Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.

Device Description

Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.

Here's a breakdown of the requested information based on the provided text:

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

For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.

Property / Acceptance Criteria (as per predicate equivalence)	Reported Device Performance (Triumph Resin Dam)
Intended Use	Resin barrier used to isolate and protect dental materials and tissues. (Matches Opal Dam)
Composition	Urethane acrylates, silica, titanium dioxide, light curing chemistry. (Different from Opal Dam's Di-urethane di-methacrylate, filler. However, the document states "Formula differences...exist, however Triumph Resin Dam was found to be biocompatible...and has similar technological and performance characteristics.")
Light Cure Capability	Yes (Matches Opal Dam)
Light Cure Setting Time	Yes, < 20 seconds (Matches Opal Dam)
Biocompatibility (Cytotoxicity)	Grade "0" - "Reactivity. None" (Found to be biocompatible per ISO 10993)
Biocompatibility (Human Skin Irritation)	"No reaction" (Found to be biocompatible per ISO 10993)
Biocompatibility (Skin Sensitization)	Grade "0" - "No visible change" (Found to be biocompatible per ISO 10993)
Flexibility/Removability	Formulated to be flexible enough (not too brittle), allowing removal in one piece. (Similar to Opal Dam, despite hardness differences. Also similar to BriteSmile in this aspect). The document notes "This difference does not effect the ability of either material to perform as a resin barrier."
Mechanical Properties (Hardness)	Hardness was compared to BriteSmile (K010935), indicating Triumph is less hard than Opal Dam but "similiar" in properties to BriteSmile, which is also formulated for one-piece removal.
Mechanical Properties (Depth of Cure)	Greater depth of cure than Opal Dam and BriteSmile. (Although different, this is not stated as a negative and is considered acceptable for substantial equivalence).

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

This document does not describe a "test set" in the context of diagnostic performance typically associated with AI. The evaluations are for biocompatibility and physical/mechanical properties.

Biocompatibility Tests (Cytotoxicity, Human Skin Irritation, Skin Sensitization): Standardized tests (ISO 10993) were performed. The sample sizes for these specific tests are not detailed in this summary but would be defined by the ISO standard. The provenance of the data is not specified beyond being generated for this submission.
Physical/Mechanical Properties (Hardness, Depth of Cure, Setting Time): These are laboratory measurements. Sample sizes are not specified for each measurement, but they would be conducted on samples of the device material. Data provenance is not further detailed.

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 is not applicable to the evaluation of this device. The "ground truth" for biocompatibility is established by the standardized methods of ISO 10993, and for physical properties by laboratory testing procedures. There are no "experts" establishing conventional ground truth in the sense of clinical diagnoses.

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

Not applicable. There is no adjudication method described as this is not a diagnostic study involving human interpretation.

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

Not applicable. This device is a physical dental material, not an AI or diagnostic tool, and therefore no MRMC study was performed.

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

Not applicable. This device is a physical dental material, not an algorithm.

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

The "ground truth" for this device's evaluation relies on:

Standardized Biological Evaluation Protocols: For biocompatibility, ISO 10993 serves as the "ground truth" framework.
Physical/Chemical Measurement Standards: For properties like setting time, depth of cure, and hardness, these are determined through established laboratory measurement techniques, often against internal specifications or industry standards.
Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to a legally marketed predicate, meaning it performs similarly and raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical dental material, not an AI model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2016

DENALI CORPORATION Dr. Jan G. Stannard President 134 Old Washington Street Hanover, Massachusetts, 02339

Re: K151945

Trade/Device Name: Triumph Resin Dam Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber dam and accessories Regulatory Class: I Product Code: EIE Dated: January 14, 2016 Received: January 19, 2016

Dear Dr. Stannard:

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 -

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

510 (k) Number K151945 (if known)

Device Name

Triumph Resin Dam

Indications for Use:

Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

For Use only by a Licensed Dentist. Rx Use Only.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

区

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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510 (k) Summary

Image /page/3/Picture/2 description: The image shows the logo and contact information for Denali Corporation. The logo features a stylized graphic with a blue sphere and a curved line. The text includes the company name, address (134 Old Washington Street, Hanover, MA 02339 USA), phone number (781.826.9190), fax number (781.826.4465), and website (denalicorporation.com).

February 17, 2016

ADDRESS	DENALI CORPORATION134 Old Washington Street / Hanover, MA 02339-1629
OWNER/CONTACT PERSON	Dr. Jan G. StannardTEL: 781-826-9190 / FAX: 781-826-4465 / j.stannard@denalicorporation.com
TRADE NAME	Triumph Resin Dam
COMMON NAME	Resin Dam
CLASSIFICATION NAME	RUBBER DAM AND ACCESSORIES, CLASS I (21 CFR 872.6300,Product EIE
REGISTRATION	3006367836
PRIMARY PREDICATE DEVICE	OpalDam (K971284) Ultradent Products, Inc.
REFERENCE PREDICATE DEVICE	BriteSmile (K010935), BriteSmile Inc,
EQUIVALENCE	The primary predicate product has been found to be substantially equivalent under the510(k) premarket notification process as Class I Dental Devices underCFR 872.6300, RUBBER DAM AND ACCESSORIES.
DEVICE DESCRIPTION	Triumph Resin Dam is a light-cured, resin dam material recommended to block out orprotect dental materials or tissues. Triumph contains polymerizable monomers that whenlight-cured form a protective barrier. When set the resin has a low strength allowingits removal from the protected surfaces.
INTENDED USE	Triumph Resin Dam is a resin-based, light-cured protective barrier material recom-mended to protect dental materials or tissues. For Use only by a Licensed Dentist.Rx Use Only.
TECHNOLOGICALCHARACTERISTICSSUMMARY and Intended Use	Triumph Resin Dam has the same technological characteristics as the primary predicatedevice OpalDam including: design, similar composition, biocompatibility, performance,principle of operation, ageing, intended use, physical characteristics, setting, depth of cureand mechanical properties; compressive strength and hardness,as summarized in the table below. The inclusion of protection ofdental materials does not alter its intended use nor, does it alterits function. Materials as well as tissue may be affected bybleaching actions.

COMPARISON OF TRIUMPH RESIN DAM TO PRIMARY PREDICATE PRODUCT
PROPERTY	Triumph Resin Dam	Opal Dam
Intended Use	Resin barrier used to isolate and protect dentalmaterials and tissues.	Resin barrier used to isolate andprotect dental materials and tissue
Composition	Urethane acrylates, silica, titanium dioxide,light curing chemistry.	Di-urethane di-methacrylate, filler(possibly mica), light curing chemistry.
Light Cure Capability	Yes	Yes
Light Cure Setting Time	Yes, < 20 seconds	Yes, < 20 seconds

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T 781.826.9190 F 781.826.4465 denalicorporation.com

510 (k) Summary

Triumph Resin Dam was evaluated for biocompatibility as per ISO 10993 "Biological Eval-BIOCOMPATIBILITY uation of Medical Devices". Tests conducted were cytotoxicity, human skin irritation and skin sensitization. Triumph Resin Dam was found to be biocompatible. For ISO10993 Cytotoxicity Testing, Triumph Resin Dam had a Grade "0". "Reactivity. None". As per ISO 10993 "Tests for Irritation and Skin Sensitization", with respect to irritation Triumph was graded as "No reaction", with respect to Skin sensitization, Triumph was rated as Grade "0" - "No visible change". These results are summarized in the Table of Results -Biological Evaluation of Triumph Resin Dam per ISO 10993.

Results - Biological Evaluation of Triumph Resin Dam - per ISO 10993
Test Method	Description	Result
Cytotoxicity	None	0
Human Skin Irritation Test	No Reaction	0
Skin Sensitization Test	No Visible Change	0

SUBSTANTIAL EQUIVALENCE DETERMINATION AND SUMMARY

Triumph Resin Dam is substantially equivalent in design, similar composition, biocompatibility, performance, ageing, and intended use, to Opal Dam (K971284). This assessment is based upon a comparison of the physical and mechanical characteristics, depth of cure, and setting time. Formula dif-ferences between Triumph and the predicate product exist, however Triumph Resin Dam was found to be biocompatible as per ISO 10993 and has similiar technological and performance characteristics as the predicate product OpalDam. The differences that exist between Opal

Dam and Triumph are that Opal Dam is harder and has less depth of cure than Triumph. Both products however are formulated to be flexible enough (not too brittle), allowing removal in one piece. This difference does not effect the ability of either material to perform as a resin barrier. Although the composition of Triumph may not be the same as OpalDam, the properties of these two materials were found to be similiar. Triumph was with respect to hardness found to the reference device, BriteSmile (K010935). In this comparison BriteSmile also like Triumph was formulated to allow removal in one piece. Again Triumph has a greater depth of cure than BriteSmile.

CONCLUSIONS

Triumph Resin Dam has been found to be substantially equivalent in design, composition, principle of operation, ageing, biocompatibility, performance, properties, and intended use, to OpalDam.

Regulation Number and Section

§ 872.6300 Rubber dam and accessories.

(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.