(182 days)
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.
The provided information describes the acceptance criteria and performance data for a dental ceramic device named "rainbow™ LS Block," submitted for 510(k) premarket notification. The study primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device (IPS e.max CAD).
Here's the breakdown of the information that can be extracted from the document, organized according to your requested points.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing the performance data, including criteria and results, primarily from bench testing and biocompatibility.
| No. | Items | Criteria | Reported Device Performance (Result) | Standard |
|---|---|---|---|---|
| Biocompatibility Testing | ||||
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization (Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulus threshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemic toxicity | None acute Systemic toxicity | ISO 10993-11 |
| 5 | Genotoxicity (Ames, Micronucleus) | None genotoxicity | None genotoxicity | ISO 10993-3 |
| Performance Bench Testing | ||||
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size < ±5% | (C-type) W 0.03%, L 3.90%, H 0.21% | ISO 6872 |
| (Disk type) W 3.42%, L2.36%, H 0.07% | ISO 6872 | |||
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom from extraneous materials | Not Freedom from extraneous materials | Not Freedom from extraneous materials | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.00628 Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 $ \mu $g/cm² | Solubility: 12 $ \mu $g/cm² | ISO 6872 |
| 8 | Flexural strength | More than 100MPa | Average: 370MPa | ISO 6872 |
| 9 | Linear thermal expansion ($10^{-6}K^{-1}$) | 9.95($\pm0.5$) $X 10^{-6}K^{-1}$ | Average: 9.95 $X 10^{-6}K^{-1}$ | ISO 6872 |
| 10 | Glass-transition temperature | Less than 579$\pm20$ °C | 579 °C | ISO 6872 |
Study Details
2. Sample size used for the test set and the data provenance
The document indicates that the evaluation was based on bench testing and biocompatibility testing. It does not specify a "test set" in the context of clinical data or images. The sample sizes for the specific tests (e.g., number of samples for flexural strength, chemical solubility) are not explicitly stated in this summary but are implied to be sufficient for compliance with the referenced ISO standards.
The data provenance is from GENOSS Co., Ltd., a company based in Korea (1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea). The study appears to be retrospective in the sense that it's a summary of completed lab tests rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this study. The ground truth for this device (a dental material) is established through physical and chemical property measurements and standardized biological tests, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
This question is not applicable. There is no "test set" requiring human adjudication as this is not a diagnostic AI device or a clinical outcome study. The tests are benchtop measurements guided by ISO standards.
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
This question is not applicable. This is a submission for a dental material (porcelain block) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm or AI component mentioned for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on standardized physical, chemical, and biological measurements specified by international standards like ISO 6872 (dental ceramics) and ISO 10993 (biological evaluation of medical devices). For example:
- Flexural strength: Measured in MPa against a standard criterion.
- Chemical solubility: Measured in $ \mu $g/cm² against a standard criterion.
- Biocompatibility: Assessed against criteria like "None cytotoxicity," "None sensitization," etc., based on established biological assays.
8. The sample size for the training set
This question is not applicable. This submission is for a physical dental material, not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
GENOSS Co., Ltd. % Kim Byungsun Assistant Manager ICT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs. New Jersey 07632
Re: K160144
Trade/Device Name: rainbow™ LS Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 13, 2016 Received: June 15, 2016
Dear Kim Byungsun:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/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 bold and sans-serif.
Indication for use
510(k) Number:
Device Name: rainbow™ LS Block
Indication for use:
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indication for use
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Image /page/3/Picture/0 description: The image contains the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters "OSS" are connected by a green line that runs underneath them.
510(k) Summary
03/28/2016
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Phone/Fax | +82-31-888-5100/ +82-31-888-5595 |
| Contact person | Han Yein / RAyihan@genoss.com |
| Summary Date | 03/28/2016 |
2. Device Name
| Proprietary name | : rainbow TM LS Block |
|---|---|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |
3. Predicated Device
K051705 IPS e.max CAD
4. Description
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.
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Image /page/4/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 bold and slightly rounded, giving the word a modern and professional look.
5. Indication for use
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
6. Technological Characteristics
rainbow™ LS Block has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of rainbow™ LS Block, IPS e.max CAD is as following
| Device name | rainbow™ LS Block | IPS e.max CAD | Comparison | |
|---|---|---|---|---|
| Manufacturer | Genoss Co., Ltd. | ivoclar vivadent | N/A | |
| 510(k) Number | New Device | K051705 | N/A | |
| Materials | SiO2, Li2CO3, Ca3(PO4)2,P2O5, ZnO, Al2O3, La2O3,K2CO3, ZrO2 | SiO2, Li2O, K2O, MgO,ZnO, Al2O3, P2O5, ZrO2 | SimilarThe major materials oflithium disilicate dentalceramic(subject andpredicate device) are SiO2and Li2O.The each compositionof other materials isless than 5%. | |
| Form | Preformed block | Preformed block | Same | |
| Type, class ofdental ceramic | Type II - Class 2 | Type II - Class 2 | Same | |
| Sterilization | Non-sterile | Non-sterile | Same | |
| Indication for use | rainbow™ LS Block canbe used for manufacturingCrown, Veneer, Inlay andOnlay. | IPS e.max CAD is aCAD/CAM machinableglass ceramic based onlithium disilicate for thepreparation of full ceramiccrowns, inlays, onlays, andfull ceramic 3-unit anteriorbridges. | SimilarThe subject has morestrong bending strengththan the predicate devices.Subject not intended foranterior bridges. | |
| Use | Prescription | Prescription | Same | |
| Technical characteristics | ||||
| Bending Strength(Flexural strength) | 370MPa | 360MPa | SimilarBending strength islittle higher than predicatedevice but there is nodifference in performanceand safety. | |
| Linear Thermalexpansion( $10^{-6}K^{-1}$ ) | 10.3±0.5 | 10.45 | Same | |
| Radioactivity(Bq/g) | 0.00628 | <0.03 | Radioactivity is lower thanpredicate device | |
| Chemical Solubility( $\mu g/cm^2$ ) | 12 | 40 | Chemical solubilitysatisfies requirement byISO 6872:2008 forClass 2 dental ceramics.(< 100 $\mu g/cm^2$ ) | |
| Glass transitiontemperature | (579±20) °C | approx. 549 °C | SimilarGlass transitiontemperature of the subjectand predicate device aresimilar. Each haveindividual sinteringschedule by glasstransition temperature. | |
| Biocompatibility | None cytotoxicityNone sensitizationNone systemic toxicityNone acute oral toxicityNone genotoxicity | None cytotoxicityNone sensitizationNone systemic toxicityNone acute oral toxicityNone genotoxicity | same | |
| Shapes& Sizes | C-typeImage: C-type | Width 8.0 | Width 12.5 | Similar |
| Disk typeImage: Disk type | Width 15, 20mmLength 22mmHeight 3, 5, 7, 9mm | Width 12.5 |
510(k) Summary
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Image /page/5/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 and are connected by a line at the bottom.
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Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The letters are connected to each other, and the overall design is modern and eye-catching.
7. Performance Data
Biocompatibility testing on the proposed rainbow™ LS Block has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized consensus 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 nonsensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization(Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulusthreshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemictoxicity | None acute Systemictoxicity | ISO 10993-11 |
| 5 | GenotoxicityAmesMicronucleus | None genotoxicity | None genotoxicity | ISO 10993-3ISO 10993-3 |
The proposed rainbow™ LS Block was evaluated using the following performance bench testing to confirm the performance characteristics:
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Visual | No impuritiesand No specific changes | No impuritiesand No specific changes | ISO 6872 |
| 2 | Size | Size error of;Standard Size < ±5% | (C-type) Size error of;Standard Size < ±5%W 0.03%, L 3.90%,H 0.21% | ISO 6872 |
| (Disk type) Size error of;Standard Size < ±5%W 3.42%, L2.36%H 0.07% | ||||
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom fromextraneous materials | Not Freedom fromextraneous materials | Not Freedom fromextraneous materials | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.00628Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 $ \mu $ g/cm² | Solubility: 12 $ \mu $ g/cm² | ISO 6872 |
| 8 | Flexural strength | More than 100MPa | Average: 370MPa | ISO 6872 |
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Image /page/7/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 bold and slightly italicized, giving the word a dynamic appearance.
| Linear thermalexpansion | $9.95(\pm0.5) X 10^{-6}K^{-1}$ | Average: $9.95 X 10^{-6}K^{-1}$ | ISO 6872 | |
|---|---|---|---|---|
| 9 | ||||
| 10 | Glass-transitiontemperature | Less than $579\pm20$ °C | 579 °C | ISO 6872 |
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ LS Block met the established specifications necessary for consistent performance according to its intended use.
7. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that rainbow™ LS Block is acceptable and substantially equivalent to predicate devices
§ 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.