COPRA TEMP PMMA-DISK

K131664 · White Peaks Dental Systems GmbH & Co. KG · EBG · Dec 18, 2013 · Dental

Device Facts

• Record ID: K131664
• Device Name: COPRA TEMP PMMA-DISK
• Applicant: White Peaks Dental Systems GmbH & Co. KG
• Product Code: EBG · Dental
• Decision Date: Dec 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

Device Story

Copra Temp is a PMMA (polymethylmethacrylate) milling blank used to fabricate temporary crowns and bridges. Dental professionals use CAD/CAM technology to design and mill the blanks into patient-specific restorations. The device is intended for temporary use (up to 6 months) in the oral cavity while a patient awaits a permanent restoration. It supports up to two pontics between two abutment teeth. The device is processed in dental laboratories or clinics using standard milling systems. The output is a temporary dental prosthesis that restores function and aesthetics during the interim period before final restoration placement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included physical property evaluation and biocompatibility testing per ISO 10477, ISO 10993-1, ISO 10993-3, ISO 10993-5, and ISO 10993-10. Flexural strength was measured at 113 MPa.

Technological Characteristics

Material: 100% PMMA (polymethylmethacrylate). Form factor: Milling blanks of variable thickness. Manufacturing: CAD/CAM milling. Standards: ISO 10477 (polymer-based crown/bridge materials), ISO 10993 series (biocompatibility). No electronic components or software algorithms.

Indications for Use

Indicated for fabrication of temporary crowns and bridges in the oral cavity for up to 6 months while awaiting permanent restoration. For use by dental professionals/technicians.

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

• Zeno PMMA Disc (K080182)
• BRIGHTGLASS Discs (K122025)

Submission Summary (Full Text)

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K131664

DEC 18 2013

#### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

1. APPLICANT

White Peaks Dental Systems GmbH & Co. KG Langeheide 9 45239 Essen Germany

PHONE: [phone] FAX: [phone] EMAIL: [e-mail] Date Prepared: June 12, 2013

# 2. SUBMITTER and CONTACT

John P. Waters Consultant Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: [phone] FAX: [phone] EMAIL: [e-mail]

### 3. DEVICE NAME

Copra Temp

# 4. COMMON OR USUAL NAME AND CLASSIFICATION

Temporary Crown and Bridge Resin Regulation Number: 872.3770 Product Code: EBG Classification: Class II

# 5. PREDICATE DEVICE INFORMATION

Zeno PMMA Disc (K080182) BRIGHTGLASS Discs (K122025)

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# 6. DEVICE DESCRIPTION

White Peaks Copra Temp is a device made from high quality 100% PMMA (polymethylmethacrylate) and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed using CAD technology and uses scans or models for the basis of the restoration to be milled. Copra Temp Blanks are available in a variety of thicknesses for different milling systems and are also available in a variety of Vita shades.

# 7. INDICATIONS FOR USE STATEMENT

White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

| (new) White Peaks Copra Temp | BRIGHTGLASS | ZENO PMMA |
|--------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| Class II Device | Class II device | Class II device |
| 510(k) Pending | 510(k) 122025 | 510(k) 080182 |
| PMMA | PMMA | PMMA |
| Various Vita Shades | Various Vita Shades | Two (2) Vita Shades |
| Variable Thickness Milling Blank | Variable Thickness Milling<br>Blank | Milling Blank in two (2)<br>thicknesses |
| Machined using any milling<br>system | Machined in all appropriate<br>CAM Milling Centers | Machined in all machines of<br>the ZENO Tech system |
| Flexural Strength 113 MPA | Flexural Strength 106 MPA | Flexural Strength 105 MPA |

#### 8. SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES

#### 9. SAFETY AND EFFECTIVNESS

PMMA has a well-documented history for use in medical device applications and has been in use for many years. Based on the similarities in materials, descriptions, use, and device characteristics we believe our Copra Temp device is substantially equivalent to the predicates.

#### 10. PRE-CLINICAL TESTING AND STANDARDS USED

Pre-clinical testing was performed to determine the physical properties of Copra Temp and for Biocompatibility and the tests passed per the requirements of ISO:10477, ISO:10993-1, ISO: 10993-3, ISO: 10993-5 and ISO:10993-10.

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

December 18, 2013

White Peaks Dental Systems GmbH & Company KG C/O Mr. John P. Waters Consultant Whip Mix Corporation 361 Farmington Avenue LOUISVILLE KY 40217

Re: K131664

Trade/Device Name: COPRA TEMP Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: September 18, 2013 Received: September 27, 2013

Dear Mr. Waters:

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. Waters

· 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.irca.gov/medicaldevices/resourcesforindustry/default.htm

Sincerely yours,

Image /page/3/Picture/8 description: The image contains the text "Kwame O. Ulmer-S". The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. The text is in a bold, sans-serif font. The background of the image is white.

for

Erin Keith, 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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DEVICE NAME: COPRA TEMP

## INDICATIONS FOR USE:

White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X

OR

Over-The-Counter Use:

Susan Runner
Mary S. Runner -S
DISM 2013.12.09
08:05:58 '05'00'