Easy On Universal Glaze & Stain is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.

Device Description

Doctus Global offers two kinds of Easy On Universal Glaze & Stain:

V Easy On Universal Stain for artificial teeth
Easy On Universal Gum Stain for dental prosthesis, artificial gum tissue portion.
V Easy Liners for Porcelain powder build-up process.
V Easy Add On for Correcting and Repair process.
Easy On Crystal Glaze for glazing Lithium disilicate CAD/CAM block crown and bridge
V Build Up Liquid for porcelain powder build up process

Both systems and other items are a useful finishing system made of paste type Stain & Glaze for dental ceramics.

Fluorescent layering materials for staining and glazing. With Easy On Universal Stain & Gum Stain, you can easily and quickly achieve high quality dental ceramic prosthesis.

Easy On Universal Stain consists of different types of self-glazing colors with various levels of translucency, each Unique replicate natural tooth shade and gum tissue colors and structures, such as incisal translucency, mamelons, detail expressions, halos, and gum tissue.

Over paint Easy On Universal Stains we layer Easy On Universal Structures. With Easy On Universal Structure you can create tooth surface textures found in natural enamel area and gum tissues, in light and thin thicknesses of 0.1 mm - 0.3 mm. With easy applying and high stability. individual surface structures can easily be integrated into the paste with small brush. The low firing temperature does not change the details of the surface, so reliable and aesthetic results are achieved with one or two firings.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental device, "Easy On Universal Glaze & Stain." This document is not for an AI/ML medical device, but rather for a traditional medical device (dental materials). Therefore, the questions related to AI/ML specific aspects like ground truth, training sets, MRMC studies, and expert adjudication are not applicable to this submission.

The acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance testing and biocompatibility testing against established international standards for dental ceramic materials (ISO 6872:2015 and ISO 10993 series).

Here's a breakdown of the requested information based on the provided document, with an emphasis on what is applicable:

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

The document lists the acceptance criteria for the "Easy On Universal Glaze & Stain" device based on the ISO 6872:2015 standard for "Dentistry - Ceramic materials" and other general performance tests. The test results are stated to have met these requirements.

ISO 6872 Cl.	Test Item	Acceptance Criteria (Requirements)	Reported Device Performance
5.1	Uniformity	The color shall be uniformly dispersed	Meets requirements
5.2	Extraneous materials	It shall be free from extraneous materials	Meets requirements
5.3	Mixing and condensation	Shall not form lumps or granules during mixing, and shall neither crack nor crumble during drying.	Meets requirements
7.2	Radioactivity	Uranium238 shall be less than 1.0 Bq/g	Meets requirements
7.3	Flexural strength	It shall not be less than 50 MPa	$\ge$ 50 MPa
7.4	Linear thermal expansion coefficient	It shall be within (12.0 ± 0.5) x 10⁻⁶ K⁻¹	Meets requirements
7.5	Glass transition temperature	It shall be within (560 ± 20) °C	Meets requirements
7.6	Chemical solubility	The mass loss shall be less than 100 µg/cm²	Meets requirements

Additional Performance Tests:

Test Item	Acceptance Criteria (Requirements)	Reported Device Performance
Appearance	When tested by visual inspection, it shall be free from extraneous materials and suitable for use.	Meets requirements
Package	When tested by visual inspection, it shall be no damage, extraneous materials and other harmful defects for usage.	Meets requirements
Weight	When measured the weight using a balance, the tolerance shall be within ±5%.	Meets requirements

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

Sample Size: The document does not specify the exact sample sizes used for each performance test. It only states that the tests were performed according to the specified ISO standard.
Data Provenance: Not explicitly stated regarding country of origin for the test data, but the manufacturer is based in South Korea (Doctus Global). The studies are non-clinical (laboratory-based) and thus the terms retrospective/prospective clinical study do not apply.

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

Not Applicable. This is a non-clinical device. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or measurement established by human experts or other means. For this dental material, "ground truth" is established by laboratory measurements conforming to international material standards. No human expert interpretation of images or data for a diagnostic purpose is involved.

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

Not Applicable. As explained above, this is a non-clinical device. Adjudication methods are relevant for clinical studies involving human interpretation or subjective assessments, typically in AI/ML performance evaluations.

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 a non-clinical device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems in comparison to human readers, which is not relevant for a dental glaze and stain product.

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

Not Applicable. This device does not involve an algorithm or AI.

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

For this non-clinical device, "ground truth" is established by objective, quantitative measurements obtained through standardized laboratory testing methods (e.g., flexural strength, chemical solubility, physical properties) as defined by ISO 6872:2015. Biocompatibility "ground truth" is established through tests based on ISO 10993 series.

8. The sample size for the training set:

Not Applicable. This is a non-clinical device; there is no "training set" in the context of AI/ML.

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

Not Applicable. There is no training set for this conventional medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

June 30, 2023

Doctus Global % Bokyeong Kim Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 SOUTH KOREA

Re: K231264

Trade/Device Name: Easy On Universal Glaze & Stain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 28, 2023 Received: May 2, 2023

Dear Bokyeong Kim:

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/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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231264

Device Name Easy On Universal Glaze & Stain

Indications for Use (Describe)

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

|--|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized house shape with a window inside a curved shape, suggesting a smile. The text "Doctus G" is written in a bold, modern font below the house shape. Underneath the company name is the tagline "Making Your Happy Smile".

510(k) Summary

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

April 28, 2023

2. Submitter's Information [21 CFR 807.92(a)(1)]

●	Name of Sponsor:- Address:	GMS Consulting4th Floor, Digital Cube, 34, Sangamsan-ro, Mapo-gu, Seoul,Republic of Korea,03909
●	Contact Name:- Telephone No.:- Email Address:	Beom-jin Choi, R&D Principal Researcher+82-10-8989-5741doctus2021@naver.com
●	Name of Manufacturer:- Address:	Doctus GlobalRN.313, 51, Samwon-ro, Deogyang-gu, Goyang-si,

Gyeonggi-do, Republic of Korea

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Regulation Name	Porcelain Powder for Clinical Use
Product Name	Easy On Universal Glaze & Stain
Model Name	Easy On Universal Stain
Regulation Number	872.6660
Classification Product Code	EIH
Device Class	2
510k Review Panel	Dental

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Image /page/4/Picture/0 description: The image shows the logo for Doctus G. The logo features a stylized letter 'D' with a small house icon inside, suggesting a connection to home or real estate. Below the symbol, the name "Doctus G" is written in a bold, modern font, with the 'G' being slightly larger and in a different color. The tagline "Making Your Happy Smile" is present below the name.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

Predicate Device #1

510(k) Number: K193588
Applicant: Dental Direkt GmbH ●
Regulation Name: Porcelain Powder for Clinical Use
Proprietary Name: DD Contrast ●
Classification Product Code: EIH
Regulation Number: 21 CFR 872.6660

The predicate device has not been subject to a design-related recall

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Image /page/5/Picture/0 description: The image shows the logo for Doctus G. The logo features a stylized letter 'D' with a small house icon inside, suggesting a connection to home or real estate. Below the symbol, the name "Doctus G" is written in a modern font, with the 'G' being larger and in a different color. The tagline "Making Your Happy Smile" is present below the name.

5. Description of the Device [21 CFR 807.92(a)(4)]

5.1. General

Doctus Global offers two kinds of Easy On Universal Glaze & Stain:

V Easy On Universal Stain for artificial teeth
Easy On Universal Gum Stain for dental prosthesis, artificial gum tissue portion.
V Easy Liners for Porcelain powder build-up process.
V Easy Add On for Correcting and Repair process.
Easy On Crystal Glaze for glazing Lithium disilicate CAD/CAM block crown and bridge
V Build Up Liquid for porcelain powder build up process

Both systems and other items are a useful finishing system made of paste type Stain & Glaze for dental ceramics.

Fluorescent layering materials for staining and glazing. With Easy On Universal Stain & Gum Stain, you can easily and quickly achieve high quality dental ceramic prosthesis.

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Image /page/6/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized house shape with a window inside a teal circle. Below the circle, the company name "Doctus G" is written in a bold, gray font. Underneath the company name is the tagline "Making Your Happy Smile" in a smaller font.

5.2. Device composition

- The components of the kit below table are sold individually or in kits. {1) ~ 2}}
1. Easy On Universal Stain Full Kit

Image /page/6/Picture/5 description: The image shows a kit with various colors and tools. There are 16 small containers with different colors, including light brown, red, light blue, enamel, red brown, pink, dark blue, clear, dark brown, orange, gray, white, ivory, and glaze. There is also a small bottle labeled "EASTON" and a thin brush.

Composition

Easy On UniversalGlaze	Stain-Shade A	Stain-Shade B	Stain-Shade C
Stain-Shade D	Stain-Light Brown	Stain-Red Brown	Stain-Dark Brown
Structure Stain-Enamel	Stain-White	Stain-Ivory	Stain-Pink

510(k) Summary

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Image /page/7/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized letter "D" with a window inside, suggesting a connection to homes or buildings. Below the "D" is the company name, "Doctus G", in a modern, sans-serif font. The tagline "Making Your Happy Smile" is present below the company name.

Image: Stain-Red	Image: Stain-Orange	Image: Stain-Light Blue	Image: Stain-Dark Blue
Stain-Red	Stain-Orange	Stain-Light Blue	Stain-Dark Blue
Image: Stain-Gray	Image: Structure Stain-Clear	Easy On Universal Glaze Liquid
Stain-Gray	Structure Stain-Clear	Easy On Universal Glaze Liquid
Image: Brush
Brush

No.	Name	Description
1	Easy OnUniversal Glaze	A transparent glaze layer is formed on the outer surface of the ceramicInlay, Onlay, Crown, Crown & Bridge and Zirconia dental prosthesis
2	Stain-Shade A	Among the basic shade of teeth, the stain that expresses the basiccolors of the A
3	Stain-Shade B	Among the basic shade of teeth, the stain that expresses the basiccolors of the B
4	Stain-Shade C	Among the basic shade of teeth, the stain that expresses the basiccolors of the C
5	Stain-Shade D	Among the basic shade of teeth, the stain that expresses the basiccolors of the D
6	Stain-Light Brown	Stain that expresses bright brown color on the exterior of dentalprosthesis
7	Stain- Red Brown	Stain that expresses red brown color on the exterior of dental prosthesis
8	Stain- Dark Brown	Stain that expresses dark brown color on the exterior of dental

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Image /page/8/Picture/0 description: The image is a logo for Doctus G. The logo features a stylized house inside of a teal-colored shape. The text "Doctus G" is written in a bold font below the shape. There is also some smaller text below the main text that says "Making Your Happy Smile."

		prosthesis
9	Structure Stain-Enamel	Stain that expresses the color and transparent of the Enamel layer
10	Stain-White	Stain that expresses the lightest part of the surface of dental prosthesis
11	Stain-Ivory	Stain that expresses lighter part of the surface of dental prosthesis
12	Stain-Pink	Stain representation of gingiva and cervical part of the dental prosthesis
13	Stain-Red	Stain representation of gingiva and red color part of the dentalprosthesis
14	Stain-Orange	Stain representation of occlusal and cervical part of the dentalprosthesis
15	Stain-Light Blue	Stain that expresses the enamel layer of the anterior and posterior tooth
16	Stain-Dark Blue	Stain that expresses the enamel layer of the anterior and posterior tooth
17	Stain-Gray	Stain that expresses the enamel layer of the anterior and posterior tooth
18	StructureStain-Clear	Stain for representing the most transparent layer of the overallappearance of dental prosthesis
19	Easy On UniversalGlaze Liquid	If the viscosity of the product increases during use, dilute it
20	Brush	Painting instrument

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Image /page/9/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized house with a window inside a rounded square, with swooshes underneath. The text "Doctus G" is written in a bold, sans-serif font, with the "G" slightly offset and larger than the rest of the letters. Below the company name is the slogan "Making Your Happy Smile".

1. Easy On Universal Gum Stain Full Kit
  Image /page/9/Picture/3 description: The image shows a kit with various components arranged in a black tray. There are 13 small containers with different colored substances labeled with codes such as G1, G2, G3, G4, G5, G6, G7, G51, G52, G53, G54, G55, Dark Red, and Purple. Additionally, there is a bottle labeled "EASY ON", a container labeled "Glaze", a white rectangular card with the "EASY ON" logo, and a thin brush.
Composition

Image: Easy On Universal Glaze	Gum Stain-G1	Gum Stain-G2	Gum Stain-G3
Gum Stain-G4	Gum Stain-G5	Gum Stain-G6	Gum Stain-G7
Gum Stain-Dark Red	Gum Stain-Purple	Gum Structure Stain-GS1	Gum Structure Stain-GS2

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Image /page/10/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized letter "D" with a window inside, suggesting a connection to homes or buildings. Below the "D" is the company name, "Doctus G", in a modern, sans-serif font. The tagline "Making Your Happy Smile" is present below the company name.

	Gum Structure Stain-GS3	Gum Structure Stain-GS4
	Brush
	Pallet
No.	Name	Description
1	Easy On Universal Glaze	A transparent glaze layer is formed on the outer surface of the ceramic Inlay, Onlay, Crown, Crown & Bridge and Zirconia dental prosthesis
2	Gum Stain-G1
3	Gum Stain-G2
4	Gum Stain-G3	Stains for the gingiva part of the dental prosthesis. Becomes darker as it increases by 1 to 7
5	Gum Stain-G4
6	Gum Stain-G5
7	Gum Stain-G6
8	Gum Stain-G7
9	Gum Stain-Dark Red	Stain for expressing the dark red color of the attached gingiva part of dental prosthesis
10	Gum Stain-Purple	Stain for expressing the purple color of the attached gingiva part of dental prosthesis
11	Gum Structure Stain-GS1
12	Gum Structure Stain-GS2	Stains for the gingiva part outer detail texture expression of the dental prosthesis. Becomes darker as it increases by 1 to 5
13	Gum Structure Stain-GS3
14	Gum Structure Stain-GS4
15	Gum Structure Stain-GS5
16	Easy On Universal Glaze Liquid	If the viscosity of the product increases during use, dilute it

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Image /page/11/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized letter "D" with a small house icon inside, suggesting a connection to homes or real estate. Below the "D" is the company name "Doctus G" in a bold font, and underneath that is the tagline "Making Your Happy Smile" in a smaller font. The logo uses a teal color scheme, giving it a modern and clean appearance.

17	Brush	Painting instrument
18	Pallet	Products for mixing and diluting stains

The items below are sold individually only. {3) ~ 6)}

Easy Liner

Image: Easy Liner Light	Image: Easy Liner Dark	Image: Easy Liner Pink
Easy Liner Light	Easy Liner Dark	Easy Liner Pink

No.	Name	Description
1	Easy Liner Light	Materials for increasing the combined strength and shearstrength of Zirconia copping and Ceramic Powder in theprocess of firing and completing by adding Ceramic Powder toa substructure made of bright Zirconia framework
2	Easy Liner Dark	Materials for increasing the combined strength and shearstrength of Zirconia copping and Ceramic Powder in theprocess of firing and completing by adding Ceramic Powder toa substructure made of bright Zirconia framework
3	Easy Liner Pink	Materials for increasing the combined strength and shearstrength of Zirconia copping and Ceramic Gum color Powderin the process of firing and completing by adding Ceramic GumPowder to a substructure made of bright Zirconia framework

4) Easy Add On

Easy Add On Enamel	Easy Add On Clear
------------------------	-----------------------

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Image /page/12/Picture/0 description: The image shows the logo for Doctus G. The logo features a stylized letter 'D' with a small house icon inside, suggesting a connection to home or real estate. Below the symbol, the name "Doctus G" is written in a modern font, with the 'G' being larger and in a different color. The tagline "Making Your Happy Smile" is present below the name.

No.	Name	Description
1	Easy Add OnEnamel	Materials for complete the finished dental prosthesis, thatcomplements the appearance of the enamel translucentlayer on the outer surface of the artificial tooth
2	Easy Add OnClear	Materials for complete the finished dental prosthesis, thatcomplements the appearance of the translucent layer onthe outer surface of the artificial tooth

Easy On Crystal Glaze, Stain-Khaki, Structure Stain Sky Blue

Image: Easy On Crystal Glaze	Image: Stain-Khaki	Image: Structure Stain - Sky Blue
Easy On Crystal Glaze	Stain-Khaki	Structure Stain - Sky Blue

No.	Name	Description
1	Easy On CrystalGlaze	Materials for during the crystallization process by heattreatment of lithium disilicate ceramic prosthesis, thesurface of the dental prosthesis is glazed
2	Stain-Khaki	Stain that expresses khaki color on the exterior ofdental prosthesis
3	Structure Stain-Sky Blue	Stain that expresses the light blue color andtransparent of the enamel layer

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Image /page/13/Picture/0 description: The image is a logo for Doctus G. The logo features a stylized house shape inside of a rounded square, with a teal swoosh underneath. The text "Doctus G" is written in a bold font below the house shape. Underneath the text is the phrase "Making Your Happy Smile".

Easy On Build Up Liquid, Easy On Universal Glaze Liquid (50)

Image /page/13/Picture/3 description: The image shows two bottles of Easy On liquid. The bottle on the left is labeled "Easy On Build Up Liquid". The bottle on the right is labeled "Easy On Universal Glaze Liquid (50)". Both bottles are white and have a white cap.

No.	Name	Description
1	Easy OnBuild Up Liquid	Liquid material by mixing dental porcelain powder whenbuild up process
2	Easy On UniversalGlaze Liquid (50)	If the viscosity of the product increases during use, diluteit

6. Indications for Use [21 CFR 807.92(a)(5)]

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Image /page/14/Picture/0 description: The image contains a logo for a company called "Doctus G". The logo features a stylized house icon with a window inside a rounded square, which is encircled by a teal crescent shape. Below the icon, the company name "Doctus G" is written in a bold, sans-serif font, with the "G" being slightly larger and in a different style. The tagline "Making Your Happy Smile" is present below the company name.

7 . Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

There are no significant differences in the technological characteristics of these devices compared to the predicate device which adversely affect safety or effectiveness. A table comparing the key features of the subject device and the predicate device is provided below table.

	Proposed Device	Predicate Device	Note
K Number	-	K193588
Manufacturer	Doctus Global	Dental Direkt GmbH
Product name	Easy On Universal Glaze &Stain	DD Contrast
Product Code	EIH	EIH	Same
RegulationNumber	21 CFR 872.6660	21 CFR 872.6660	Same
510(k) ReviewPanel	Dental	Dental	Same
Indications forUse	Easy On Universal Glaze &Stain is suitable for theesthetic individualization ofmonolithic or minimallyreduced dental crown andbridge constructions madeof zirconium dioxide orlithium disilicate.	The DD contrast®veneering ceramics systemis suitable for the estheticindividualization ofmonolithic or minimallyreduced dental crown andbridge constructions madeof zirconium dioxide orlithium disilicate.	Same
Product forveneering /individualizationof dentalframeworks	Yes	Yes	Same
Frameworkmaterial	Zirconium dioxide andlithium disilicate	Zirconium dioxide andlithium disilicate	Same
Minimal amountof fires	1	1	Same
For all sizes ofdentalframeworks	Yes	Yes	Same
Classificationacc. to ISO6872	Type 1, class 1b	Type 1, class 1b	Same
Material	Feldspar ceramics(Glass Oxide)	Feldspar ceramics	Same
Form	Pastes and liquids	Pastes and liquids	Same
Shades	Different tooth and	Different tooth and	Same

[Table. Comparison of Proposed Device to Predicate Device]

510(k) Summary

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Image /page/15/Picture/0 description: The image is a logo for a company called "Doctus G". The logo features a stylized house with a window inside of a circle. The circle is teal and has a swoosh design around it. The text "Doctus G" is written in a bold font below the circle, and the tagline "Making Your Happy Smile" is written in a smaller font below the company name.

	Proposed Device	Predicate Device	Note
	individualization shades	individualization shades
Physicalproperties	Conform to ISO 6872:2015	Conform to ISO 6872:2015	Same
Flexural strength	$\ge$ 50 MPa	$\ge$ 50 MPa	Same
Single use	Yes	Yes	Same
Sterility	Non-sterile	Non-sterile	Same

Doctus Global believes that the new product Easy On Universal Glaze & Stain is substantially equivalent to the predicate device when used as instructed by knowledgeable and trained dental personnel. There is no change of the intended use of the new device and no difference in fundamental scientific technology. The new device is made from the same materials as the predicate device. The new device was verified in accordance with the abovementioned FDA recognized standards.

In conclusion, Easy On Universal Glaze & Stain is substantially equivalent to the legally marketed predicate device.

8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

The following data were provided in support of the substantial equivalence determination:

1. Bio-compatibility
  Bio-compatibility test is performed according to below:
FDA Guidance document Use of International Standard ISO 10993-1, Biological evaluation of . medical devices- Part 1: Evaluation and testing within a risk management process
. ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
ISO 10993-6:2016 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
. ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Performance Test

510(k) Summary

13 / 15

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Image /page/16/Picture/0 description: The image shows a logo for a company called "Doctus G". The logo features a stylized letter "D" with a small house icon inside, surrounded by a crescent shape. Below the "Doctus G" text, there is a tagline that reads "Making Your Happy Smile".

The performance tests were performed according to ISO 6872:2015 Dentistry - Ceramic materials, and the test results showed that the proposed device meets the requirements specified in the standard.

ISO 6872 Cl.	Test item	Requirements
5.1	Uniformity	The color shall be uniformly dispersed
5.2	Extraneous materials	It shall be free from extraneous materials
5.3	Mixing and	It shall neither from lumps, nor granules during mixed,
	condensation	and it shall neither crack, nor crumble during drying.
7.2	Radioactivity	Uranium238 shall be less than 1.0 Bq/g
7.3	Flexural strength	it shall not be less than 50MPa
7.4	Linear thermal	It shall be within (12.0±0.5) x10-6K-1
	expansion coefficient
7.5	Glass transition	It shall be within (560±20)°C
	temperature
7.6	Chemical solubility	The mass loss shall be less than 100 µg/cm²

The requirements for other test items are as follows.

Test item	Requirements
Appearance	When tested by visual inspection, it shall be free form extraneous materials andsuitable for use.
Package	When tested by visual inspection, it shall be no damage, extraneous materialsand the other harmful defects for usage.
Weight	When measured the weight using a balance, the tolerance shall be withing±5%.

9. Clinical Test Summary [21 CFR 807.92(b)(2)]

Clinical testing is not included in this submission.

10.Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

There are no significant differences between proposed device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.

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Image /page/17/Picture/0 description: The image shows the logo for Doctus G. The logo features a stylized letter 'D' with a small house icon inside, suggesting a connection to home or real estate. Below the symbol, the name "Doctus G" is written in a bold, modern font, with the 'G' being slightly larger and in a different color. The tagline "Making Your Happy Smile" is present below the name.

11.Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the Easy On Universal Glaze & Stain is substantially equivalent in safety and effectiveness to the predicate device as described herein.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.