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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Copra Temp device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices (Zeno PMMA Disc and BRIGHTGLASS Discs) through material properties and intended use. The key performance metric highlighted is flexural strength.

Acceptance Criteria / Performance Metric	Reported Device Performance (Copra Temp)	Predicate Device (BRIGHTGLASS) Performance	Predicate Device (ZENO PMMA) Performance
Flexural Strength (MPA)	113 MPA	106 MPA	105 MPA
Material Composition	PMMA	PMMA	PMMA
Intended Use	Temporary crowns and bridges, up to 6 months in oral cavity	Temporary crowns and bridges, up to 6 months in oral cavity	Temporary crowns and bridges, up to 6 months in oral cavity
Device Class	Class II	Class II	Class II
Manufacturing Method (CAD/milling)	Designed with CAD, milled	Designed with CAM, milled	Designed with ZENO Tech system, milled

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical performance study. The data presented for flexural strength is from pre-clinical testing.

Sample Size: Not explicitly stated for flexural strength testing, but it would have been part of the pre-clinical testing mentioned.
Data Provenance: The testing was "pre-clinical," implying laboratory or bench testing rather than human subject data. The country of origin for the data is implicitly Germany, where White Peaks Dental Systems GmbH & Co. KG is located. The data is retrospective in that it's reported from completed tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the submission describes pre-clinical material testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" for flexural strength would be the measured value according to established ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a material (temporary crown and bridge resin), not an imaging or diagnostic device that typically involves human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for the reported performance (flexural strength) was objective measurement according to recognized international standards. The document states:

"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."
- ISO 10477: Dental polymer-based crown and veneering materials (likely where flexural strength methods are derived).
- The other ISO standards relate to biocompatibility, not direct performance comparison for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device or software. The device itself is a material for fabrication.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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

APPLICANT

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

PHONE: 49 281 206458-0 FAX: 49 281 206458-13 EMAIL: info@white-peaks-dental.com Date Prepared: June 12, 2013

2. SUBMITTER and CONTACT

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

PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: jwaters@whipmix.com

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

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 MillingBlank	Milling Blank in two (2)thicknesses
Machined using any millingsystem	Machined in all appropriateCAM Milling Centers	Machined in all machines ofthe 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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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-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol, indicating the department's name and country.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X

Over-The-Counter Use:

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

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
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.(b)
Classification. Class II.