Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.

AI/ML Overview

This document describes the premarket notification for the Pekkton® ivory dental device. The information provided focuses on demonstrating substantial equivalence to predicate devices and verifying the biological safety and performance of the device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. However, it lists several biological evaluation tests and states that the "acceptance criteria were met."

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Tests:
Cytotoxicity (EN ISO 10993-5)	No cytotoxic potential	Meets requirements: Investigated material Pekkton® ivory can be evaluated to have no cytotoxic potential.
Irritation (EN ISO 10993-10)	Acceptable	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Delayed Type Hypersensitivity (EN ISO 10993-10)	Acceptable	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Acute Systemic Toxicity (EN ISO 10993-11)	Acceptable	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Subchronic and chronic systemic toxicity (EN ISO 10993-11)	Acceptable	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Implantation (EN ISO 10993-6)	Acceptable	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Genotoxicity (EN ISO 10993-3)	No genotoxic potential	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Carcinogenicity (EN ISO 10993-3)	No carcinogenic potential	Meets requirements: Biological risks evaluated; clinical evaluation and testing demonstrated safety.
Chemical characterization (EN ISO 10993-18)	No potentially organic toxic leachable substances	Meets requirements: None of the investigated extracts exhibited any product-related peaks, indicating no potentially organic toxic leachable substances were released.
USP Plastic Class VI	Meets USP 34 (88) requirements	Meets requirements: Systemic injection tests exhibited no adverse clinical signs. Concluded that the test material Pekkton® ivory meets the requirements of the USP Plastic Class VI.
Physical/Mechanical Tests:
Chemical and physical properties	According to material data sheet (Predicate benchmarks)	Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices.
Bond strength to veneering composites	Acceptable levels	Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices.
Static fracture load	Acceptable levels	Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices.
Fatigue tests	Acceptable levels	Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices.
Simulated use tests	Acceptable performance	Meets requirements: Tested and shown to be equivalent in performance characteristics to the predicate devices.

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

The document does not specify the exact sample sizes for each test in the test set. It mentions that the studies were performed "in compliance with international GLP regulations," which implies controlled laboratory settings. The data provenance is from Cendres+Métaux SA, Switzerland, and the testing was retrospective (meaning conducted specifically for the 510(k) submission, not as part of an ongoing clinical trial).

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

This information is not provided. The testing described is primarily laboratory-based (biocompatibility, chemical, physical) rather than relying on human expert interpretation for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable/provided. The tests are objective laboratory measurements, not reliant on expert adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable/provided. The device is a dental material (Pekkton® ivory) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

This information is not applicable/provided. The device is a material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test set was established through standardized laboratory testing protocols and established scientific methods, as defined by international standards (e.g., ISO 10993 series, USP 34 <88>) for biocompatibility, and material science methodologies for chemical and physical properties. For example:

Biocompatibility: The "ground truth" for cytotoxicity was the observable impact on L929 mouse fibroblasts. For chemical characterization, it was the absence of product-related peaks in GG/MS / ICP analyses.
Physical/Mechanical Properties: The "ground truth" was based on quantitative measurements (e.g., bond strength, fracture load, fatigue) compared against benchmarks from predicate devices or established material data sheets.

8. The Sample Size for the Training Set

This information is not applicable/provided. The submission describes a device validation through physical and biological testing, not a machine learning model that requires a "training set."

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

This information is not applicable/provided as there is no training set for a machine learning model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized letter "M". The text and the letter are in a bold, sans-serif font. The logo appears to be for a company that deals with ashes and metals.

K123638

510(k) Summary

FEB 2 1 2013

Applicant's Name and Address

Submitter: .

Cendres+Métaux SA Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 +41 58 360 20 10 Fax:

Contact Person:

Tanja Bongni Regulatory Affairs Manager

Date of Submission: October 30, 2012

Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

Pekkton® ivory Crown and bridge, temporary, resin Temporary crown and bridge resin 21 CFR 872.3770

Legally Marketed Device to which Equivalence is Claimed (Predicate Device)

Predicate Devices:
Straumann RC TemporaryAbutment	Telio® CAD	KMD-Mark1 Tissue Marker
K093027	K093708	K093473

Figure 1: Predicate Devices

For details please refer to chapter "Comparison / Compatibility; Substantially Equivalence".

Description of the Device

Device Description:

Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. : > Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.

Intended Use of the Device:

Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.

Summary Technological Characteristics:

The proposed Pekkton® ivory is substantially equivalent to the performance of the predicate devices. The difference between our device and the predicates is incidental and not significant. Any differences do not affect the safety and effectiveness of the device when used as labeled.

The material is a semi-crystalline thermoplast.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized symbol that resembles a lowercase "m" or a curved shape. The text and symbol are in a bold, sans-serif font and are black against a white background. The overall design is simple and modern.

Comparison /Compatibility Substantially Equivalence:

The proposed Pekkton® ivory is substantially equivalent to the performance of the corresponding predicate devices. The difference between our device and the predicates is incidental and not significant. Any differences do not affect the safety and effectiveness of the device when used as labeled.

Figure 2 summarizes the substantial equivalence comparison to the predicate devices:

	Pekkton®ivory	StraumannRC TemporaryAbutment	Telio® CAD	Predicate DevicesKMD-Mark1-TissueMarker	Remark
USA:510(k) no	(Thissubmission)	K093027	K093708	K093473
DeviceDescription,Design	Dental crownand bridge,temporaryresin.Non-sterile.	Dentalprosthetictemporaryrestoration.Non-sterile.	Dental crownand bridge,temporaryresin.Non-sterile.	ImplantableRadiographicMarker.	Similar devicedescription asTelio® CAD.
Regulation,ProductCode	872.3770,EBG	872.3630,NHA (for theAbutments)	872.3770,EBG	878.4300,NEU	Same regulationas Telio® CAD
Indicationsfor use	Long termcrowns /temporary 3-unit bridges	The RCTemporaryAbutmentsare intendedfor use inStraumannRC BoneLevel DentalImplant fortemporaryrestorations ofsingle crownsand bridgesfor up to sixmonths.	Temporaryveneeredcrowns /bridges (up to 4units)	Implantable clip.Radiographicallymark soft tissueduring a surgicalprocedure or forfuture surgicalprocedures	Sameindications foruse as Telio®CAD
Material	Base Material:PEKK+ Pigments	PEEK (white)with titaniuminlay	Base Material:Polymethylme-thacrylate,+Pigments	Base Material:PEKK+ Pigments	Same basematerial asKMD-Mark1
Chemicaland physicalproperties,Performance	According tomaterial datasheet	According toraw materialdata sheet	According tomaterial datasheet	Not relevant	Most similarphysical andchemicalproperties asTelio® CAD and/ or StraumannRC TemporaryAbutment
Processingroute	Meltprocessing	Raw material:Melt	Non relevant	Not applicable	Similarmanufacturing

Page 2 of 4

{2}------------------------------------------------

	Pekkton®ivory	Predicate Devices
	Pekkton®ivory	StraumannRC TemporaryAbutment	Telio® CAD	KMD-Mark1 TissueMarker	Remark
mechanism	(heat andpressure) ofthermoplastic	processing(heat andpressure) ofthermoplastic			principle asStraumann RCTemporaryAbutment

Figure 2: Device Comparison Table

We conclude that for all significant parameters (please refer to Figure 2, column "Remark") Pekkton® ivory is substantially equivalent to its above mentioned predicate devices.

Summary of Testing to Demonstrate Safety and Effectiveness / Conclusion:

For the risk assessment of biological risks, the procedures and provisions of EN ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", were applied. Based upon the criteria set out in this standard, the product is biologically classified as an "external communicating device" with "permanent" (> 30 days) contact to "tissue, bone or dentine".

Therefore, in accordance with the aforementioned standards and in accordance with EN ISO 7405:2008 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials and in accordance with "510(k) Memorandum - #G95-1 Attachment B -- Table 2 Supplementary Evaluation Tests for Consideration", the following risks were particularly considered:

-	Cytotoxicity	EN ISO 10993-5:2009
-	Irritation	EN ISO 10993-10:2010
-	Delayed Type Hypersensitivity	EN ISO 10993-10:2010
-	Acute Systemic Toxicity	EN ISO 10993-11:2009
-	Subchronic and chronic systemic toxicity	EN ISO 10993-11:2009
-	Implantation	EN ISO 10993-6:2009
-	Genotoxicity	EN ISO 10993-3:2009
-	Carcinogenicity	EN ISO 10993-3:2009
-	Chemical characterization	EN ISO 10993-18:2009
-	USP Plastic Class VI	USP 34 (88)

The following investigations regarding biocompatibility were conducted:

USP Plastic Class VI Testing

The biological reactivity of the Pekkton® ivory was investigated in compliance with international GLP regulations, using the USP Plastic Class VI test regimen pursuant to USP 34 <88>. In summary, the testing provided the following results: The systemic injection tests exhibited no adverse

clinical signs. Considering the reported data, it is concluded that the test material Pekkton® ivory meets the requirements of the USP Plastic Class VI.

Gas-chromatographic Fingerprint Investigations

In order to investigate potential organic leachable substances which may be released from Pekktor® ivory, a comparative analytical study was performed comparing the Pekkton® ivory extracts

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized letter "M" that is bold and black. The text is also black and in a sans-serif font. The logo appears to be for a company that deals with ashes and metals.

prepared from PEKK based materials were subjected to an aqueous and organic extraction followed by GG/MS / ICP analyses of the respective extracts. The study was performed in compliance with international GLP regulations and served the scope of a material characterization as requested by ISO 10993-18.

In summary, none of the investigated extracts of Pekkton® ivory, the tested PEKK based material exhibited any product-related peaks. This indicates that no potentially organic toxic leachable substances were released from the investigated material under the conditions of the test.

Cytotoxicity

The potential of cytotoxicity potential of Pekkton® ivory was investigated in compliance with international GLP regulations, using the biological in vitro cytotoxicity test with L929 mouse fibroblasts in accordance with EN ISO 10993-5.

Based upon the observed results and under the test-conditions chosen, the investigated material Pekkton® ivory can be evaluated to have no cytotoxic potential in terms of EN ISO 10993-5 when manufactured and applied in accordance with the instructions for use.

Cendres+Métaux SA evaluated the biological risks for irritation, delayed typersensitivity, acute systemic toxicity, subchronic systemic toxicity, implantation, genotoxicity, carcinogenicity reproductive and developmental toxicity - immunotoxicity for Pekkton® ivory. The clinical evaluation and testing demonstrated safety and effectiveness for its intended use. Pekkton® ivory holds the CE mark. No incidents or adverse events have been reported since its market launch.

Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. Non-clinical testing consisted of analysis of devices to identify worst-case test samples. The evaluation was based on FDA guidance "Guidance for Industry and FDA Staff, Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions."

Chemical- and physical properties have been tested. Furthermore, bond strength to veneering composites. determination of the static fracture load and fatigue tests as well as simulated use tests have been conducted to evaluate the performance characteristics of Pekkton® ivory. The test methods were based on established standards and guidelines. Testing has shown that Pekkton® ivory is equivalent in performance characteristics to the predicate devices. The acceptance criteria were met.

The summary of chemical-, physical characteristics as well as application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three parallel lines forming a shape similar to a bird or a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

February 21, 2013

Ms. Tanja Bongni Regulatory Affairs Manager Cendres + Métaux SA Rue de Boujean 122 Biel/Bienne Switzerland 2501

Re: K123638

Trade/Device Name: Pekkton® Ivorv Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: October 30, 2012 Received: November 26, 2012

Dear Ms. Bongni:

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.

{5}------------------------------------------------

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/CentersOffices/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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/5/Picture/7 description: The image shows the name "Kwame Ulmer" in a bold, sans-serif font. The letters "e", "O", "A", and "U" are stylized with a pattern of lines and shapes, making them visually distinct from the other letters. The name appears to be a logo or branding element, with the stylized letters adding a unique and recognizable touch.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

K 123638

Pekkton® ivory

510(k) Number (if known):

Device Name:

Indications for Use:

Pekkton® ivory is intended to be used for long-term,

temporary dental crowns and bridges frameworks.

× Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner 2013:02.20 1-1-1-1-37 -05'00'

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K123638

Page 1 of 1

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.