(137 days)
BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges.
BeCe PRESS is a dental ceramic system for veneering metal copings and frameworks using a press on alloy technique. The pressing ingots are composed of a two-phase leucite reinforced silicate ceramic. The restoration is processed according to the lost wax technique. The opaqued mteal framework is first waxed-up in the desired shape an function and invested. After burning out of the wax the heated, ductile BeCe PRESS ceramic is pressed into the previously created hollow space by a special ceramic press-furnace. After devesting, the restoration can be individually characterized by shade/stains and glaze materials with accompanying liquids
This document describes the premarket notification (510(k)) summary for BeCe Press, a dental ceramic system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the BeCe Press ceramic system is "substantially equivalent" to a legally marketed predicate device, "IPS InLine PoM System" (K071848). For a 510(k) submission, "substantial equivalence" is the primary acceptance criterion. This means the device has the same intended use and technological characteristics as the predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
Specific performance criteria for the BeCe Press are provided, and they are compared implicitly to the predicate device or industry standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance (BeCe Press) |
|---|---|---|
| Intended Use | Restorations of natural teeth in the form of metal-ceramic crowns and bridges; pressable ceramics on precious or non-precious alloys (CTE 13.8 to 14.6 x 10-6 K-1). | BeCe Press ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. Pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges. |
| Material Composition | Two-phase leucite reinforced silicate ceramic for veneering metal copings and frameworks. | Composed of a two-phase leucite reinforced silicate ceramic. |
| Coefficient of Thermal Expansion (CTE) | Compatible with metal frameworks (CTE of 14.6 x 10-6 K-1 from 20ºC to 500ºC for alloys). | CTE after 2 firings: 13.0*. CTE after 4 firings: 13.0*. *It's important to note the discrepancy: the intended use states CTE of alloys (14.6 x 10-6 K-1) and the device performance shows its own CTE (13.0). The implication is that a compatibility study or standard has deemed this difference acceptable for clinical use, or the value for the alloys is the critical acceptance criteria for device compatibility rather than the ceramic itself. Without the predicate's detailed performance, direct comparison here is limited. The Indications for Use section provides a range of 13.8 to 14.6 x 10-6 K-1 for alloys, further suggesting a compatibility range. |
| Chemical Solubility | Industry standard for dental ceramics (typically ≤ 20 µg/cm²). | ≤ 20 µg/cm² |
| 3-point Flexural Strength | Industry standard for dental ceramics (typically > 100 MPa). | > 100 MPa |
| Processing Method | Compatible with lost wax technique and ceramic press-furnace. | Processed according to the lost wax technique, pressed by a special ceramic press-furnace. |
| Contraindications | Established for safe use (e.g., metal substructure required). | Intended solely for dental applications, used by dental technicians/trained people. Not designed to be used with restorations without a metal substructure or frame. Recommends using BEGO-approved frameworks. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for performance testing (e.g., for CTE, chemical solubility, flexural strength). It provides the results of these tests.
Data provenance (country of origin, retrospective/prospective) is also not specified in this summary. However, given that the manufacturer is Bego Bremer Goldschlägerei GmbH in Bremen, Germany, it is highly probable that the testing was conducted in Germany, likely in a laboratory setting. The typical nature of these material science tests suggests they are prospective, conducted as part of the product development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This category is not applicable to the type of performance data presented. The "ground truth" for material properties like CTE, solubility, and flexural strength is established through standardized physical and chemical testing protocols (e.g., ISO standards for dental materials), not expert consensus. These are objective measurements rather than subjective interpretations.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the data are objective material property measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being assessed. BeCe Press is a dental material, not a diagnostic or interpretive device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, standalone performance was demonstrated through the reported material properties. The CTE, chemical solubility, and 3-point flexural strength values are intrinsic properties of the BeCe Press material itself, measured independently of any human interpretation or intervention beyond the testing procedure.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation consists of objective physical and chemical measurements obtained through standardized laboratory testing of the BeCe Press material. This includes:
- Coefficient of Thermal Expansion (CTE)
- Chemical Solubility
- 3-point Flexural Strength
These measurements are compared against established industry standards or specifications for dental ceramics to demonstrate fitness for intended use and substantial equivalence.
8. Sample Size for the Training Set:
This information is not provided because BeCe Press is a physical dental material, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this traditional medical device (dental material).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a small, slightly distorted square shape. The square has a double border, with the inner border being more defined than the outer one. The overall appearance of the square is somewhat rough and uneven, suggesting it may be hand-drawn or a low-resolution image.
Premarket notification /510(k) Submission BeCe Press 5-510{k) Summary
JUL - 6 2009
5-510(k) Summary
owner's name:
address:
phone:
fax numbers: name of contact person: date the summary was prepared: Establishment Registration number: name of the device: trade or proprietary name: : the classification name: ﺔ ﺑﻴﻨﻴ : Legally marketed device to which your firm is claiming equivalence Company: " 2017 - 18:4 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم ి నిలు భూ Device: : : 上 1999 10 10 14 510(k) No .:
Bego Bremer Goldschlägerei GmbH Wilhelm-Herbst-Strasse 1 28359 Bremen Germany +49-241 2028 138 +49-241 2028 44 138 Michael Essler 2007-12-15 3007074187 BeCe Press BeCe Press Porcelain Powder for Clincal use (21 CFR 872.6660 Product Code EIH) Ivoclar Vivadent Inc.
IPS InLine PoM System K071848
17/190 Page/of Revision 1.18 2008-12-16 Date
{1}------------------------------------------------
Premarket notification /510(k) Submission BeCe Press 5-510(k) Summary
Intended use/ Indications for Use
BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or nonprecious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges.
Technology characteristics
BeCe PRESS is a dental ceramic system for veneering metal copings and frameworks using a press on alloy technique. The pressing ingots are composed of a two-phase leucite reinforced silicate ceramic.
The restoration is processed according to the lost wax technique. The opaqued mteal framework is first waxed-up in the desired shape an function and invested. After burning out of the wax the heated, ductile BeCe PRESS ceramic is pressed into the previously created hollow space by a special ceramic press-furnace. After devesting, the restoration can be individually characterized by shade/stains and glaze materials with accompanying liquids
Performance data
Image /page/1/Figure/8 description: This image shows a table with technical specifications for a ceramic material labeled as "BeCe PRESS Ceramic". The table includes properties such as CTE (Coefficient of Thermal Expansion) after 2 and 4 firings, chemical solubility, and 3-point flexural strength. The CTE values for both 2 and 4 firings are listed as 13.0, while the chemical solubility is less than or equal to 20 µg/cm², and the flexural strength is greater than 100 MPa.
Contraindications
BeCe PRESS is intended solely for dental applications,used by dental technicians and trained persons/people. This product is not designed to be used with restorations that do not have a metal substructure or frame. It is strongly recommended that only metal frameworks expressly approved by BEGO should be used for the press on alloy technique with BeCe PRESS ceramics. All other alloys not tested by BEGO must be tested by the user before any restoration for a patient is created. Users are solely responsible for subsequent use in all cases.
As such the BeCe Press can be concluded substantial equivalent to the predicate device.
Revision Date 008-12-16
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2009
Mr. Michael Essler Product Manager Ceramics BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Wilhelm-Herbst-Strasse 1 Bremen GERMANY 28359
Rc: K090434
Trade/Device Name: BeCe Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 15, 2009 Received: May 27, 2009
Dear Mr. Essler:
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.
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- Mr. Essler
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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sueen Punoe
Susan Runner, D.D.S., M.A. Acting Division 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 K090434
510(k) Number (if known):
Device Name: BeCe Press
Indications of use:
BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 13.8 to 14.6 x 10-6 K-1 (20℃ to 500℃) after application of opaquer. Applications range from single tooth crowns to various size bridges.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1.
Héé Huxley Soc NSA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090434
16/190 Page/of Revision 1.18 2008-12-16 Date
§ 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.