(76 days)
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
The Dental 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. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.
The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Type 0) | Reported Device Performance | Result |
|---|---|---|---|
| Consistency | < 35mm | 32 mm | PASS |
| Compatibility with gypsum | < 75 um | Complied | PASS |
| Detail Reproduction | < 75 um | Complied | PASS |
| Linear dimensional change % | < 1.5 | 0.72 | PASS |
| Elastic recovery | ≥ 96.5% | 98.23% | PASS |
| Strain in compression % | 0.8 ~ 20% | 4.41 | PASS |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each of the physical property tests. It mentions that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device." The data provenance is not specified in terms of country of origin, nor whether it was 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. This is a non-clinical study evaluating the physical properties of a dental impression material, not a study involving human or image-based ground truth established by experts. The ground truth for these tests is defined by the standards (ISO 4823) and the quantitative acceptance criteria.
4. Adjudication method for the test set:
Not applicable, as this is a non-clinical study measuring physical properties against established standards.
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 document pertains to the physical properties of a dental impression material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a non-clinical study for a medical device (material), not an algorithm.
7. The type of ground truth used:
The ground truth used for this study is based on established international standards for dental elastomeric impression materials, specifically ISO 4823. The acceptance criteria are quantitative measurements derived from these standards.
8. The sample size for the training set:
Not applicable. This is a non-clinical study assessing the physical properties of a material, not a machine learning model 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 non-clinical physical property evaluation.
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July 28, 2021
Nanchang Dental Bright Technology Co., Ltd Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA
Re: K211489
Trade/Device Name: Dental Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: May 26, 2021 Received: June 1, 2021
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.
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
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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 (OS) 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, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211489
Device Name Dental Impression Material
Indications for Use (Describe)
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
| 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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Nanchang Dental Bright Technology Co., Ltd Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone, Nanchang, Jiangxi, China
K211489 510(K) Summary
A. Applicant:
Nanchang Dental Bright Technology Co., Ltd Address: Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone, Nanchang, Jiangxi, China Contact Person: Justin Qin Tel: +86 15079010001 Mail: Justin@enjoywhite.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Dental 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:
K201483 Impression Material Zhengzhou Huaer Electro Optics Technology Co., Ltd.
D. Indications for use of the device:
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
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Nanchang Dental Bright Technology Co., Ltd Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone, Nanchang, Jiangxi, China
E. Device Description:
The Dental 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.
The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.
F. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
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
-
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 | Predicate Device | Proposed Device | Result |
|---|---|---|---|
| Manufacturer | Zhengzhou Huaer ElectroOptics Technology Co., Ltd | Nanchang Dental BrightTechnology Co., Ltd | - |
| 510K number | K201483 | - | - |
| Model Name | Impression Material | Dental Impression Material | - |
| Classification | Class II Device, ELW (21 CFR872.3660) | Class II Device, ELW (21 CFR872.3660) | Same |
| Indications for use | Used for all crown, bridge,and orthodontic impressiontechniques. | The Dental ImpressionMaterial is intended for usewith all crowns, bridges, andorthodontic impressiontechniques to reproduce thestructure of a patient's teethand gums. | Actually sameindicationsdescribedwith differentwords. |
| Standard conformed | ISO4823 | ISO4823 | Same |
| Physical properties | - Classification according toISO4823: Type 0- Dimensional accuracy:Max.1.5%- Consistency: Max. 35mm | - Classification according toISO4823: Type 0- Dimensional accuracy:Max.1.5%- Consistency: Max. 35mm | Same |
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Nanchang Dental Bright Technology Co., Ltd Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone, Nanchang, Jiangxi, China
| - Compatibility with the dieand cast materials: 75 μmreproduction | - Compatibility with the dieand cast materials: 75 μmreproduction | ||
|---|---|---|---|
| - Curve of the shrinkage(Strain in compression):Min.0.8 ~ Max.20% | - Curve of the shrinkage(Strain in 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 ofManipulation | 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 withgypsum | Complied | < 75 um | PASS |
| Detail Reproduction | Complied | < 75 um | PASSS |
| Linear dimensionalchange % | 0.72 | < 1.5 | PASS |
| Elastic recovery | 98.23% | ≥ 96.5% | PASS |
| Strain incompression % | 4.41 | 0.8 ~ 20% | PASS |
l. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K201483.
§ 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).