(356 days)
K 924182
Not Found
No
The device description and performance studies focus on the material properties and clinical application of a dental liner, with no mention of AI or ML.
No
The document describes a dental liner intended as a protective barrier. It is not described as treating a disease or condition, making it a non-therapeutic device.
No
This device is a dental lining material intended for use as a protective barrier and for lining cavities, not for diagnosing medical conditions.
No
The device description clearly states it is a "radiopaque one component visible light curing liner containing calcium hydroxide" and lists chemical components, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for application to dentin as a protective barrier and for lining cavities. This is a direct application within the body (or on a part of the body) for a therapeutic or protective purpose.
- Device Description: The description details a material applied to dentin, which is a tissue within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a physiological state, health, or disease. IVDs are typically used for tests on blood, urine, tissue samples, etc.
Therefore, the LC Calcium Hydroxide Liner is a medical device, but it falls under a different classification than an IVD. It's a dental material used directly in patient care.
N/A
Intended Use / Indications for Use
Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping)
Lining of cavities for following filling procedures
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
LC Calcium Hydroxide Liner is a radiopaque one component visible light curing liner containing calcium hydroxide. It is intended for indirect pulp capping and for lining of cavities where filling procedures will follow and can be applied in thin layers followed by light curing of the material. The chemical components include fillers, resins, an alkalining agent, as well an initiator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin (teeth)
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)
Non-clinical performance data for this device included the following:
Working time, the barcol hardness and the pH-value.
Testing also included water sorption, water solubility, and flexural strength , and depth of cure were all tested according to ISO 4049.
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.
K 924182
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
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.
0
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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
S & C Polymer Silicon- und Composite Spezialitaeten GmbH Dr. Christian Boettcher Official Corresponent / Director Regulatory Affairs Robert-Bosch-Strasse 2 Elmshorn, Schleswig-Holstein 25335 GERMANY
Re: K141047
Trade/Device Name: LC Calcium Hydroxide Liner Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: March 5, 2015 Received: March 9, 2015
Dear Dr. Boettcher:
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.
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tina
Kiang -S
for 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
Enclosure
2
Indications for Use
510(k) Number (if known) K141047
Device Name
LC Calcium Hydroxide Liner
Indications for Use (Describe)
Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping)
Lining of cavities for following filling procedures
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
Submitter
Name of company: S&C Polymer Silicon- und Composite Spezialitaeten GmbH Address: Robert-Bosch-Strasse 2, D-25335 Elmshorn (Germany) Phone: 0049 4121 483 0 Fax: 0049 4121 483 184 Contact Person: Dr. Christian Boettcher
Date of preparation: April 6th 2015
Device Name:
| Trade name: | LC Calcium Hydroxide Liner |
|---|---|
| Common Name: | Calcium Hydroxide Liner |
| Classification Name: | Liner, Cavity, Calcium Hydroxide, per 21CFR § 872.3250 |
| Classification: | II |
| Product Code: | EJK |
Devices for which Substantial Equivalence is Claimed:
Calcimol LC, VOCO GmbH, K 924182
Device description:
LC Calcium Hydroxide Liner is a radiopaque one component visible light curing liner containing calcium hydroxide. It is intended for indirect pulp capping and for lining of cavities where filling procedures will follow and can be applied in thin layers followed by light curing of the material. The chemical components include fillers, resins, an alkalining agent, as well an initiator.
Intended Use of the Devices:
LC Calcium Hydroxide Liner is intended for:
- Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping)
- lining of cavities for following filling procedures
4
Performance Data:
Non-clinical performance data for this device included the following:
Working time, the barcol hardness and the pH-value.
Testing also included water sorption, water solubility, and flexural strength , and depth of cure were all tested according to ISO 4049.
Technological Characteristics:
| Subject device | Predicate device | |
|---|---|---|
| Appearance | white paste | white paste |
| Form of delivery | black syringe | black syringe |
| Method of polymerization | light cure | light cure |
| Application | extrusion via pressure | |
| onto the back of the syringe | ||
| followed by application | ||
| through needles | extrusion via pressure | |
| onto the back of the syringe | ||
| followed by application | ||
| through needles | ||
| Ingredients (general description) | fillers | |
| resins | ||
| alkalining agent | ||
| initiators | fillers | |
| resins | ||
| alkalining agent | ||
| initiators | ||
| Mechanism of Action | application | |
| light curing | application | |
| light curing |
The subject device shares both similarities and differences to the noted predicate. The subject device has the same chemical composition as the predicate device; however, the subject device has been reformulated using different quantities of the chemical components. Performance testing was done to validate the change in the chemical composition and the subject device was found to perform as well as the predicate.
In regards to the intended use, the Indication for Use, the target population, the anatomical sites, the design, the performance, the standards to be met, the materials, and the biocompatibility the product of this submission is substantially equivalent to the predicate device.