(127 days)
Not Found
No
The 510(k) summary describes a dental material (zirconia) and its intended use for fabricating dental restorations. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to algorithmic performance. The description focuses solely on the material properties and fabrication method.
No.
The device is a raw material (yttria stabilized zirconia as a milling blank) used for fabricating dental restorations, not a device that directly performs a therapeutic function on a patient.
No
The device is a material (yttria stabilized zirconia) used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description explicitly states that the device "consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations" and is available as a "milling blank." This indicates a physical material, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental restorations (crowns and bridges). This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a material (zirconia) used in a milling process to create these restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is a material used to create a device that will be used inside the body.
N/A
Intended Use / Indications for Use
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- Partial-veneered and fully veneered crowns and bridges -
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
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)
Not Found
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/1 description: The image shows the logo for BEGO, a dental company. The logo consists of a stylized, abstract shape on the left, resembling a heart or a stylized letter 'B'. To the right of the shape is the word 'BEGO' in bold, sans-serif font. The logo is black and white.
5 510(k) Summary
| Owner's name: | BEGO Bremer Goldschlägerei
Wilh. Herbst GmbH & Co. KG | |
|----------------------|--------------------------------------------------------------------------|--------------|
| Address: | Wilhelm-Herbst-Str. 1
28359 Bremen / Germany | |
| Phone: | +49 421 2028 112 | |
| Fax: | +49 421 2028 44-112 | NOV 1 2 2013 |
| Contact person: | Dr. Heike Gustke | |
| Date prepared: | April 16, 2013 | |
| Device name: | BeCe CAD Zirkon HT+ | |
| Common name: | Powder, porcelain | |
| Classification name: | Porcelain powder for clinical use
(21 CFR 872.6660, product code EIH) | |
| Predicate device: | LAVA™ Frame (K011394) | |
Device Description
BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
Indications for use
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- -Partial-veneered and fully veneered crowns and bridges
Premarket Notification
BeCe CAD Zirkon HT+
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
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Image /page/1/Picture/0 description: The image shows the logo for BEGO, a dental company. The logo consists of a stylized graphic to the left of the word "BEGO" in bold, sans-serif font. The graphic resembles a stylized heart or a pair of wings. The text is in all capital letters and is aligned horizontally.
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
Milling machines that are compatible with BeCe CAD Zirkon HT+:
- Roeders milling machines (Soltau/Germany) .
Comparison to predicate devices
BeCe CAD Zirkon HT+ is substantially equivalent to the predicate device regarding the indications for use, material properties, technical parameters, processing and biocompatibility. However, there are slight differences between BeCe CAD Zirkon HT+ and predicate device regarding flexural strength, chemical solubility and coefficient of thermal expansion. These slight differences do not adversely affect safety and effectiveness of BeCe CAD Zirkon HT+ compared to the predicate device. In addition, BeCe CAD Zirkon HT+ fulfills the requirements of ISO 6872, ANSI ADA Specification No. 69 and No. 38 as well as ISO 10993-10 and DIN EN ISO 10993-18.
Based on the test results BeCe CAD Zirkon HT+ is substantially equivalent to the predicate device.
Premarket Notification
BeCe CAD Zirkon HT+
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three wavy lines extending from its body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2013
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG C/O Dr. Heike Gustke Regulatory Affairs Manager Wilhelm-Herbst-Str. I 28359 Bremen GERMANY
Re: K132102
Trade/Device Name: BeCe CAD Zirkon HT+ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 22, 2013 Received: September 4, 2013
Dear Dr. Gustke:
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
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 (2) 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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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/McdicalDevices/Safety/ReportalProblem/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,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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/4/Picture/0 description: The image shows the logo for BEGO, a dental company. The logo consists of a stylized symbol on the left and the word "BEGO" on the right. The symbol is an abstract design, and the letters in "BEGO" are blocky and outlined. The logo is black and white.
Indications for Use
K132 ir; 2 510(k) Number (if known): _
BeCe CAD Zirkon HT+ Device Name:
Indications For Use:
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- Partial-veneered and fully veneered crowns and bridges -
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/14 description: The image shows a digital signature of Robert S. Betz. The signature includes the name "Robert S. Betz -S" in a stylized font on the left side. On the right side, there is text indicating the signature was digitally signed by Robert S. Betz, along with details such as DN (c=US, o=U.S. Government, au=HHS, ou=FDA, ou=People, cn=Robert S. Betz-S), a numerical identifier (0.9.2342.19200300,100.1.1=1300117248), and the date and time of the signature (Date: 2013.11.08 10.47:30 -05:00').
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