K Number

Device Name

COPRA TEMP PMMA-DISK

Manufacturer

WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG

Date Cleared

2013-12-18

(194 days)

Product Code

EBG

Regulation Number

872.3770

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K080182, K122025

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a PMMA material for temporary dental restorations designed using standard CAD technology, with no mention of AI or ML.

Therapeutic

No
The device is a temporary dental restorative material and its purpose is to serve as a placeholder for a permanent restoration, not to treat or cure a disease or condition.

Diagnostic

The device is a temporary restoration material used for fabricating crowns and bridges, not for diagnosing any condition.

SaMD (Software as a Medical Device)

The device is a physical material (PMMA) used for fabricating temporary crowns and bridges, not a software program. While CAD technology is mentioned for design, the device itself is the physical material.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
This device, White Peaks Copra Temp, is a material used to fabricate temporary dental restorations that are placed directly into the patient's mouth. It is a physical device used for treatment/restoration, not for analyzing biological samples.

The description clearly states its purpose is for "fabrication of temporary crowns and bridges" and is "intended for use in the oral cavity". This aligns with a dental prosthetic or restorative device, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

EBG

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental Professional (Technician)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080182, K122025

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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)

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 Milling
Blank	Milling Blank in two (2)
thicknesses
Machined using any milling
system	Machined in all appropriate
CAM Milling Centers	Machined in all machines of
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

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.

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

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K131664 510(k) NUMBER (if KNOWN)

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'