Subpart F—Therapeutic Devices
FDA submissions for Subpart F—Therapeutic Devices in the Dental (DE) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 872.5410–872.5580
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DYJ | Retainer, Screw Expansion, Orthodontic | 872.5410 | 1 | 5 |
| DYO | Band, Material, Orthodontic | 872.5410 | 1 | 3 |
| DZC | Wire, Orthodontic | 872.5410 | 1 | 30 |
| DZD | Tube, Orthodontic | 872.5410 | 1 | 8 |
| ECI | Band, Elastic, Orthodontic | 872.5410 | 1 | 25 |
| ECM | Band, Preformed, Orthodontic | 872.5410 | 1 | 2 |
| ECN | Clamp, Wire, Orthodontic | 872.5410 | 1 | 0 |
| ECO | Spring, Orthodontic | 872.5410 | 1 | 7 |
| EJF | Bracket, Metal, Orthodontic | 872.5410 | 1 | 103 |
| NQS | Bracket, Metal, Orthodontic, Reprocessed | 872.5410 | 1 | 0 |
| QJJ | Indirect Bonding Tray | 872.5410 | 1 | 0 |
| DYW | Bracket, Plastic, Orthodontic | 872.5470 | 2 | 42 |
| NJM | Bracket, Ceramic, Orthodontic | 872.5470 | 2 | 60 |
| NLC | Bracket, Plastic, Orthodontic, Reprocessed | 872.5470 | 2 | 0 |
| NXC | Aligner, Sequential | 872.5470 | 2 | 143 |
| OYH | Orthodontic Vibratory Accessory | 872.5470 | 2 | 5 |
| PLH | Orthodontic Led Accessory | 872.5470 | 2 | 2 |
| PNN | Orthodontic Software | 872.5470 | 2 | 33 |
| DZB | Headgear, Extraoral, Orthodontic | 872.5500 | 2 | 36 |
| DYT | Maintainer, Space Preformed, Orthodontic | 872.5525 | 1 | 4 |
| KMY | Positioner, Tooth, Preformed | 872.5525 | 1 | 12 |
| KKO | Ring, Teething, Fluid-Filled | 872.5550 | 2 | 27 |
| MEF | Ring, Teething, Non-Fluid Filled | 872.5550 | 1 | 1 |
| LTF | Stimulator, Salivary System | 872.5560 | 2 | 3 |
| QTT | Over The Counter Electrical Salivary Stimulatory System | 872.5560 | 2 | 2 |
| LQZ | Device, Jaw Repositioning | 872.5570 | 2 | 27 |
| LRK | Device, Anti-Snoring | 872.5570 | 2 | 210 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | 872.5570 | 2 | 6 |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | 872.5570 | 2 | 5 |
| ORY | Tongue Suspension System | 872.5570 | 2 | 10 |
| OZR | Intraoral Pressure Gradient Device | 872.5570 | 2 | 6 |
| PLC | Sleep Appliances With Patient Monitoring | 872.5570 | 2 | 9 |
| QCJ | Closed Loop Auto Titration Device For Oral Appliances | 872.5571 | 2 | 1 |
| QNO | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | 872.5575 | 2 | 3 |
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | 872.5580 | 2 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Apr 15, 2026 |
| K252942 | ShaeferH | Shaeferh, LLC | Apr 10, 2026 |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | Apr 6, 2026 |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | Mar 4, 2026 |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | Mar 3, 2026 |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | Mar 2, 2026 |
| K253282 | ZSmile System | Dror Orthodesign , Ltd. | Feb 3, 2026 |
| K252507 | SmileInspector | Amv Consulting, LLC | Jan 7, 2026 |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | Jan 7, 2026 |
| K253343 | Celebrace Software | Celebrace | Dec 29, 2025 |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | Dec 18, 2025 |
| K253868 | QuietLab Pro | QuietLab, LLC | Dec 5, 2025 |
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | Nov 27, 2025 |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | Nov 25, 2025 |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | Nov 7, 2025 |
| K252525 | AIO Breathe | Aiomega, LLC | Nov 6, 2025 |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | Nov 3, 2025 |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | Oct 29, 2025 |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | Oct 24, 2025 |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | Oct 23, 2025 |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | Oct 22, 2025 |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | Oct 9, 2025 |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | Oct 3, 2025 |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | Sep 17, 2025 |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | Sep 11, 2025 |
| K251758 | Serafin® | Tns Co., Ltd. | Sep 11, 2025 |
| K250353 | Oniris; Oniris Plus | Oniris | Sep 4, 2025 |
| K252380 | Invisalign System | Align Technology, Inc. | Aug 29, 2025 |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Aug 27, 2025 |
| K251616 | Clear Miracle | Ods Co., Ltd. | Jul 22, 2025 |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | May 21, 2025 |
| K250122 | SleepRight Snore Aid | Splintek, Inc. | May 19, 2025 |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | May 8, 2025 |
| K250198 | Laon Ortho | Laon Medi, Inc. | Apr 23, 2025 |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | Apr 21, 2025 |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | Apr 8, 2025 |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | Feb 20, 2025 |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | Jan 16, 2025 |
| K242929 | Fas Aligner System | Xplora 3D Europe S.L | Dec 20, 2024 |
| K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | Dec 19, 2024 |
| K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | Dec 12, 2024 |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | Oct 11, 2024 |
| K240501 | Spark Clear Aligner System | Ormco Corporation | Oct 11, 2024 |
| K233497 | Rest Assure System | Somnomed, Inc. | Oct 3, 2024 |
| K234089 | DNA Appliance | Vivos Therapeutics | Sep 16, 2024 |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | Aug 8, 2024 |
| K241137 | Clear Moves Aligner | Clear Moves Aligners | Aug 1, 2024 |
| K241187 | Alien Aligners | Alien Milling Technologies | Jul 26, 2024 |
| K241412 | Invisalign System | Align Technology, Inc. | Jun 18, 2024 |
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | May 16, 2024 |
| K233625 | RAYDENT SW | Ray Co., Ltd. | May 16, 2024 |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | May 9, 2024 |
| K232735 | EMA 3D | Ema Sleep Incorporated | May 3, 2024 |
| K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | Apr 18, 2024 |
| K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | Apr 5, 2024 |
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | Apr 4, 2024 |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | Apr 3, 2024 |
| K232564 | Align Studio | Laon Medi, Inc. | Mar 12, 2024 |
| K240597 | TERA HARZ CLEAR | Graphy, Inc. | Mar 5, 2024 |
| K233754 | AIO Breathe | Aiomega, LLC | Feb 23, 2024 |
| K233544 | MESHEET | Dentis Co., Ltd. | Feb 22, 2024 |
| K232074 | Serafin® | Tns Co., Ltd. | Feb 22, 2024 |
| K240427 | airVata | Gelb Practice Solutions, Inc. | Feb 14, 2024 |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | Jan 16, 2024 |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | Jan 11, 2024 |
| K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | Dec 15, 2023 |
| K232063 | SaliPen | Saliwell , Ltd. | Dec 13, 2023 |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | Nov 28, 2023 |
| K232549 | NemoCast | Software Nemotec S.L. | Nov 21, 2023 |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Prismatik Dentalcraft, Inc. | Nov 14, 2023 |
| K230199 | Byte Aligner System | Dentsply Sirona, Inc. | Oct 18, 2023 |
| K232429 | Titan Dental Design | Clearadvance, LLC | Oct 13, 2023 |
| K233257 | 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products | Sep 29, 2023 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. | Sep 26, 2023 |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. | Sep 18, 2023 |
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2023 |
| K231884 | TRIOCLEAR System | Modern Dental Laboratory (Dg) Co., Ltd. | Sep 1, 2023 |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | Sep 1, 2023 |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | Jul 12, 2023 |
| K232011 | Cleo | American Orthodontics | Jul 7, 2023 |
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | Jun 16, 2023 |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | Jun 13, 2023 |
| K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | Jun 13, 2023 |
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | Jun 9, 2023 |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | Jun 6, 2023 |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | Jun 5, 2023 |
| K231464 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | May 22, 2023 |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | May 10, 2023 |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | May 4, 2023 |
| K223141 | STR8 Clear Aligner | Str8 Oral Care | Apr 24, 2023 |
| K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | Apr 17, 2023 |
| K221537 | Nightwear Aligners | Smylio, Inc. | Apr 5, 2023 |
| K222619 | Ensmile | Ensmile Pvt, Ltd. | Mar 16, 2023 |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | Blue Sky Bio, LLC | Feb 24, 2023 |
| K223338 | Toothsi, Smilealigners | Makeo Healthcare Technologies Private Limited | Feb 9, 2023 |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | Jan 18, 2023 |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | Dec 30, 2022 |
| K222894 | Invisalign System, Pre-Formed Attachment System | Align Technology, Inc. | Dec 22, 2022 |
| K222308 | Al Smile Aligner | Nanjing Jiahe Dental Technology Co., Ltd. | Dec 20, 2022 |
| K220688 | SilentZPro 2.0 | Shinrin-Yoku Traders, LLC | Dec 2, 2022 |
