ARGEN PMMA

K140894 · The Argen Corporation · EBG · Jul 31, 2014 · Dental

Device Facts

• Record ID: K140894
• Device Name: ARGEN PMMA
• Applicant: The Argen Corporation
• Product Code: EBG · Dental
• Decision Date: Jul 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Device Story

ARGEN PMMA consists of polymethylmethacrylate (PMMA) discs or blanks; used by dental professionals in CAD/CAM systems to mill long-term temporary substructures for crowns and bridgework. The device serves as a raw material for subtractive manufacturing; it is a hot-cured polymer with high polymerization grade. The device is intended for clinical dental settings. It provides aesthetic, physical, and chemical properties comparable to existing dental acrylic materials, facilitating the creation of temporary dental restorations.

Clinical Evidence

No clinical data. Bench testing only. Material evaluated for biological safety per ASTM F895-84:1984, ISO 10993.5:1999, and US Pharmacopeia XXVIII. Physical testing confirmed comparable e-modulus, flexural strength, and deflection to predicate devices.

Technological Characteristics

Polymethylmethacrylate (PMMA) hot-cured polymer. Form factor: discs/blanks for CAD/CAM milling. Biocompatibility tested per ASTM F895-84 and ISO 10993.5.

Indications for Use

Indicated for use as polymethylmethacrylate blanks for milling long-term temporary dental substructures for crowns and bridgework in CAD/CAM systems.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• VIPI Block (K102341)
• WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED (K071548)
• EGRAL IMCROWN (K061809)
• TEMPORARY CROWN AND BRIDGE MATERIAL (K060293)

Submission Summary (Full Text)

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JUL 3 1 2014

Alloy Makers To The World

Image /page/0/Picture/3 description: The image shows the logo and contact information for The Argen Corporation. The logo features a stylized letter "A" in bold, black font, with the word "ARGEN" appearing to the right of the "A". Below the logo, the text provides the company's address as 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The telephone number is [phone], and the fax number is [phone].

# 510(k) Summary

Submitted by:

The Argen Corporation 5855 Oberlin Drive, San Diego, CA 92121 [phone] x471 (PHONE), [phone] (FAX)

Contact person: Craig Jolicoeur

Date prepared: 4/02/2013

Trade name: ARGEN PMMA Common name: PMMA Resin Classification name: Temporary Crown and Bridge Material (21 CFR 872.3770 Product Codes EBG, ELM)

Legally marketed devices for which our organization is claiming substantial equivalence:

| 510(k)<br>Number | Trade Name | Manufacturer |
|------------------|--------------------------------------------------------|------------------------------------------------------------|
| K102341 | VIPI Block | VIPI INDUSTRIA, COMERCIO,<br>EXPORTACAO E<br>IMPORTACAO DE |
| K071548 | WIELAND ZENO CAO TEMPORARY<br>PMMA DISC, TOOTH-COLORED | MERZ DENTAL GMBH |
| K061809 | EGRAL IMCROWN | MERZ DENTAL GMBH |
| K060293 | TEMPORARY CROWN AND BRIDGE<br>MATERIAL | DENTSPLY INTERNATIONAL.<br>INC. |

Device Description: Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.

Intended Use: ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Predicate devices: K071548, K061809, K060293.

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Summary of the physical testing conducted on the device:

> ARGEN PMMA discs are substantially equivalent and/or identical ' to the dental devices listed above.

The proposed and predicate devices are both composed of polymethylmethacrylate. A hot cured polymer, and have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. The polymerization grade of both devices is high. In addition, they have the same aesthetic function.

We can conclude that ARGEN PMMA discs have comparable technological characteristics to the predicate device.

# Summary of the biological testing conducted on the device:

Although this device comes into direct contact with the patient, the material is considered to be non-toxic. The material was tested in accordance with ASTM F895-84:1984. ISO 10993.5:1999 and US Pharmacopeia XXVIII.

PMMA resin continues to be the universal versatile polymer in denture dentistry.

The Acrylic PMMA block has the same biological performance as substantially equivalent Dental Acrylic teeth.

## Substantial equivalence:

The proposed and predicate devices are composed of a polymethyl metacrylate hot cured polymer. All devices have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. All devices have comparable e-modulus, flexural strength and deflection. The polymerization grade of both devices is high. And they have the same aesthetic function.

#### Conclusion:

We are claiming substantial equivalence of the ARGEN PMMA disc to the predicate devices.

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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 circle is a stylized symbol that resembles a person embracing another person, representing the department's mission of protecting the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

July 31, 2014

The Argen Corporation Mr. Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, CA 92121-4718

Re: K140894

Trade/Device Name: ARGEN PMMA Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 2, 2014 Received: May 5, 2014

Dear Mr. Jolicoeur:

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.

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### Page 2 - Mr. Jolicoeur

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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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 The Argen Corporation, a company that makes alloys. The logo features a stylized letter 'A' with the company name written across it. The company's address is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The phone number is [phone], and the fax number is [phone].

# Indications for Use Statement

510(k) Number (if known):

Device Name: ARGEN PMMA

Indications For Use:

ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

**Prescription Use** *X*
(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use _ · (21 CFR 807 Subpart C)

# Sheena A. Green -S 2014.07.31 07:45:38 -04'00'