Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Space Preformed Maintainer
FDA device type “Maintainer, Space Preformed, Orthodontic”.
- Companies listing it
- 7760 makers
- Brands and models
- 253
- 510(k) clearances
- 40 in five years
- FDA name
- Maintainer, Space Preformed, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list DYT
77 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Align Technology, Inc. | United States | Maker | Invisalign Retainer · lnvisalign Specifix Attachment System · lnvisalign Specifix Attachment System (include Engagement Features) · Vivera 3D retainer · +1 | 16 | 2026 |
| GC America Inc. | United States | Maker | everStickORTHO | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| Deltamed GmbH | Germany | Maker | P pro Splint | 6 | 2024 |
| LuxCreo Inc. | United States | Maker | LuxCreo Clear Retainer System · LuxCreo Dental Clear Aligner Resin | 4 | 2026 |
| American Orthodontics | United States | Maker | Bite Blocks · Bondable Retainer · Bondable Space Maintainer · Tongue Director | 44 | 2026 |
| Park Dental Research Corp | United States | Maker | Volo DigiLine23 | 8 | 2026 |
| Good Sleep Co Pte Ltd | Singapore | Maker | Hushd Pro Guard · Splint | 3 | 2025 |
| Vertex-Dental B.V. | Netherlands | Maker | Ceramill Ortho Flex · Ceramill Ortho Rigid · Dental LT Clear · E-Guard · +3 | 7 | 2024 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Smylio | United States | Maker | FXBright Retainers · FXClear Retainers · FXTetra Bright Retainers · Smylio Retainer 1 | 4 | 2026 |
| Detax GmbH | Germany | Maker | Primeprint Guide 2 | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Modern Dental Laboratory Co., Ltd. | China | Maker | Basic retainer · Bleaching retainer · Ecodont retainer · Finishing retainer · +2 | 2 | 2024 |
| Formlabs Inc. | United States | Maker | Dental LT Clear V2 Resin | 2 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | Reveal® Retainers | 8 | 2025 |
| NuSmile, Ltd. | United States | Maker | Chairside Space Maintainer | 2 | 2026 |
| Wuxi EA Medical Instruments Technologies Limited | China | Maker | Retainer | 2 | 2023 |
| Kids-E-Dental LLP | India | Maker | e-space maintainer | 1 | 2024 |
| ODS Co., Ltd. | South Korea | Maker | ODS Clear Resin - Retainer | 1 | 2025 |
| Archform Inc. | United States | Maker | Archform Retainer | 1 | 2021 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| pro3dure medical GmbH | Germany | Maker | GR-16 x-ray · GR-19.1 OA · GR-19.1 OA I MSI · Imprimo LC Splint comfort · +1 | 2 | 2021 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Separators | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Braided Lingual Retainer Wire · EZ Bond - Lower · EZ Bond - Upper · FLEA - Lower · +8 | — | — |
| Digital Dental Laboratories, Inc. DBA Orthodent | Canada | Maker | Band loop space maintainer · Band loop space regainer · Bihelix - soldered · Crozat crib and crescent · +36 | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | aligner chewies | — | — |
| Shanghai Maxflex Medical Technology Co., Ltd. | China | Maker | Thermoforming sheet: D-LMEA-370-F120-130-H D-LMEA-460-F120-100-H D-LMEA-550-F120-200-H D-LMEA-370-F125-130-H · Thermoforming sheet: D-LMEA-460-F125-100-H D-LMEA-550-F125-200-H D-LMEA-550-F125-060-E · Thermoforming sheet: M-EC-100-F120-050-C M-EC-100-F125-100-N M-EC-100-F125-076-N M-EC-100-F125-063-N · Thermoforming sheet: M-EC-100-F120-050-E M-EC-100-F120-063-E M-EC-100-F120-040-C · +72 | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Maintainer, Space Preformed, Orthodontic · Maintainer, Space Preformed, Orthodontic (All types of Maintainers) | — | — |
| Aditek do Brasil SA | Brazil | Maker | — | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | ACTIVA · D-bar · SIA ORTHODONTIC MANUFACTURER | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Ortho Dental Lab, LLC | United States | Maker | SmileSet Night Guards | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Maintainer, Space Preformed, Orthodontic | — | — |
| Candid Care Co. | United States | Maker | Candid Care Retainer · Candid Care Retainer Kit FGS-0003 · FGS-0003 PermaForm Retainer · FGS-2003 PermaForm Retainer Glidewell · +2 | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | CUSTOMIZED Retainer | — | — |
| Suzhou laixin 3D Technology Co.,Ltd | China | Maker | NightGuard Resin (NightGuard, NightGuard Hard, NightGuard Soft) · Splint Resin (Splint, Splint Flex, Splint Flexi, Splint Hard, Splint Soft, DentalGuard, Dental Clear) | — | — |
| dentona AG | Germany | Maker | dentona flexisplint · dentona vivapink · dentona vivatemp · optimill memopink · +7 | — | — |
| HyperCert Limited | United States | Maker | Basic retainer · Bleaching retainer · Ecodont retainer · Finishing retainer · +2 | — | — |
| J C India | India | Maker | Rainbow preformed space maintainer | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | — | — | — |
| Libral Traders Pvt Ltd | India | Maker | MAINTAINER, SPACE PREFORMED, ORTHODONTIC | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | MAINTAINER, SPACE PREFORMED, ORTHODONTIC | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | LuxCreo Clear Retainer System · LuxCreo Dental Clear Aligner Resin | — | — |
| Zhejiang Longmed Medical Technology Co., Ltd. | China | Maker | Anti-snoring Braces · Lip Trainer · Mouth Guard, Lubyd · Preformed Tooth Positioner · +1 | — | — |
| Dantech Digital Dental Solutions Private Limited | India | Maker | Orthodontic Retainer | — | — |
| EOCA MD Pty Limited | Australia | Maker | Munchies | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Anhui Chuangnuo Medical equipment Co., LTD | China | Maker | Maintainer, Space Preformed, Orthodontic | — | — |
| Chewly Pty. Ltd. | Australia | Maker | iChew | — | — |
| Hype Align Clear Orthodontics, Limitada | Costa Rica | Maker | Hype Align | — | — |
| Shenzhen Bairunheng Technology Co., Ltd. | China | Maker | Orthodontic Brackets;Model:16159542 | — | — |
| Angelalign Manufacturing Corp. | United States | Maker | — | — | — |
| Moses | United States | Maker | Unplastic Retainer | — | — |
| NACS, Inc | United States | Maker | Clear Liner | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| DongGuan Gooodol Mould & Product CO.,LTD | China | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Voco GmbH | Germany | Foreign exporter | V-Print ortho | 117 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | Dima Print Splint Clear | 37 | 2026 |
| Imagine Milling Technologies, LLC | United States | Contract manufacturer | Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid | 4 | 2026 |
| Amann Girrbach AG | Austria | Foreign exporter | NextDent Ortho Flex | 3 | 2026 |
| Rmo, Inc. | United States | Manufacturer | RMO Separators · Space Maintainer, Lingual Arch, Bimetric Arch, Preformed Lingual | 1 | 1990 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Relining | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Denture resin | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Lingual Retainer 3-3 · Linguall Rerainer Gold | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | — | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Munchies Firm Refill Pack · Munchies Gentle Refill Pack · Munchies Maxx Refill Pack · Munchies Starter Pack · +1 | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Space Maintainer | — | — |
| Primotec LLC | United States | Repacker / relabeler | CLEAR FLEX · primoflex CLEAR | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Ezcad Dental Lab | United States | Repacker / relabeler | Space Maintainer | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 Apr 1994 | K935856 | DENTAURUM SPACE MAINTAINER | Dentauraum, Inc. |
| 7 Apr 1987 | K864376 | FIBERBOND | Dentec, Inc. |
| 21 Sep 1981 | K812239 | UNITEK PALATAL BAR | Unitek Corp. |
| 30 Jun 1978 | K780814 | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. |
Official records: FDA product classification for DYT · 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