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 |
| K925321 | A-DEC 2146 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
| K925322 | A-DEC 2147 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K925323 | A-DEC 2183 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 |
| K925324 | A-DEC 2184 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
| K925325 | A-DEC 2185 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K931169 | MDT DENTAL CHAIR | Mdt Corp., Inc. | 1993-05-20 |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | Planmeca USA, Inc. | 1992-12-21 |
| K922175 | HEALTHPAK CHAIR SOX BARRIERS | Healthpak, Inc. | 1992-08-06 |
| K923306 | HEALTHPAK UTILITY SOX BARRIERS | Healthpak, Inc. | 1992-08-05 |
| K920017 | IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1992-03-02 |
| K920016 | IMPROVED DENTAL CHAIR | Den-Tal-Ez Mfg Co., Inc. | 1992-03-02 |
| K913535 | A-DEC DECADE 1020 CHAIR | A-Dec, Inc. | 1991-10-09 |
| K913059 | A-DEC KNEEBREAK 1030 CHAIR | A-Dec, Inc. | 1991-10-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800000996264 | OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS | Osstem Implant Co.,Ltd. | 2025-09-04 |
| 07899581340925 | Dental Chair | Alliage S/A Indústrias Médico Odontológica | 2025-07-25 |
| 08800000995984 | OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS | Osstem Implant Co.,Ltd. | 2025-04-24 |
| 08800000995977 | OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS | Osstem Implant Co.,Ltd. | 2025-04-24 |
| 08800053083249 | Luvis Chair (LC700C) | DENTIS CO. ,LTD | 2024-09-19 |
| H816MBB0312H2 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MDC0115S2 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MBB2930C2 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MBB0528X2 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MDC0115S1 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MBB2930C1 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MBB0528X1 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| H816MBB0312H1 | ProBarrier | MicroCare, LLC | 2022-10-26 |
| ERICV00000110 | Vanguard | Ritter Concept GmbH | 2022-08-17 |
| ERICVP0000110 | Vanguard | Ritter Concept GmbH | 2022-08-17 |
| ERICVS0000110 | Vanguard | Ritter Concept GmbH | 2022-08-17 |
| ERICVSP000110 | Vanguard | Ritter Concept GmbH | 2022-08-17 |
| 06430035420162 | Planmeca Chair | Planmeca Oy | 2017-05-08 |
| H816BB0312H1 | Barrier | CERTOL INTERNATIONAL, LLC | 2017-01-13 |
| H816BB0312H2 | Barrier | CERTOL INTERNATIONAL, LLC | 2017-01-13 |
| H816DC0115S1 | Barrier | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816BB2930C1 | Barrier | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816BB0528X1 | BARRIER | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816BB0528X2 | BARRIER | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816BB2930C2 | Barrier | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816DC0115S2 | Barrier | CERTOL INTERNATIONAL, LLC | 2016-09-23 |