Miscellaneous devices · 21 CFR 872 Subpart G
Dental Chair without Operative Unit
A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure.
- Companies listing it
- 10278 makers
- Brands and models
- 217
- 510(k) clearances
- 00 in five years
- FDA name
- Chair, Dental, Without Operative Unit
Companies that list NRU
102 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentis Co., Ltd. | South Korea | Maker | Luvis Chair (LC700C-chair only plus) · Luvis Chair (LC700C-chair only) | 37 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | 2nd Assi | 30 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | K3 - Chair only · K3-Chair only | 68 | 2026 |
| Cefla S.C. | Italy | Maker | R1 · R7. · Stern 300 P NordAm | 15 | 2026 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Dental chair and accessories (Model: S600, S690, S610) | 5 | 2026 |
| Firstar Dental Company | United States | Maker | — | 3 | 2026 |
| Dentalez, Inc. | United States | Maker | CORE Chair · NuSimplicity Chair | 9 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Headrest Covers | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | DENTAL CHAIR | 2 | 2026 |
| HDI Inc. | South Korea | Maker | Denu Bite Block Cover · Denu Digital Sensor Cover · Denu Intraoral Camera Cover | 2 | 2022 |
| A-dec, Inc. | United States | Maker | A-dec 311 Dental Chair · A-dec 311flt Dental Chair · A-dec 311R Refurbished Dental Chair · A-dec 311xlc Dental Chair · +25 | 68 | 2022 |
| Planmeca Oy | Finland | Maker | Planmeca Pro50 Chair | 25 | 2023 |
| Midmark Corporation | United States | Maker | Elevance · Midmark | 7 | 2025 |
| Shinhung Company, Ltd. | South Korea | Maker | Chair-C1, Chair-G7 | 2 | 2023 |
| Olsen Indústria E Comércio S.A. | Brazil | Maker | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | 2 | 2022 |
| DCI International LLC | United States | Maker | Dental Chair | 1 | 2025 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Dental Chair, Dental Stool | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Dental Chair without operative unit | 1 | 2023 |
| Aseptico, Inc. | United States | Maker | ADC-01 -ASEPTICHAIR WITH CASE · ADC-01-BLU - ASEPTICHAIR BLUE WITH CASE · ADC-01-RED - ASEPTICHAIR RED WITH CASE · ADC-01CS -ASEPTICHAIR WITH CASE · +14 | 17 | 2015 |
| Takara Belmont Corporation | Japan | Maker | Belmont Equipment | 7 | 2017 |
| Beaverstate Dental, Inc. | United States | Maker | EPIC | 2 | 1995 |
| Shanghai Dental Instrument Factory Co., Ltd. | China | Maker | SDIF DENTAL CHAIR WI | 2 | 2006 |
| Boyd Industries, Inc. | United States | Maker | E3010CB · E3010FB · E3010LC · E3010LS · +18 | 1 | 2002 |
| Ergonomic Products, Inc. | United States | Maker | Ergonomic Products 3 Series Dental Chair | 1 | 2014 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental chair without operating unit | — | — |
| SPS/Crosstex International | United States | Maker | Air/water Syringe Sleeve · Barrier Film · Digital Sensor Sleeves · Syringe Sleeves · +2 | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Chair | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | headrest cover, Tray Cover, tray paper, chair cover, table cover, bedding cover | — | — |
| BH Medical Products Co., Ltd | China | Maker | headrest cover · Tray Cover · tray paper | — | — |
| NuCare LLC | United States | Maker | Headrest Cover | — | — |
| AMD Medicom Inc | Canada | Maker | Hedy Air/Water Sleeve · Hedy Chair Sleeve · Hedy Headrest cover · Hedy Tray Sleeve · +3 | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Headrest Covers | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Headrest cover · Tray cover · Tray liner paper | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Headrest cover | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Mobilio Dental Chair | — | — |
| AC Equipamentos Medicos e Odontologicos LTDA | Brazil | Maker | 6700M Marathon Chair · 8700 DY Daytona Chair | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Barrier Sleeves | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Head Rest Covers | — | — |
| Summit Dental Systems LLC. | United States | Maker | 6700M Marathon Chair · 8700 DY Daytona Chair | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Headrest cover | — | — |
| Mastercraft Dental Co. of Texas | United States | Maker | Independence Chair · Matador Chair · Maxus Chair · Optima Chair | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Plastic covers, plastic bags, plastic sleeves | — | — |
| Dukal Corporation | United States | Maker | Dukal Headrest Covers | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Chair, Dental, without operative unit | — | — |
| Palmero Healthcare | United States | Maker | Air/Water Syringe Protector · Barrier Film · Bite Block Cover · Chair Protector · +5 | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | Plastic covers, plastic bags, plastic sleeves | — | — |
| Euronda SPA | Italy | Maker | Kit Monoart Dentist Chair Cover | — | — |
| Omnia SRL | United States | Maker | Omnitex sheath | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | Barrier Films, Plastic Covers, Plastic Bags | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | Dental Apron/Bib/Headrest Cover | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | Dental Bib, Headrest Cover | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Barrier Films, Plastic Covers, Plastic Bags | — | — |
| Hallim Point Implant Co., Ltd. | South Korea | Maker | ARTE · DENTAL UNIT & CHAIR (CHALLENGE · ECLIPSE · ETC) · +3 | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | Dental Chair Without Operative Unit | — | — |
| Greatcare 4u sdn bhd | Malaysia | Maker | HEADREST COVER | — | — |
| Royal Dental MFG., Inc. | United States | Maker | Alliant · Domain · Royal · Series I · +2 | — | — |
| Dntlworks Equipment Corp. | United States | Maker | DNTLworks | — | — |
| DTE Oregon, Inc | United States | Maker | 3800 Operatory Chair · 3900 Operatory Chair · 6400 Operatory Chair | — | — |
| Medicom Group | Canada | Maker | HEAD REST COVERS · MEDICOM | — | — |
| Sinol Dental Limited | China | Maker | Dental Chair | — | — |
| Dome Inc. | United States | Maker | Dome Innovation Chair | — | — |
| Kuang Yeu Co. Ltd | Taiwan | Maker | Kuang Yeu | — | — |
| Tecnodent S.R.L | Italy | Maker | LINDA EVO · LINDA NEXT · VALE | — | — |
| BGSS Company Asia Limited | China | Maker | BARRIER SLEEVES | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | 311xlc · 317 Orthochair | — | — |
| Changzhou Shengjie Medical Product Co., Ltd | China | Maker | Tray Cover | — | — |
| Mark Enterprises | India | Maker | Dental (Chair (Automatic/Manual) / Bed / Operating Accessories)- MEDE-01, MEDE-02, MEDE-03, MEDE-04 · DENTAL CHAIRS & DENTAL OPERATING ACCESSORIES | — | — |
| Marken Healthtech Limited | India | Maker | Dental (Chair (Automatic/Manual) / Bed / Operating Accessories)- · MEDE-01, MEDE-02, MEDE-03, MEDE-04 | — | — |
| Petoskey Plastics | United States | Maker | Dental Chair Cover non sterile | — | — |
| Danyang New Hope Medical Equipment Co., Ltd | China | Maker | Dental Chair | — | — |
| Foshan Any Home Care Medical Technology Co.,Ltd. | China | Maker | Electric dental chair | — | — |
| Jiangyin Huaying Light Industrial Products Co., LTD | China | Maker | — | — | — |
| Medical Technology Industries, Inc. | United States | Maker | MTI; 705, 710, 721, 724, 722, 729 | — | — |
| P. Bhogilal Private Limited | India | Maker | EDC 30DLX, EDC 30STD, MDC 30DLX, MDC 10STD | — | — |
| Zhangjiagang Bitoor Co., Ltd. | China | Maker | Dental chair plastic headrest cover, Disposable dental chair plastic bag, Disposable headrest cover, Disposable bag | — | — |
| Dexta Corporation | United States | Maker | — | — | — |
| ZhangJiaGang BlackBox Plastic Products Co., Ltd | China | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Barrier Sleeves · Salvin Disposable Sterile Self Stick Light Handle Covers | 23 | 2025 |
| Shenzhen Xpectvision Technology Co., Ltd. | China | Foreign exporter | Sensor sheath, Model XVC001, XVC002, XVC003, XVC004 | 2 | 2024 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Barrier Films, Barrier Envelopes, Chair Sleeves · TPC Laguna Patient Chair | 3 | 2007 |
| KaVo North America | United States | Lister | Spirit 1700 Series Dental Chair · Spirit 1800 Series Dental Chair · Spirit 3000 Series Dental Chair | 1 | 2017 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA 10-1/2" x 14" Tray Sleeves · Valdent USA 27.5" x 24" Half Chair Sleeve | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Cover | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | DENTAL CHAIR | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Dental Supplies Inc | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | FLIGHT DENTAL SYSTEMS- A-Series (A12, A6S, A2, A10, A6R) | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Dental Chair | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | paper tray cover | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bags | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | ATOMO dental chair | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Headrest Covers | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | Barrier Films, Plastic Covers, Plastic Bags | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| BGSS Company Inc. | United States | Repacker / relabeler | BARRIER SLEEVES | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Suzhou MECCAN Imp.& Exp.Corp. | China | Contract manufacturer | — | — | — |
Official records: FDA product classification for NRU · 21 CFR 872.6250.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026