(59 days)
Not Found
No
The 510(k) summary describes a dental glaze and stain system, which are materials used for esthetic individualization of dental prosthetics. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on material properties according to ISO standards.
No.
The device is a dental stain and glaze used for esthetic individualization and finishing of dental restorations, not for treating any medical condition or disease.
No
The device is a material (glaze and stain) used for the esthetic individualization of dental restorations, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical material (paste type Stain & Glaze) used for dental ceramics, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate." This describes a material used in the fabrication and finishing of dental prosthetics.
- Device Description: The description details materials like stains, glazes, liners, and build-up liquids used in dental ceramic processes. These are materials applied to dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or aid in the treatment of any medical condition by examining specimens from the human body. IVDs are specifically designed for this purpose.
- Performance Studies: The performance studies focus on material properties relevant to dental restorations (flexural strength, thermal expansion, solubility), not diagnostic accuracy or clinical outcomes related to patient health.
In summary, the Easy On Universal Glaze & Stain is a dental material used for aesthetic purposes in the creation of dental prosthetics, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Doctus Global offers two kinds of Easy On Universal Glaze & Stain:
- Easy On Universal Stain for artificial teeth
- Easy On Universal Gum Stain for dental prosthesis, artificial gum tissue portion.
- Easy Liners for Porcelain powder build-up process.
- Easy Add On for Correcting and Repair process.
- Easy On Crystal Glaze for glazing Lithium disilicate CAD/CAM block crown and bridge
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental crown and bridge constructions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
knowledgeable and trained dental personnel.
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)
The following data were provided in support of the substantial equivalence determination:
- 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
- Bio-compatibility test is performed according to below:
- Performance Test
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Uniformity: The color shall be uniformly dispersed
- Extraneous materials: It shall be free from extraneous materials
- Mixing and condensation: It shall neither from lumps, nor granules during mixed, and it shall neither crack, nor crumble during drying.
- Radioactivity: Uranium238 shall be less than 1.0 Bq/g
- Flexural strength: it shall not be less than 50MPa
- Linear thermal expansion coefficient: It shall be within (12.0±0.5) x10^-6 K^-1
- Glass transition temperature: It shall be within (560±20)°C
- Chemical solubility: The mass loss shall be less than 100 µg/cm²
- Appearance: When tested by visual inspection, it shall be free form extraneous materials and suitable for use.
- Package: When tested by visual inspection, it shall be no damage, extraneous materials and the other harmful defects for usage.
- Weight: When measured the weight using a balance, the tolerance shall be withing ±5%.
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.
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
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K231264
Device Name Easy On Universal Glaze & Stain
Indications for Use (Describe)
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.
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)
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3
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 Consulting
4th 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
+82-10-8989-5741
doctus2021@naver.com |
| ● | Name of Manufacturer: - Address: | Doctus Global
RN.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 |
4
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
5
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.
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.
6
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}}
-
- 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 Universal
Glaze |
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
7
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 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 | Stain-Shade A | Among the basic shade of teeth, the stain that expresses the basic |
| colors of the A | ||
| 3 | Stain-Shade B | Among the basic shade of teeth, the stain that expresses the basic |
| colors of the B | ||
| 4 | Stain-Shade C | Among the basic shade of teeth, the stain that expresses the basic |
| colors of the C | ||
| 5 | Stain-Shade D | Among the basic shade of teeth, the stain that expresses the basic |
| colors of the D | ||
| 6 | Stain-Light Brown | Stain that expresses bright brown color on the exterior of dental |
| prosthesis | ||
| 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 |
8
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 dental |
| prosthesis | ||
| 14 | Stain-Orange | Stain representation of occlusal and cervical part of the dental |
| prosthesis | ||
| 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 | Structure | |
| Stain-Clear | Stain for representing the most transparent layer of the overall | |
| appearance of dental prosthesis | ||
| 19 | Easy On Universal | |
| Glaze Liquid | If the viscosity of the product increases during use, dilute it | |
| 20 | Brush | Painting instrument |
9
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".
-
- 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.
- Easy On Universal Gum Stain Full Kit
-
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 | Gum Structure Stain-GS5 | Easy On Universal Glaze Liquid | |
|---|---|---|---|---|
| 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 |
11
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 shear |
| strength of Zirconia copping and Ceramic Powder in the | ||
| process of firing and completing by adding Ceramic Powder to | ||
| a substructure made of bright Zirconia framework | ||
| 2 | Easy Liner Dark | Materials for increasing the combined strength and shear |
| strength of Zirconia copping and Ceramic Powder in the | ||
| process of firing and completing by adding Ceramic Powder to | ||
| a substructure made of bright Zirconia framework | ||
| 3 | Easy Liner Pink | Materials for increasing the combined strength and shear |
| strength of Zirconia copping and Ceramic Gum color Powder | ||
| in the process of firing and completing by adding Ceramic Gum | ||
| Powder 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 On | |
| Enamel | Materials for complete the finished dental prosthesis, that | |
| complements the appearance of the enamel translucent | ||
| layer on the outer surface of the artificial tooth | ||
| 2 | Easy Add On | |
| Clear | Materials for complete the finished dental prosthesis, that | |
| complements the appearance of the translucent layer on | ||
| the 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 Crystal | |
| Glaze | Materials for during the crystallization process by heat | |
| treatment of lithium disilicate ceramic prosthesis, the | ||
| surface of the dental prosthesis is glazed | ||
| 2 | Stain-Khaki | Stain that expresses khaki color on the exterior of |
| dental prosthesis | ||
| 3 | Structure Stain | |
| -Sky Blue | Stain that expresses the light blue color and | |
| transparent of the enamel layer |
13
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 On | |
| Build Up Liquid | Liquid material by mixing dental porcelain powder when | |
| build up process | ||
| 2 | Easy On Universal | |
| Glaze Liquid (50) | If the viscosity of the product increases during use, dilute | |
| it |
6. Indications for Use [21 CFR 807.92(a)(5)]
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.
14
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 |
| Regulation | |||
| Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| Use | 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. | The DD contrast® | ||
| veneering ceramics system | |||
| is suitable for the esthetic | |||
| individualization of | |||
| monolithic or minimally | |||
| reduced dental crown and | |||
| bridge constructions made | |||
| of zirconium dioxide or | |||
| lithium disilicate. | Same | ||
| Product for | |||
| veneering / | |||
| individualization | |||
| of dental | |||
| frameworks | Yes | Yes | Same |
| Framework | |||
| material | Zirconium dioxide and | ||
| lithium disilicate | Zirconium dioxide and | ||
| lithium disilicate | Same | ||
| Minimal amount | |||
| of fires | 1 | 1 | Same |
| For all sizes of | |||
| dental | |||
| frameworks | Yes | Yes | Same |
| Classification | |||
| acc. to ISO | |||
| 6872 | 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
15
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 | ||
| Physical | |||
| properties | 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:
-
- Bio-compatibility
Bio-compatibility test is performed according to below:
- Bio-compatibility
-
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
16
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 and |
| suitable for use. | |
| Package | When tested by visual inspection, it shall be no damage, extraneous materials |
| and 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.
17
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.