(154 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental sealant material, with no mention of AI or ML.
No
The device is a sealant for teeth, used for preventative purposes rather than treating an existing disease or condition.
No
Explanation: The device is described as a "light-curing material for sealing the enamel pits and fissures of teeth" and a "fissure sealant." Its intended use is to prevent dental caries by sealing pits and fissures, which is a therapeutic/preventative action, not a diagnostic one.
No
The device description clearly states it is a light-curing material composed of resin, photo initiator, and inorganic fillers, packaged in syringes or bottles. This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "seal the enamel pits and fissures of teeth." This is a direct treatment or preventative measure applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a light-curing material applied to the teeth. This aligns with a dental material used in a clinical procedure, not a reagent or instrument used for in vitro testing.
- Anatomical Site: The anatomical site is the "enamel pits and fissures of teeth," which is part of the patient's body. IVDs typically interact with samples (blood, urine, tissue, etc.) taken from the body.
- Performance Studies: The performance studies described are "in-vitro bench tests" on the material itself (depth of cure, flexural strength, etc.), not studies evaluating its ability to diagnose a condition based on patient samples.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.
Product codes
EBC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel pits and fissures of teeth
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 |
| 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
4
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:
| | Technological
Characteristics | 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 light
curing material for sealing the enamel pits
and fissures of teeth. | 3MTM ESPETM ClinproTM Sealant is
indicated for:
Pit and fissure sealant. |
| | Prescription/over-
the-counter use | Prescription | Prescription |
| | Color-change
technology | The color-change technology is a unique
color-change feature. The product (Type | The color-change technology is a unique
color-change feature. The product is pink |
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| Technological
| Characteristics | Subject device | Primary predicate device |
|---|---|---|
| Proseal Enamel Coating Resin(K230455) | 3M™ ESPET™ Clinpro™ Sealant(K992326) | |
| F) is pink when applied to the tooth | ||
| surface, and changes to an opaque | ||
| off-white color when exposed to light. The | ||
| pink color aids the dental professional in | ||
| the accuracy and amount of material | ||
| placed during the sealant procedure. When | ||
| light-cured, the pink sealant will transform | ||
| to an opaque off-white color. The change | ||
| of color from pink to opaque off-white is | ||
| not a cure indicator. | when applied to the tooth surface, and | |
| changes to an opaque off-white color when | ||
| exposed to light. The pink color aids the | ||
| dental professional in the accuracy and | ||
| amount of material placed during the sealant | ||
| procedure. When light-cured, the pink | ||
| sealant will transform to an opaque off-white | ||
| color. The change of color from pink to | ||
| opaque 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 physical | |
| properties as they all meet the criteria per ISO 6874 and FDA Staff Dental Composite | ||
| Resin Devices -Premarket Notification [510(k)] Submissions Document issued on: | ||
| October 26, 2005”. | ||
| FDA-Recognized | ||
| Standards | 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.