BECE PRESS

K090434 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · EIH · Jul 6, 2009 · Dental

Device Facts

• Record ID: K090434
• Device Name: BECE PRESS
• Applicant: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
• Product Code: EIH · Dental
• Decision Date: Jul 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended 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.

Device Story

BeCe PRESS is a two-phase leucite-reinforced silicate ceramic system used by dental technicians to create metal-ceramic dental restorations. The process utilizes the lost wax technique: a metal framework is waxed-up, invested, and burned out; the ceramic ingot is then heated and pressed into the hollow space using a specialized ceramic press-furnace. The resulting restoration is devested and finished with stains and glaze. The device is used in dental laboratories to fabricate crowns and bridges. The output is a custom dental prosthesis that restores natural tooth form and function, benefiting the patient by providing durable, aesthetic tooth replacement.

Clinical Evidence

Bench testing only. Performance data includes 3-point flexural strength (>100 MPa), chemical solubility (≤20 µg/cm²), and Coefficient of Thermal Expansion (CTE) measurements after 2 and 4 firings (13.0).

Technological Characteristics

Two-phase leucite-reinforced silicate ceramic. Form factor: pressable ingots. Processing: lost wax technique, ceramic press-furnace. CTE: 13.8 to 14.6 x 10-6 K-1 (20ºC to 500ºC). Mechanical properties: flexural strength >100 MPa, chemical solubility ≤20 µg/cm².

Indications for Use

Indicated for dental patients requiring metal-ceramic crowns and bridges. Contraindicated for restorations lacking a metal substructure or frame; use only with BEGO-approved metal frameworks or alloys tested by the user.

Regulatory Classification

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.

Predicate Devices

• IPS InLine PoM System (K071848)

Submission Summary (Full Text)

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K090434

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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 [phone] [phone] 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

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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

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## 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.

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# 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 [phone] or [phone] 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

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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

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