The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon. Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.

AI/ML Overview

Based on the provided text, the document is a 510(k) summary for a dental "Impression Material" and does not describe an AI/ML-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, human-in-the-loop performance, etc.) are not applicable to this submission.

The document discusses the substantial equivalence of the "Impression Material" to a predicate device based on non-clinical tests and material properties.

Here's an analysis of the provided information, noting where the requested criteria are not applicable:

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

The relevant information is in "Table 2 Performance parameter" on page 5.

Item	Reported Device Performance (`Proposed device`)	Acceptance Criteria (Type 0)	Result
Consistency	32 mm	< 35mm	PASS
Compatibility with the die and cast materials	Complied	< 75 μm reproduction	PASS
Linear dimensional change %	0.69	< 1.5	PASS
Elastic recovery	97.73%	≥ 96.5%	PASS
Strain in compression %	4.52	0.8 ~ 20%	PASS

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for each test, but standard material testing typically involves a set number of samples for each specific property evaluation. This is a material, not a "device" in the AI/ML sense, so "test set" does not refer to a data cohort.
Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting. The manufacturer is "Zhengzhou Huaer Electro Optics Technology Co., Ltd" in China, so the testing was presumably performed there or by an outsourced lab. Given it's material testing, it would be "prospective" in the sense that samples were prepared and tested to demonstrate compliance.

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

Not Applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for material properties is established by adherence to defined ISO standards (ISO 4823 for Dentistry - Elastomeric impression materials, and ISO 10993 for biocompatibility), which specify the test methodologies and acceptable ranges.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As explained above, this is material property testing, not an AI/ML diagnostic or image-analysis device.

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/ML device. No MRMC study was performed. The submission explicitly states: "No clinical study is included in this submission." (Page 4, Section G)

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

Not Applicable. Not an AI/ML device.

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

The ground truth for this device is based on established quantifiable physical and biological properties as defined by International Organization for Standardization (ISO) standards:
- ISO 4823 Dentistry - Elastomeric impression materials for physical properties.
- ISO 10993 Biological Evaluation of Medical Devices (Parts 5, 10, 11) for biocompatibility.
The "acceptance criteria" are derived directly from these standards, meaning the material must perform within the specified ranges to be considered acceptable for its intended use.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment method for it. The product's compliance is shown through non-clinical testing against industry standards.

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 8, 2020

Zhengzhou Huaer Electro Optics Technology Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K201483

Trade/Device Name: Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: September 8, 2020 Received: September 11, 2020

Dear Ivy Wang:

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.

{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 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 mediation-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 Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K201483

Device Name Impression Material

Indications for Use (Describe)
Used for all crown, bridge, and orthodontic impression techniques.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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 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."

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

K201483

510(K) Summary

Date of Summary prepared: 2020-10-02

A. Applicant:

Zhengzhou Huaer Electro Optics Technology Co., Ltd Address: Floor 11, B of Building 18, the National University Science Park of Henan Province, Zhengzhou city, China, 450000 Contact Person: Li XiaoJun Tel: +86 13592524674 Mail: admin@cnhuaer.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Impression Material Common Name: Dental Impression Material

Regulatory Information Classification Name: Material, Impression Classification: Class II. Product code: ELW Regulation Number: 872.3660 Review Panel: Dental

C. Predicate device:

K152518 Vonflex S™ Putty VERICOM Co., Ltd.

D. Intended use of the device:

Used for all crown, bridge, and orthodontic impression techniques.

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

K201483

E. Device Description:

The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.

It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon.

Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.

F. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
A ISO 4823 Dentistry - Elastomeric impression materials

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate device

Table 1 Comparison Table

Device	Proposed Device	Predicate Device	Result
Manufacturer	Zhengzhou Huaer ElectroOptics Technology Co., Ltd	VERICOM Co., Ltd.	-
510K number	K201483	K152518	-
Model Name	Impression Material	Vonflex S™ Putty	-
Classification	Class II Device, ELW (21 CFR872.3660)	Class II Device, ELW (21 CFR872.3660)	Same
Intend use	Used for all crown, bridge,and orthodonticimpression techniques.	It is used for all crown, bridgeand orthodontic impressiontechniques.	Same
Standard conformed	ISO4823	ISO4823	Same
Physical properties	- Classification according toISO4823: Type 0- Dimensional accuracy:Max.1.5%- Consistency: Max. 35mm- Compatibility with the die andcast materials: 75 μm	- Classification according toISO4823: Type 0- Dimensional accuracy:Max.1.5%- Consistency: Max. 35mm- Compatibility with the die andcast materials: 75 μm	Same

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

K201483

	reproduction- Curve of the shrinkage (Strainin compression): Min.0.8 ~Max.20%	reproduction- Curve of the shrinkage (Strainin compression): Min.0.8 ~Max.20%
Raw Material	Vinyl polysiloxane	Vinyl polysiloxane	Same
Mixing Ratio	1:1	1:1	Same
Sterility	Non-sterile	Non-sterile	Same
Method of Manipulation	Hand-kneaded mixes	Hand-kneaded mixes	Same
Biocompatibility	ISO 10993	ISO 10993	Same

Table 2 Performance parameter

Item	Proposed device	Acceptance Criteria (Type 0)	Result
Consistency	32 mm	< 35mm	PASS
Compatibility withthe die and castmaterials	Complied	< 75 um reproduction	PASS
Linear dimensionalchange %	0.69	< 1.5	PASS
Elastic recovery	97.73%	$\ge 96.5%$	PASS
Strain incompression %	4.52	0.8 ~ 20%	PASS

I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantial equivalence with the legally marketed predicate device, Vonflex S™ Putty under K152518.

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).