Therapeutic devices · 21 CFR 872 Subpart F
Preformed Tooth Positioner
FDA device type “Positioner, Tooth, Preformed”.
- Companies listing it
- 9884 makers
- Brands and models
- 249
- 510(k) clearances
- 120 in five years
- FDA name
- Positioner, Tooth, Preformed
510(k) clearances per year, 1976–2026
Companies that list KMY
98 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | REF04 ClearCorrect System Retainer | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Essix (Sports) Mouthguard · Essix A+ · Essix ACE · Essix C+ · +5 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | Glidewell TuffSplint Appliance Resin | 56 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | 3D Printing Material Splint | 16 | 2026 |
| Voco GmbH | Germany | Maker | Curvy · V-Print ortho · V-Print SG | 117 | 2026 |
| SprintRay Inc. | United States | Maker | Motto Day 1 Tray 1 · NightGuard Firm · NightGuard Firm 2 (Midnight Purple) · NightGuard Flex · +2 | 8 | 2026 |
| Hiossen Inc. | United States | Maker | Tooth Positioner | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | AOB Splint · Bleaching Trays · Bruxism Splint · Damon Retention Splint · +12 | 203 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | Splint Soft Resin SS01; Splint Hard Resin SH01 | 6 | 2026 |
| Graphy, Inc. | South Korea | Maker | Tera Tainer (Model : TA-83) | 6 | 2025 |
| LuxCreo Inc. | United States | Maker | LuxCreo Dental Night Guard Resin | 4 | 2026 |
| American Orthodontics | United States | Maker | atmos® material - tooth positioner, Vero | 44 | 2026 |
| Vivos Therapeutics, Inc. | United States | Maker | V-Starter Kids · V-Starter PreTeen · Vivos Grow (VG) · Vivos Guide System · +1 | 3 | 2024 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Hard Splint UV | 3 | 2026 |
| Somnomed, Inc. | United States | Maker | Morning Repositioner | 11 | 2026 |
| Vertex-Dental B.V. | Netherlands | Maker | NextDent Ortho Flex | 7 | 2024 |
| Pac-Dent Inc. | United States | Maker | Rodin 3D Resin Clear Bite Spl | 5 | 2022 |
| Keystone Industries | United States | Maker | KeyPrint KeySplint Hard · KeySplint Soft · Proform Splint and ProSplint · Proform Super Clear Retainer | 2 | 2025 |
| Detax GmbH | Germany | Maker | FREEPRINT splintmaster flex 1000g · FREEPRINT splintmaster taff 1000g · Primeprint Guide 2 · Primeprint Splint SF 1000g · +5 | 2 | 2025 |
| Formlabs Inc. | United States | Maker | Dental LT Clear V2 Resin · Dental LT Comfort Resin | 2 | 2026 |
| Zhejiang Yinchili Medical Technology Co.,Ltd | China | Maker | REF04 ClearCorrect System Retainer, Clear Retainer (YCL-A-R, YCL-C-R) | 2 | 2023 |
| The Argen Corporation | United States | Maker | Argen Clear Retainer · Argen Flex | 11 | 2024 |
| Ortho Organizers, Inc. | United States | Maker | Clear Advantage material | 8 | 2025 |
| Dreve Dentamid GmbH | Germany | Maker | BioBleach hart/soft · Biolon · Drufolen H · Drufosoft · +4 | 6 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | Pre-Ortho Type1-LH · PreOrtho Initial · PreOrtho Type1-LS · PreOrtho Type1-MH · +11 | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Custom retainer · Custom tooth positioner · Pre-Finisher · Pre-finisher appliance with seating spring | 5 | 2022 |
| Myofunctional Research Co. Usa Inc. | United States | Maker | Bruxogard · Myobrace · Myoretainr · Myotalea · +5 | 3 | 2026 |
| Riton 3D Technology Co., Ltd | China | Maker | Splint Model HS1-T · Splint Model SS1-T | 1 | 2024 |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | China | Maker | Dental Orthodontic Retainer instruments (Positioner, Tooth, Preformed, Preformed tooth positione, Braces Orthodont, · orthodont dental, dental orthodont, orthodontic tools dental · Orthodontics, Dental Orthodontic Brackets, Dental Orthodontics, Dental Orthodontic Retainer instruments, | 1 | 2025 |
| Id Korea Co., Ltd. | South Korea | Maker | ID Light Cure System | 1 | 2025 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | Tray and Temporary Splint | 11 | 1996 |
| Whip Mix Corporation | United States | Maker | VeriFIT Splint | 8 | 2016 |
| Micerium S.P.A. | Italy | Maker | Amcop Bioactivator · ELASTOOSAS | 6 | 2011 |
| Airway Management, Inc. | United States | Maker | AM Aligner | 5 | 2018 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic teeth positioner | 4 | 2011 |
| Suncoast Dental Corp. | United States | Maker | Positioner Set 1, 2 · Spacer Set 1, 2, 3, 4 | 2 | 1981 |
| pro3dure medical GmbH | Germany | Maker | ACRY Print RU-005 Guide · dima Print Splint clear · FLOW Hard Splint · GR-10 guide · +8 | 2 | 2021 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Biotech Dental Smilers, SAS | France | Maker | FROGGYMOUTH · MYOSIMPLE · SMILERS | 1 | 2021 |
| ASO International Manila, Inc. | Philippines | Maker | — | 1 | 2021 |
| Royal Dental Laboratory | China | Maker | Preformed Tooth Positioner | 1 | 2020 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Orthocryl · Orthocryl black & white · Orthocryl Color concentrate · Orthocryl Disco glitter · +2 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Positioner | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Positioner | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ORTHOMETRIC PRO ALIGNER X | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental splint | — | — |
| Lacigrus International | Pakistan | Maker | POSITIONER, TOOTH, PREFORMED | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Dental splint | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | AccuGuard | — | — |
| Vedia Solutions, Division of Laxmi Dental Limited | India | Maker | Taglus Aligner Removal Tool · Taglus Aligner Resin · Taglus Denture Resin · Taglus Flexi Denture Resin · +15 | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Preformed Tooth Positioner | — | — |
| Nadir & Co. | Pakistan | Maker | Bracket Positioner | — | — |
| Daddy D Pro | Pakistan | Maker | POSITIVE POSITIONER | — | — |
| Ortho Dental Lab, LLC | United States | Maker | SmileSet Retainers | — | — |
| LM-Instruments Oy | Finland | Maker | LM-Activator · LM-Activator2 · LM-Dental · LM-Trainer | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Positioner Tooth Preformed | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Splint · PriZma 3D Bio Splint Soft | — | — |
| Laboratorios Dentales de Zona Franca, S.A. | Costa Rica | Maker | Comfort 3D Bite Splint · Thermoforming Nightguard/Mouthguard/Bleaching Tray | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | — | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | DENTAL NIGHT GUARD | — | — |
| Scheu-Dental GmbH | Germany | Maker | BIOCRYL C · BIOPLAST, BIOPLAST XTREME · COPYPLAST, COPYPLAST C · DURAN, DURAN+ · +6 | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | — | — | — |
| Richbolt Enterprises | Pakistan | Maker | RICHBOLT ENTERPRISES | — | — |
| Forest-One Co., Ltd. | Japan | Maker | T1 Initial · T1-LH · T1-LS · T1-MH · +11 | — | — |
| Aurum Group Ltd. | Canada | Maker | ORTHODONTIC APPLIANCE · TEETH POSITIONER | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA STAMPO EVA | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Thermoforming Material (Hard Crystal, PP Plate, Soft Opaque, Bicolor, Black, Blue, Green, Pink or White) | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | POSITIONER, TOOTH, PREFORMED | — | — |
| Burbank Dental Lab | United States | Maker | — | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | THERMOFORMING SHEETS FOR ALLIGNERS , ACETATE SHEETS | — | — |
| Erkodent Erich Kopp GmbH | Germany | Maker | Erkodur · Erkoflex · Erkolen · Erkolign · +3 | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | LuxCreo Dental Night Guard Resin | — | — |
| Proto3000 Inc. | Canada | Maker | Vertex-Dental B.V. | — | — |
| Alta Smiles, Inc | United States | Maker | — | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Dental Foil · Mouthguard | — | — |
| Eptamed srl | Italy | Maker | Equilibratori dentali · Freedom · Freedom Deep | — | — |
| JamesB Dental Studio | United States | Maker | JBDS | — | — |
| HUBEI YJT INTELLIGENT TECHNOLOGY GROUP CO., LTD. (formerly k | China | Maker | Dental Orthodontic Retainer instruments Model:YT-01,YT-02,YT-03,YT-04,YT-05,YT-06 | — | — |
| Sweetguard Inc | United States | Maker | Sweetguards Dental Retainer | — | — |
| Aurum Classic Ltd. | Canada | Maker | — | — | — |
| Jumar Corporation | United States | Maker | Aqualizer Mouthpiece | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Dental Manufacturing S.p.A. | Italy | Foreign exporter | ACRY PRINT 3D RU-005 GUIDE | 1 | 2026 |
| Sleepcare, LLC | United States | Repacker / relabeler | Rise and Bite | 1 | 2026 |
| G&H Wire Company | United States | Contract manufacturer | NEOsmile | 2 | 2008 |
| Rmo, Inc. | United States | Manufacturer | Kussick Orthopedic Incline; Kussick Tongue Retrainer | 1 | 1990 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | SHEETS FOR TRAYS | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Sport Mouthguard | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | POSITIONER, TOOTH, PREFORMED | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer | — | — |
| Hongkong Loyal Beauty Technology Limited | Hong Kong SAR China | Foreign exporter | POSITIONER, TOOTH, PREFORMED | — | — |
| Nuvola World S.R.L. | Italy | Foreign exporter | FREEDOM · Freedom Deep | — | — |
| ATFC Limited | Canada | Foreign exporter | Amcop Bioactivator; ELASTOOSAS · preformed - FROGGYMOUTH | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 14 Apr 1995 | K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. |
| 13 Feb 1995 | K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. |
| 6 Jan 1994 | K924351 | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies |
| 13 Sep 1993 | K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. |
| 8 Jul 1993 | K924975 | THE ORTHOTRAINER | Myofunctional Research Co. Usa Inc. |
| 23 Jun 1993 | K924974 | THE TMJ APPLIANCE | Myofunctional Research Co. Usa Inc. |
| 9 Nov 1990 | K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics |
| 31 Mar 1989 | K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics |
| 10 Jan 1984 | K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin |
| 12 Aug 1983 | K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman |
| 9 Jun 1982 | K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. |
| 28 Jun 1978 | K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. |
Official records: FDA product classification for KMY · 21 CFR 872.5525.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026