(87 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a thermoplastic used for dental frameworks, with no mention of AI or ML.
No
The device is a material (semi-crystalline thermoplastic) used to create temporary dental crowns and bridges frameworks, not a device that directly administers therapy or treatment.
No
Explanation: The device is a material used for dental crowns and bridges, not for diagnosing medical conditions. Its intended use is to create frameworks for restorative dental work.
No
The device description clearly states that Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks, which is a physical material, not software. The summary also describes non-clinical testing of physical and chemical properties, bond strength, fracture load, and fatigue tests, all related to a physical material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental crowns and bridges frameworks. This is a structural component used in the mouth, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The device is a thermoplastic blank used to manufacture dental frameworks. This aligns with a medical device used for treatment or restoration, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
The device is clearly a dental prosthetic material, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.
Product codes (comma separated list FDA assigned to the subject device)
EBG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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, classifying the product as an "external communicating device" with "permanent" (> 30 days) contact to "tissue, bone or dentine". Therefore, tests for Cytotoxicity, Irritation, Delayed Type Hypersensitivity, Acute Systemic Toxicity, Subchronic and chronic systemic toxicity, Implantation, Genotoxicity, Carcinogenicity, Chemical characterization, and USP Plastic Class VI were conducted based on referenced ISO standards.
USP Plastic Class VI Testing: Investigated biological reactivity of Pekkton® ivory in compliance with international GLP regulations, using the USP 34 test regimen. Results showed no adverse clinical signs in systemic injection tests, concluding that Pekkton® ivory meets USP Plastic Class VI requirements.
Gas-chromatographic Fingerprint Investigations: Performed a comparative analytical study in compliance with international GLP regulations to investigate potential organic leachable substances, comparing Pekkton® ivory extracts prepared from PEKK based materials subjected to aqueous and organic extraction, followed by GG/MS / ICP analyses. No product-related peaks were exhibited, indicating no potentially organic toxic leachable substances were released under test conditions.
Cytotoxicity: Investigated potential cytotoxicity of Pekkton® ivory in compliance with international GLP regulations, using the biological in vitro cytotoxicity test with L929 mouse fibroblasts in accordance with EN ISO 10993-5. Results showed no cytotoxic potential when manufactured and applied according to instructions for use.
Biological risks for irritation, delayed typersensitivity, acute systemic toxicity, subchronic systemic toxicity, implantation, genotoxicity, carcinogenicity reproductive and developmental toxicity - immunotoxicity were evaluated. Clinical evaluation and testing demonstrated safety and effectiveness.
Non-clinical test data supported the substantially equivalence claim; clinical testing was not necessary. Non-clinical testing included analysis of worst-case test samples based on "Guidance for Industry and FDA Staff, Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions." Chemical and physical properties, bond strength to veneering composites, static fracture load, fatigue tests, and simulated use tests were conducted based on established standards and guidelines. Testing showed Pekkton® ivory is equivalent in performance characteristics to predicate devices, and acceptance criteria were met.
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.
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
§ 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.
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.
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 Temporary | ||
| Abutment | 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 | Straumann
RC Temporary
Abutment | Telio® CAD | Predicate Devices
KMD-Mark1-Tissue
Marker | Remark |
|--------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| USA:
510(k) no | (This
submission) | K093027 | K093708 | K093473 | |
| Device
Description,
Design | Dental crown
and bridge,
temporary
resin.
Non-sterile. | Dental
prosthetic
temporary
restoration.
Non-sterile. | Dental crown
and bridge,
temporary
resin.
Non-sterile. | Implantable
Radiographic
Marker. | Similar device
description as
Telio® CAD. |
| Regulation,
Product
Code | 872.3770,
EBG | 872.3630,
NHA (for the
Abutments) | 872.3770,
EBG | 878.4300,
NEU | Same regulation
as Telio® CAD |
| Indications
for use | Long term
crowns /
temporary 3-
unit bridges | The RC
Temporary
Abutments
are intended
for use in
Straumann
RC Bone
Level Dental
Implant for
temporary
restorations of
single crowns
and bridges
for up to six
months. | Temporary
veneered
crowns /
bridges (up to 4
units) | Implantable clip.
Radiographically
mark soft tissue
during a surgical
procedure or for
future surgical
procedures | Same
indications for
use as Telio®
CAD |
| Material | Base Material:
PEKK
- Pigments | PEEK (white)
with titanium
inlay | Base Material:
Polymethylme-
thacrylate,
+Pigments | Base Material:
PEKK - Pigments | Same base
material as
KMD-Mark1 |
| Chemical
and physical
properties,
Performance | According to
material data
sheet | According to
raw material
data sheet | According to
material data
sheet | Not relevant | Most similar
physical and
chemical
properties as
Telio® CAD and
/ or Straumann
RC Temporary
Abutment |
| Processing
route | Melt
processing | Raw material:
Melt | Non relevant | Not applicable | Similar
manufacturing |
Page 2 of 4
2
| | Pekkton®
ivory | Predicate Devices | | | |
|-----------|--------------------------------------------|----------------------------------------------------------|------------|----------------------------|-------------------------------------------------------|
| | Pekkton®
ivory | Straumann
RC Temporary
Abutment | Telio® CAD | KMD-Mark1 Tissue
Marker | Remark |
| mechanism | (heat and
pressure) of
thermoplastic | processing
(heat and
pressure) of
thermoplastic | | | principle as
Straumann RC
Temporary
Abutment |
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 . 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