(244 days)
No
The device description and performance studies focus on the material properties and fabrication process of a ceramic ingot, with no mention of AI or ML technologies.
No.
The device is a ceramic ingot used to fabricate dental restorations such as veneers, inlays, and crowns, which are structural components of dental prostheses rather than devices intended to treat or alleviate a disease or condition.
No
Explanation: The device is a ceramic ingot used for fabricating dental restorations like veneers, crowns, and bridges. Its intended use focuses on the creation of physical dental prosthetics, which is a therapeutic or restorative function, not a diagnostic one. Diagnostic devices are used to identify or detect diseases or conditions.
No
The device description clearly states it is a "press-heated ceramic ingot" and describes its physical properties and packaging, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the fabrication of dental restorations (veneers, crowns, bridges, etc.) for placement in the mouth. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a ceramic ingot used to create physical dental prosthetics. It is not designed to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing any form of diagnostic output.
- Performance Studies: The performance studies focus on biocompatibility and mechanical properties (bench testing according to ISO 6872), which are relevant to the physical properties and safety of a dental material, not its diagnostic accuracy.
In Vitro Diagnostic devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.
Product codes
EIH
Device Description
Initial LiSi Press is a press-heated ceramic ingot formed through melting the raw materials at a very high temperature. The melting process eliminates all volatile substances and the final product is a complex oxide ceramic available in various shades and translucencies. All of the components of the applicant device have already been used in the predicate devices.
The restorations may be further characterized through layering, glazing and staining, and are then cemented in place as the final restoration.
The device is packaged in 5 ingots per tube and is available in a range of shades, including high, medium and low translucency, as well as high and medium opacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior region (for crowns and bridges), premolar region (for bridges), implant abutment (for crowns and bridges)
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)
Non Clinical Performance Testing
A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Bench performance testing was conducted in accordance with ISO 6872:2008 (Dentistry - Ceramic materials) and is suitable for its intended use.
Clinical Performance Testing
No clinical testing has been performed on this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with a stylized wing-like shape extending above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
GC America Inc. Mark Heiss, D.D.S. Director, Academic & Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
Re: K153136
Trade/Device Name: Initial LiSi Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 27, 2016 Received: June 1, 2016
Dear Dr. Heiss:
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.
1
Page 2 - Mark Heiss, D.D.S
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 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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is complex and illegible. There is also a small "-s" near the name.
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
2
Section 4 - Indications for Use Statement
Indications for Use
510(k) Number (if known): K153136
Device Name: Initial LiSi Press
Indications for Use:
Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/1 description: The image shows the text "'GC'" in a stylized, sans-serif font. The text is a teal color. The quotation marks are placed before and after the letters "GC".
GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 371-5103
1. Submitter
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 926-3090 |
| Fax: | (708) 926-9100 |
| Alternate Contact: | Lori Rietman |
| Phone: | (708) 926-3092 |
Date Prepared: May 27, 2016
2. Device Name
| Proprietary Name: | Initial LiSi Press |
|---|---|
| Classification Name: | Powder, Porcelain |
| Device Classification: | Class II, 872.6660 |
| Product Code: | EIH |
3. Predicate Device
| Company | Device | 510(k) No. | Code No. | Predicate |
|---|---|---|---|---|
| IVOCLAR VIVADENT, INC | IPS E.MAX PRESS / | |||
| IPS E.MAX PRESS MULTI | K120134 | EIH | Primary | |
| IVOCLAR VIVADENT, INC | IPS E.MAX CAD / | |||
| IPS E.MAX ZIRCAD | K051705 | EIH | Reference |
4. Description of Device
Initial LiSi Press is a press-heated ceramic ingot formed through melting the raw materials at a very high temperature. The melting process eliminates all volatile substances and the final product is a complex oxide ceramic available in various shades and translucencies. All of the components of the applicant device have already been used in the predicate devices.
The restorations may be further characterized through layering, glazing and staining, and are then cemented in place as the final restoration.
4
The device is packaged in 5 ingots per tube and is available in a range of shades, including high, medium and low translucency, as well as high and medium opacity.
- HT (High Translucency): HT-BLE, HT-E57, HT-E57, HT-E59, HT-E59, HT-NTL, HT-AMB, HT-B00, HT-B0, HT-A0, HT-A1, HT-A2, HT-A3, HT-A3.5, HT-A4, HT-B1, HT-B2, HT-B3, HT-B4, HT-C1, HT-C2, HT-C3, HT-C4, HT-D2, HT-D3, HT-D4 (27)
- MT (Medium Translucency): MT-B00, MT-A0, MT-A1, MT-A2, MT-A3, MT-A3, MT-A4, MT-B1, MT-B2, MT-B3, MT-B4, MT-C1, MT-C2, MT-C3, MT-C4, MT-D2, MT-D3, MT-D4, MT-0, MT-A, MT-B, MT-C, MT-D (24)
- LT (Low Translucency): LT-B00, LT-A0, LT-A1, LT-A2, LT-A3, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-B4, LT-C1, LT-C2, LT-C3, LT-C4, LT-D2, LT-D3, LT-D4, LT-0, LT-A, LT-B, LT-C, LT-D (24)
MO (Medium Opacity): MO-0, MO-1, MO-2, MO-3, MO-4 (5) HO (High Opacity): HO-0, HO-1, HO-2, HO-3, HO-4 (5)
-
న్. Indications for Use
Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3unit bridge up to the second premolar placed on top of an implant abutment. -
- Non Clinical Performance Testing
A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- Non Clinical Performance Testing
Bench performance testing was conducted in accordance with ISO 6872:2008 (Dentistry - Ceramic materials) and is suitable for its intended use.
-
- Clinical Performance Testing
No clinical testing has been performed on this device.
- Clinical Performance Testing
8. Technological characteristics
The applicant device is a silica and lithium based glass ceramics that includes silicon dioxide (SiO2), lithium oxide (Li2O), other oxides, and coloring oxides. The glass ceramic applicant device is formed into an ingot which is used in heat-pressed technology to fabricate all ceramic dental restorations. The percentage of chemical components varies to vield a range of shades and transmission of light from high translucent to opaque to optimize esthetics when restorations are placed near natural teeth or other previously restored teeth.
5
| Applicant device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Product category | Initial LiSi Press | IPS e.max Press | IPS e.max CAD |
| Trade name | Press-heated ceramic ingot | Press-heated ceramic ingot | CAD/CAM ceramic block |
| Manufacturer | GC CORPORATION | IVOCLAR VIVADENT, INC | IVOCLAR VIVADENT, INC |
| Indications for use | Fabrication of occlusal veneers, thin veneers, | ||
| veneers, inlays, onlays, crowns in the | |||
| anterior and posterior region, 3-unit bridges | |||
| in the anterior region, 3-unit bridges in the | |||
| premolar region up to the second premolar | |||
| as the terminal unit, crown or splinted crown | |||
| on top of an implant abutment and 3-unit | |||
| bridge up to the second premolar placed on | |||
| top of an implant abutment. | For the creation of occlusal veneers, thin | ||
| veneers, veneers, inlays, onlays, crowns in | |||
| the anterior and posterior region, 3-unit | |||
| bridges in the anterior region, 3-unit bridges | |||
| in the premolar region up to the second | |||
| premolar as the terminal abutment and | |||
| crown, splinted crown or 3 unit bridge up to | |||
| the second premolar placed on top of an | |||
| implant abutment. | 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. |
IPS e.max ZirCAD consists of machinable
zirconia blocks for the preparation of full ceramic
crowns, onlays and 3- and 4- unit bridges and
inlay bridges (anterior and molar.) |
| Product description | Initial LiSi Press is a heat-pressed ceramic
ingot for full ceramic restorations of both
anterior and posterior. | IPS e.max Press is lithium disilicate glass-
ceramic ingots for the Press technology. | IPS e.max CAD is a lithium disilicate glass-
ceramic blocks for the CAD/CAM technology.
IPS e.max ZirCAD is a yttrium-stabilized
zirconium oxide block. |
Table 5.1 Comparison of applicant device to primary and reference predicate
Page 5.3 of 5.4
6
9. Substantial equivalence
The applicant device and primary predicate device both are silica lithium based ceramics with formulations of ceramic oxides used in combination to create a range of shades and translucencies; and that the form of the device is an ingot that is used in heat-pressed technology to fabricate all ceramic restorations. The difference is that the chemical formulation is not identical; however bench testing for both devices was conducted in accordance with ISO 6872:2008 (Dentistry - Ceramic Materials) confirming that the physical properties of the applicant device are comparable to the primary predicate for the same intended use.
The applicant device is similar to the reference device in that both are also silica lithium based ceramics and includes other glass and ceramic oxides in the device formulation. While the technology used to fabricate the all ceramic restoration differs in that the applicant device uses heatpressed technology and the reference device uses CAD/CAM technology; the differences in chemical composition and technology used to fabricate the all ceramic restorations do not alter the raise concerns about the intended use of the applicant device.
Wording of indications for use statement of the applicant device for fabrication of crown or splinted crown on top of an implant abutment has the same intended meaning as the words for creation of crown, and splinted crown. The indications for use are equivalent for Initial LiSi Press and the primary predicate device.
10. Conclusion
Based on device formulation and non clinical performance testing, including bench testing and biocompatibility assessment, Initial LiSi Press is substantially equivalent to the predicate devices.
Page 5.4 of 5.4