(84 days)
Not Found
No
The summary describes a dental alloy and its processing method, with no mention of AI or ML.
No
BegoPal+ is a material (alloy) used for fabricating dental restorations like crowns and bridges, not a device that itself provides therapy. Its intended use is for the fabrication of these restorations, which functionally replace missing tooth structure.
No
Explanation: The device is a dental alloy used for fabricating restorations, not for diagnosing medical conditions.
No
The device is a physical dental alloy (powder) used for fabricating restorations, not a software product.
Based on the provided information, BegoPal+ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fabrication of crown and bridge restorations, which are dental prosthetics used in the mouth of a patient. IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a dental alloy processed by selective laser melting for creating dental restorations. This aligns with a material used in the body, not for testing samples from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
Therefore, BegoPal+ is a dental material intended for use within the human body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
Product codes (comma separated list FDA assigned to the subject device)
EJH
Device Description
BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
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 test results according to ISO 22674, ISO 9693-1, ISO 10271 and ISO 10993 show that the safety and effectiveness have not been affected by the introduction of palladium in a cobaltchromium alloy and by the different processing of the alloy. Based on the test results BegoPal+ is substantially equivalent to the predicate devices.
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
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
123929
Image /page/0/Picture/1 description: The image shows the logo for BEGO, a dental company. The logo consists of a stylized heart shape on the left and the word "BEGO" in block letters on the right. The heart shape is made up of two curved lines that form the outline of a heart, with the top left portion filled in with a darker shade. The letters in "BEGO" are outlined with a double line, giving them a three-dimensional appearance.
5 510(k) Summary
MAR 1 4 2013
| 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 |
| Contact person: | Dr. Heike Gustke |
Date prepared:
| Device name: | |
|---|---|
| Common name: | |
| Classification name: |
Predicate devices:
November 20, 2012
BegoPal+ dental alloy base metal alloy (21 CFR 872.3710, product code EJH)
ﯿﺖ
Wirobond C K032136 Wirobond C+ 510(k) exempt Callisto CP+ 510(k) exempt
Device Description
BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
Premarket Notification
BegoPal+
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Page 1 of 2
1
Image /page/1/Picture/0 description: The image shows the logo for BEGO, a dental company. The logo consists of a stylized heart shape on the left and the word "BEGO" on the right. The heart shape is made up of two curved lines that form the outline of a heart. The word "BEGO" is written in a bold, sans-serif font, and each letter is outlined with a thin line.
Indications for use
BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
SLM rapid prototyping devices that are compatible with BegoPal+
EOSINT M 270, EOSINT M 280
(Manufacturer: EOS GmbH, Robert-Stirling-Ring 1, 82152 Krailling, Germany) SLM 125HL, SLM 250HL
(Manufacturer: SLM Solutions GmbH, Roggenhorster Straße 9c, 23556 Lübeck, Germany)
Comparison to predicate devices
BegoPal+ is substantially equivalent to the predicate devices regarding to the indications for use, technical parameters and biocompatibility. The differences between BegoPal+ and predicate devices are product shape, processing and material composition.
The test results according to ISO 22674, ISO 9693-1, ISO 10271 and ISO 10993 show that the safety and effectiveness have not been affected by the introduction of palladium in a cobaltchromium alloy and by the different processing of the alloy. Based on the test results BegoPal+ is substantially equivalent to the predicate devices.
Premarket Notification
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of an eagle with three wavy lines extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Dr. Heike Gustke BEGO Bremer Goldschlägerei Wilhelm-Herbst GmbH & Company, KG Wilhelm-Herbst-Strasse 1 Bremen, Germany 28359
Re: K123929
Trade/Device Name: BegoPal+ Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: December 18, 2012 Received: December 20, 2012
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. Ilsting 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 - Dr. Gustke
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 (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.
Image /page/3/Picture/7 description: The image contains the text "Kwame O. Ulmer for". The text "Kwame" is in bold font and is located on the left side of the image. The text "O. Ulmer" is in bold font and is located in the center of the image. The text "for" is in a regular font and is located on the right side of the image.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "BEGO" in a stylized font, with a logo to the left of the word. The logo is a stylized shape that resembles a heart or a pair of wings. The letters in the word "BEGO" are blocky and have a slightly distressed appearance. The image is in black and white.
Indications for Use
K123929 510(k) Number (if known): _
Device Name:
BegoPal+
Indications For Use:
BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
Prescription Use __ X (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)
Mary S. Runner -
SV
Sun Runner, DDS, BA 2013.03.11
13:05:59-04'00'
(Division Sign-Off) (Division Sign-On) Infection Control, Dental Devices
510(k) Number:
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