Dental device manufacturers in Japan
61 companies have an FDA-registered establishment in Japan, across 79 sites. 51 manufacture dental devices there or own their specifications.
What they make
Dental hand instruments12Toothbrushes12Dental handpieces8Dental cements6Denture resins & teeth5Dental ceramics & zirconia5Dental needles & syringes4Orthodontic wires & bands4Surgical drills & motors4Impression trays4Dental composites4Bonding agents4Temporary crown & bridge materials4Polishing & prophylaxis4
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Nakanishi, Inc. | Japan | Maker | A450L · AB450L SU · AIR MOTOR HANDPIECE TN-102 · AK400L · +792 | 37 | 2026 |
| Shofu Inc | Japan | Maker | BEAUTICEM VENEER KIT · BEAUTIFIL · BEAUTIFIL BULK · BEAUTIFIL BULK FLOWABLE · +162 | 96 | 2025 |
| GC America Inc. | United States | Maker | BULK FujiCEM(AutoCompatible) · CAVITRON · Ceramic Primer · Ceramic Primer II · +365 | 137 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CERABIEN · CERABIEN MiLai · CERABIEN ZR · CERABIEN ZR SS BASIC FULL KIT · +90 | 32 | 2025 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Basis · BASIS FLOW II · Basis Hi · Basis Twin Cure · +22 | 3 | 2026 |
| DENKEN-HIGHDENTAL Co., Ltd. | Japan | Maker | AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase · Rezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super Primer · Super Primer · Kolben Wax, Sprue Wax · +1 | 1 | 2022 |
| Tokuyama Dental Corporation | Japan | Maker | E-1 Esthetic Composite System · Estelite Bulk Fill Flow · Estelite Color · Estelite Omega · +32 | 19 | 2021 |
| Takara Belmont Corporation | Japan | Maker | PHOT-X II, MODEL 303 · PHOT-X-IIS Model 505 · 097 Bel-Ray II · Belmont · +4 | 7 | 2017 |
| The Yoshida Dental Mfg. Co., Ltd. | Japan | Maker | ImageWorks Panoura · Panoura 18S · Panoura X-ERA · X-era Smart | 6 | 2019 |
| Micron Corporation | Japan | Maker | AW-100 · Micron SSS · SA-100 · TA-100 · +6 | 5 | 2018 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Neo Blue Tips · Neo Clear Tips · Evadyne · Neo Flexpoint · +4 | 5 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| Osada Electric Co., Ltd. | Japan | Maker | OSADA SAW, BONE, AC POWERED · OSADA HANDPIECE, DIRECT DRIVE, AC-POWERED · OSADA SCALER, ULTRASONIC | 2 | 1994 |
| Sun Medical Co., Ltd. | Japan | Maker | iCEM Universal Plus | 2 | 2015 |
| Nakamura Dental Handpiece Mfg. Co., Ltd. | Japan | Maker | ACCLEAN · CONTRA ANGLE · HyGenie · ND · +5 | 1 | 2012 |
| 株式会社ＹＤＭ | Japan | Maker | Contraster for Anterior L · Contraster for Anterior S · Contraster for Posterior · Photographic Mirror Crystal for Buccal & Lingual · +192 | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | JIZAI GLIDER · MANI D FINDERS · MANI FLARE FILES · MANI FLARE FILES NiTi · +44 | — | — |
| J. Morita MFG Corp. | Japan | Maker | MODEL XDP1 · Veraview FX800 Model X800N · VERAVIEW IC 5 · Veraview X800 · +29 | — | — |
| Sanko Electronics Corporation | Japan | Maker | EL400JS120 · EL400S120 · FC-78 · NE136 · +22 | — | — |
| Dentech Corp. | Japan | Maker | MOUTHPIECE, SALIVA EJECTOR · Dentech Corporation · INSTRUMENTS, DENTAL HAND · METAL MIRROR · +9 | — | — |
| Lion Corporation | Japan | Maker | NONIO Toothbrush Type-Rich Medium · NONIO Toothbrush Type-Rich Soft · NONIO Toothbrush Type-Sharp Medium · NONIO Toothbrush Type-Sharp Soft · +16 | — | — |
| Bethel Co., Ltd. | Japan | Maker | Irri-Tip 25 double side vent · Irri-Tip 27 double side vent · Irri-Tip 30 double side vent · Septodont Precision Tips · +12 | — | — |
| Forest-One Co., Ltd. | Japan | Maker | T1 Initial · T1-LH · T1-LS · T1-MH · +11 | — | — |
| Tani Electronics Corporation | Japan | Maker | FC-78 · Surgic Pro NON-OPT(120V) · Surgic Pro OPT(120V) · Surgic Pro OPT(230V) · +1 | — | — |
| IONIC Corporation | Japan | Maker | KISS YOU IONPA · KISS YOU IONPA home · hyG · ionic · +3 | — | — |
| Taiyo Kogyo Co., Ltd. Hanyu Technical Plant | Japan | Maker | VA370 · VA370 Lux · VA370ADNA · VA370LUXADNA · +5 | — | — |
| Shioda Dental Co. | Japan | Maker | SHIODA · TASK | — | — |
| JM Ortho Corporation | Japan | Maker | Energy Chain · Energy Thread · K-2 O-Ring · Tough-O | — | — |
| Orbray Co Ltd | Japan | Maker | LayZir Disc · LAYZIR DISC, SHOFU DISK ZR, LUCENT SUPRA, ZIRCONIA DISC · SHOFU DISK ZR Lucent Supra · Zirconia Disc | — | — |
| Chikami Miltec Inc. | Japan | Maker | Q.C.M. RETAINER WIRE · (RWS-42, RWS-48, RWS-54, RWL-42, RWL-48, RWL-54, RWL-W50) · (RWS-P36, RWL-P36, RWS-P50, RWL-P50) | — | — |
| Kiyoujochugiku Co., Ltd | Japan | Maker | Dent Clear · C-736 Tooth Brightner | — | — |
| Aitec Co., Ltd. | Japan | Maker | HM TOOTHBRUSH · MIRACULOUS TOOTHBRUSH | — | — |
| Force Engineering Co.ltd | Japan | Maker | FC-78 · EM13M | — | — |
| Kyowa Limited | Japan | Maker | POLIGRIP COMFORT STRIPS · POLYGRIP COMFORT STRIPS | — | — |
| SHIKEN Co.,Ltd. | Japan | Maker | Soladey · Soladey Rhythm 2 | — | — |
| Tochigi Seiko Co., Ltd. | Japan | Maker | Ninjection Dental Needle · STERIJECT | — | — |
| Dentalpro Co., Ltd. | Japan | Maker | DENTALPRO | — | — |
| HOKUBI Co.,Ltd. | Japan | Maker | Toothbrush | — | — |
| Maruemu Works Co., Ltd. | Japan | Maker | GUMMETAL | — | — |
| Nipro Corporation | Japan | Maker | Dental Needle | — | — |
| Nishio Co., Ltd. | Japan | Maker | Miracle toothbrush BIG | — | — |
| Nishiwaki Industrial Co., Ltd. | Japan | Maker | TRIP MATE | — | — |
| Panasonic Corporation | Japan | Maker | Electric toothbrush | — | — |
| Sato Pharmaceutical Co., Ltd. | Japan | Maker | Acess Toothbrush | — | — |
| VIVATEC Co.,Ltd. | Japan | Maker | TOOTHBRUSH, MANUAL | — | — |
| 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence Co.,Ltd | Japan | Maker | WE Light Class II | — | — |
| Air Water Realize Inc. | Japan | Maker | — | — | — |
| Fine Company Ltd. | Japan | Maker | — | — | — |
| Polymer Engineering Laboratories Ltd. | Japan | Maker | — | — | — |
| TOSOH Corporation | Japan | Maker | — | — | — |
| Yuwa Seisakusho KK | Japan | Maker | — | — | — |
| J. Morita USA, Inc. | United States | Maker | CF Carbon Fiber Post · GF Glass Fiber Post · MORITA DISPOSABLE DENTAL NEEDLE · FormCore DC Core Build-up Material · +9 | 42 | 2022 |
| Setagaya Seiki Co., Ltd. | Japan | Foreign exporter | — | 1 | 2026 |
| Daiso USA LLC | United States | Foreign exporter | Pointed Toothbrush and Dental Mirror. · Teflon Floss & Pick 40P WHITE x 40 PCs. · Denture Cleansing Tablet · AQUA 1 DOUBLE ACTION BRISTYLE TOOTHBRUSH REGULAR HEAD 4-ROW · +121 | — | — |
| Paltac Corporation | Japan | Foreign exporter | DENTALPRO · Dentor Systema · Toothbrush 3 Rows Slim Compact Regular · Toothbrush 3 Rows Slim Compact Soft · +3 | — | — |
| Shinnnichi Corporation Co.,ltd | Japan | Foreign exporter | Blanvina Wide-head Toothbrush | — | — |
| Sti-Ir | Japan | Foreign exporter | Manual Toothbrush | — | — |
| TOP Corporation | Japan | Foreign exporter | TOP Infection Protection Kit | — | — |
| Alfresa Pharma Corporation | Japan | Foreign exporter | — | — | — |
| Muji U.s.a. Limited | United States | Foreign exporter | — | — | — |
| Toyo Polymack Co., Ltd. | Japan | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026