Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

Q: Who is the manufacturer of Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Genoss Co., Ltd. filed the 510(k) submission for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (K214086).

Q: What is the FDA product code for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Hysil Impression Materials (K170736).

Q: Who can help prepare an FDA 510(k) submission like Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K214086 · Genoss Co., Ltd. · ELW · Dec 15, 2022 · Dental

Device Facts

Record ID	K214086
Device Name	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Applicant	Genoss Co., Ltd.
Product Code	ELW · Dental
Decision Date	Dec 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended Use

Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression

Device Story

Bright Impress is a vinyl polysiloxane (addition-reaction silicone) dental impression material. Available in five viscosities (Light, Medium, Heavy, Bite, Putty), it is used by dental professionals to capture precise anatomical details of teeth and oral structures. The material is applied to the oral cavity via tray or syringe; it sets to form a stable, accurate negative replica of the dental anatomy. These impressions are used to fabricate crowns, bridges, dentures, and orthodontic appliances. The device provides high hydrophilicity, dimensional accuracy, and tensile strength to ensure reliable clinical outcomes. It is a non-sterile, prescription-only dental material.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 and DIN 13903 standards. Metrics included consistency, working time, detail reproduction (20-75μm), linear dimensional change (≤1.5%), elastic recovery (≥96.5%), strain in compression, hardness, and flexural strength. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity) performed per ISO 10993.

Technological Characteristics

Material: Vinyl polysiloxane (addition-reaction silicone elastomer). Form factors: Light, Medium, Heavy, Putty, and Bite viscosities. Standards: ISO 4823 (impression materials), DIN 13903 (bite registration), ISO 10993 (biocompatibility). Non-sterile. Standalone dental material.

Indications for Use

Indicated for dental impression procedures including inlay, onlay, crown, and bridge preparations, functional impressions, denture impressions, and study models in human patients.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

Hysil Impression Materials (K170736)

Related Devices

K213890 — IMICRYL Impression Materials · Imicryl Dis Malzemeleri San. VE Tic. A.S. · Feb 11, 2022
K161774 — i-Sil · Spident Co., Ltd. · Sep 30, 2016
K040053 — PRECISION VPS IMPRESSION MATERIAL · Discus Dental, Inc. · Mar 25, 2004
K132869 — SILDENT · Hrs Co., Ltd. · Jun 19, 2014
K143382 — DentiAnn Smart Sil · Seilglobal Co., Ltd. · Feb 23, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 15, 2022 Genoss Co., Ltd. Woojung Park Staff 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16229 Korea, South Re: K214086 Trade/Device Name: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: November 16, 2022 Received: November 16, 2022 Dear Woojung Park: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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, # Bobak Shirmohammadi -S For 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 {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K214086 #### Device Name Bright Impress - Light, Bright Impress - Medium, Bright Impress - Putty, Bright Impress - Bite Indications for Use (Describe) Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The logo is simple and modern. # 510(k) Summary K214086 #### 1. Company | | Submitter | |----------------|----------------------------------------------------------------------------------------------------------| | Name | GENOSS Co., Ltd. | | Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea | | Phone/Fax | +82-70-7098-8938/ +82-31-888-5105 | | Contact person | Woojung Park / RA wjpark@genoss.com | | Summary Date | 12/11/2021 | #### 2. Device Name | Proprietary name: | Bright Impress – Light, Bright Impress – Medium, Bright Impress – Heavy, Bright Impress – Putty, Bright Impress – Bite | |-------------------------|------------------------------------------------------------------------------------------------------------------------------| | Regulation description: | Impression Material | | Classification name: | Dental Impression Material | | Common Name: | Material, Impression | #### 3. Predicate Device K170736 Hysil Impression Materials #### 4. Description Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color. The letters are connected to each other. #### 5. Technological Characteristics Bright Impress was compared with the predicate device 'HySil Impression Material' in clinical, technical, biological view. The characteristics that differed from the predicate device were performed by gap analysis, which confirmed equivalence with the predicate device. Technological characteristics of Bright Impress and HySil Impression Material are as following; # 5.1 Bright Impress – Heavy, Bright Impress – Medium, Bright Impress – Light, Bright Impress – Putty | Device name | Bright Impress-Heavy, Bright Impress-Medium, Bright Impress-Light, Bright Impress-Putty | HySil-Heavy, Mono, Light, Putty | | |-------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacture | Genoss Co.,Ltd. | Osstem Implant Co., Ltd. | | | 510(K) Number | New device | K170736 | | | Target population | Human tooth | Human tooth | | | Clinical | Indication for use | Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression | HySil Putty is to be used as preliminary materials for: - Two-step Putty-wash impression technique - One-step Putty-wash impression technique HySil Heavy is to be used as heavy-bodies materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - Two-step impression technique using dual viscosities - Functional impression HySil Mono is to be used as a medium-bodies tray or syringeable impression material for: - Taking impressions over fixed / removable restorations and implants (i.e., transferring impression posts and bridge components) - Functional impression | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "GENOSS" in green font. The first three letters, "GEN", are in a darker shade of green, while the last three letters, "OSS", are in a lighter shade of green. The font is sans-serif and appears to be bold. | | | | | | | - Fabricating full or partial dentures - Reline impressions - Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques - Transferring root posts when fabricating posts and cores indirectly HySil Light is to be used as syringeable impression materials for: - Two-step putty-wash impression technique - One-step putty-wash impression technique - Two-step impression technique using dual viscosities - Reline impression - Fabricating full or partial dentures | | | | | |-----------|------------------------------|--------------------|---------------|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|-------------|--| | | | | | | | | | | | | | | Site of application | | Human teeth | | | | Human teeth | | | | | | Type | Light | Medium | Heavy | Putty | Light | Mono | Heavy | Putty | | | | Type of ISO4832 | 3 | 2 | 1 | 0 | 3 | 2 | 1 | 0 | | | | Working Time | 126sec | 117sec | 112sec | - | 2.850 min | 2.612 min | 2.022 min | - | | | | Mixing Time | - | - | - | 30sec | - | - | - | 38sec | | | Technical | Consistency | 42.7mm | 39.0mm | 27.0mm | 26.0mm | 45.60 mm | 35.65 mm | 28.47 mm | 31.27 mm | | | | Compatibility with Gypsum | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | | Linear Dimensional change | 0.15% | 0.18% | 0.0% | 0.07% | 0.03% | 0.02% | 0.02% | 0.031% | | | | Elastic recovery | 98.48% | 99.18% | 99.00% | 97.98 | 98.7% | 98.6% | 98.8% | 99.8% | | | | Strain-in compression | 2.54% | 2.26% | 1.7% | 1.06% | 2.30% | 3.00% | 2.30% | 1.6% | | | | Material | Polyvinyl Siloxane | | | | Polyvinyl Siloxane | | | | | | | Biological | Chemical Safety | Biocompatible | | | | Biocompatible | | | | | | | Sterilization | Non sterile | | | | Non sterile | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected and have a rounded appearance. #### 5.2 Bright Impress – Bite | | Device name | Bright Impress-Bite | HySil-Bite | |------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Manufacture | Genoss Co.,Ltd. | Osstem Implant Co., Ltd. | | | 510(K) Number | New device | K170736 | | | Target population | Human tooth | Human tooth | | Clinical | Indication for use | Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression | HySil Bite is used for impression as below: - Taking occlusal surfaces - confirming occlusal surfaces - Recording after putting the articulator | | | Site of application | Human teeth | Human teeth | | | Working Time | Pass | Pass | | | Minimum residence time in the mouth | ≤ 90sec | ≤ 90sec | | | Hardness | ≥ 20HD | 50 HD | | | Flexural Strength | Pass | Pass | | Technical | Recovery after deformation | < 0.1mm | < 0.1mm | | | Linear Dimensional change | ≤ 1.5% | -0.16 % | | | Material | Polyvinyl Siloxane | Polyvinyl Siloxane | | Biological | Chemical Safety | Biocompatible | Biocompatible | | | Sterilization | Non sterile | Non sterile | ## 6. Indication for use Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression 510(k) Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "GENOSS" in green font. The first four letters, "GENO", are in a darker green, while the last two letters, "SS", are in a lighter green. The font is bold and sans-serif. The letters are all capitalized. #### 7. Biocompatibility Data Biocompatibility testing on the proposed Bright Impress has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed: #### 7.1 Bright Impress - Light (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|--------------------------------------------|--------------|---------------------------|-----|-----------------| | 1 | Cytotoxicity (MEM Test) | ISO 10993-05 | None cytotoxicity | P | MGK-2022-001757 | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2019-000355 | | 3 | Irritation or intracutaneous reactivity | ISO 10993-10 | None irritation | P | MTK-2019-000355 | | 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemic toxicity | P | MTK-2019-000355 | #### 7.2 Bright Impress - Medium (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|--------------------------------------------|--------------|------------------------|-----|-----------------| | 1 | Cytotoxicity (MEM Test) | ISO 10993-05 | None cytotoxicity | P | MGK-2022-001756 | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2019-000357 | | 3 | Irritation or intracutaneous reactivity | ISO 10993-10 | None irritation | P | MTK-2019-000357 | | 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemic toxicity | P | MTK-2019-000357 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for GENOSS. The word "GEN" is in dark green, while "OSS" is in a lighter green. The font is sans-serif and bold. # 7.3 Bright Impress - Heavy (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|-------------------------|--------------|---------------------|-----|-----------------| | 1 | Cytotoxicity (MEM Test) | ISO 10993-05 | None cytotoxicity | P | MGK-2022-001758 | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2018-000723 | | 3 | Oral Mucosa Irritation | ISO 10993-10 | None irritation | P | MTK-2018-000724 | ## 7.4 Bright Impress - Putty (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|--------------------------------------------|--------------|------------------------|-----|-----------------| | 1 | Cytotoxicity (MEM Test) | ISO 10993-05 | None cytotoxicity | P | MGK-2022-001755 | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2019-000359 | | 3 | Irritation or intracutaneous reactivity | ISO 10993-10 | None irritation | P | MTK-2019-000359 | | 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemic toxicity | P | MTK-2019-000359 | # 7.5 Bright Impress - Bite (P: Pass, F: Fail) | No. | Test | Method | Acceptance criteria | P/F | Report No. | |-----|--------------------------------------------|--------------|------------------------|-----|-----------------| | 1 | Cytotoxicity (MEM Test) | ISO 10993-05 | None cytotoxicity | P | MGK-2022-001759 | | 2 | Sensitization | ISO 10993-10 | None sensitization | P | MTK-2019-000327 | | 3 | Irritation or intracutaneous reactivity | ISO 10993-10 | None irritation | P | MTK-2019-000326 | | 4 | Systemic toxicity(acute) | ISO 10993-11 | None systemic toxicity | P | MTK-2019-000328 | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color. The font is sans-serif and has a modern look. #### 8. Performance Data The proposed Bright Impress was evaluated using the following performance bench testing to confirm the performance characteristics: # 8.1 Bright Impress - Light | No. | Items | Properties | Method | Doc No. | |-----|------------------------------|----------------------------------------|-------------------|-------------| | 1 | Visual | No substance material | Visual inspection | | | 2 | Volume | Size error of Standard Size < ±5% | Electronic Scale | | | 3 | Package | No damage | Visual Inspection | | | 4 | Color | Contrasting color of base and catalyst | Visual Inspection | | | 5 | Consistency | $ \geq 36mm $ | ISO 4823 | | | 6 | Working Time | $ \geq 120 sec $ | ISO 4823 | | | 7 | Detail reproduction | 20μm reproduction without interruption | ISO 4823 | 제19-02-019호 | | 8 | compatibility with gypsum | 50μm reproduction without interruption | ISO 4823 | | | 9 | Linear Dimensional change | $ \leq 1.5% $ | ISO 4823 | | | 10 | Elastic recovery | $ \geq 96.5% $ | ISO 4823 | | | 11 | Strain in compression | 2.0~20% | ISO 4823 | | ## 8.2 Bright Impress – Medium | No. | Items | Properties | Method | Doc No. | |-----|------------------------------|----------------------------------------|-------------------|-------------| | 1 | Visual | No substance material | Visual inspection | | | 2 | Volume | Size error of Standard Size < ±5% | Electronic Scale | | | 3 | Package | No damage | Visual Inspection | | | 4 | Color | Contrasting color of base and catalyst | Visual Inspection | | | 5 | Consistency | 31mm~41mm | ISO 4823 | | | 6 | Working Time | ≥ 90 sec | ISO 4823 | | | 7 | Detail reproduction | 20µm reproduction without interruption | ISO 4823 | 제19-02-022호 | | 8 | compatibility with gypsum | 50µm reproduction without interruption | ISO 4823 | | | 9 | Linear Dimensional change | ≤ 1.5% | ISO 4823 | | | 10 | Elastic recovery | ≥ 96.5% | ISO 4823 | | | 11 | Strain in compression | 2.0~20% | ISO 4823 | | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is sans-serif and has a modern look. # 8.3 Bright Impress – Heavy | No. | Items | Properties | Method | Doc No. | |-----|------------------------------|----------------------------------------|-------------------|-------------| | 1 | Visual | No substance material | Visual inspection | | | 2 | Capacity | Size error of Standard Size < ±5% | Electronic Scale | | | 3 | Package | No damage | Visual Inspection | | | 4 | Component Colour | Contrasting color of base and catalyst | Visual Inspection | | | 5 | Consistency | ≤ 35mm | ISO 4823 | | | 6 | Working Time | ≥ 60 sec | ISO 4823 | | | 7 | Detail Reproduction | 50µm reproduction without interruption | ISO 4823 | CDM-18-0065 | | 8 | Compatibility with Cypsum | 50µm reproduction without interruption | ISO 4823 | | | 9 | Linear Dimensional Change | ≤ 1.5% | ISO 4823 | | | 10 | Elastic Recovery | ≥ 96.5% | ISO 4823 | | | 11 | Strain-in- compression | 0.8~20% | ISO 4823 | | # 8.4 Bright Impress – Putty | No. | Items | Properties | Method | Doc No. | |-----|------------------------------|----------------------------------------------|-------------------|-------------| | 1 | Visual | No substance material | Visual inspection | | | 2 | Volume | Size error of Standard Size $\lt \pm$ 5% | Electronic Scale | | | 3 | Package | No damage | Visual Inspection | | | 4 | Color | Contrasting color of base and catalyst | Visual Inspection | | | 5 | Consistency | $\leq$ 35mm | ISO 4823 | 제19-02-016호 | | 6 | Working Time | $\leq$ 30 sec | ISO 4823 | | | 7 | Detail reproduction | 75 $\mu$ m reproduction without interruption | ISO 4823 | | | 8 | compatibility with gypsum | 75 $\mu$ m reproduction without interruption | ISO 4823 | | | 9 | Linear Dimensional change | $\leq$ 1.5% | ISO 4823 | | | 10 | Elastic recovery | $\geq$ 96.5% | ISO 4823 | | | 11 | Strain in compression | 0.8~20% | ISO 4823 | | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO," are in a dark green color, while the last three letters, "OSS," are in a lighter green shade. The letters are connected, giving the word a continuous, flowing appearance. #### 8.5 Bright Impress – Bite | No. | Items | Properties | Method | Doc No. | |-----|----------------------------------------|----------------------------------------|-------------------|-------------| | 1 | Visual | No substance material | Visual inspection | | | 2 | Volume | Size error of Standard Size < ±5% | Electronic Scale | | | 3 | Package | No damage | Visual Inspection | | | 4 | Color | Contrasting color of base and catalyst | Visual Inspection | | | 5 | Working Time | ≤ 30 sec | DIN 13903 | | | 6 | Minimum residence time in the mouth | ≤ 90sec | DIN 13903 | 제19-02-045호 | | 7 | Hardness | ≥ 20HD | DIN 13903 | | | 8 | Flexural Strength | ≥ 8.0N | DIN 13903 | | | 9 | Recovery after deformation | < 0.1mm | DIN 13903 | | | 10 | Linear Dimensional change | ≤ 1.5% | DIN 13903 | | All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright Impress met the established specifications necessary for consistent performance according to its intended use. #### 9. Conclusion Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that Bright Impress is acceptable and safe, substantially equivalent to predicate device.