The DenTek Ultimate™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

Device Description

The DenTek Ultimate™ Dental Guard is a one-piece, posterior-occlusion dental guard consisting of two moldable bite-pads connected by a flexible band that rests behind the user's front teeth. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's maxillary pre-molars after the guard has been heated via submersion in boiled water. The DenTek Ultimate™ Dental Guard is supplied pre-loaded into a flexible molding tray that allows the user to accurately place and comfortably hold the heated device during the molding process. When in place, the guard maintains separation between upper and lower teeth, reducing noise and damage to the teeth associated with teeth grinding.

AI/ML Overview

This document describes the regulatory submission for the DenTek Ultimate™ Dental Guard (K180933). The review confirms substantial equivalence to a predicate device, the DenTek™ Custom Comfort Nightguard Version 2 (K091660), for the indication of protecting against bruxism or nighttime teeth grinding.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerically-defined thresholds. Instead, it describes performance characteristics that the device was tested against to demonstrate substantial equivalence to its predicate. The "reported device performance" is essentially that the device performed sufficiently in these tests to meet the subjective goals of the tests and support its intended use.

Here's a breakdown of the performance data reported (which served as evidence of meeting implied "acceptance criteria" for substantial equivalence):

Acceptance Criteria (Implied by Test Objective)	Reported Device Performance
Ability to take a distinct impression of the teeth when molded as directed.	"Impression test: Simulation study demonstrating the finished guard's ability to take a distinct impression of the teeth when molded as directed."
Ability to keep upper and lower teeth separated when the jaw is clenched.	"Separation test: Simulation study demonstrating the finished guard's ability to keep the teeth separated when the jaw is clenched."
Ability to stay in place after fitting.	"Stability test: Simulation study demonstrating the finished guard's ability to stay in place after fitting."
Durability equivalent to the predicate device to support a six-month usable life.	"Comparative wear test: Simulation study demonstrating the finished guard's durability is equivalent to that of the cited predicate device. (Note: This study was used to support the labeled six-month usable life of the DenTek Ultimate™ Dental Guard, which matches that of the predicate device.)"
Non-cytotoxic (no cell toxicity).	"In Vitro Cytotoxicity Assay (Elution method) in accordance with ISO 10993-5;" - Demonstrated not cytotoxic.
Not a contact skin sensitizer.	"Guinea Pig Maximization Test (Sensitization) in accordance with ISO 10093-10, Section 7.5 and Annex E;" - Demonstrated not contact skin sensitizers.
Not irritating to the buccal mucosa.	"Oral Mucosa Irritation Test in accordance with ISO 10993-10 Annex B.3." - Demonstrated not irritating to the buccal mucosa.

2. Sample Size Used for the Test Set and the Data Provenance

The document refers to "simulation studies" for the impression, separation, stability, and comparative wear tests. It does not explicitly state the sample size (e.g., number of guards tested, number of simulated applications) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that these were "simulation studies." For the biocompatibility tests, specific ISO standards are cited, which typically involve standardized methods and sample sizes for the biological material/animals used, but the specific number used in this particular study is not given.

Given the nature of the device (over-the-counter dental guard) and the type of submission (510(k) for substantial equivalence), in-depth clinical trials with large human test sets are often not required if technical and bench testing is sufficient to demonstrate similarity to a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the non-clinical performance tests. These were likely evaluated based on objective measurements or observations by trained technicians or engineers involved in the testing, adhering to predefined protocols for each simulation.

For the biocompatibility tests, the ground truth is established by the results of the standardized assays themselves, interpreted by qualified personnel in toxicology/biocompatibility, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

No adjudication method is described for the "test set" (which consists of bench tests and biocompatibility assays). The outcomes of these tests are direct results from the experimental setup, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The DenTek Ultimate™ Dental Guard is a physical medical device for protection against bruxism, not a diagnostic tool requiring human reader interpretation in the same way.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an algorithm or AI system. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

For the impression, separation, stability, and comparative wear tests, the "ground truth" would be the objective physical performance observed during the simulation studies. For instance, whether an impression was "distinct" would be based on visual criteria, whether teeth were "separated" would be a physical measurement, and "durability" would be assessed against expected wear characteristics.

For the biocompatibility tests, the ground truth is established by the biological response of cells (cytotoxicity) or animals (sensitization, irritation) as measured and interpreted according to the specific ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, there is no "training set" for this device.

Summary

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Medtech Products Inc. % Vincent Argiro Director Regulatory Affairs Prestige Brands Holdings 660 White Plains Road Tarrytown, New York 10591

Re: K180933

Trade/Device Name: DenTek Ultimate Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: August 8, 2018 Received: August 9, 2018

Dear Vincent Argiro:

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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 17, 2018

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S3

For 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

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Indications for Use

510(k) Number (if known)

Device Name DenTek Ultimate Dental Guard

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

DenTek Ultimate™ Dental Guard

K # 180933

1. Submitter

Name & Address:	Medtech Products Inc.660 White Plains RoadTarrytown, NY, 10591
Contact:	Vincent Argiro, RAC
Title:Phone number:	Director, Regulatory Affairs(914) 524-8721
Email:	vargiro@prestigebrands.com

1. Date Prepared September 14, 2018

3. Device Identification

Trade/Proprietary Name:	DenTek Ultimate™ Dental Guard
Common/Usual Name:	Over-the-Counter Dental Guard
Classification Name:	Mouthguard, Over-the Counter
Regulation Number:	N/A
Product Code:	OBR
Device Class:	Unclassified
Classification Panel:	Division of Anesthesiology, General Surgery, Infection Control andDental Devices

4. Legally Marketed Predicate Device(s)

Primary Predicate: DenTek™ Custom Comfort Nightguard Version 2 (K091660), Product
Code OBR

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Reference Device:

5. Device Description

6. Intended Use

The DenTek Ultimate™ Dental Guard is an over-the-counter (OTC) device that is intended to be used by lay people to reduce the damage caused by nighttime teeth grinding.

The DenTek Ultimate™ Dental Guard bears the following indications for use statement:

The DenTek Ultimate ™ Dental Guard intended use statement is identical to that of the predicate devices.

7. Substantial Equivalence Discussion

The following table compares the DenTek Ultimate™ Dental Guard to the chosen predicate and reference devices with respect to intended use and technological characteristics. This comparison of the devices provides detailed information demonstrating the basis for the determination of substantial equivalence. Any minor differences are discussed in the narrative below the table.

	Proposed Device	Predicate Device	Reference Device	Differences
Trade Name /Device Name	DenTek Ultimate™Dental Guard	DenTek™ CustomComfort NightGuard Version 2	DenTek™ NewComfort-Fit®Dental Guard	N/A
510(k) Number	K180933	K091660	K123849	N/A
Date Cleared	90 days from dateof receipt by FDA	06/12/2009	01/10/2013	N/A
Original applicant	Medtech Products	DenTek Oral Care,	DenTek Oral Care,	N/A

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	Inc.	Inc.	Inc.
REGULATORY CLASSIFICATION
Regulatory Class	Unclassified	Unclassified	Unclassified	None
Name of GenericDevice Type	Mouthguard,Over-the-Counter	Mouthguard,Over-the-Counter	Mouthguard,Over-the-Counter	None
Regulation	N/A	N/A	N/A	None
Product Code	OBR	OBR	OBR	None
ApplicablePerformanceStandards orSpecial Controls	None specified byFDA for ProductCode OBR	None specified byFDA for ProductCode OBR	None specified byFDA for ProductCode OBR	None
DEVICE DESCRIPTION - SUBSTANTIAL EQUIVALENCE COMPARATORS
Intended Use	Keep upper andlower teethseparated duringsleep.	Keep upper andlower teethseparated duringsleep.	Keep upper andlower teethseparated duringsleep.	None
OTC or Rx	OTC	OTC	OTC	None
Indications for Use	For protectionagainst bruxism ornighttime teethgrinding. It isintended to reducedamage to theteeth and reducethe noiseassociated withbruxing orgrinding.	For protectionagainst bruxism ornighttime teethgrinding. It isintended to reducedamage to theteeth and toprevent the noiseassociated withbruxing orgrinding.	For protectionagainst bruxism ornighttime teethgrinding. It isintended to reducedamage to theteeth and reducethe noiseassociated withbruxing orgrinding.	None
Target Population	Adults 18 andolder	Adults 18 andolder	Adults 18 andolder	None
TechnologicalCharacteristics	Flexible, moldableguard used as abarrier betweenteeth.	Flexible, moldableguard used as abarrier betweenteeth.	Flexible, adjustableguard used as abarrier betweenteeth.	Same as predicate
DEVICE DESCRIPTION - DESIGN FEATURES
Contact Materials	Ethylene-vinylacetate copolymer	Ethylene-vinylacetate copolymer	Ethylene-vinylacetate copolymer	Minor (similar toboth cited devices)
Other Materials	None	Ethylene andmethyl acrylatecopolymer	None	Same as reference
Design /	Posterior	Full occlusion, boil-	Posterior	Minor (similar toboth cited devices)

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Presentation	occlusion, boil-and-fit dentalguard	and-fit dentalguard	occlusion, ready-to-wear dentalguard	both cited devices)
Method ofManufacture	Injection molding	Injection molding	Injection molding	None
Method of Cleaning	Toothpaste ormouthwash, brushfollowed by coolwater rinse.	Toothpaste ormouthwash, brushfollowed by coolwater rinse.	Toothpaste ormouthwash, brushor effervescentcleaningtablet/powderfollowed by coolwater rinse.	Same as predicate
Fit	One size fits all viatraditional heatand bite.	One size fits all viatraditional heatand bite.	One size fits all viaadjustable bitepad-position.	Same as predicate
Dimensions (L x W xH)	30.1 mm x 61.9mm x 12.01 mm	42 mm x 64.8 mmx 11.15 mm	40 mm – 48 mm x42 mm x 16 mm	Minor (similar toboth cited devices)
Weight	3.2 grams	7.8 grams	2.5 grams	Minor (similar toboth cited devices)
Fitting TrayIncluded	Yes	Yes	No	Same as predicate
Accessories	Storage case	Storage case	Storage case	None
Multiple Use Device	Yes	Yes	Yes	None
Sterile Device	No	No	No	None
Leaflet included	Yes	Yes	Yes	None
Use environment	Home	Home	Home	None
Anatomical site ofuse	Oral Cavity	Oral Cavity	Oral cavity	None

The table above identifies a few minor differences between the proposed device and the cited predicate and reference devices. While the contact material for all devices is an ethylene-vinyl acetate copolymer, the specific copolymer used in the proposed device has an ethylene-to-vinyl acetate ratio that falls between the ratios used in the predicate and reference devices. Also, the design of the proposed device blends the boil-and-fit molding method of the predicate with the posterior-occlusion format of the reference device. Finally, though not identical, the measurements of the proposed guard are similar to both cited devices (i.e., the bite radius and vertical profile dimensions are within 10% of the predicate device, but with a lesser depth due to the partialocclusion design, and the weight of the proposed product falls between the weights of the other two devices).

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In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent (SE) when it has the same intended use and technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any differences between the subject device and the cited predicate are minor and do not raise different questions of safety or effectiveness and this application establishes that the device is as safe and effective as the predicate. It is on this basis that DenTek Ultimate™ Dental Guard is SE to the cited predicate device.

8. Non-Clinical Performance Data

The following bench testing was conducted to confirm the performance of the DenTek Ultimate™ Dental Guard:

. Impression test. Simulation study demonstrating the finished guard's ability to take a distinct impression of the teeth when molded as directed.
. Separation test. Simulation study demonstrating the finished guard's ability to keep the teeth separated when the jaw is clenched.
. Stability test. Simulation study demonstrating the finished guard's ability to stay in place after fitting.
. Comparative wear test. Simulation study demonstrating the finished guard's durability is equivalent to that of the cited predicate device. (Note: This study was used to support the labeled six-month usable life of the DenTek Ultimate™ Dental Guard, which matches that of the predicate device.)

The non-clinical testing of DenTek Ultimate™ Dental Guard demonstrates the device's performance providing a distinct impression of the teeth, separation, security and expected use life and therefore supports the substantial equivalence to the cited predicate.

Additionally, the following tests for biocompatibility were conducted on both the DenTek Ultimate™ Dental Guard and the provided forming tray:

In Vitro Cytotoxicity Assay (Elution method) in accordance with ISO 10993-5; .
. Guinea Pig Maximization Test (Sensitization) in accordance with ISO 10093-10, Section 7.5 and Annex E;
. Oral Mucosa Irritation Test in accordance with ISO 10993-10 Annex B.3.

These studies demonstrated that DenTek Ultimate™ Dental Guard and the forming tray were not cytotoxic, were not contact skin sensitizers, and were not irritating to the buccal mucosa, which further supports the device's substantial equivalence to the predicate.

9. Clinical Performance Data

There are no differences in intended use and technological characteristics between the DenTek Ultimate Dental Guard and the predicate that necessitate conducting a clinical trial.

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10. Statement of Substantial Equivalence

As demonstrated in this application, the proposed device, the DenTek Ultimat™ Dental Guard, has the same intended use as the identified predicate device, DenTek™ Custom Comfort Nightguard Version 2 (K091660), and employs the same basic technological characteristics; any differences between the proposed device and the predicate are minor and do not constitute different technological characteristics. The relevant information on biocompatibility and the performance testing confirm the DenTek Ultimate™ Dental Guard fulfills its intended use as safely and effectively as the legally marketed predicate device. The DenTek Ultimate™ Dental Guard is therefore substantially equivalent to the cited predicate.

Regulation Number and Section

N/A