The Urbanek Device is an intraoral, maxillary posterior dis-occluding device designed to aid in the treatment of clenching and bruxing associated with TMD/TMJ. The purpose of the device is to keep posterior maxillary and mandibular teeth (molars and premolars) from occluding in the centric or eccentric positions. Constructed of heat cured dental resin and two metal ball clasps for retention, the device is customized for each patient (per prescription by a dentist). The device is designed to be worn for 24 hours per day (except at meals), 7 days per week for a set interval of time (e.g., 9 weeks). At scheduled follow-up visits, patients are assessed for symptom relief and the device inspected for comfort, proper design, excessive wear and vertical dimension for the inter-incisal distance with the device in place. The device may be adjusted for comfort and inter-incisal distance to ensure no posterior tooth or portion of a tooth occludes with the opposing tooth.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. Instead, it describes a substantial equivalence determination for the "Urbanek Device" (K170985) against predicate devices (NTI-TSS NTI Tension Suppression System and MigraTherapy LLC Brux-TMD QuickSplint).

The document explicitly states:

Performance Testing: "Performance testing has not been performed as there are no recognized standards to which prescription mouthguards are tested; however, the material composition of the Urbanek Device base has been found in legally marketed devices and found previously safe for dental use since 2001 and meets the requirements of ISO 20795-1:2008 Dentistry -- Base polymers -- Part I: Denture base polymers (previously ISO 1567:1999)."

Therefore, I cannot provide the requested information. The device's clearance was based on its substantial equivalence to previously cleared devices, particularly regarding its materials and mechanism of action (disocclusion), rather than specific performance testing demonstrating fulfillment of a set of acceptance criteria.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

TMJ Services, LLC % Dawn Norman Executive Vice President MRC-X, LLC 6075 Poplar Ave; Suite 500 Memphis. Tennessee 38119

Re: K170985 Trade/Device Name: Urbanek Device Regulatory Class: Unclassified Product Code: MQC Dated: August 24, 2017 Received: August 25, 2017

Dear Ms. Dawn Norman:

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 (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. 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.

September 25, 2017

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170985

Device Name Urbanek Device

Indications for Use (Describe)

The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to aid in the relief of symptoms of TMD/TMJ.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K170985

510(k) Summary

Proprietary Name	Urbanek Device
Date of Submission:	September 25, 2017
Company:	TMJ ServicesATTN: Anthony P. Urbanek, DDS, MD, MS2009 Mallory LnFranklin, TN 37067Phone: 615-771-2189
EstablishmentRegistration:	N/A
Primary Contact:	Dawn Norman, MSExec. Vice President MRC-X, LLC6075 Poplar Avenue, Suite 500Memphis, TN, 38119Phone: 618-604-3064
Company/SecondaryContact:	TMJ ServicesAnthony P. Urbanek, DDS, MD, MS2009 Mallory LnFranklin, TN 37067Phone: 615-771-2189
Trade Name:	Urbanek Device
Common Name:	Mouthguard, Prescription
Classification:	Unclassified
Product Code:	MQC, OCO
Regulation Number:	Pre-amendment
Panel:	Dental

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Predicate Devices:

Primary Predicate Device:

. NTI-TSS Inc.: NTI Tension Suppression System – K010876 (Cleared 06/20/2001)
Reference Predicate Device:
MigraTherapy, LLC Brux: TMD QuickSplint-K111066 (Cleared 11/22/2011) .
Device Description: The Urbanek Device is an intraoral, maxillary posterior dis-occluding device designed to aid in the treatment of clenching and bruxing associated with TMD/TMJ. The purpose of the device is to keep posterior maxillary and mandibular teeth (molars and premolars) from occluding in the centric or eccentric positions. Constructed of heat cured dental resin and two metal ball clasps for retention, the device is customized for each patient (per prescription by a dentist).

The device is designed to be worn for 24 hours per day (except at meals), 7 days per week for a set interval of time (e.g., 9 weeks). At scheduled follow-up visits, patients are assessed for symptom relief and the device inspected for comfort, proper design, excessive wear and vertical dimension for the inter-incisal distance with the device in place. The device may be adjusted for comfort and inter-incisal distance to ensure no posterior tooth or portion of a tooth occludes with the opposing tooth.

This device is effective because it allows the posterior teeth to be separated (disoccluded) for a period of time in the centric relation position. Disocclusion helps to relieve TMJ/TMD symptoms by stabilizing jaw muscles and joints. By stabilizing jaw muscles and joints to prevent overuse, inflammation of tissue within the temporomandibular joint resolves and healing is allowed to occur.

Indications for Use: The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.

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Device	Urbanek Device(Subject Device)	NTI-TSS NTI TensionSuppression System(K010876); PrimaryPredicate	MigraTherapy LLC Brux- TMDQuickSplint (K111066);Reference
Product Code	OCO, MQC	OCO	MQC
Indications forUse	The Urbanek Device is forthe amelioration of clenchingand bruxing associated withTMD and is to be used to aidin the relief of symptoms ofTMD/TMJ.	Treatment of tooth wearfrom bruxing andclenchingTreatment of musclepain associated withmuscle dysfunctionDiagnostic treatmentplanningThe NTI-tss protocol isindicated for theprevention of medicallydiagnosed migraine painand jaw disordersthrough the reductionof trigeminallyinnervated muscularactivity	1. Protection of teeth andrestorations from injury dueto bruxism or clenching.2. Temporary relief ofTemporomandibular JointDisorder (TMD) and bruxism byreducing muscle tension.3. Temporary treatment ofTemporomandibular Disorder(TMD) along with the relief ofassociated headaches and pains.The intended user includes patientsdiagnosed with bruxism, patientswith headaches and pain related tobruxism, Patients with TMD, patientswith headaches and pain related toTMD and patients who may damageteeth or dental restorations from theclenching and grinding related tobruxism activity.
Material	• Thermoplasticresin• ASTM 313Stainless Steel	• Thermoplasticresins	• Polycarbonate tray• vinyl polysiloxane liner
Mechanismof action	Disocclusion	Disocclusion	Disocclusion
Removable?	Yes	Yes	Yes
Deviceplacement	Palate and anteriormaxillary arch	Anterior maxillary ormandibular arch	Anterior maxillary ormandibular arch
Location ofdisocclusion	Upper molars andpremolars	Lower incisors	Upper/lower incisors frombicuspid tobicuspid

Comparison of Subject and Predicate Intraoral Devices

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TechnologicalCharacteristics:	The material base for the Urbanek Device is FDA cleared and previouslydemonstrated to be safe for dental use. The Urbanek Device issubstantially equivalent to the predicate and reference devices as itsprimary mode of action, like that of the predicate and reference devices, isto keep the posterior maxillary and mandibular teeth (molars andpremolars) from occluding in the centric or eccentric positions. Thisdisocclusion results in the alleviation of pressure on thetemporomandibular joints. The primary difference between the proposeddevice and the predicate(s) is where the device sits within the oral cavity.The Urbanek Device sits on the palate of the mouth while the NTI-TSS NTTension Suppression System uses the lower incisors and the Brux TMDQuickSplint is an anterior bite plate that covers either the upper or lowerfront teeth from bicuspid to bicuspid. Although, the positions of the devicewithin the oral cavity are different, the intent in all of the devices isdisocclusion. The proposed and predicate devices are all patient specificand reusable for the given patient.
Performance Testing:	Performance testing has not been performed as there are no recognizedstandards to which prescription mouthguards are tested; however, thematerial composition of the Urbanek Device base has been found in legallymarketed devices and found previously safe for dental use since 2001and meets the requirements of ISO 20795-1:2008 Dentistry -- Basepolymers -- Part I: Denture base polymers (previously ISO 1567:1999).
Conclusion:	The subject Urbanek Device has similar indications for use, mode ofaction, technological characteristics and materials as the predicatedevices. The minor differences between the Urbanek device and thepredicate devices raise no new questions of safety and effectiveness.Thus, the Urbanek Device is substantially equivalent to the predicatedevices.

TechnologicalCharacteristics:

The material base for the Urbanek Device is FDA cleared and previouslydemonstrated to be safe for dental use. The Urbanek Device issubstantially equivalent to the predicate and reference devices as itsprimary mode of action, like that of the predicate and reference devices, isto keep the posterior maxillary and mandibular teeth (molars andpremolars) from occluding in the centric or eccentric positions. Thisdisocclusion results in the alleviation of pressure on thetemporomandibular joints. The primary difference between the proposeddevice and the predicate(s) is where the device sits within the oral cavity.The Urbanek Device sits on the palate of the mouth while the NTI-TSS NTTension Suppression System uses the lower incisors and the Brux TMDQuickSplint is an anterior bite plate that covers either the upper or lowerfront teeth from bicuspid to bicuspid. Although, the positions of the devicewithin the oral cavity are different, the intent in all of the devices isdisocclusion. The proposed and predicate devices are all patient specificand reusable for the given patient.

Performance Testing:

Performance testing has not been performed as there are no recognizedstandards to which prescription mouthguards are tested; however, thematerial composition of the Urbanek Device base has been found in legallymarketed devices and found previously safe for dental use since 2001and meets the requirements of ISO 20795-1:2008 Dentistry -- Basepolymers -- Part I: Denture base polymers (previously ISO 1567:1999).

Conclusion:

The subject Urbanek Device has similar indications for use, mode ofaction, technological characteristics and materials as the predicatedevices. The minor differences between the Urbanek device and thepredicate devices raise no new questions of safety and effectiveness.Thus, the Urbanek Device is substantially equivalent to the predicatedevices.

Regulation Number and Section

N/A