(81 days)
Not Found
No
The summary describes a dental restoration material and its fabrication process using CAD/CAM, with no mention of AI or ML.
No.
The device is a material for dental restorations and does not actively treat or prevent a disease; it is a passive replacement for damaged tooth structure.
No
The device is a material (glass-type) used for fabricating dental restorations (inlays, onlays, veneers, crowns), not for diagnosing conditions.
No
The device description clearly states it is a "glass type material used for aesthetic purposes" and comes in a "block form," 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 is for dental restorations (inlays, onlays, veneers, crowns). This is a structural and aesthetic application within the body, not for testing samples taken from the body to diagnose a condition.
- Device Description: The device is a glass material used for aesthetic purposes and fabricated using CAD/CAM devices. This aligns with a material used for creating physical restorations, not for performing diagnostic tests.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
MonoBloc BM Series is glass type material used for aesthetic purposes of inlays, onlays, veneers and crowns. This looks like a block form and corresponds to ISO 6872 Type 2 Class 1. It can be fabricated using dental CAD/CAM devices such as CERECTM inLab and CERECTM MCXL.
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 following properties were tested according to ISO 6872 and the all results met the test criteria.
- ISO 6872 Uniformity, Extraneous materials, Chemical Solubility and Flexural Strength
- ISO 9693 Linear Thermal Expansion and Glass Transition Temperature
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
§ 872.6660 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/0 description: The image shows the logo for HASS Corporation. The logo is in black and white, with the word "HASS" in large, bold letters. Below the word "HASS" is the word "CORPORATION" in smaller letters. The logo is simple and clean, and it is likely used to represent the company in a professional setting.
510(k) Summary
AUG 26 2011
ﺮ ﺍﻟﻤ
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: __ 05/20/2011
-
- Submission Sponsor
| Submitter | |
|---|---|
| Name | HASS CORP. |
| Address | Rm.301 & 306, Venture Plaza II, |
| Block Ga-2-3, Gangneung Science Park, Daejeon-dong, | |
| Gangneung, Gangwon-do, Korea | |
| Phone | Tel: +82-70-7712-1300 |
| Fax | Fax: +82-33-644-1231 |
-
- Submission Correspondent
LK Consulting Group 951 Starbuck St. Unit J. Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: info@LKconsultinggroup.com
- Submission Correspondent
-
- Device
Trade Name: MonoBloc BM Series Common Name: Dental Frame Material for Dental Prosthesis Classification Name: Porcelain Powder for Clinical Use Classification regulation: 21 CFR 872.6660 Product Code: EIH
- Device
-
- Description:
MonoBloc BM Series is glass type material used for aesthetic purposes of inlays, onlays, veneers and crowns. This looks like a block form and corresponds to ISO
- Description:
1
Image /page/1/Picture/0 description: The image shows the logo for HASS Corporation. The word "HASS" is written in large, bold, black letters. Below the word "HASS" is the word "CORPORATION" written in smaller, black letters.
6872 Type 2 Class 1. It can be fabricated using dental CAD/CAM devices such as CERECTM inLab and CERECTM MCXL.
-
- Indication for use:
MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
- Indication for use:
-
- Safety and Effectiveness:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intend use and different technological characteristics, and it can be demonstrated that the device as safe and effective as the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
- Safety and Effectiveness:
It has been shown in this 5109(K) submission that the differences between the MonoBloc BM Series and the predicate devices do not raise any questions regarding its safety and effectiveness.
-
- Physical Characteristics
The following properties were tested according to ISO 6872 and the all results met the test criteria.
- Physical Characteristics
-
= ISO 6872 Uniformity, Extraneous materials, Chemical Solubility and Flexural Strength
-
· ISO 9693 Linear Thermal Expansion and Glass Transition Temperature
-
- Conclusion
Based on the information provided in this premarket notification, MonoBloc BM Series is safe, effective and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing three other figures, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hass Corporation C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833
AUG 26 2011
Re: K111573
Trade/Device Name: MonoBloc BM Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: II Product Code: EIH Dated: May 31, 2011 Received: June 6, 2011
Dear Ms. Chung:
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.
3
Page 2 - Ms. Chung
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Susan Runyon
"Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K111573
Device Name: MonoBloc BM Series
Indications for Use:
MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
Prescription Use ど (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111573