(220 days)
MARK3 is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.
MARK3 alginate impression material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous pink colored powder with nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is smooth, which gives excellent gypsum compatibility
The provided document describes the MARK3 Alginate Impression Material (K141092) and its performance data. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Physical Parameters | Acceptance Criteria (ADA18 Requirements) | Reported Device Performance (MARK3 K141092) |
|---|---|---|
| Appearance | (Not specified in ADA18 table) | Powder |
| Color | (Not specified in ADA18 table) | Pink |
| Compatibility & Detail Reproduction | 0 - 50 μm | Complies |
| Recovery from Deformation | >95 % | Complies |
| Strain in Compression | 5 - 20 % | Complies |
| Compressive Strength | > 0.35 MPa | Complies |
| Deterioration (This likely refers to a strength measurement after some period) | > 0.294 MPa | Complies |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The document simply states "Performance Data" and lists "Complies" for each parameter without indicating the number of samples tested for each physical property.
- Data Provenance: Not explicitly stated. It is implied that the testing was conducted by Cavex Holland BV, given the nature of the submission. The origin (e.g., country) of the specific data is not mentioned, nor is a retrospective or prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to this submission. The device is an impression material, and its performance criteria are based on physical properties defined by industry standards (ADA18 Requirements), not on expert interpretations of medical images or patient outcomes. Therefore, no experts were used to establish "ground truth" in the clinical sense for this type of device.
4. Adjudication method for the test set:
- This is not applicable as the evaluation is based on objective physical measurements against established standards, not on subjective interpretations requiring adjudication.
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 is not applicable. The device is an alginate impression material, a physical product, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical impression material, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for evaluating the MARK3 Alginate Impression Material is based on pre-established physical and mechanical property requirements specified by the ADA18 standard. These are objective measurements rather than expert consensus on clinical findings or pathological outcomes.
8. The sample size for the training set:
- This is not applicable. This is a physical product, not a machine learning model, so there is no concept of a "training set" for model development.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4,2014
Cavex Holland BV Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem 2031CJ THE NETHERLANDS
Re: K141092
Trade/Device Name: MARK3 Alginate Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Material, Impression Regulatory Class: II Product Code: ELW Dated: October 28, 2014 Received: November 14, 2014
Dear Mr. Woortman:
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. Woortman
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN): K141092
DEVICE NAME: MARK3 Alginate Impression Materials
INDICATIONS FOR USE:
MARK3 is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.
Prescription Use X (Per 21 CFR 801.109) 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)
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Image /page/3/Picture/0 description: The image shows a gloved hand holding a small object, possibly in a medical or laboratory setting. The background is blurred and light blue, suggesting a sterile environment. In the lower right corner, there is a logo that says "CAVEX" in a stylized font, with a blue color scheme.
Date: 2014 December 04
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Submitter/Manufacturer:Establishment:Registration number:Owner/operator number:Primary Contact Person: | Cavex Holland BVFustweg 5, 2031CJ Haarlem, The Netherlands96145739033296Richard WoortmanManager Technical ServicesCavex Holland BVPhone: +31 (0)235307700Email: r.woortman@cavex.nl |
|---|---|
| Distributor / Importer:Establishment:Registration number:Owner/operator number:Official Correspondent: | Cargus Int'l, Inc.135N Rt. 9w, Congers, NY 10920, USA24377809033437Bryan Markiet135N Rt. 9w, Congers, NY 10920, USAPhone: 845-2672600 |
| Device:Trade name:Common use:Classification Names:Regulation Number:Product Code:Primary Predicate:Secondary Predicate: | Mark3 Alginate Impression MaterialImpression MaterialMaterial, ImpressionCFR 872.3660ELWK981970K011419, K051207, K013336, K023466, K032116 |
| Device Description: | MARK3 alginate impression material is a dust free alginateimpression material with a creamy consistency for generaldental practice and for orthodontics. It is presented in the formof a homogeneous pink colored powder with nice mint flavor.The material has exceptional good elastic properties and a hightear-resistance. The impression surface is smooth, which givesexcellent gypsum compatibility |
| Intended Use: | MARK3 is an irreversible hydrocolloid dental impression materialused by the dentist for taking impressions of the oral cavity withthe purpose of constructing a gypsum cast that is a copy of thesituation in the mouth. It is a general purpose impressionmaterials for making study models, first impressions for theconstruction of individual trays, situation models, orthodonticimpressions. |
CAVEXY OUR IMPRESSION IS OUR CONCERN
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Image /page/4/Picture/1 description: The image shows a person wearing gloves and holding a small object, possibly a needle or similar tool. The background is a light blue color, creating a sterile or medical-like atmosphere. In the lower right corner, there is a logo that says "CAVEX" in blue and white lettering.
Technical Characteristics:
The technology for the proposed device MARK3 is comparable to the predicate devices.
Basically the alginate, a soluble salt of alginic acid (extracted from brown seaweed), serves as the thickener for water, giving the paste, upon mixing, the correct consistency.
It also reacts chemically with calcium sulphate to make the paste harden into a solid impression.
The fillers (diatomaceous earth) give the mixture its mechanical strength and proper handling characteristics.
A retarder, sodium pyrophosphate, is used for achieving the proper hardening-time. Sufficient working time to mix, apply and take a proper impression and short setting time in the mouth.
Stabilizers will improve the surface-smoothness of the gypsum-cast and the pigment facilitates the "reading" of the impression by the dentist for a good judgment of its quality.
Peppermint oil is added to overcome the "gagging" reflex which can occur during the impression taking.
Paraffin oil is added in order to prevent dust formation during dosing and mixing of the powder.
Performance Data:
| Physical Parameters | Proposed device | ADA18Requirements |
|---|---|---|
| K141092 | ||
| MARK3 | ||
| Appearance | Powder | |
| Color | Pink | |
| Compatibility & Detail Reproduction | Complies | 0 - 50 μm |
| Recovery from Deformation | Complies | >95 % |
| Strain in Compression | Complies | 5 - 20 % |
| Compressive Strength | Complies | > 0.35 Mpa |
| Deterioration | Complies | > 0.294 MPa |
Biocompatibility:
MARK3 alginate impression material, primary predicate device and secondary devices contacts directly with the oral mucosa (3 - 5 minutes) therefore they are categorized as surface contact devices with limited contact duration. Testing is performed for cytotoxicity (ISO19993-5 ), sensitization and irritation (ISO10993-10). The test results demonstrated that the proposed device MARK3 is biocompatible.
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Image /page/5/Picture/0 description: In the image, a hand wearing a white glove is holding a needle. The background is a light blue color. In the lower right corner, there is a blue logo that says "CAVEX" in white letters.
Conclusion:
The technical characteristics, material composition, principles of operation and indications for use of the proposed device MARK3 alginate (K141092) is comparable to several secondary devices. Therefore, Cavex Holland BV considers the MARK3 Alginate Impression Material to be as safe, as effective and performance substantially equivalent to the predicate devices.
eCopy Statement:
The eCopy is identical to the paper copy
Richard Woortman
Manager Technical Services
Cavex Holland BV
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).