armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.

AI/ML Overview

The provided FDA 510(k) summary for the Mavrik Dental Systems Ltd.'s armor LC™ device does not include the detailed acceptance criteria or the study data proving the device meets those criteria for the specific performance tests listed. The document generally states that the device "functioned as intended and met the pre-defined acceptance criteria" for each test.

Therefore, many of the requested details cannot be extracted from this document. However, based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test	Acceptance Criteria (Not explicitly stated for each test)	Reported Device Performance (General Statement)
Appearance and handling	N/A	Functioned as intended, met pre-defined criteria
Removal in one piece	N/A	Functioned as intended, met pre-defined criteria
Curing temperature	N/A	Functioned as intended, met pre-defined criteria
Sensitivity to ambient light	N/A	Functioned as intended, met pre-defined criteria
Viscosity	N/A	Functioned as intended, met pre-defined criteria
Depth of cure	N/A	Functioned as intended, met pre-defined criteria
Flexural strength	N/A	Functioned as intended, met pre-defined criteria
Biocompatibility (Cytotoxicity)	Met ISO 10993-5 (Uncured: 5 min exposure; Cured: 48 hr elution)	Found to be biocompatible
Biocompatibility (Irritation & Sensitization)	Met ISO 10993-10 (Uncured: 4 hr; Cured: 7 days)	Found to be biocompatible
Biocompatibility (Dentistry specific)	Met ISO 7405	Found to be biocompatible

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the performance tests.
Data Provenance: The studies were "Mavrik Dental Systems conducted several performance tests," implying they were conducted by the manufacturer. The document does not specify the country of origin, but the applicant's address is Israel. The tests are "Non-Clinical Performance Data" and "Bench Performance Testing," indicating they are likely laboratory-based studies rather than retrospective or prospective clinical studies involving human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a non-clinical bench testing and biocompatibility study, not a study requiring expert readers for ground truth establishment.

4. Adjudication method for the test set:

Not applicable as this is a non-clinical bench testing and biocompatibility study.

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 is not an AI-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an AI algorithm. The performance described is for the device itself (a light-cured resin dam).

7. The type of ground truth used:

For Bench Performance Testing: The "ground truth" would be the pre-defined acceptance criteria based on engineering specifications and comparison to predicate devices, but these specific criteria are not detailed in the document.
For Biocompatibility: The "ground truth" or standard for acceptance was compliance with specific international consensus standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405).

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI that would require a training set.

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

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

Summary

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May 3, 2019

Mavrik Dental Systems Ltd % Sherwyn Davidson QA/RA Director 25 Ha Haroshet Street 6th Fl., Raanana, 4365613 Israel

Re: K182118

Trade/Device Name: armor LCTM Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam And Accessories Regulatory Class: Class I Product Code: EIE Dated: April 3, 2019 Received: April 3, 2019

Dear Sheila Hemeon-Heyer:

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 aware 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.

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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 (QS) 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 mediation-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,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182118

Device Name armor LCTM

Indications for Use (Describe)

armor LCTM is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Mavrik Dental Systems Ltd.'s armor LCTM Device

Applicant's name:	Mavrik Dental Systems Ltd.			armor LCTM device(K182118)	Primary PredicateTriumph Resin Dam(K151945)	Reference Predicate:OpalDam(K971284)
Contact Person:	Sherwyn DavidsonQA/RA Director25 Ha Haroshet Street 6th Fl.,Raanana, 4365613, IsraelTel. +972-9-9740100Fax +972-9-9740101Sherwyn.davidson@mavrikdental.com		Device Class	Class I	Class I	Class I
Date Prepared:	April 30, 2019			ClassificationPanel	Dental	Dental	Dental
Name of Device:	armor LC TM			Product Code	EIE	EIE	EIG
Common or Usual Name:	Rubber dam and accessories		RegulationDescription	Rubber dam andaccessories	Rubber dam andaccessories	Dental hand instrument
Classification:	Product Code:	EIE	Regulationnumber	21 C.F.R. §872.6300	21 C.F.R. §872.6300	21 CFR 872.4565
	Regulation No:	21 C.F.R. §872.6300	Indications forUse	armor LC™ is a resin-based, light-curedprotective barrier materialrecommended to protectdental materials ortissues.	Triumph Resin Dam is aresin-based, light-curedprotective barrier materialrecommended to protectdental materials ortissues.	OpalDam resin is used toprotect soft tissueadjacent to the teethduring in-office bleaching.OpalDam is used withOpalescence Xtra (35%hydrogen peroxide)"power" bleaching agent.
	Class:	Class: I	Device Type	Light cured rubber dam	Light cured rubber dam	Light-cured rubber dam
	Classification Panel:	Dental	Composition	Urethane dimethacrylate,cetyl alcohol, light curingchemistry, flavor	Urethane acrylates, light-curing chemistry, silica,titanium dioxide	Diurethanedimethacrylate, cetylalcohol, light-curingchemistry, titaniumdioxide
Predicate Device:	Primary predicate: Triumph Resin Dam (K151945)Reference predicate: OpalDam (K971284)		Light CureCapabilities:	Yes	Yes	Yes
Light CureSetting Time:	<20 seconds	<20 seconds	<20 seconds
Flexibility toallow removalin one piece,when appliedaround a dentaltooth model	Yes	Yes	Yes
Biocompatible	Yes	Yes	Yes
Sterilization	Non-sterileNot intended to besterilized by end-user	Non-sterileNot intended to besterilized by end-user	Non-sterileNot intended to besterilized by end-user

Intended Use / Indications for Use

armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

Device Description

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Substantial Equivalence

The following table provides a comparison of the armor LC™ to the primary and reference predicate devices:

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Substantial Equivalence Discussion:

armor LC™ device has the same indications for use statement as the primary predicate device, Triumph Resin Dam, which was found to be substantially equivalent to the reference predicate device, OpalDam. The only technological difference between armor LC™ and the two named predicate devices is minor differences in their chemistry. All three products include acrylates as the base monomer, light curing chemistry for polymerization, and fillers to achieve the desired mechanical properties. While the exact chemical compositions of the predicate devices is unknown, the main difference appears to be that armor LC™ does not include titanium dioxide, which is added to some resins as a filler or pigment. armor LC™ also includes a rum flavor ingredient, which has no impact on the device properties. Side-by-side bench testing comparing armor LC™ to the predicate devices demonstrated substantial equivalence of the handling and technical characteristics.

Non-Clinical Performance Data

Bench Performance Testing

Mavrik Dental Systems conducted several performance tests to demonstrate that armor LCTM device complies with performance standards and that it functions as intended. Bench performance tests included:

. Appearance and handling
Removal in one piece ●
Curing temperature ●
Sensitivity to ambient light ●
Viscosity
Depth of cure
. Flexural strength

In all instances, armor LC™ device functioned as intended and met the pre-defined acceptance criteria.

Biocompatibility

armor LC™ is a surface contact device in limited contact with mucosal membranes. The testing required by FDA and ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing Within A Risk Management Process" are cytotoxicity, irritation, and skin sensitization. Testing was conducted on the final, finished armor LCTM device in accordance with the international recognized consensus standards listed below and was found to be biocompatible.

ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices .
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices -● Part 5: Tests for in vitro cytotoxicity
- o Uncured material - Direct contact method with exposure of 5 minutes. The material must be cured within 1 minute of application in clinical use.

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o Cured material ISO elution method with exposure of 48 hours
· ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- Uncured material 4 hours
- o Cured material 7 days
· ISO 7405 Second edition 2008-12-15, Dentistry Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]

Conclusion

The armor LCTM device is substantially equivalent to the predicate device in design, composition, principle of operation, biocompatibility, performance, and intended use.

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.