Rainbow LS Pressing

K151846 · Genoss · EIH · Jan 14, 2016 · Dental

Device Facts

• Record ID: K151846
• Device Name: Rainbow LS Pressing
• Applicant: Genoss
• Product Code: EIH · Dental
• Decision Date: Jan 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.

Device Story

rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot used in dental laboratories. It is processed via the press technique to fabricate dental restorations, specifically inlays, onlays, and crowns. The device serves as a restorative material with strength and esthetics comparable to natural teeth. It is intended for prescription use by dental professionals. The material is non-sterile and requires laboratory processing to achieve the final anatomical shape of the dental restoration. The resulting restorations are used to replace missing or damaged tooth structure, potentially benefiting the patient by restoring dental function and appearance.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 6872:2008 (dentistry - ceramic materials) including bending strength (569 MPa), linear thermal expansion coefficient, chemical solubility (35.75 µg/cm²), and glass transition temperature. Biocompatibility testing performed per ISO 10993-1:2009, including cytotoxicity (ISO 10993-5), irritation/intracutaneous reactivity (ISO 10993-10), sensitization (ISO 10993-10), acute systemic toxicity (ISO 10993-11), and genotoxicity (ISO 10993-03).

Technological Characteristics

Lithium disilicate glass-ceramic ingot. Composition: SiO2, Li2CO3, Ca3(PO4)2, P2O5, ZnO, Al2O3, La2O3, K2CO3. Bending strength: 569 MPa. Linear thermal expansion coefficient: (10.3±0.5) x 10-6K-1. Chemical solubility: 35.75 µg/cm². Glass transition temperature: (550±20) ℃. Non-sterile. Complies with ISO 6872:2008 (Type II - Class 2/3).

Indications for Use

Indicated for the manufacture of inlays, onlays, and crowns in dental patients.

Regulatory Classification

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.

Predicate Devices

• IPS e.max Press and IPS e.max Press Multi (K120134)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2016

GENOSS Co., Ltd. c/o Mr. Dachan Kwon iCT America, Inc. 180 Sylvan Avenue, 2nd Floor Englewood Cliffs, New Jersey 07632

Re: K151846

Trade/Device Name: rainbow™ LS Pressing Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: December 4, 2015 Received: December 8, 2015

#### Dear Mr. Kwon:

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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina Kiang
-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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## Indication for use

510(k) Number: K151846

rainbow™ LS Pressing Device Name:

Indication for use:

rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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

Page 1 of 1

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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 "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The logo is simple and modern.

# 510(k) Summary

01/05/2016

## 1. Company

| | Submitter |
|----------------|----------------------------------------------------------------------------------------------------------|
| Name | GENOSS Co., Ltd. |
| Address | 1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105<br>Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Phone/Fax | [phone]/ [phone] |
| Contact person | Byungsun Kim / RA<br>[e-mail] |
| Summary Date | 01/05/2016 |

## 2. Device Name

| Proprietary name | : rainbow™ LS Pressing |
|---------------------|-------------------------------------|
| Regulation number | : 21 CFR 872.6660 |
| Classification name | : Porcelain powder for clinical use |
| Product code | : EIH |
| Device class | : Class II |

## 3. Predicate Device

K120134 IPS e.max Press and IPS e.max Press Multi

#### 4. Description

rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.

### 5. Indication for use

rainbow™ LS Pressing is used in the manufacture of Inlays, Onlays and Crowns.

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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.

## 6. Technological Characteristics

The following comparison table of the technological characteristics of the subject device and the predicate devices outlines and provides the similarities and the substantial equivalency of the rainbow™ LS Pressing and the predicate.

| Device name | rainbowTM LS Pressing | IPS e.max Press<br>and IPS e.max Press Multi | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Genoss Co., Ltd. | Ivoclar Vivadent,<br>Incorporated | N/A |
| 510(k) Number | New Device | K120134 | N/A |
| Materials | SiO2, Li2CO3, Ca3(PO4)2,<br>P2O5, ZnO, Al2O3, La2O3,<br>K2CO3. etc. | SiO2, Li2O, K2O, MgO,<br>ZnO, Al2O3, P2O5 etc. | Similar<br>The major materials of<br>lithium disilicate dental<br>ceramic(subject and<br>predicate device) are SiO2<br>and Li2O.<br>The each composition<br>of other materials is<br>less than 5%.<br>The difference of<br>composition is Ca3(PO4)2.<br>Ca3(PO4)2 is decomposed<br>into 3CaO and P2O5.<br>The CaO acts as stabilizer. |
| Form | Pre-formed Ingot | Pre-formed Ingot | Same |
| Type, class of<br>dental ceramic | Type II - Class 2 | Type II - Class 3 | Similar<br>Although the subject<br>device refers to Type II-<br>Class 2 dental ceramic, the<br>bending strength satisfies<br>requirement by<br>ISO 6872:2008 for<br>Class 3 dental ceramics<br>(> 300 MPa). |
| Sterilization | Non-sterile | Non-sterile | Same |
| | | | |
| Indication for use | rainbow™ LS Pressing is<br>used in the manufacture of<br>Inlays, Onlays and<br>Crowns. | IPS e.max Press and IPS<br>emax Press Multi is an all-<br>ceramic system for the<br>creation of Occlusal<br>veneers, Thin Veneers,<br>Veneers, Inlays, Onlays,<br>Crowns in the anterior and<br>posterior region, 3-unit<br>bridges in the anterior<br>region, 3-unit bridges in<br>the premolar region up to<br>the second premolar as the<br>terminal abutment, Crown,<br>splinted crown or 3 unit<br>bridge up to the second<br>premolar placed on top of<br>an implant abutment. | Similar<br>The subject and predicate<br>devices can be used to<br>make Inlays, Onlays and<br>Crowns, because the<br>bending strength and<br>chemical solubility of<br>devices satisfy<br>requirement by<br>ISO 6872:2008 for<br>Class 4 dental ceramics.<br>(> 300 Mpa, < 2000µg/cm²) |
| Use | Prescription | Prescription | Same |
| Technical characteristics | | | |
| Bending Strength<br>(Flexural strength) | 569 MPa | 400 Mpa | Bending strength is<br>higher than required by<br>ISO 6872:2008 for<br>Class 3 dental ceramics.<br>( > 300 Mpa ) |
| Linear thermal<br>expansion<br>coefficient | $(10.3±0.5) x 10-6K-1$ | $10.5 x 10-6K-1$ | Same |
| Chemical Solubility<br>(µg/cm²) | 35.75 | 40 | Chemical solubility<br>satisfies requirement by<br>ISO 6872:2008 for<br>Class 2 or 3 dental<br>ceramics.<br>(< 100µg/cm²) |
| Glass transition<br>temperature | (550±20) ℃ | approx. 549 ℃ | Same |
| Biocompatibility | Biocompatible | Biocompatible | The Products are<br>biocaompatible according<br>to ISO 10993-1<br>'Biological evaluation of<br>medical devices –<br>Part 1: Evaluation and<br>testing within a risk<br>management process. |

## Comparison of Characteristics

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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. The font is sans-serif and has a modern look.

# 510(K) Number: K151846

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#### 510(K) Number: K151846

Image /page/6/Picture/1 description: The image shows the logo for GENOSS. The logo is in green and consists of the word "GENOSS" in a sans-serif font. The first three letters, "GEN", are in a darker green, while the last three letters, "OSS", are in a lighter green. The logo is simple and modern.

Image /page/6/Figure/2 description: The image shows a comparison of shapes and sizes of what appears to be dental materials. On the left, there is a cylinder with a diameter of 12.5mm and a height of 10mm. In the middle, there are multiple cylinders with a diameter of 12.5mm and heights of 10mm and 20mm. The right side of the image is labeled 'Similar'.

There are three minor differences that are worth discussing:

- 1) The difference of 'Indication for use' is not critical to the intended use.
Considering the bending strength of devices satisfies requirement by ISO 6872:2008 for Class 4 dental ceramics(> 300 MPa), the subject and predicate devices can be used to make Inlays, Onlays and Crowns.

- 2) The subject and predicate device have slight difference in materials. But they both are lithium disilicate dental ceramic which have SiO2 and Li2O as the major materials. The each composition of other materials is less than 5%. The difference of chemical composition is Cas(PO4)2, which is decomposed into 3CaO and P2O5. The CaO acts as stabilizer. It enhances the structure of Li2O-SiO2 system(the basic lithium disilicate system) and increases the viscosity of glass. This difference has no effect on the device. The non-clinical test and biocompatibility test) demonstrate the Technical characteristics.
- 3) The differences of technological characteristics(Bending strength, chemical solubility) are within what is expected of this type of device. The performance test results satisfy the requirement for Type II - Class 2 or 3 dental ceramic by ISO 6872:2008.

#### 7. Summary of non-clinical testing

Non-clinical device testing was conducted to confirm the performance of the subject device. Bench testing was conducted in accordance with the FDA recognized consensus standard(Recognition number : 4-178: ISO 6872 Third edition 2008-09-01, dentistry - ceramic materials) Bench tests for performance comparison of the subject device and the predicate device includes the following testing:

- Bending Strength - Linear thermal expansion coefficient
- Chemical Solubility

- Glass transition temperature
- 510(k) Summary

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# GENOSS

Technical characteristics of both devices satisfy the criteria for Type II - Class 2 or 3' dental ceramic by ISO 6872:2008. Slight differences between the proposed and predicate devices do not raise any new issues of safety and effectiveness.

Biocompatibility testing was conducted on the device pursuant to the ISO 10993-1:2009 Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process.

- Cytotoxicity test(ISO 10993-5)
- Irritation or intracutaneous reactivity(ISO 10993-10)
- Sensitization(ISO 10993-10)
- Acute systemic toxicity(ISO 10993-11)
- Genotoxocity(ISO 10993-03)

The result of biocompatibility testing demonstrated that no issue of biocompatibility arises.

#### 8. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. concludes that rainbow™ LS Pressing is substantially equivalent to predicate device.