(169 days)
Not Found
No
The device description and intended use focus on the physical properties and mechanical function of a dental guard, with no mention of AI or ML technology.
Yes
The device is intended for protection against bruxism and teeth grinding, and for short-term pain relief from muscle spasm due to occlusal interference, as well as prevention of chronic tension and temporomandibular joint (TMJ) syndrome. These are therapeutic indications.
No
The device is a dental guard designed to protect against bruxism and teeth grinding, and to provide short-term pain relief from muscle spasms related to occlusal interference. Its intended use focuses on prevention and physical protection rather than diagnosing a condition or disease.
No
The device description clearly states it is a "dental guard composed of a moldable thermoplastic inner lining... and a hard outer shell," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The device described is a dental guard designed to be worn in the mouth to protect teeth from grinding and clenching. It is a physical device that interacts directly with the user's teeth and jaw.
- Intended Use: The intended use clearly states protection against bruxism, teeth grinding, and jaw clenching, and short-term pain relief from muscle spasm due to occlusal interference. These are mechanical and physical functions, not diagnostic tests performed on samples.
The description of the device, its intended use, and the lack of any mention of analyzing biological samples all indicate that this is a physical medical device, not an IVD.
N/A
Intended Use / Indications for Use
OTC: Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching.
Rx: Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle
Product codes (comma separated list FDA assigned to the subject device)
OBR, MQC
Device Description
The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
110468 RANDMARK DENTAL PRODUCTS LLC
284 Elkins Ln. Lusby, MD 20657
(410) 326-6235
AUG - 5 2011
SECTION 5.0
SUMMARY OF SAFETY & EFFECTIVENESS
This summary of 510 (k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92.
1 5.1
Sponsor Identification 5.1.1
- .............................................................................................................................................................................. Randmark Dental Products LLC 284 Elkins Ln Lusby, MD 20657 Tel: 410-326-6235 Fax: 501-637-7204 ..............................................................................................................................................................................
Sponsor/Manufacturer Establishment Registration Number: NA 5.1.2
Submission Correspondent 5.13 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Norman F. Estrin, Ph.D. Managing Partner ESTRIN CONSULTING GROUP LLC 9109 Copenhaver Drive Potomac, MD 20854 Tel: (301) 279-2899 Fax:(301) 294-0126 estrin(a)yourFD.A.consultans.com ..............................................................................................................................................................................
5.2
000016
00005
1
KII 0468
Device Trade Names 5.3
.............................................................................................................................................................................
..............................................................................................................................................................................
Model Numbers 5.3.1
5.3.2 -
Not currently available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Common Name: Dental Guard
..............................................................................................................................................................................
- Classification Name: None . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3.3
Regulation Numbers: None 5.3.4 .........
Proposed Regulation Class: unclassified 5.3.5 -
- Device Product Code: OBR, MQC 5.3.6 ...
- Medical Specialties: Dental 5.3.7 5.4 Device Description
The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.
5.5 INDICATIONS FOR USE No T ON OOE
OTC:
Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Protection against teeth grinding, bruxism and jaw clenching.
Rx:
Short-term pain relief from muscle spasm due to occlusal interference.
For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the
temporalis muscle.
000017
2
00006
2
PREDICATE DEVICES 5.6
-
Predicate Devices: SleepRight Products listed below (K071404) (Applicant: Power 5.61 Products. Inc. - Splintek)
NTI Tension Suppression System (K010876)(Applicant: NTI-TSS, Inc.) -
5.62
.
............................................................................................................................................................................
| 5.6.3 | Product Code | Predicate Device Names: |
|---|---|---|
| OBR | SleepRight® -Select | |
| OBR | SleepRight®-Low Profile | |
| OBR | SleepRight®-Advance | |
| OCO | NTI Tension Suppression System | |
| MQC | SleepRight® - Low Profile Rx | |
| MQC | SleepRight® - Advance Rx | |
| OCO | NTI Tension Suppression System |
SUBSTANTIAL EQUIVALENCE 5.7 -----
OTC: The Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the three above listed SleepRight products under Product code OBR. The Freeway Comfort™ Bite Guard mouth guard has the same intended uses, indications and similar technological characteristics as its predicate devices. The minor technological differences between the Freeway Comfort™ Bite Guard mouth guard and the predicate devices raise no new questions of safety or effectiveness. Thus, the Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the three SleepRight® products and the NTI product noted above.
Rx: The Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the two SleepRight products shown above with the Product Code MQC. The Freeway Comfort" Bite Guard mouth guard has the same intended uses, indications and similar technological characteristics as its predicate devices. The minor technological differences between the Freeway Comfort™ Bite Guard mouth guard and the predicate devices raises no new questions of safety or effectiveness. Thus, the Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the above noted two SleepRight products with the Product Code MQC and the NTI Tension Suppression System with the Product Code OCO. Note that the Freeway Comfort" Bite Guard mouth guard is not claiming substantial equivalence to the NTI Tension Suppression System for either OTC or Rx uses for the NTI migraine treatment claims.
000019 00008
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Randmark Dental Products, LLC C/O Norman F. Estrin, Ph.D. Managing Partner Estrin Consulting Group, LLC 9109 Copenhaver Drive Potomac, Maryland 20854
AUG - 5 2011
Re: K110468
Trade/Device Name: Freeway Comfort™ Bite Guard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC, OBR Dated: July 28, 2011 Received: July 29, 2011
Dear Dr. Estrin:
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.
4
Page 2 – Dr. Estrin
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
4.0 Indications for Use
510(k) Number (if known): K110468 Device Name: Freeway Comfort™ Bite Guard
Indications for Use:
OTC:
Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Protection against teeth grinding, bruxism and jaw clenching.
Rx:
Short-term pain relief from muscle spasm due to occlusal interference.
For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle
| Prescription Use | X | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Page __ of __ |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | 000014 |
| 00004 | |
| 510(k) Number: | K110468 |