Vittra APS Unique

• K Number: K210231
• Device Name: Vittra APS Unique
• Manufacturer: Dentscare Ltda
• Date Cleared: 2021-10-14 ( 259 days)
• Product Code: EBF
• Regulation Number: 872.3690

Intended Use

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).

Device Description

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.

Predicate Devices

K191306

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental composite material and its physical properties and performance characteristics. There is no mention of software, algorithms, data processing, or any other elements typically associated with AI/ML. The "APS" system refers to a chemical photoinitiation system, not an AI/ML system.

Therapeutic

No
The device is a light-curing composite material used for restorations and does not actively treat a disease or condition.

Diagnostic

No.
The device is a light-curing composite material used for direct restorations in teeth, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Light-curing composite," which is a physical material used in dental restorations, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for direct restorations in teeth. This is a therapeutic and restorative application, not a diagnostic one.
• Device Description: The description details a light-curing composite material used for filling cavities. This is a material used in the body (or on the body, in the case of teeth) for treatment, not for testing samples from the body to diagnose a condition.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
• Performance Studies: The performance studies focus on the physical and chemical properties of the composite material (depth of cure, strength, water absorption, radiopacity, color stability), which are relevant to its function as a restorative material, not a diagnostic test.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (in the body) for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes (comma separated list FDA assigned to the subject device)

EBF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral, teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental prosthetics and authorized laboratories and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:
Test: Sensitivity to environment lighting - ISO 4049
Results: All samples were presented to be physically homogeneous, thus Vittra APS Unique and the predicate device meet the specifications of the ISO 4049 standard.

Test: Depth of Cure - ISO 4049
Results: The results showed that the subject device and predicate device are according the entry requirement related to the depth of cure and the values specified in ISO 4049.
Vittra APS Unique: 4.91 mm
Llis: 2.44 mm
Vittra APS: 2.43 mm

Test: Colour tone stability after radiation and water absorption - ISO 4049 and ISO 7491
Results: All comparisons were carried out by observers with normal eyesight. They did not attest to any color difference in the samples analysed. The results presented prove that the Vittra APS Unique, Llis and Vittra APS resins are in accordance with products entry requirements as specified in the ISO4049 standard.

Test: Radiopacity - ISO 4049
Results: The average results obtained for radiopacity of Vittra Unique APS FGM was 2.23, thus being higher than that specified in ISO 4049.
Vittra APS Unique: 2.23 mm
Llis: 1.98 mm
Vittra APS: 2.31 mm

Test: Flexing Resistance - ISO 4049
Results: All results below are within the specified limit, so the materials follow ISO 4049.
Vittra APS Unique: 137.8 MPa
Llis: 138.8 MPa
Vittra APS: 142.6 MPa

Test: Water sorption and solubility. - ISO 4049
Results: The results show that Vittra APS Unique and the predicate device products meet the entry requirement for sorption and water solubility, in accordance with ISO 4049.
Sorption/Solubility (µg/mm³)
Vittra APS Unique: 7.93 / 1.59
Llis: 16.32 / 4.78
Vittra APS: 15.55 / 4.06

Test: Accelerated Stability Studies
Results: Considering the results observed at the end of the 274 days test period, the shelf-life of 3 years in the storage condition of 30 °C for the product can be confirmed.

Test: Long-term Stability Study
Results: Shelf-life test has not yet been completed, the product is being commercialized based on the results of accelerated stability acquired during the prototype.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191306

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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 ([e-mail]) or phone [phone] 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: [phone]

D) Contact Person:

Roberta Uyara

Tel.: [phone]

• 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

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.

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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 and
Common Name | Vittra APS Unique
Dentscare | Llis, Vittra APS
Dentscare |
|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 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 laboratories
and clinics.
Vittra APS Unique must be stored in
temperatures between 5° to 30°C | Dental prosthetics and authorized laboratories and
clinics.
Llis, Vittra APS must be stored in temperatures between
5° 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 or
substances in contact with the
same human tissues
or body fluids? | YES | YES |
| Is the product in compliance to
EN 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 clinical
condition? | yes | yes |
| Is it used at the same site in the
body? | yes | yes |
| Is it used in a similar
population? | yes | yes |
| Is it used for the same intended
purpose? | yes | yes |
| Is not foreseen to deliver
significantly different
performances? | no | no |
| Is it similar conditions of use? | yes | yes |
| Is it similar specifications and
properties | yes | yes |
| Is it similar principles of
operation? | 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 isolation
or relative isolation	YES	YES
Application according to
adhesive technique	YES	YES
Size for increments	1.5 mm	1.5-2 mm
Light curing unit	Power: ≥ 450mW/cm2
Wavelength: 400-500nm	Power: Llis ≥ 450mW/cm2, Vittra APS 700mW/ cm2
Wavelength: 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/mm³
Solubility: 1.59 µg/mm³	Sorption: 16.32 µg/mm³
Solubility: 4.78 µg/mm³	Sorption: 15.55 µg/mm³
Solubility: 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	Report
Sensitivity to
environment
lighting -
ISO 4049	According to the ISO 4049
standard, acceptance is related
to the physical homogeneity of
the sample, so the material
was compared after the test to
the same material pressed
between coverslips, but
without exposure to ambient
light. Thus, there is no
difference between the
samples.	After to read samples in triplicate,
it was found that all samples were
presented to be physically
homogeneous, thus Vittra APS
Unique and the predicate device
meet the specifications of the ISO
4049 standard.
Depth of
Cure - ISO
4049	According to ISO 4049, the
specified for this material is
that its curing depth is: > 1.5
mm.	The results showed that the
subject device and predicate
device are according the entry
requirement related to the depth of
cure and the values specified in
ISO 4049.
Vittra APS Unique: 4.91 mm
Llis: 2.44 mm
Vittra APS: 2.43 mm
Colour tone
stability
after
radiation
and water
absorption -
ISO 4049
and
ISO
7491	The acceptance must be
performed provided that there
is no more than a small change
in colour, it must be proven as
follows:
a) comparisons should be
made by visual inspection and
analysed by three observers
with normal vision, who do not
identify any differences in	All comparisons were carried out
by observers with normal eyesight.
They did not attest to any color
difference in the samples analysed.
The results presented prove that
the Vittra APS Unique, Llis and
Vittra APS resins are in accordance
with products entry requirements
as specified in the ISO4049
standard.
	colour, this comparison must
be carried at a distance of 200
to 300 mm for a period of no
more than 2 seconds;
b) perform the comparison
cited in a) in a light chamber at
Day Light - D65 mode;
c) perform the comparison in
paragraph a), by placing the
specimen on a diffuse white
background of 90%
approximate reflectance, and it
should have as a limiting size
the size of the specimen, which
must be surrounded by a grey
background with a diffuse
reflectance of 30 ± 5%.
Radiopacity -
ISO 4049	According to ISO 4049, the
material is considered
radiopaque if the specimen has
a value of > $1.0$ mm when
compared to the aluminum
scale, therefore, the value of
"X" obtained through the
equation of the line, must be > $1$ .	The average results obtained for
radiopacity of Vittra Unique APS
FGM was $2.23$ , thus being higher
than that specified in ISO 4049.
Vittra APS Unique: $2.23$ mm
Llis: $1.98$ mm
Vittra APS: $2.31$ mm
Flexing
Resistance -
ISO 4049	According to the ISO 4049
standard the specification for
flexural strength is ≥ $80$ MPa.	All results below are within the
specified limit, so the materials
follow ISO 4049.
Vittra APS Unique: $137.8$ MPa
Llis: $138.8$ MPa
Vittra APS: $142.6$ MPa
Water
sorption and
solubility.	Sorption: Maximum of $40$ μm/mm3.	The results show that Vittra APS
Unique and the predicate device
products meet the entry
- ISO 4049	Solubility: maximum of 7.5 μm/mm³.	requirement for sorption and water
solubility, in accordance with ISO

Sorption/Solubility (µg/mm³)
Vittra APS Unique: 7.93 / 1.59
Llis: 16.32 / 4.78
Vittra APS: 15.55 / 4.06 | |
| Accelerated
Stability
Studies | Study created to accelerate the
possible chemical degradation
and/or physical changes of the
product in forced conditions of
storage. | Considering the results observed at
the end of the 274 days test period,
the shelf-life of 3 years in the
storage condition of 30 °C for the
product can be confirmed. | |
| Long-term
Stability
Study | Study designed to verify the
physical and chemical
characteristics of the product
during the expected shelf life.
The results are used to confirm
the expiration date and
storage conditions. | Shelf-life test has not yet been
completed, the product is being
commercialized based on the
results of accelerated stability
acquired 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.