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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the DenTek Ready-Fit Disposable Dental Guard. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel medical devices, especially those involving AI or complex performance metrics.

Based on the document, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative, measurable format with specific thresholds that the device performance is then measured against. Instead, the "Substantial Equivalence Chart" acts as a comparison against a predicate device across various attributes. The 'Conclusion' column in this chart implicitly serves as a form of acceptance, indicating whether the subject device is considered "Equivalent" or "Substantially Equivalent" to the predicate.

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Subject Device K151149)
Indications for Use: Equivalent to predicate's protection for nighttime teeth grinding/bruxism, reducing damage to teeth by cushioning and keeping them apart.	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. (Equivalent to predicate)
User Population: OTC, age 18 and up	OTC, age 18 and up (Equivalent to predicate)
Technological Characteristics: Posterior-occlusive mouthguard with two molar bite surfaces connected by a buccal retaining strap, serving the same purpose as the predicate's bite plates.	A posterior-occlusive mouthguard, comprised of two molar bite surfaces, each with 3 cylinders (bite tubes), connected by a buccal retaining strap. (Substantially Equivalent to predicate; design differences do not affect substantial equivalence as they serve the same purpose)
Materials: Comprised completely of EMA material	Comprised completely of EMA material (Equivalent to predicate)
Fit: One Size Fits All, worn on upper or lower teeth	One Size Fits All, worn on upper or lower teeth (Equivalent to predicate)
Dimensions (l x w x h): Similar to predicate (4.5cm L x 3.5cm W x 1.7cm H)	3.8cm L x 3.9cm W x 1.9cm H (Substantially Equivalent to predicate; differences are very small and have similar overall shape/function)
Weight: Similar to predicate (0.06 ounce)	0.04 ounce (Substantially Equivalent to predicate; differences are very small and have similar overall shape/function)
Sterilization: Not provided sterile	Device is not provided sterile. (Equivalent to predicate)
Method of Disinfection or Cleaning: Discarded after one night's use, no cleaning instructions	The device is meant to be discarded after one night's use. No instructions for cleaning are included. (Equivalent to predicate)
Standards with which Device Complies: None specified for Product Code OBR	None specified for Product Code OBR (Equivalent to predicate)
Bench Test Results: Material properties (density, melt flow, Shore Hardness A and D, tensile strength, elongation at break, tensile modulus) consistent with intended use and performance.	DenTek conducted an in-home use test (IHUT) to validate that the design meets intended use and performance. Physical properties testing (ASTM D792, ISO 1183, ASTM D1238, ISO 1133) and mechanical properties tests (ASTM 2240, ISO 868, ASTM 638, ISO 527-2) were conducted on the material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions an "in-home use test (IHUT)" but does not specify the sample size for this test.
Data Provenance: The IHUT was conducted in April 2015. No country of origin is specified, but given the company's address is in Maryville, Tennessee, USA, it's highly likely the test was conducted in the USA. It appears to be a prospective test, as it was conducted specifically to validate the device's design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the device is a dental guard, not an AI or diagnostic imaging device that typically requires expert-established ground truth for its performance evaluation. The "in-home use test" would likely involve user feedback on fit, comfort, and perceived effectiveness in protecting against grinding, rather than expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The device's evaluation is not based on expert interpretation or medical imaging, so adjudication methods commonly used in those contexts are not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical dental guard, not an AI or diagnostic assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical dental guard, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical properties and mechanical properties tests, the "ground truth" would be established by the standardized testing procedures (e.g., ASTM D792 for density, ASTM D1238 for melt flow, etc.) and their inherent methodologies for measuring material characteristics.

For the "in-home use test (IHUT)," the "ground truth" or validation would likely be based on user feedback and self-reported outcomes regarding the device's fit, comfort, and efficacy in protecting against teeth grinding, aligning with the stated "intended use and performance."

8. The sample size for the training set

This is not applicable. This document describes a physical medical device (dental guard), not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. No training set is mentioned or implied for this physical device.

Summary

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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.

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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 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

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Indications for Use Statement Section 4:

510(k) Number (if known): K151149

Device Name: Ready-Fit Disposable Dental Guard

Indications for Use:

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)

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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

Indications for Use/Intended Use

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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 DisposableDental Guard(K151149) Subject Device	Grind No More(K082301)Predicate Device	Conclusion
Indications forUse	Ready-Fit Disposable DentalGuard is indicated forprotection for nighttime teethgrinding or bruxism. It isintended to reduce damage toteeth by cushioning them andkeeping them apart duringgrinding.	Grind No More is indicated forprotection against bruxism ornighttime teeth grinding. It isintended to reduce damage tothe teeth and to prevent thenoise associated with bruxing orteeth grinding.	Equivalent
User Population	OTC, age 18 and up	OTC, age 18 and up	Equivalent
DESIGN
TechnologicalCharacteristics	A posterior-occlusivemouthguard, comprised oftwo molar bite surfaces, eachwith 3 cylinders (bite tubes),connected by a buccalretaining strap.	A posterior-occlusivemouthguard, comprised oftwo molar bite plates, eachwith alignment grooves,connected by a buccalretaining strap.	SubstantiallyEquivalent1
Materials	Comprised completely ofEMA material	Comprised completely ofEMA material	Equivalent
Fit	One Size Fits All, worn onupper or lower teeth	One Size Fits All, worn onupper or lower teeth	Equivalent

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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	SubstantiallyEquivalent2
Weight	0.04 ounce	0.06 ounce	SubstantiallyEquivalent2
Sterilization	Device is not provided sterile.	Device is not provided sterile.	Equivalent
Method ofDisinfection orCleaning	The device is meant to bediscarded after one night'suse. No instructions forcleaning are included.	The device is meant to bediscarded after one night'suse. No instructions forcleaning are included.	Equivalent
Standards withwhich DeviceComplies	None specified for ProductCode OBR	None specified for ProductCode OBR	Equivalent

1. 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.
1. 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.

Regulation Number and Section

N/A