(88 days)
Not Found
No
The summary describes a dental material (pulp capping agent/liner) and does not mention any computational or analytical capabilities that would involve AI or ML.
Yes
The device is a pulp capping agent and liner, which are used to treat and protect the dental pulp, thus providing a therapeutic benefit to the patient.
No
The device is described as a "pulp capping agent" and "liner," and its "Indications for Use" are "1. Pulp capping agent" and "2. Liner." This indicates it's a therapeutic material used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a "Resin modified light cure pulp capping material / liner," which 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/Indications for Use: The intended uses are "Pulp capping agent" and "Liner." These are procedures performed directly on a patient's tooth structure, not on samples taken from the body for diagnostic purposes.
- Device Description: The description "Resin modified light cure pulp capping material / liner" further reinforces that it's a material used in a dental procedure, 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), detecting biomarkers, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to protect and treat the dental pulp, which is a therapeutic and protective function, not a diagnostic one.
N/A
Intended Use / Indications for Use
- Pulp capping agent
- Liner
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
Resin modified light cure pulp capping material / liner (indications from labeling).
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)
Not Found
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
§ 872.3250 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of the logos is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font size than the rest of the text.
November 20, 2020
S&C Polymer Silicon- und Composite Spezialitaten GmbH Christian Bottcher Official Correspondent to FDA, Reg. Compliance Officer Robert-Bosch-Str. 2 Elmshorn, Schleswig-Holstein 25335 GERMANY
Re: K202413
Trade/Device Name: LC ResinCal PC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK Dated: August 11, 2020 Received: August 24, 2020
Dear Christian Bottcher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K202413
Device Name
LC ResinCal PC
Indications for Use (Describe)
-
Pulp capping agent
-
Liner
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
1. Submitter
| Name of company: | S&C Polymer Silicon- und Composite Spezialitäten GmbH |
|---|---|
| Address: | Robert-Bosch-Str. 2, 25335 Elmshorn, Germany |
| Phone: | 0049 4121 483 0 |
| Fax: | 0049 4121 483 184 |
| Contact person: | Dr. Christian Böttcher |
| Date prepared: | 20. November 2020 |
2. Device name
| Trade name: | LC ResinCal PC |
|---|---|
| Common name: | Liner and pulp capping material |
| Device classification name: | Calcium hydroxide cavity liner |
| (Regulation description) | |
| Regulatory number: | 872.3250 |
| Product code: | EJK |
| 510(k) number: | K202413 |
3. Device description
Resin modified light cure pulp capping material / liner (indications from labeling).
4. Intended use of the devices
LC ResinCal PC is a light cure resin reinforced pulp capping material with MTA-fillers, designed to perform as a barrier and to protect the pulp. Its physical properties and uses are similar to the predicate device.
5. Indication for use of the devices
- Pulp capping agent
- Liner
Detailed information on the indication of the subject device LC ResinCal PC can be found in the device description of this 510(k) submission.
6. Device for which substantial equivalence is claimed
Primary predicate device: TheraCal LC (Bisco)
510(k) number: K063237 (introduced into the US-Market 2006)
7. Device comparison with the predicate device
The primary predicate device TheraCal LC (Bisco) has been found to be substantially equivalent under the 510(k) premarket notification as class II dental device under CFR 872.3250 Code EJK.
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| | Subject device
LC ResinCal PC | Primary predicate device
TheraCal LC (Bisco) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Resin modified light cure
pulp capping material / liner | Resin-Modified
Calcium
Silicate Pulp Protectant/Liner |
| Intended use | Light cure resin reinforced
pulp capping material with
MTA-fillers, designed to
perform as a barrier and to
protect the pulp. | Light-cured resin-modified
calcium
pulp
protectant/liner designed to
perform as a barrier and to
protect the dental pulpal
complex. |
| Mechanism of action | Light curing | Light curing |
| Indications | - Pulp capping agent
- Liner | - Pulp capping agent
- Liner |
| Ingredients
(general description) | - Portland cement - Photo intiators
- Resins (e.g. BIS-GMA*) | - Portland cement
- Photo intiators
- Resins (e.g. BIS-GMA*) |
| Form of delivery | black syringe | black syringe |
- BIS-GMA (Bisphenol A-glycidyl methacrylate)
8. Similarities and differences
8.1. Similarities
LC ResinCal PC and the primary predicate device TheraCal LC (Bisco) have a similar description and intended use as a light cure resin reinforced pulp capping material with MTAfillers, designed to perform as a barrier and to protect the pulp. The mechanism of action and the indications (as pulp capping agent and liner) are also the same. The general chemical composition, the working properties (intensity, wavelength and curing time) and the physical properties (working time, depth of cure, barcol hardness and calcium release) are very similar, as described in the device description and in the substantial equivalence discussion of this 510(k) submission.
8.2 Differences
The detailed chemical composition of the subject device LC ResinCal PC, as described in the device description of this 510(k) submission differs from the chemical composition of the primary predicate device TheraCal LC (Bisco).
Discussion of the differences
The additional ingredients of the subject device LC ResinCal PC are typical ingredients for dental materials. A research on the FDA medical device premarket notification (510(k)) database shows, that all ingredients have been used in the other products which are already 510(k) registered and are therefore allowed to be marketed in the United States.
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9. Conclusion
The comparison worked out above and the further elaboration of information within this 510(k) submission demonstrate that the subject device LC ResinCal PC is substantially equivalent to the primary predicate device TheraCal LC (Bisco) in terms of description, intended use, indications for use, chemical composition.