This document is a 510(k) Pre-Market Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the requested information (1-9) about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided directly from the given text. The document describes a comparison to a predicate, not a performance study against predefined acceptance metrics for the new device.

However, I can extract information related to the device comparison and the basis of the substantial equivalence claim.

Here's what can be inferred or directly stated from the provided text, while acknowledging the limitations regarding a "study that proves the device meets the acceptance criteria" in the traditional sense of a performance study:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicitly based on Predicate Equivalence): The document implies that the "acceptance criteria" for the new device, LC ResinCal PC, are that its performance and characteristics are "substantially equivalent" to the predicate device, TheraCal LC (Bisco). While explicit numerical acceptance criteria for a new performance study are not given, the goal is to match or be comparable to the predicate.
Reported Device Performance (Comparative): The performance is reported in terms of similarities to the predicate across various attributes.

Feature / Performance Aspect	Predicate Device (TheraCal LC)	Subject Device (LC ResinCal PC)	Comparison / "Performance"
Description	Resin-Modified Calcium Silicate Pulp Protectant/Liner	Resin modified light cure pulp capping material / liner	Similar
Intended Use	Light-cured resin-modified calcium pulp protectant/liner designed to perform as a barrier and to protect the dental pulpal complex.	Light cure resin reinforced pulp capping material with MTA-fillers, designed to perform as a barrier and to protect the pulp.	Similar
Mechanism of Action	Light curing	Light curing	Same
Indications	- Pulp capping agent- Liner	- Pulp capping agent- Liner	Same
Ingredients (General)	- Portland cement- Photo initiators- Resins (e.g. BIS-GMA*)	- Portland cement- Photo initiators- Resins (e.g. BIS-GMA*)	Very similar (stated as "general chemical composition... very similar")
Working Properties	(Not explicitly detailed, but implied to be similar)	(Not explicitly detailed, but implied to be similar)	Very similar (intensity, wavelength, curing time)
Physical Properties	(Not explicitly detailed, but implied to be similar)	(Not explicitly detailed, but implied to be similar)	Very similar (working time, depth of cure, barcol hardness, calcium release)
Form of Delivery	black syringe	black syringe	Same

2. Sample size used for the test set and the data provenance

This document does not describe a clinical or lab "test set" in the context of performance testing for the new device with a specific sample size. The "test" here is a comparison to a predicate device based on its known characteristics and regulatory clearance.
Data Provenance: The data provenance for the comparison is based on the characteristics of the predicate device (TheraCal LC, K063237, introduced to the US market in 2006) and the detailed chemical composition and properties of the subject device (LC ResinCal PC). No information on country of origin for specific "test data" is provided, nor whether it's retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this 510(k) summary. "Ground truth" in this document is effectively the established performance and safety profile of the predicate device, and the detailed specifications of the new device being compared. No experts were used to establish a "ground truth" for a test set in a diagnostic or clinical performance study.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication in the context of a performance study. The "adjudication" is essentially the FDA's review and determination of substantial equivalence based on the provided comparative data.

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

Not applicable. This is not an AI/imaging device, nor does the document describe any MRMC or comparative effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the comparison is the established characteristics and regulatory clearance of the predicate device (TheraCal LC) as known and accepted by the FDA when it was cleared under K063237. For the new device, the "ground truth" of its properties is based on the manufacturer's internal testing and documentation of its chemical composition and physical properties.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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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

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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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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 deviceLC ResinCal PC	Primary predicate deviceTheraCal LC (Bisco)
Description	Resin modified light curepulp capping material / liner	Resin-ModifiedCalciumSilicate Pulp Protectant/Liner
Intended use	Light cure resin reinforcedpulp capping material withMTA-fillers, designed toperform as a barrier and toprotect the pulp.	Light-cured resin-modifiedcalciumpulpprotectant/liner designed toperform as a barrier and toprotect the dental pulpalcomplex.
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.

Regulation Number and Section

§ 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.