(153 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a ready-to-wear dental guard, with no mention of AI or ML technologies.
Yes
The device is described as reducing damage to teeth by cushioning them and keeping them apart during grinding, which is a form of treatment for bruxism.
No
This device is described as a mouthguard intended for protection against teeth grinding, not for diagnosing any condition.
No
The device description clearly indicates it is a physical, ready-to-wear mouthguard made of material with tested physical and mechanical properties. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Ready-Fit Disposable Dental Guard Function: This device is a physical appliance worn in the mouth to protect teeth from grinding. It does not involve the analysis of any biological specimens.
The description clearly indicates it's a physical device for mechanical protection, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthguard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
18 and up
Intended User / Care Setting
OTC
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
DenTek conducted an in-home use test (IHUT) during the month of April 2015, to validate that the design of Ready-Fit Disposable Dental Guard meets the intended use and performance of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DenTek conducted an in-home use test (IHUT) during the month of April 2015, to validate that the design of Ready-Fit Disposable Dental Guard meets the intended use and performance of the device. Physical properties testing for density (ASTM D792 -ISO 1183) and melt flow (ASTM D1238 - ISO 1133) have been conducted on the material of the guard, and mechanical properties tests for Shore Hardness A and D (ASTM 2240 - ISO 868), tensile strength and elongation at break and the tensile modulus (ASTM 638 – ISO 527-2) of the material have also been tested.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
Den Tek Oral Care, Inc. Ms. Linda Giles Regulatory & Compliance Specialist 397 Excellence Way Maryville, Tennessee 37801
Re: K151149
Trade/Device Name: Ready-Fit Disposable Dental Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: August 18, 2015 Received: August 21, 2015
Dear Ms. Giles:
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.
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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Tina
Kiang -S
for Erin I. Keith, M.S. 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 Statement Section 4:
510(k) Number (if known): K151149
Device Name: Ready-Fit Disposable Dental Guard
Indications for Use:
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Prescription Use (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use X (Per 21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Traditional 510(k) SUMMARY - K151149 Section 5.
DenTek Oral Care Inc.'s
Ready-Fit Disposable Dental Guard
510(k) Owner's Name, Address, Phone and Fax Number
DenTek Oral Care, Inc. 307 Excellence W av Maryville, TN 37801 Phone: (865) 983-1300; Fax: (865) 983-2444
Contact Person and Date Prepared
Linda Giles - Regulatory and Compliance Specialist Date Prepared: 08/18/2015 revision 2
Subject Device
Device Trade Name: Readv-Fit Disposable Dental Guard Device Common or Usual Name: dental quard, nightguard Classification Name: Mouthguard, Over-the-Counter Product Code and Class: OBR; unclassified
Predicate Device
Trade Name: Grind No More Applicant: Placontrol Inc. Classification Name: Mouthguard, Over-the-Counter Product Code and Class: OBR; unclassified 510(k) Number: K082301
Device Description
Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.
Indications for Use/Intended Use
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
4
Sec. 5 - 510(k) Summarv K151149 (cont.)
Technological Characteristics
Ready-Fit Disposable Dental Guard is a posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band. Similarly the predicate device is a posterior-only occlusive mouthquard, consisting of two molar bite plates connected by a buccal retention band. The cylinders which make up the bite surfaces of the subject device allow the user to engage the quard in the natural anatomy of the teeth, and are substantially equivalent to the predicate device's bite pads, as they serve the same purpose - to cushion the teeth and keep them teeth apart during grinding. The technological/design differences between Ready-Fit Disposable Dental Guard and the predicate device, Grind No Mores, are minor and the subject device is, therefore, technologically similar to the predicate device. Both the subject device and the predicate device are indicated for over-the-counter use and are disposable after one night's use.
Substantial Equivalence
Substantial Equivalence Chart DenTek Ora I Care , Inc . ' s Re a d y-Fit Disposable Dental Guard -K151149
| | Ready-Fit Disposable
Dental Guard
(K151149) Subject Device | Grind No More
(K082301)
Predicate Device | Conclusion |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indications for
Use | Ready-Fit Disposable Dental
Guard is indicated for
protection for nighttime teeth
grinding or bruxism. It is
intended to reduce damage to
teeth by cushioning them and
keeping them apart during
grinding. | Grind No More is indicated for
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
teeth grinding. | Equivalent |
| User Population | OTC, age 18 and up | OTC, age 18 and up | Equivalent |
| DESIGN | | | |
| Technological
Characteristics | A posterior-occlusive
mouthguard, comprised of
two molar bite surfaces, each
with 3 cylinders (bite tubes),
connected by a buccal
retaining strap. | A posterior-occlusive
mouthguard, comprised of
two molar bite plates, each
with alignment grooves,
connected by a buccal
retaining strap. | Substantially
Equivalent1 |
| Materials | Comprised completely of
EMA material | Comprised completely of
EMA material | Equivalent |
| Fit | One Size Fits All, worn on
upper or lower teeth | One Size Fits All, worn on
upper or lower teeth | Equivalent |
5
| Dimensions
(l x w x h) | 3.8cm L x 3.9cm W x 1.9cm H | 4.5cm L x 3.5cm W x 1.7cm H | Substantially
Equivalent2 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------|
| Weight | 0.04 ounce | 0.06 ounce | Substantially
Equivalent2 |
| Sterilization | Device is not provided sterile. | Device is not provided sterile. | Equivalent |
| Method of
Disinfection or
Cleaning | The device is meant to be
discarded after one night's
use. No instructions for
cleaning are included. | The device is meant to be
discarded after one night's
use. No instructions for
cleaning are included. | Equivalent |
| Standards with
which Device
Complies | None specified for Product
Code OBR | None specified for Product
Code OBR | Equivalent |
-
- Design differences do not affect substantial equivalence as the technological characteristics of both devices serve the same purpose - to reduce damage to teeth by cushioning them and keeping them apart.
-
- The differences in the device dimensions and weight are very small and the devices have a similar overall shape, fit the mouth in a similar manner and have the same function to protect the teeth from the damage of night-time grinding.
Bench Test Results
DenTek conducted an in-home use test (IHUT) during the month of April 2015, to validate that the design of Ready-Fit Disposable Dental Guard meets the intended use and performance of the device. Physical properties testing for density (ASTM D792 -ISO 1183) and melt flow (ASTM D1238 - ISO 1133) have been conducted on the material of the guard, and mechanical properties tests for Shore Hardness A and D (ASTM 2240 - ISO 868), tensile strength and elongation at break and the tensile modulus (ASTM 638 – ISO 527-2) of the material have also been tested.
Conclusion
Ready-Fit Disposable Dental Guard is substantially equivalent to the identified predicate device, Grind No More. Ready-Fit Disposable Dental Guard has the same intended uses, similar indications for use, technological characteristics, principles of operation, and has the same material composition as the predicate device.