Proseal Enamel Coating Resin is a light-curing fissure sealant and is mainly composed of methacrylate resin, photo initiator system and inorganic fillers. It is packaged in syringes or bottles.

AI/ML Overview

This document is a 510(k) Summary for the Proseal Enamel Coating Resin. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance in a diagnostic or clinical setting.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to the performance of an AI/diagnostic device, which is not what this document describes.

Here's an analysis based on the available information:

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

The document states that in-vitro bench tests were performed and that the "test results indicated that the Proseal Enamel Coating Resin meets the pass/fail criteria and supports substantial equivalence when compared to the predicate device on physical properties." It also notes that the device is classified as Class 2 sealant in accordance with ISO 6874:2015.

The specific acceptance criteria (pass/fail criteria) are implied to be derived from ISO 6874:2015 and FDA guidance "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005". However, the document does not list the specific numerical acceptance criteria.

The reported device performance is only described qualitatively as "meets the pass/fail criteria." Specific numeric performance values for each test (depth of cure, flexural strength, shear bonding strength, compressive strength, water sorption, solubility, film thickness, and elastic modulus) are not provided in this summary.

Acceptance Criteria (Derived from ISO 6874:2015 & FDA Guidance)	Reported Device Performance
(Specific numerical criteria not detailed in the document)	Meets criteria
Depth of Cure	Meets criteria
Flexural Strength	Meets criteria
Shear Bonding Strength	Meets criteria
Compressive Strength	Meets criteria
Water Sorption	Meets criteria
Solubility	Meets criteria
Film Thickness	Meets criteria
Elastic Modulus	Meets criteria

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

The document mentions "in-vitro bench tests" for physical properties and "Biocompatibility tests" but does not specify the sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a material science study, not a study evaluating human expert performance or diagnostic accuracy.

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

Not applicable. This is a material science study.

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 a material science product, not an AI or diagnostic device that would involve human readers.

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

Not applicable. This is a material science product.

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

For the physical property tests, the "ground truth" would be the scientifically established and standardized measurement protocols and evaluation criteria defined by ISO 6874:2015 and FDA guidance for dental composite resin devices. For biocompatibility tests, the ground truth would be established by ISO 10993 standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

Summary

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July 25, 2023

Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, Shandong Province 276800 CHINA

Re: K230455

Trade/Device Name: Enamel Coating Resin Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: April 3, 2023 Received: April 7, 2023

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.

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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 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.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230455

Device Name Proseal Enamel Coating Resin

Indications for Use (Describe)

Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.

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)

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K230455

005 510 (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: July 21, 2023

2. Submitter Information:

Owner's Name	Rizhao HuGe Biomaterials Company, Ltd.
Address	No.2 North Zhaoyang Road, District of Donggang, Rizhao City,Shandong Province, China 276800
Telephone	0086 633 2277268
Contact Person	Ms. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: Proseal Enamel Coating Resin Common name: Dental sealant, pit and fissure sealant Classification name: Sealant, Pit And Fissure, And Conditioner Regulatory Class: II Product Code: EBC

4. Predicate Device Information

Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
3M COMPANY	3MTM ESPETM ClinproTM Sealant	K992326	EBC	Primary

No reference devices were used in this submission.

5. Description of Device

Proseal Enamel Coating Resin is a light-curing fissure sealant and is mainly composed of methacrylate resin, photo initiator system and inorganic fillers. It is packaged in syringes or

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bottles.

6. Indications for Use

Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.

7. Summary of Physical Properties Tests

Proseal Enamel Coating Resin is classified as Class 2 sealant in accordance with ISO 6874: 2015. The physical properties were determined and tested according to ISO 6874: 2015 and FDA guidance "Guidance for Industry and FDA Staff Dental Composite Resin Devices -Premarket Notification [510(k)]Submissions Document issued on: October 26, 2005".

In-vitro bench tests were performed on the Proseal Enamel Coating Resin. The test results indicated that the Proseal Enamel Coating Resin meets the pass/fail criteria and supports substantial equivalence when compared to the predicate device on physical properties. The main test items inleude depth of cure, flexural strength, shear bonding strength, compressive strength, water sorption, solubility, film thickness and elastic modulus.

The risk analysis of Proseal Enamel Coating Resin was conducted according to ISO 14971 and the residual risk is considered acceptable.

8. Technological Characteristics

The following table shows the significant technological characteristics and indicates the similarities and differences with the predicate device:

TechnologicalCharacteristics	Subject device	Primary predicate device
	Proseal Enamel Coating Resin(K230455)	3MTM ESPETM ClinproTM Sealant(K992326)
Physical Form	Flowable Paste	Flowable Paste
Indications of Use	Proseal Enamel Coating Resin is a lightcuring material for sealing the enamel pitsand fissures of teeth.	3MTM ESPETM ClinproTM Sealant isindicated for:Pit and fissure sealant.
Prescription/over-the-counter use	Prescription	Prescription
Color-changetechnology	The color-change technology is a uniquecolor-change feature. The product (Type	The color-change technology is a uniquecolor-change feature. The product is pink

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TechnologicalCharacteristics	Subject device	Primary predicate device
	Proseal Enamel Coating Resin(K230455)	3M™ ESPET™ Clinpro™ Sealant(K992326)
	F) is pink when applied to the toothsurface, and changes to an opaqueoff-white color when exposed to light. Thepink color aids the dental professional inthe accuracy and amount of materialplaced during the sealant procedure. Whenlight-cured, the pink sealant will transformto an opaque off-white color. The changeof color from pink to opaque off-white isnot a cure indicator.	when applied to the tooth surface, andchanges to an opaque off-white color whenexposed to light. The pink color aids thedental professional in the accuracy andamount of material placed during the sealantprocedure. When light-cured, the pinksealant will transform to an opaque off-whitecolor. The change of color from pink toopaque off-white is not a cure indicator.
Curing method	Light cure	Light cure
Delivery form	Syringe or bottle	Syringe or bottle
Physical Properties	The subject device and the predicate device have substantially equivalent physicalproperties as they all meet the criteria per ISO 6874 and FDA Staff Dental CompositeResin Devices -Premarket Notification [510(k)] Submissions Document issued on:October 26, 2005”.
FDA-RecognizedStandards	ISO 6874; ISO 7405; ISO 10993-1	ISO 6874; ISO 7405; ISO 10993-1

All compositions of the subject device are based upon industry well-known chemistry. The technological characteristics of the subject device are very similar to those of the predicate device, 3M™ ESPE™ Clinpro™ Sealant (K992326). The subject device is a similar product, manufactured with similar materials and used in the same way by the same types of users and patient populations. The subject device and primary predicate device have minor difference in Composition of Materials. However, the difference does not affect the intended use or substantial equivalence, both products are intended for pit and fissure sealant. Besides, other comparison items such as physical form, curing method, delivery form and physical properties, etc. are the same or very similar. And both products are supplied for prescription use.

9. Summary of Biocompatibility

The subject device, Proseal Enamel Coating Resin, is substantially equivalent to the predicate device.

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

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Genotoxicity.

10. Clinical Performance Data

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

11. Conclusions

Based on the indications for use, technological characteristics, performance testing and comparison to predicate device, the subject device is substantially equivalent to the predicate device described herein.

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.