(353 days)
Not Found
No
The device description and performance studies focus solely on the physical and chemical properties of the impression material, with no mention of AI or ML.
No
The device is an impression material used for making dental impressions, not for treating or diagnosing a disease or condition.
No
The device is an impression material used to create molds of teeth and oral structures for the fabrication of dental restorations (crowns, bridges) and other dental appliances. It does not analyze or interpret biological signals or data to determine the presence or absence of a disease or condition.
No
The device description clearly states it is a silicone elastomer-based material, which is a physical substance, not software. The performance studies also focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Bright Impress is an "impression material" used by dental professionals to create impressions of teeth and surrounding structures. This is a physical process of capturing a mold, not a test performed on a biological sample to diagnose or monitor a condition.
- Intended Use: The intended uses listed are all related to creating physical impressions for dental procedures (crowns, bridges, dentures, study models). None of these involve analyzing a biological sample for diagnostic purposes.
- Device Description: The description focuses on the material properties (silicone elastomer, hydrophilicity, dimensional accuracy, etc.) relevant to its function as an impression material, not on its ability to detect or measure substances in a biological sample.
Therefore, Bright Impress is a dental material used for creating physical impressions, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Impression of inlay, onlay crown, and bridge preparation
- Crown, bridge impression
- Inlay and onlay impression
- Functional impression
- Denture impression
- Study model impression
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human tooth, Human teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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 proposed Bright Impress was evaluated using performance bench testing to confirm the performance characteristics according to ISO 4823 and DIN 13903. Tests included visual inspection, volume/capacity, package integrity, color, consistency, working time, minimum residence time in the mouth (for Bite material), hardness (for Bite material), flexural strength (for Bite material), detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, and strain in compression. All test results demonstrated that the materials chosen, manufacturing process, and design met established specifications necessary for consistent performance according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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
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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)
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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
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
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.
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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 |
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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 | | | |
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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 |