(175 days)
No
The device description and performance summary do not mention any AI or ML components or capabilities. The device is a physical, customized intraoral appliance.
Yes
The device description explicitly states that "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 intended use further clarifies its purpose for "amelioration of clenching and bruxing associated with TMD" and to "aid in the relief of symptoms of TMD/TMJ," both of which describe therapeutic interventions.
No
The device is described as an intraoral device for the amelioration of clenching and bruxing associated with TMD, designed to aid in the treatment of symptoms rather than to diagnose a condition.
No
The device description clearly states it is an "intraoral, maxillary posterior dis-occluding device" constructed of "heat cured dental resin and two metal ball clasps," indicating it is a physical hardware device.
Based on the provided information, the Urbanek Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Urbanek Device is an intraoral device that is placed inside the mouth to treat a condition (TMD/TMJ). It does not analyze any biological samples.
- The intended use is therapeutic. The device is designed to ameliorate clenching and bruxing and aid in the relief of symptoms of TMD/TMJ. This is a treatment function, not a diagnostic one.
- The device description focuses on its physical structure and how it interacts with the teeth. It describes the materials, design, and how it's worn and adjusted. This is consistent with a therapeutic device.
In summary, the Urbanek Device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, OCO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Palate and anterior maxillary arch (Oral cavity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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
2
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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3
K170985
510(k) Summary
| Proprietary Name | Urbanek Device |
|---|---|
| Date of Submission: | September 25, 2017 |
| Company: | TMJ Services |
| ATTN: Anthony P. Urbanek, DDS, MD, MS | |
| 2009 Mallory Ln | |
| Franklin, TN 37067 | |
| Phone: 615-771-2189 | |
| Establishment | |
| Registration: | N/A |
| Primary Contact: | Dawn Norman, MS |
| Exec. Vice President MRC-X, LLC | |
| 6075 Poplar Avenue, Suite 500 | |
| Memphis, TN, 38119 | |
| Phone: 618-604-3064 | |
| Company/Secondary | |
| Contact: | TMJ Services |
| Anthony P. Urbanek, DDS, MD, MS | |
| 2009 Mallory Ln | |
| Franklin, TN 37067 | |
| Phone: 615-771-2189 | |
| Trade Name: | Urbanek Device |
| Common Name: | Mouthguard, Prescription |
| Classification: | Unclassified |
| Product Code: | MQC, OCO |
| Regulation Number: | Pre-amendment |
| Panel: | Dental |
4
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.
5
| Device | Urbanek Device
(Subject Device) | NTI-TSS NTI Tension
Suppression System
(K010876); Primary
Predicate | MigraTherapy LLC Brux- TMD
QuickSplint (K111066);
Reference |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OCO, MQC | OCO | MQC |
| 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. | Treatment of tooth wear
from bruxing and
clenching
Treatment of muscle
pain associated with
muscle dysfunction
Diagnostic treatment
planning
The NTI-tss protocol is
indicated for the
prevention of medically
diagnosed migraine pain
and jaw disorders
through the reduction
of trigeminally
innervated muscular
activity | 1. Protection of teeth and
restorations from injury due
to bruxism or clenching.
2. Temporary relief of
Temporomandibular Joint
Disorder (TMD) and bruxism by
reducing muscle tension.
3. Temporary treatment of
Temporomandibular Disorder
(TMD) along with the relief of
associated headaches and pains.
The intended user includes patients
diagnosed with bruxism, patients
with headaches and pain related to
bruxism, Patients with TMD, patients
with headaches and pain related to
TMD and patients who may damage
teeth or dental restorations from the
clenching and grinding related to
bruxism activity. |
| Material | • Thermoplastic
resin
• ASTM 313
Stainless Steel | • Thermoplastic
resins | • Polycarbonate tray
• vinyl polysiloxane liner |
| Mechanism
of action | Disocclusion | Disocclusion | Disocclusion |
| Removable? | Yes | Yes | Yes |
| Device
placement | Palate and anterior
maxillary arch | Anterior maxillary or
mandibular arch | Anterior maxillary or
mandibular arch |
| Location of
disocclusion | Upper molars and
premolars | Lower incisors | Upper/lower incisors from
bicuspid to
bicuspid |
Comparison of Subject and Predicate Intraoral Devices
6
| Technological
Characteristics: | The material base for the Urbanek Device is FDA cleared and previously
demonstrated to be safe for dental use. The Urbanek Device is
substantially equivalent to the predicate and reference devices as its
primary mode of action, like that of the predicate and reference devices, is
to keep the posterior maxillary and mandibular teeth (molars and
premolars) from occluding in the centric or eccentric positions. This
disocclusion results in the alleviation of pressure on the
temporomandibular joints. The primary difference between the proposed
device 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 NT
Tension Suppression System uses the lower incisors and the Brux TMD
QuickSplint is an anterior bite plate that covers either the upper or lower
front teeth from bicuspid to bicuspid. Although, the positions of the device
within the oral cavity are different, the intent in all of the devices is
disocclusion. The proposed and predicate devices are all patient specific
and reusable for the given patient. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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). |
| Conclusion: | The subject Urbanek Device has similar indications for use, mode of
action, technological characteristics and materials as the predicate
devices. The minor differences between the Urbanek device and the
predicate devices raise no new questions of safety and effectiveness.
Thus, the Urbanek Device is substantially equivalent to the predicate
devices. |