K Number
K160144
Device Name
rainbow LS Block
Manufacturer
Date Cleared
2016-07-21

(182 days)

Product Code
Regulation Number
872.6660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
Device 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.
More Information

Not Found

No
The description focuses on the material composition and manufacturing process of a dental ceramic block, with no mention of AI or ML in the device description, intended use, or performance studies.

No
The device is a dental ceramic block used to manufacture crowns, veneers, inlays, and onlays, which are prosthetic replacements for teeth, not therapeutic treatments. The performance studies focus on material characteristics and biocompatibility, not therapeutic efficacy.

No

The device is a dental ceramic used for manufacturing dental prosthetics like crowns and veneers, not for diagnosing medical conditions.

No

The device description clearly states it is a dental ceramic block made of Lithium disilicate, which is a physical material, not software. The performance studies also focus on the physical and biological properties of this material.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for manufacturing dental restorations (Crown, Veneer, Inlay, Onlay). This is a structural and restorative application within the body, not a diagnostic test performed on samples taken from the body.
  • Device Description: The device is a dental ceramic material used to create physical dental prosthetics. It is not designed to analyze biological samples or provide diagnostic information.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring analytes
    • Providing information for diagnosis, monitoring, or prognosis of a disease or condition

The device is clearly a dental material used in the creation of medical devices (dental prosthetics). The performance studies focus on the material's physical properties and biocompatibility for its intended use in the mouth.

N/A

Intended Use / Indications for Use

rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 rainbow™ LS Block was evaluated using performance bench testing to confirm the performance characteristics regarding:

  • Visual characteristics: No impurities and No specific changes (Result: No impurities and No specific changes)
  • Size: Size error of; Standard Size

§ 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.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.

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
NameGENOSS Co., Ltd.
Address1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105
Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax+82-31-888-5100/ +82-31-888-5595
Contact personHan Yein / RA
yihan@genoss.com
Summary Date03/28/2016

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 namerainbow™ LS BlockIPS e.max CADComparison
ManufacturerGenoss Co., Ltd.ivoclar vivadentN/A
510(k) NumberNew DeviceK051705N/A
MaterialsSiO2, Li2CO3, Ca3(PO4)2,
P2O5, ZnO, Al2O3, La2O3,
K2CO3, ZrO2SiO2, Li2O, K2O, MgO,
ZnO, Al2O3, P2O5, ZrO2Similar
The major materials of
lithium disilicate dental
ceramic(subject and
predicate device) are SiO2
and Li2O.
The each composition
of other materials is
less than 5%.
FormPreformed blockPreformed blockSame
Type, class of
dental ceramicType II - Class 2Type II - Class 2Same
SterilizationNon-sterileNon-sterileSame
Indication for userainbow™ LS Block can
be used for manufacturing
Crown, Veneer, Inlay and
Onlay.IPS e.max CAD is a
CAD/CAM machinable
glass ceramic based on
lithium disilicate for the
preparation of full ceramic
crowns, inlays, onlays, and
full ceramic 3-unit anterior
bridges.Similar
The subject has more
strong bending strength
than the predicate devices.
Subject not intended for
anterior bridges.
UsePrescriptionPrescriptionSame
Technical characteristics
Bending Strength
(Flexural strength)370MPa360MPaSimilar
Bending strength is
little higher than predicate
device but there is no
difference in performance
and safety.
Linear Thermal
expansion
( $10^{-6}K^{-1}$ )10.3±0.510.45Same
Radioactivity
(Bq/g)0.00628