Midmark Dental Delivery System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION November 3, 2025 Midmark Corporation Rachel Schwieterman Regulatory Affairs Specialist 60 Vista Drive Versailles, Ohio 45380 Re: K251626 Trade/Device Name: Midmark Dental Delivery System Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA Dated: October 2, 2025 Received: October 3, 2025 Dear Rachel Schwieterman: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251626 - Rachel Schwieterman Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K251626 - Rachel Schwieterman Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} Midmark Dental Delivery System Page 11 of 65 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251626 | ? | | Please provide the device trade name(s). | | ? | | Midmark Dental Delivery System | | | | Please provide your Indications for Use below. | | ? | | Midmark Dental Delivery Systems are intended to provide dental professionals with low voltage electric, air, and water to operate dental handpieces, syringes, and accessories during dental examinations and procedures. | | | | Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water, and suction to operate dental handpieces, syringes, and accessories during dental examinations and procedures. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} Midmark Dental Delivery System 510(k) Summary  Designing better care.™ Midmark Corporation 60 Vista Drive Versailles, Ohio 45380 1-800-MIDMARK midmark.com In accordance with 21 CFR §807.92, a 510(k) summary is provided below with the required information. # 1. Administrative Information | Table 1. Administrative Information | | | --- | --- | | Date Summary Prepared | October 30, 2025 | | 510(k) Sponsor Address | Midmark Corporation 60 Vista Drive Versailles, Ohio 45380 | | Contact Person | Rachel Schwieterman Regulatory Affairs Specialist Email: rtschwieterman@midmark.com Phone: 937-526-8567 Fax: 937-526-8482 | | Trade Name | Midmark Dental Delivery System | | Common Name | Dental Operative Unit | | Classification Name | Dental Operative Unit and Accessories (21 CFR 872.6640, Product Code EIA) | | Device Classification | Class I | | Review Panel | Dental | | 510(k) Number | K251626 | # 2. Equivalent Predicate Comparators | Table 2. Predicate Device | | | | | --- | --- | --- | --- | | Manufacturer Name | Trade Name | 510(k) No. | Decision Date | | Midmark Corporation | Elevance Delivery Unit | K120239 | August 24, 2012 | Midmark Corporation {5} Midmark Dental Delivery System 510(k) Summary ## 3. Indications for Use Midmark Dental Delivery Systems are intended to provide dental professionals with low voltage electric, air, and water to operate dental handpieces, syringes, and accessories during dental examinations and procedures. Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water, and suction to operate dental handpieces, syringes, and accessories during dental examinations and procedures. ## 4. Models | Table 3. Models | | --- | | Model Number | Model Name | | DS-1100-001 | Midmark Left Right - Chair Mounted Dental Delivery System | | DS-1200-001 | DS-1200-CABINET Midmark 12 O'clock - Dental and Assistant's Cabinet-Mounted Delivery System | | DS-1200-COLUMN Midmark 12 O'clock Dental and Assistant's Column-Mounted Delivery System | | ADS-1100-001 | Midmark Chair Mounted - Assistant's Delivery System | | ADS-1200-001 | Midmark 12 O'clock - Cabinet Mounted- Assistant's Delivery System | ## 5. Device Description The Midmark Dental Delivery System encompasses two types of dental units: Dental Delivery Systems and Assistant's Delivery Systems. The Dental Delivery System is a workstation for the dental clinical space that provides air, water and electrical power for the operation of dental instruments. The system has two models with three mounting options that can provide instrument positioning for right-handed and left-handed clinicians practicing to the patient's side or for clinicians practicing at the 12 o'clock position. The DS-1100-001 model mounts to the base of the Midmark Dental Chair. This model has a combination of swing arms and a flex arm providing both horizontal and vertical positioning of the delivery unit. The DS-1200-001 model mounts to a cabinet or column base and also includes an Assistant's Delivery System. The cabinet mount has a combination of swing arms providing horizontal positioning of the delivery unit to either side of a clinician practicing behind the patient at the 12 o'clock position. The adjustable column mount option that connects to a cabinet adds vertical positioning adjustment to the DS-1200-001. Midmark Corporation {6} Midmark Central Delivery System 510(k) Summary The Dental Delivery System contains an air and water control manifold designed to route coolant air, drive air, and water to the active dental handpiece. This manifold consists of a pneumatically actuated diaphragm mechanism and an integrated air and water distribution block. When handpieces are docked in their respective instrument holders, air pressure in the handpiece line applies force to the diaphragm within the manifold, closing the associated air ports and preventing air and water flow. When a handpiece is undocked from its holder, a valve within the holder releases the air pressure against the diaphragm. When the foot control is activated, drive and coolant air pressures overcome the diaphragm, opening the previously closed air port. The foot control activation simultaneously sends a pneumatic signal to open the corresponding water valve within the manifold assembly. As a result, the drive air, coolant air, and coolant water are able to flow through the distribution pathways to the undocked handpiece. Returning the handpiece to its holder triggers the holder's valve mechanism to re-pressurize the diaphragm, re-closing the air and water distribution pathways. The Assistant's Delivery System is a workstation for the dental clinical space that provides air, water, and vacuum for the operation of dental instruments. The ADS-1100-001 model mounts to the head end of the Midmark Dental Chair. A junction box located at the foot end of the chair base provides a contained space for the connection of the Assistant's Delivery System to air, water, and vacuum sources. The ADS-1200-001 mounts to a Midmark cabinet base. The DS-1200-001 Assistant's Delivery System mounts on a movable arm which is common to the Dental Delivery System. The Assistant's Delivery System mounts to the lower side of its supporting arm and the Dental Delivery System mounts to the upper side of the arm allowing both to pivot independently for positioning of the instruments to the clinician. The cabinetry base has a space for the connection of the Assistant's Delivery System to air, water, and vacuum sources. Device specifications are provided in Table 4. | Table 4. Midmark Dental Delivery System Specifications | | | --- | --- | | Specification | Value | | Electrical Ratings | 36V 5.5A | | Fuse Ratings | 3.15 A | | Compressed Air Input | 80 – 100 psig | | Water Input | 40 – 60 psig | | Vacuum | 250 Nl/min | | Drive Air Output | 55 Nl/min @ 45psig | | Coolant Air Output | 1.5 Nl/min @ 35psig | | Coolant Water Output | 50ml/min @ 18psig | | DS-1100-001 length x width x height | 59" x 19" x 36" | | ADS-1100-001 length x width x height | 38" x 11" x 31" | | DS-1200-001 length x width x height | 45" x 19" x 32" | Midmark Corporation {7} Midmark Dental Delivery System 510(k) Summary Table 4. Midmark Dental Delivery System Specifications | Specification | Value | | --- | --- | | ADS-1200-001 length x width x height | 44" x 17" x 22" | | DS-1100-001 Weight | 76 lbs | | ADS-1100-001 Weight | 17 lbs | | DS-1200-001 Weight | 98 lbs | | ADS-1200-001 Weight | 43 lbs | | Operating Environment | Temperature: 59 to 95°F Humidity: 10 to 90% (non-condensing) Pressure: 10 to 15.3 psi | | Work Surface/Tray Size | The worksurface is inlaid with a removeable silicone rubber mat and will accommodate a 9.75" x 13.50" tray | # 6. Technological Characteristics Refer to Table 5 for a comparison of the Midmark Dental Delivery System technological characteristics with those of its predicate. Changes made to the Midmark Dental Delivery System do not raise new issues of safety or effectiveness. The Intended Use of the Midmark Dental Delivery System remains identical to that of the predicate device. Table 5. Comparison of Technological Characteristics | Characteristic | Subject Device: Midmark Dental Delivery System | Predicate Device: Elevance Delivery Units | Comparison | | --- | --- | --- | --- | | FDA 510(k) Clearance | K251626 | K120239 | N/A | | Product Code | EIA | EIA | Equivalent | | Class | Class I | Class I | Equivalent | | Regulation | 872.6640 | 872.6640 | Equivalent | Midmark Corporation {8} Midmark Dental Delivery System 510(k) Summary Table 5. Comparison of Technological Characteristics | Characteristic | Subject Device: Midmark Dental Delivery System | Predicate Device: Elevance Delivery Units | Comparison | | --- | --- | --- | --- | | Indications for Use | Midmark Dental Delivery Systems are intended to provide dental professionals with low voltage electric, air, and water to operate dental handpieces, syringes, and accessories during dental examinations and procedures. Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water, and suction to operate dental handpieces, syringes, and accessories during dental examinations and procedures. | The Midmark Elevance Instrument Delivery System is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low voltage electricity to hand-held dental instruments. | Similar | | Midmark Dental Delivery System Components | Doctor's instrument head and mount arms, assistant's instrument head and mount arms, air, water, and vacuum distribution, low voltage power supply | Doctor's instrument head and mount arms, assistant's instrument head and mount arms, air, water, and vacuum distribution, low voltage power supply | Equivalent | | Operatory Environment | Dental Chair, Dental Light, Cuspidor, 12 o'clock Cabinet | Dental Chair, Dental Light, Cuspidor, 12 o'clock Cabinet | Equivalent | | Dental Delivery System Instrument Components and Controls: | | | | | Delivery Unit Mount Options | Midmark Dental Chair or 12 o'clock Column/Cabinet mounted swing arms | Elevance Dental Chair or 12 o'clock Cabinet mounted swing arms | Similar | | Delivery Unit Height Adjustment | Spring-loaded flex arm | Spring-loaded flex arm | Equivalent | | Flex Arm Release | Not required | E-field sensor and pilot air switch | Different | | Delivery Unit Instrument Holders | Four or six positions are available, up to five instruments may be controlled by a pneumatic foot control | Four or six positions are available, up to five instruments may be controlled by a pneumatic foot control | Equivalent | | System Master Switch | Pneumatic valve | Pneumatic valve | Equivalent | Midmark Corporation Page 5 of 10 {9} Midmark Dental Delivery System 510(k) Summary Table 5. Comparison of Technological Characteristics | Characteristic | Subject Device: Midmark Dental Delivery System | Predicate Device: Elevance Delivery Units | Comparison | | --- | --- | --- | --- | | Instrument Detection | Pneumatic pilot valve and air actuated electronic signal | Pneumatic pilot valve and optical sensor | Similar | | Instrument Air and Water Line Actuation | Midmark proprietary diaphragm module | Midmark proprietary kink valves | Different | | Instrument Drive Air Volume | Manually adjustable pinch valves | Proportional solenoid valve | Different | | Instrument Coolant Water Volume | Manually adjustable needle valves | Proportional solenoid valve | Different | | Instrument Coolant Air Volume | Manually adjustable needle valve | Manually adjustable needle valve | Equivalent | | Handpiece Line Flush | Manually actuated pilot valve | Electronic solenoid pilot valve. | Different | | Syringe Air and Water Volume | Manually adjustable pinch valves | Manually adjustable needle valves | Similar | | Air and Water Shutoff for Bien Air Endodontics Mode | Not available | Electronic solenoid valve | Different | | Air and Water External Ports | Panel mounted couplers with automatic shutoff | Panel mounted couplers with automatic shutoff (included on the assistant's unit) | Equivalent | | Foot Control | Provides variable drive air to engage and operate doctor's instruments; includes a wet/dry switch | Provides variable drive air to engage and operate doctor's instruments; includes a wet/dry switch | Equivalent | | Instrument Lubrication Oil Collection System | Plastic housing with gauze | Plastic housing with gauze | Equivalent | | Midmark Dental Chair and Light Remote Control | Touchpad membrane | Touchpad | Equivalent | | Software Updates | Software updates via a wired CAN message from a network connected Midmark Dental Chair. | Software updates via USB on the display control PCBA | Different | | USB Port | Pass-through USB extender and USB port | Pass-through USB extender and USB port | Equivalent | | Dental Delivery System Instrument Options (Non-Midmark Manufactured Devices): | | | | Midmark Corporation Page 6 of 10 {10} Midmark Dental Delivery System 510(k) Summary | Characteristic | Subject Device: Midmark Dental Delivery System | Predicate Device: Elevance Delivery Units | Comparison | | --- | --- | --- | --- | | Air-Driven Handpiece Connector Options | High-speed or low-speed handpiece connector with or without integrated illumination | High-speed or low-speed handpiece connector with or without integrated illumination | Equivalent | | Bien Air Electric Motor | Not available | Single or dual system including Bien Air control module. Motor settings provided via a touchpad and display screen. | Different | | Piezoelectric Scaler | Includes scaler control module with setting adjusted manually via potentiometer. | Includes scaler control module with setting provided via a touchpad and display screen. | Similar | | Magneto-Strictive Scaler | Includes scaler control module with setting adjusted manually via potentiometer. | Includes scaler control module with setting provided via a touchpad and display screen. | Similar | | Syringe options | 3-way air and water syringe or air only syringe; accepts autoclavable or disposable tips | 3-way air and water syringe or air only syringe; accepts autoclavable or disposable tips | Equivalent | | Assistant's Delivery System Components and Controls: | | | | | Assistant's Unit Mount Options | Midmark Dental Chair or 12 o'clock Cabinet/Column mounted swing arms | Elevance Dental Chair or 12 o'clock Cabinet mounted swing arms | Similar | | Assistant Instrument Holders | Four holders are standard | Four holders are standard | Equivalent | | Midmark Dental Chair and Light Remote Control | Touchpad membrane | Touchpad | Equivalent | | Vacuum Solids Collector | Solids collector built into housing, accepts disposable baskets | Solids collector built into housing, accepts disposable baskets | Equivalent | | Syringe Water and Air Controls | Manual needle valves | Manual pinch valves | Similar | Midmark Corporation Page 7 of 10 {11} Midmark Dental Delivery System 510(k) Summary | Characteristic | Subject Device: Midmark Dental Delivery System | Predicate Device: Elevance Delivery Units | Comparison | | --- | --- | --- | --- | | Assistant's Delivery System Instrument Options (Non-Midmark Manufactured Devices): | | | | | High Volume Evacuator (HVE) | HVE housing with shutoff, accepts disposable tips | HVE housing with shutoff, accepts disposable tips | Equivalent | | Illuminated HVE | Zyris Isolite illuminated HVE option | Not available | Different | | Saliva Ejector (SE) | SE housing with shutoff, accepts disposable tips | SE housing with shutoff, accepts disposable tips | Equivalent | | Syringe Options | 3-way air/water syringe or air only syringe; accepts autoclavable or disposable tips | 3-way air/water syringe or air only syringe; accepts autoclavable or disposable tips | Equivalent | | Air/Water/Electric Supply Components: | | | | | Water Distribution | Self-contained water bottle system or city water regulator and shutoff valve. | Self-contained water bottle system or city water regulator and shutoff valve. | Equivalent | | Air Distribution | Air regulator and shutoff valve | Air regulator and shutoff valve | Equivalent | | Power Supply | 36Vdc Low voltage output with 120Vac input | 24Vac Low voltage output with 120Vac or 240Vac input | Similar | ## 7. Non-Clinical Test Data Non-clinical testing and evaluations were performed for the Midmark Dental Delivery System. The non-clinical tests demonstrated that the Midmark Dental Delivery System meets the applicable requirements of the referenced standards, and the results support that the device performs as safe and as effective as the legally marketed predicate device for its intended use. Electrical Safety and Electromagnetic Compatibility: The Midmark Dental Delivery System was evaluated to IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC TS 60601-4-2 to ensure compliance with electrical safety standards. Performance Testing: The Midmark Dental Delivery System was evaluated to ISO 7494-1, ISO 7494-2, and ISO 9168 to verify performance of the device. Midmark Corporation Page 8 of 10 {12} Midmark Dental Delivery System 510(k) Summary Reprocessing Testing: The Midmark Dental Delivery System had reprocessing validations conducted in accordance with the FDA guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”, issued March 17, 2015. Additional verification testing was completed on the dental unit water lines according to ISO 16954. Software Verification: The software of the Midmark Dental Delivery System was verified in accordance with the FDA guidance “Content of Premarket Submissions for Device Software Functions”, issued June 14, 2023. Biocompatibility: Biocompatibility testing was completed for the Midmark Dental Delivery System utilizing ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. A summary of evaluations are shown in Table 6. Based on the results of studies performed, the Midmark Dental Delivery System does not raise new issues of safety or effectiveness. Table 6. Non-Clinical Performance Data | Standard | Standard Name | | --- | --- | | IEC 60601-1-2:2020 Ed. 4.1 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | ANSI/AAMI ES60601-1:2005+A2:2010(R2012)+A1:2012+A2:2021 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] | | IEC 60601-1:2005/A1:2012/A2:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | IEC 80601-2-60:2019 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment | | IEC TS 60601-4-2:2024 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | | ISO 7494-1:2018 | Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements | Midmark Corporation {13} Midmark Dental Delivery System 510(k) Summary Table 6. Non-Clinical Performance Data | Standard | Standard Name | | --- | --- | | ISO 7494-2:2022 | Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems | | ISO 9168:2009 | Dentistry - Hose connectors for air driven dental handpieces | | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | | ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation | | ISO 16954:2015 | Dentistry — Test methods for dental unit waterline biofilm treatment | ## 8. Clinical Performance Data Clinical data was not required. ## 9. Conclusion In terms of Intended Use, design, material, principles of operation, energy source, and performance in nonclinical testing, Midmark has determined that the subject Midmark Dental Delivery System is substantially equivalent and is as safe and effective and performs as well as or better than the legally marketed predicate device, the Elevance Delivery Unit (K120239). Midmark Corporation