A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.

AI/ML Overview

This document does not describe a study involving a medical device with AI components or an AI/ML algorithm that requires specific performance metrics like sensitivity, specificity, or measures of human reader improvement.

The device in question, "A-Silicone for Bite Registration," is a dental impression material. The information provided relates to its substantial equivalence application to the FDA, focusing on its physical and chemical properties and biocompatibility.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI) are not applicable to this kind of medical device submission.

However, I can extract the acceptance criteria and performance data for the physical properties testing that was conducted:

1. Acceptance Criteria and Device Performance (Physical Properties)

Items	Requirements per ISO 4823 (Acceptance Criteria)	Reported Device Performance (Test Conclusion)
Component colours	Different components in contrasting colours	Satisfactory
Consistency	$\leq$ 35mm	Satisfactory
Linear dimensional change	$\leq$ 1.5%	Satisfactory
Detail reproduction	75 $\mu$ m	Satisfactory
Elastic recovery	$\geq$ 96.5%	Satisfactory

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical, laboratory-based physical properties tests.

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

The document does not specify the sample size for each physical properties test.
Data provenance: The tests were conducted internally by "Shandong Huge Dental Material Corporation" as per "our company's" pre-test planning approaches and test methods. The country of origin for the data can be inferred as China, where the manufacturer is located. The tests are retrospective to the submission date.

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

Not applicable. The ground truth for physical properties (e.g., consistency, dimensional change, detail reproduction) is established by standardized laboratory measurement techniques defined by ISO 4823, not by expert consensus in a clinical sense.

4. Adjudication method for the test set:

Not applicable. The physical properties tests follow standardized protocols. There is no mention of adjudication, which is common in clinical imaging studies.

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 device is a material, not an AI diagnostic tool.

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

Not applicable. This device is a material, not an AI algorithm.

7. The type of ground truth used:

For physical properties: The ground truth is defined by the objective, measurable standards set forth in ISO 4823 Fourth edition 2015-08-01 Dentistry - Elastometric impression materials.
For biocompatibility: The ground truth is established by the results of tests performed fully following the ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation).

8. The sample size for the training set:

Not applicable. This device is a material, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 24, 2020

Maggie Zheng, Regulatory Affairs Manager Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City. CHINA 276800 Shandong Province

Re: K201684

Trade/Device Name: A-Silicone for Bite Registration Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 15, 2020 Received: June 22, 2020

Dear Maggie Zheng:

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 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

{1}------------------------------------------------

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 Srinvas "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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201684

Device Name A-Silicone for Bite Registration

Indications for Use (Describe) A-Silicone for Bite Registration is indicated for making occlusal registrations.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect

ete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

the

{3}------------------------------------------------

K201684

510 (k) Summary

This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

1. Date Summary Prepared: September 24, 2020
1. Submitter Information:

Name	Shandong Huge Dental Material Corporation
Address	No. 68 Shanhai Road, Donggang District, Rizhao CityShandong Province, 276800, P.R. China
Telephone	086-633-2277285
Fax	086-633-2277298
Contact Person	Mrs. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: A-Silicone for Bite Registration

Common name: Bite Registration

Classification name: Impression material (21 CFR 872.3660)

Regulatory Class: II

Product Code: ELW

4. Predicate Device Information

Table 1: Predicate Device Information
Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
Zhermack S. P. A.	Occlufast Rock	K024034	ELW	Primary

This predicate have not been subject to a design-related recall.

No reference devices were used in this submission.

5. Description of Device

{4}------------------------------------------------

HUGE

6. Indications for Use

A-Silicone for Bite Registration is indicated for making occlusal registrations.

7. Technological Characteristics

All components of the A-Silicone for Bite Registration are based upon industry well-known chemistry. A-Silicone for Bite Registration is vinylpolysiloxane based materials which has two components addition-type (platinum-catalyzed) silicone rubber. If two parts were mixed together, it will transform into elastomeric materials by the platinum-catalyzed addition curing reaction. The following table shows the technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:

Table 4: Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device(A-Silicone for Bite Registration)	Primary predicate device(Occlufast Rock, K024034)
Descriptionof Material	Vinylpolysiloxane based	Vinylpolysiloxane based
Mode of Action	Addition-curing bite registration	Addition-curing bite registration
Indications of Use	A-Silicone for Bite Registration isindicated for making occlusalregistrations.	Zhermack OCCLUFAST ROCK a dentalimpression material intended to beplaced on a preformed impression tray andused to reproduce the structure ofa patient's teeth and gums.
Prescription/over-the-counter use	Prescription	Prescription
Physical Form	Double cartridge system 1:1	Double cartridge system 1:1
Accessories	Mixing tips, Dispenser	Mixing tips, Dispenser
Physical Properties	HUGE ZHERMACK Remarks Trade name A Silicone ForBite Registration Occlufast Rock / Consistency(≤35mm) 20mm 23mm Similar Linear dimensionalchange(<1.5%) - 0.2% - 0.2% Same

{5}------------------------------------------------

Table 4: Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device(A-Silicone for Bite Registration)	Primary predicate device(Occlufast Rock, K024034)
Detail reproduction(75µm)	75µm	Same
Elastic recovery( $≥$ 96.5%)	99%	Same

The subject device and primary predicate device have minor different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence, both products are intended for bite registration work in the surgery and laboratory. Besides, other comparison items such as description of material, mode of action, physical form, accessories and physical properties, etc. are the same. And both products are supplied for prescription use.

8. Summary of Non-clinical performance testing

Physical properties testing

A-Silicone for Bite Registration has similar physical and chemical properties as the predicate devices. A-Silicone for Bite Registration was tested and met the applicable requirements of the FDA Recognized Consensus standard: ISO 4823 Fourth edition 2015-08-01 Dentistry -Elastometric impression materials.

Summary of Physical Properties Testing
Items	Requirements per ISO 4823	Requirements of our companyand Pre-test planning approachesand test methods of our company	Test Conclusion
Component colours	Different components intended foruse in the same mixture shall besupplied in contrasting colours toprovide a means of determiningwhen the components have beenthoroughly mixed.	Same as ISO 4823	Satisfactory
Consistency	$\leq$ 35mm	Same as ISO 4823	Satisfactory
Linear dimensionalchange	$\leq$ 1.5%	Same as ISO 4823	Satisfactory
Detail reproduction	75 $\mu$ m	Same as ISO 4823	Satisfactory
Elastic recovery	$\geq$ 96.5%	Same as ISO 4823	Satisfactory

{6}------------------------------------------------

Biocompatibility testing

The subject device. A-Silicone for Bite Registration, is substantially equivalent to the predicate device that have been legally marketed for decades and with no clinical adverse events. The formulation of the subject device does not contain any non-conventional chemicals compared to the legally marketed predicate device.

Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization and Irritation.

9. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed for the subject device.

10. Conclusions

Based on the indications for use, technological characteristics, performance testing and other information provided in this premarket notification, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate device affecting neither the general intended use nor substantial equivalence. Shandong Huge Dental Material Corporation concludes that the subject device is substantially equivalent to the predicate device described herein.

Regulation Number and Section

§ 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).