(157 days)
Not Found
No
The summary describes a material (polymers) used for fabricating dentures, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is a material used for a denture base, which replaces missing teeth. It is a prosthetic device, not a therapeutic one that treats or cures a disease or condition.
No
The device, "Denture Base Polymers," is used for fabrication and repair of dentures, which is a therapeutic and restorative purpose, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly states it is composed of powder and liquid materials (polymethyl methacrylate and methyl methacrylate), which are physical components, 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 for the "fabrication and repair of partial and full denture base for patients with missing teeth." This is a restorative dental device used to replace missing teeth, not a device used to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description details the chemical composition of the materials used to create the denture base. This aligns with a material used for fabrication, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Anatomical Site: While it's used "on teeth," this refers to the placement of the fabricated denture, not a diagnostic test performed on the teeth themselves or samples from the teeth.
- Performance Studies: The statement "Clinical performance testing has not been performed on the subject device" further supports that this is not a diagnostic device, as IVDs typically require performance studies related to their diagnostic accuracy.
In summary, the device is a material used to create a dental prosthesis, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
Product codes
EBI
Device Description
Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional / used in hospital, dental clinic and relevant places
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
Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity; Sensitization; Irritation or Intracutaneous Reactivity; Acute Systemic Toxicity; Material-Mediated Pyrogenicity; Subchronic Toxicity; Genotoxicity and Implantation. Clinical performance testing has not been performed on the subject device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2022
Shandong Huge Dental Material Corporation Maggie Zheng Regulatory Affairs Manager No. 68 Shanhai Road, Donggang District Rizhao City, Shandong 276800 China
Re: K220680
Trade/Device Name: Denture Base Polymers Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: April 27, 2022 Received: May 2, 2022
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, 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) K220680
Device Name Denture Base Polymers
Indications for Use (Describe)
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing 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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005 510 (k) Summary K220680
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
1. Date Summary Prepared: July 20, 2022
2. Submitter Information:
Name | Shandong Huge Dental Material Corporation |
---|---|
Address | No. 68 Shanhai Road, Donggang District, Rizhao City, Shandong |
Province, 276800, P.R. China | |
Telephone | 086-633-2277268 |
Contact Person | Ms. Maggie Zheng |
Contact Title | Regulatory Affairs Manager |
zhengxy@hugedent.com |
3. Device Name
Trade name: Denture Base Polymers Common name: Dental base material Classification name: resin, denture, relining, repairing, rebasing (21 C.F.R. 872.3760) Regulatory Class: II Product Code: EBI
4. Substantially Equivalent Device
| Company Name | Device Name | 510 (k)
NO. | Substantially
Equivalent (SESE)
Decision Date | Product code | Remarks |
|---------------------|----------------------------------------------------------------|----------------|-----------------------------------------------------|--------------|------------------------|
| VERTEX-DENTAL
BV | Vertex Rapid
Simplified | K102654 | 12/03/2010 | EBI | Primary
Predicate |
| VERTEX-DENTAL
BV | Vertex Self Curing,
Vertex Castavaria,
Vertex Castapress | K102640 | 03/25/2011 | EBI | Secondary
Predicate |
These predicate devices have not been subject to a design-related recall.
5. Description of Device
Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.
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Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth, and its extensive indications can meet the needs of the production of complete denture.
6. Indications for use
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
7. Summary of Physical and Chemical Properties Tests
-
Chemical Composition:
The device has similar chemical composition as the predicate devices. All of them are mainly composed of Polymethyl methacrylate and Pigments (Powder) and Methyl methacrylate, Ethyleneglycol dimethacrylate (Liquid). -
Technological characteristics:
The device has the same technological characteristics as the predicate devices (Heat Curing and Self Curing). And the device is similar in specifications and shades as the predicate devices. -
Properties:
The device has comparable physical and chemical properties as the predicate devices.
(Meeting the requirements of ISO standards for the Dental base material, ISO 20795-1)
- Applications:
The device has similar indications for use as the sum of the predicate devices: fabrication and repair of partial and full denture base.
8. Technological Characteristics:
The new device, Denture Base Polymers, has the same design, main materials and chemical composition as the predicate device.
Comparison Items | New Device | Primary Predicate | Secondary Predicate |
---|---|---|---|
Denture Base Polymers | Vertex Rapid Simplified | Vertex Self Curing, Vertex Castavaria, Vertex Castapress | |
K220680 | K102654 | K102640 | |
1) Regulatory Classifications | same | same | same |
2) Indications for use | This product is used for fabrication and repair of partial and full denture base for patients with missing teeth. | The Vertex Rapid Simplified is indicated for: |
- Fabrication of full dentures
- Fabrication of partial dentures | Vertex cold-curing denture base materials are indicated for:
- Manufacture of full and partial dentures
- Repair of full and partial dentures
- Rebasing of full and partial dentures
- Relining of full and partial |
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HUGE
Comparison Items | New Device | Primary Predicate | Secondary Predicate | |||||
---|---|---|---|---|---|---|---|---|
Denture Base Polymers | ||||||||
K220680 | Vertex Rapid Simplified | |||||||
K102654 | Vertex Self Curing, Vertex | |||||||
Castavaria, Vertex Castapress | ||||||||
K102640 | ||||||||
3) | Contraindications | NA | NA | dentures | ||||
NA | ||||||||
4) | Composition | |||||||
of Materials | PMMA, MMA, EDMA | PMMA, MMA, EDMA | PMMA, MMA, EDMA | |||||
5) | Physical | |||||||
Properties | New | |||||||
Device | Physical | |||||||
parameters | Flexural | |||||||
strength | Water | |||||||
absorption | Solubility | Residual | ||||||
methyl | ||||||||
methacrylate | ||||||||
monomer | Flexural | |||||||
modulus | ||||||||
Type 1: ≥ 65 MPa | ||||||||
Type 2: ≥ 60 MPa | ≤ 32 ug/mm³ | Type 1: ≤ 1.6 ug/mm³ | ||||||
Type 2: ≤ 8.0 ug/mm³ | Type 1: ≤ 2.2% | |||||||
Type 2: ≤ 4.5% | Type 1: ≥ 2000 MPa | |||||||
Type 2: ≥ 1500 MPa | ||||||||
Type 1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | ||||||||
Type 2 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | ||||||||
Primary Predicate | ||||||||
(K102654) | ||||||||
Secondary Predicate | ||||||||
(K102640) | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | Meet the criteria | |||||||
per ISO 20795-1 | ||||||||
6) | Labeling | similar | similar | similar | ||||
7) | Target Population | dental patients | dental patients | dental patients | ||||
8) | Anatomical Site | on teeth | on teeth | on teeth | ||||
9) | Where Used | used in hospital, dental clinic | ||||||
and relevant places | used in hospital, dental clinic | |||||||
and relevant places | used in hospital, dental clinic | |||||||
and relevant places | ||||||||
10) | Human Factors | dental professional | dental professional | dental professional | ||||
11) | Design | same | same | same | ||||
12) | Cautions | similar | similar | similar | ||||
13) | Standards Met | same | same | same | ||||
14) | Biocompatibility | biocompatible | biocompatible | biocompatible | ||||
15) | Sterility | Non-sterile | Non-sterile | Non-sterile | ||||
16) | Chemical Safety | similar | similar | similar |
9. Summary of Biocompatibility
The new device, Denture Base Polymers, is substantially equivalent to the predicate devices that have been on the market for years and with no clinical adverse events. The formulation of new device does not contain any new or non-conventional chemicals compared to the legally marketed predicate device.
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We selected our Denture Base Polymers (Model: Type 2 Class 1) as the representative in biocompatibility tests and those biocompatibility test reports can be used in the biological evaluation of Denture Base Polymers.
Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity; Sensitization; Irritation or Intracutaneous Reactivity; Acute Systemic Toxicity; Material-Mediated Pyrogenicity; Subchronic Toxicity; Genotoxicity and Implantation.
10. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed on the subject device.
11. Summary of Substantial Equivalence
As with the comparison shown in substantial equivalence discussion, these devices are same or similar in almost all aspects. The details of indications for use, composition of materials, physical properties, labeling, stability/shelf life and cautions are slightly different, but the minor differences between the new device and the predicate devices are out of significance and do not affect neither the general intended use nor substantial equivalence.
We conclude that our Denture Base Polymers is substantially equivalent to the predicate devices described herein.