(356 days)
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
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.
This document is a 510(k) premarket notification for a dental device, specifically a calcium hydroxide liner, and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information.
The document discusses "LC Calcium Hydroxide Liner" and focuses on:
- Regulatory information: Classification, product code, and substantial equivalence to a predicate device (Calcimol LC, VOCO GmbH, K 924182).
- Device description: White paste, light-cure, for indirect pulp capping and cavity lining.
- Performance data: Non-clinical tests like working time, barcol hardness, pH-value, water sorption, water solubility, flexural strength, and depth of cure, all tested according to ISO 4049. These are standard material property tests for dental composites, not AI-related evaluations.
- Technological characteristics: Comparison with the predicate device, highlighting similarities in appearance, delivery form, polymerization, application, and general ingredients. It mentions a reformulation of the subject device with different quantities of chemical components, and that performance testing was done to validate this change.
There is no mention of:
- Acceptance criteria for an AI device
- Any study involving AI (e.g., comparative effectiveness study, standalone algorithm performance)
- Sample sizes for AI test/training sets
- Expert ground truth establishment or adjudication methods for AI
- Effect sizes of AI assistance
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets them.
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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.
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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
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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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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
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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 pressureonto the back of the syringefollowed by applicationthrough needles | extrusion via pressureonto the back of the syringefollowed by applicationthrough needles |
| Ingredients (general description) | fillersresinsalkalining agentinitiators | fillersresinsalkalining agentinitiators |
| Mechanism of Action | applicationlight curing | applicationlight 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.
§ 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.