Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The composite is radiopaque, with total inorganic load of 72% to 80% in weight (52% to 60% in volume), average particles between 0.8 and 0.9 microns. It does not contain Bis-GMA nor Bis-EMA in its formula, following the present trend of products not made with Bisphenol A (BPA).
The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device.

AI/ML Overview

The provided text describes the regulatory filing for the Dentscare Vittra APS Unique dental composite, focusing on its substantial equivalence to a predicate device (Llis, Vittra APS). The document outlines performance criteria for both devices through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (from ISO 4049 unless specified)	Vittra APS Unique Performance	Llis Performance	Vittra APS Performance
Sensitivity to ambient lighting	Physical homogeneity: No difference in physical homogeneity when compared to a non-exposed sample after visual inspection by three normal-vision observers.	All samples physically homogeneous, meets ISO 4049.	All samples physically homogeneous, meets ISO 4049.	All samples physically homogeneous, meets ISO 4049.
Depth of Cure	> 1.5 mm	4.91 mm	2.44 mm	2.43 mm
Colour tone stability after radiation and water absorption	No more than a small change in color as visually inspected by three normal-vision observers. Comparison made at 200-300 mm distance for max 2 seconds, in a D65 light chamber, on a white background (90% reflectance) surrounded by a grey background (30 ± 5% reflectance).	Observers did not attest any difference of color. Meets ISO 4049.	Observers did not attest any difference of color. Meets ISO 4049.	Observers did not attest any difference of color. Meets ISO 4049.
Radiopacity	> 1.0 mm (when compared to aluminum scale)	2.23 mm	1.98 mm	2.31 mm
Flexural Strength	≥ 80 MPa	137.8 MPa	138.8 MPa	142.6 MPa
Water Sorption	Maximum of 40 µg/mm³	7.93 µg/mm³	16.32 µg/mm³	15.55 µg/mm³
Water Solubility	Maximum of 7.5 µg/mm³	1.59 µg/mm³	4.78 µg/mm³	4.06 µg/mm³
Accelerated Stability Studies	Confirm 3-year shelf-life at 30°C.	3-year shelf-life confirmed.	(Not explicitly stated for predicate in table, but implied by substantial equivalence)	(Not explicitly stated for predicate in table, but implied by substantial equivalence)
Long-term Stability Study	Verify physical and chemical characteristics during expected shelf life.	Test not yet completed in full. Commercialized based on accelerated stability.	(Not applicable for predicate comparison in this context)	(Not applicable for predicate comparison in this context)

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

The document does not explicitly state the specific sample sizes used for each test (e.g., number of specimens for depth of cure, flexural strength). It mentions:

For Sensitivity to ambient lighting and Color tone stability, "samples in triplicate" were read, and "All comparisons were carried out by observers with normal eyesight."
For Radiopacity, "The average results obtained..." implies multiple measurements.
For Accelerated Stability Studies, the test period was "274 days."

Data Provenance: The tests were "pre-clinical tests" performed by Dentscare Ltda, a Brazilian company. The data is retrospective for the purpose of this 510(k) submission, as it reports completed test results. The country of origin of the data is Brazil, where Dentscare Ltda is located.

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

For Sensitivity to ambient lighting and Colour tone stability, "three observers with normal vision" were used for visual inspection. No further specific qualifications (e.g., "radiologist with 10 years of experience") are provided beyond "normal vision."

4. Adjudication Method for the Test Set

For visual comparisons (Sensitivity to ambient lighting, Colour tone stability), the method appears to be a consensus or majority opinion among the three observers, as it states, "The observers did not attest any difference of color." There is no explicit "2+1" or "3+1" adjudication mentioned, but simply that the observers collectively confirmed no difference.
For quantitative tests (Depth of Cure, Radiopacity, Flexural Strength, Water Sorption/Solubility), the ground truth is established by objective laboratory measurements against the ISO 4049 standard, not expert adjudication in the same sense as image interpretation.

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 submission is for a dental composite material, not an AI or imaging diagnostic device that would typically involve human readers.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on International Standards specifications, primarily ISO 4049. These standards define measurable physical and chemical properties (e.g., depth of cure, flexural strength, radiopacity) and objective criteria for visual assessments (e.g., requirements for observers' vision, test conditions for color stability).

8. The Sample Size for the Training Set

This information is not applicable as this is a physical dental composite material, not an AI model that requires a training set. The "training" for the device would be its development process and formulation, not a data-based training set.

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

This information is not applicable for the same reason as above. The "ground truth" during the development (analogous to "training") of such a material would be its chemical composition, manufacturing process, and adherence to design specifications to meet the desired physical properties.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 14, 2021

Dentscare Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065

Re: K210231/001

Trade/Device Name: Vittra APS Unique Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 20, 2021 Received: July 21, 2021

Dear Rodrigo Abreu:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices 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) K210231

Device Name Vittra APS Unique

Indications for Use (Describe)

The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth:

Direct restorations in anterior and posterior teeth (Classes I, II, III, IV, V and VI).

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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Image /page/3/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

510(k) SUMMARY-K210231

A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751 Manufacture Registration Number: 3007210751
B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL

C) Phone and Fax Numbers

Phone: +55 (47) 34416131

D) Contact Person:

Roberta Uyara

Tel.: +55 (47) 99160-4500

E) Preparation Date: October 5, 2021
F) Classification Name: Tooth shade resin material.

Common / Usual Name: Tooth shade resin material.

Proprietary Name: Vittra APS Unique

Product Code: EBF

Class: Class II

Regulation: 21 CFR 872.3690

G) Product Description

The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device.

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Image /page/4/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with wave-like lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

H) Substantial Equivalence:

The Vittra APS Unique is equivalent with the following product:

Equivalence	510(k) Number	Model	Company
Predicate	K191306	Llis, Vittra APS	Dentscare Ltda

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Image /page/5/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, accompanied by the text 'DentsCare' in a sans-serif font. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

I) Intentions for Use:

Indications for Use Comparison
Vittra APS Unique	Llis, Vittra APS
The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth:	The Llis and VITTRA APS composites are suitable for use in:
- Direct restorations in anterior and posterior teeth(Classes I, II, III, IV, V and VI).	- Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);- Core build-ups;- Teeth splinting;- Indirect restorations such as inlays, onlays and veneers;- Direct veneers with composites;- Restoration of deciduous teeth;- Diastema closing or reduction;- Modification of teeth's shape (e.g.: conoid teeth);- Cementation of tooth fragments;- Porcelain/composite repairs.

Discussion:

All resin composites can be used for both permanent and deciduous teeth. Furthernore, indications for the new device are within those of the predicate.

J) Technological Characteristics Comparison:

The predicate device used to establish substantial equivalence for the Vittra APS Unique device is outlined below. This section of this submission will provide a comparison of decinical specifications of the Vittra APS Unique to the predicate device stratified by functional modality.

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Image /page/6/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with wave-like lines inside it, and the name "DentsCare" written below. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.

Device Manufacturer andCommon Name	Vittra APS UniqueDentscare	Llis, Vittra APSDentscare
510k #	K210231	K191306
Classification	Class II	Class II
Regulation #	21 CFR 872.3690	21 CFR 872.3690
Product Code	EBF	EBF
Classification Name	Tooth shade resin material	Tooth shade resin material
Patient Population	All the groups	All the groups
Prescription Use	RX only	RX only
Environment	Dental prosthetics and authorized laboratoriesand clinics.Vittra APS Unique must be stored intemperatures between 5° to 30°C	Dental prosthetics and authorized laboratories andclinics.Llis, Vittra APS must be stored in temperatures between5° to 30°C
Applicable Standards	ISO 4049 ; ISO 10993-1	ISO 4049 ; ISO 10993-1
Device Sterilization	Not Applicable	Not Applicable
Primary Package Container:	Syringe and capsule	Syringe and capsule
Shelf life	3 years	3 years
Use the same materials orsubstances in contact with thesame human tissuesor body fluids?	YES	YES
Is the product in compliance toEN ISO 10993?	YES	YES
Tissues	Enamel and Dentin	Enamel and Dentin
Reusable	NO	NO
Duration	Permanent	Permanent
Part of body	Oral, teeth	Oral, teeth
Is it used for the same clinicalcondition?	yes	yes
Is it used at the same site in thebody?	yes	yes
Is it used in a similarpopulation?	yes	yes
Is it used for the same intendedpurpose?	yes	yes
Is not foreseen to deliversignificantly differentperformances?	no	no
Is it similar conditions of use?	yes	yes
Is it similar specifications andproperties	yes	yes
Is it similar principles ofoperation?	yes	yes

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Image /page/7/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with three horizontal lines inside the curve of the D, suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, with the "D" in a larger size and a slightly different shade than the rest of the word.

CLINICAL STEP	Vittra APS Unique (Dentscare)	LLis, Vitra APS (Dentscare)
Two options: total dam isolationor relative isolation	YES	YES
Application according toadhesive technique	YES	YES
Size for increments	1.5 mm	1.5-2 mm
Light curing unit	Power: ≥ 450mW/cm2Wavelength: 400-500nm	Power: Llis ≥ 450mW/cm2, Vittra APS 700mW/ cm2Wavelength: 400-500nm
Require finishing and polishing	YES	YES

Specification	Vittra APS Unique	Llis	Vittra APS
Sensitivity to ambient light	physically homogeneous	physically homogeneous	physically homogeneous
Depth of cure	4.91 mm	2.44 mm	2.43 mm
Flexural strength	137.8 MPa	138.8 MPa	142.6 MPa
Water sorption and solubility	Sorption: 7.93 µg/mm³Solubility: 1.59 µg/mm³	Sorption: 16.32 µg/mm³Solubility: 4.78 µg/mm³	Sorption: 15.55 µg/mm³Solubility: 4.06 µg/mm³
Radio-opacity	2.23 mm	1.98 mm	2.31mm
Color stability	The observers did not attest any difference of color	The observers did not attest any difference of color	The observers did not attest any difference of color
Tensile Bond	Not requested by ISO 4049
Shear Bond Strength	Not requested by ISO 4049

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Image /page/8/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with wave-like lines inside, accompanied by the text "DentsCare" in a sans-serif font. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

Discussion:

The subject device is similar to the predicate device in that they are light activated, radio-opaque and restorative composite to be used for permanently cementing restorations. The subject device have substantially equivalent of indications for use, mode of use, technological properties and fulfil the EN ISO 4049:2019 minimum requirements. Despite the minor differences in formulation between the subject device and the predicate, they can be considered equivalent, since these differences does not affect the product's laboratorial and clinical performance and safety.

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Image /page/9/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines emanating from the left side of the "D", resembling sound waves or air currents. Below the symbol is the text "DentsCare" in a bold, sans-serif font, also in gray.

ITDA R NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL 47 - 3441-6131

K) Applicable Standards:

In order to reach substantially equivalent to the predicate device Vittra APS Unique was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.

ISO 4049 - Dentistry - Polymer-based restorative materials

ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (EN ISO 10993-1:2009)

Conclusion:

Based on compliance with the international standard and regulation mentioned above, the device Vittra APS Unique demonstrates equivalency to the predicate device.

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Image /page/10/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

L) Non-clinical Testing:

In order to study the performance of the product, pre-clinical tests were performed according to the table below, for details about test results please see attachments below.

Test	Specification	Results
Sensitivity toenvironmentlighting -ISO 4049	According to the ISO 4049standard, acceptance is relatedto the physical homogeneity ofthe sample, so the materialwas compared after the test tothe same material pressedbetween coverslips, butwithout exposure to ambientlight. Thus, there is nodifference between thesamples.	After to read samples in triplicate,it was found that all samples werepresented to be physicallyhomogeneous, thus Vittra APSUnique and the predicate devicemeet the specifications of the ISO4049 standard.
Depth ofCure - ISO4049	According to ISO 4049, thespecified for this material isthat its curing depth is: > 1.5mm.	The results showed that thesubject device and predicatedevice are according the entryrequirement related to the depth ofcure and the values specified inISO 4049.Vittra APS Unique: 4.91 mmLlis: 2.44 mmVittra APS: 2.43 mm
Colour tonestabilityafterradiationand waterabsorption -ISO 4049andISO7491	The acceptance must beperformed provided that thereis no more than a small changein colour, it must be proven asfollows:a) comparisons should bemade by visual inspection andanalysed by three observerswith normal vision, who do notidentify any differences in	All comparisons were carried outby observers with normal eyesight.They did not attest to any colordifference in the samples analysed.The results presented prove thatthe Vittra APS Unique, Llis andVittra APS resins are in accordancewith products entry requirementsas specified in the ISO4049standard.

	colour, this comparison mustbe carried at a distance of 200to 300 mm for a period of nomore than 2 seconds;b) perform the comparisoncited in a) in a light chamber atDay Light - D65 mode;c) perform the comparison inparagraph a), by placing thespecimen on a diffuse whitebackground of 90%approximate reflectance, and itshould have as a limiting sizethe size of the specimen, whichmust be surrounded by a greybackground with a diffusereflectance of 30 ± 5%.
Radiopacity -ISO 4049	According to ISO 4049, thematerial is consideredradiopaque if the specimen hasa value of > $1.0$ mm whencompared to the aluminumscale, therefore, the value of"X" obtained through theequation of the line, must be > $1$ .	The average results obtained forradiopacity of Vittra Unique APSFGM was $2.23$ , thus being higherthan that specified in ISO 4049.Vittra APS Unique: $2.23$ mmLlis: $1.98$ mmVittra APS: $2.31$ mm
FlexingResistance -ISO 4049	According to the ISO 4049standard the specification forflexural strength is ≥ $80$ MPa.	All results below are within thespecified limit, so the materialsfollow ISO 4049.Vittra APS Unique: $137.8$ MPaLlis: $138.8$ MPaVittra APS: $142.6$ MPa
Watersorption andsolubility.	Sorption: Maximum of $40$ μm/mm3.	The results show that Vittra APSUnique and the predicate deviceproducts meet the entry
- ISO 4049	Solubility: maximum of 7.5 μm/mm³.	requirement for sorption and watersolubility, in accordance with ISO4049.Sorption/Solubility (µg/mm³)Vittra APS Unique: 7.93 / 1.59Llis: 16.32 / 4.78Vittra APS: 15.55 / 4.06
AcceleratedStabilityStudies	Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage.	Considering the results observed atthe end of the 274 days test period,the shelf-life of 3 years in thestorage condition of 30 °C for theproduct can be confirmed.
Long-termStabilityStudy	Study designed to verify thephysical and chemicalcharacteristics of the productduring the expected shelf life.The results are used to confirmthe expiration date andstorage conditions.	Shelf-life test has not yet beencompleted, the product is beingcommercialized based on theresults of accelerated stabilityacquired during the prototype.

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Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the "D" to represent teeth. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray.

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Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines emanating from the left side of the "D", resembling airflow. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray.

DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131

Conclusion: Based on the performance test applied to this Vittra APS Unique and the predicate (Llis, Vittra APS) comparison, we conclude that the subject device is substantially equivalent with the predicates, since all products, meet the same recognized standard.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.