Denture Base Resin
Device Facts
| Record ID | K230115 |
|---|---|
| Device Name | Denture Base Resin |
| Applicant | Aidite (Qinhuangdao) Technology Co., Ltd. |
| Product Code | EBI · Dental |
| Decision Date | Mar 17, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3760 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Denture Base Resin is used for the fabrication of removable dentures.
Device Story
Denture Base Resin is a PMMA-based material supplied as resin blocks (discs or horseshoe shapes) for use in dental laboratories. The device is processed via CAD/CAM milling to fabricate removable dentures. It is intended for use by dental professionals to create denture bases that are combined with prosthetic teeth. The device serves as a permanent restorative solution for patients requiring removable prosthetics. Clinical benefit is derived from the restoration of oral function and aesthetics through custom-milled, biocompatible denture bases. The device is used in a clinical or laboratory setting; the healthcare provider uses the milled output to fit the patient.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ISO 20795-1, ISO 4049, and ISO 7491. Evaluated for surface characteristics, color stability, porosity, flexural strength (87 MPa), flexural modulus (2340 MPa), residual monomer (1.29%), sorption (23.64 µg/mm3), solubility (0.25 µg/mm3), and fracture toughness.
Technological Characteristics
Materials: PMMA, methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow, ferric tetroxide. Form factor: Milled resin blocks (discs/horseshoes). Principle: CAD/CAM subtractive manufacturing. Standards: ISO 20795-1, ISO 4049, ISO 7491. Biocompatibility: ISO 10993-1 (permanent mucosal contact).
Indications for Use
Indicated for the fabrication of removable dentures in patients requiring prosthetic dental restoration.
Regulatory Classification
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.
Predicate Devices
- IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid (K151142)
Submission Summary (Full Text)
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March 17, 2023
Aidite (Qinhuangdao) Technology Co., Ltd % Julie Chen Consultant ICAS Group 155 Pingbei Rd, Minghang Shanghai, Shanghai 201100 CHINA
Re: K230115
Trade/Device Name: Denture Base Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 13, 2023 Received: January 17, 2023
Dear Julie Chen:
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
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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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K230115
### Device Name
Denture Base Resin
Indications for Use (Describe)
Denture Base Resin is used for the fabrication of removable dentures.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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# 510(K) Summary K230115
#### I. SUBMITTER:
Aidite (Oinhuangdao) Technology Co., Ltd No.9 Dushan Road, Economic and Technological Development Zone,Qinhuangdao City China Contact Person: Chen Yingying Title: Registered Engineer Tel: 15033560085 Email: chenyingying@aidite.com
Submission Correspondent: Julie Chen Email: cl.julie@hotmail.com Tel:+86 139 1804 5781
Summary prepared: 03/16/2023
#### II. DEVICE
Name of Device: Denture Base Resin Trade Name: Denture Base Resin Common Name: Denture Relining, Repairing, or Rebasing Resin Regulation Number: 21 CFR PART 872.3690 Classification Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI
#### III. PREDICATE DEVICE
Primary predicate device: K151142(IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid)
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#### IV. DEVICE DESCRIPTION
The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.
#### V. AVAIABLE MODEL
| Model | Shade | Specification |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDB-LC | A1P1、A2P1、A3P1、A3.5P1、A4P1、<br>B1P1、B2P1、C1P1、C2P1、OM1P1、<br>BL3P1、A1P2、A2P2、A3P2、<br>A3.5P2、A4P2、B1P2、B2P2、C1P2、<br>C2P2、OM1P2、BL3P2、A1P3、<br>A2P3、A3P3、A3.5P3、A4P3、B1P3、<br>B2P3、C1P3、C2P3、OM1P3、<br>BL3P3、A1P4、A2P4、A3P4、<br>A3.5P4、A4P4、B1P4、B2P4、C1P4、<br>C2P4、OM1P4、BL3P4、A1P5、<br>A2P5、A3P5、A3.5P5、A4P5、B1P5、<br>B2P5、C1P5、C2P5、OM1P5、<br>BL3P5、A1P6、A2P6、A3P6、<br>A3.5P6、A4P6、B1P6、B2P6、C1P6、<br>C2P6、OM1P6、BL3P6 | Disc shape: 95×20、95×25、<br>95×30、95×35、95×38、95×40、<br>98×20、98×25、98×30、98×35、<br>98×38、98×40 (Unit: mm)<br>Horseshoe: 101×20、101×25、<br>101×30、101×35、101×38、<br>101×40 (Unit: mm) |
| | FDB-LM | B3P2、B3P4、B3P5、B4P2、B4P4、<br>B4P5、C3P2、C3P4、C3P5、C4P2、<br>C4P4、C4P5、D2P2、D2P4、D2P5、<br>D3P2、D3P4、D3P5、D4P2、D4P4、<br>D4P5、OM2P2、OM2P4、OM2P5、<br>OM3P2、OM3P4、OM3P5、BL1P2、<br>BL1P4、BL1P5、BL2P2、BL2P4、<br>BL2P5、BL4P2、BL4P4、BL4P5 |
| | | A1P1、A2P1、A3P1、A3.5P1、A4P1、<br>B1P1、B2P1、C1P1、C2P1、OM1P1、<br>BL3P1、A1P2、A2P2、A3P2、<br>A3.5P2、A4P2、B1P2、B2P2、C1P2、<br>C2P2、OM1P2、BL3P2、A1P3、<br>A2P3、A3P3、A3.5P3、A4P3、B1P3、 |
| | B2P3、C1P3、C2P3、OM1P3、<br>BL3P3、A1P4、A2P4、A3P4、<br>A3.5P4、A4P4、B1P4、B2P4、C1P4、<br>C2P4、OM1P4、BL3P4、A1P5、<br>A2P5、A3P5、A3.5P5、A4P5、B1P5、<br>B2P5、C1P5、C2P5、OM1P5、<br>BL3P5、A1P6、A2P6、A3P6、<br>A3.5P6、A4P6、B1P6、B2P6、C1P6、<br>C2P6、OM1P6、BL3P6 | 101×40 (Unit: mm) |
| | B3P2、B3P4、B3P5、B4P2、B4P4、<br>B4P5、C3P2、C3P4、C3P5、C4P2、<br>C4P4、C4P5、D2P2、D2P4、D2P5、<br>D3P2、D3P4、D3P5、D4P2、D4P4、<br>D4P5、OM2P2、OM2P4、OM2P5、<br>OM3P2、OM3P4、OM3P5、BL1P2、<br>BL1P4、BL1P5、BL2P2、BL2P4、<br>BL2P5、BL4P2、BL4P4、BL4P5 | Disc shape: 98×30、98×35、<br>98×38 (Unit: mm) |
| | A1P1、A2P1、A3P1、A3.5P1、A4P1、<br>B1P1、B2P1、C1P1、C2P1、OM1P1、<br>BL3P1、A1P2、A2P2、A3P2、<br>A3.5P2、A4P2、B1P2、B2P2、C1P2、<br>C2P2、OM1P2、BL3P2、A1P3、<br>A2P3、A3P3、A3.5P3、A4P3、B1P3、<br>B2P3、C1P3、C2P3、OM1P3、<br>BL3P3、A1P4、A2P4、A3P4、<br>A3.5P4、A4P4、B1P4、B2P4、C1P4、<br>C2P4、OM1P4、BL3P4、A1P5、<br>A2P5、A3P5、A3.5P5、A4P5、B1P5、<br>B2P5、C1P5、C2P5、OM1P5、<br>BL3P5、A1P6、A2P6、A3P6、<br>A3.5P6、A4P6、B1P6、B2P6、C1P6、<br>C2P6、OM1P6、BL3P6 | Notched Disc: 98×20、98×25、<br>98×30、98×35、98×38、98×40<br>(Unit: mm) |
| FDB-CC | B2P5、C1P5、C2P5、OM1P5、<br>BL3P5、A1P6、A2P6、A3P6、<br>A3.5P6、A4P6、B1P6、B2P6、C1P6、<br>C2P6、OM1P6、BL3P6 | |
| | B3P2、B3P4、B3P5、B4P2、B4P4、<br>B4P5、C3P2、C3P4、C3P5、C4P2、<br>C4P4、C4P5、D2P2、D2P4、D2P5、<br>D3P2、D3P4、D3P5、D4P2、D4P4、<br>D4P5、OM2P2、OM2P4、OM2P5、<br>OM3P2、OM3P4、OM3P5、BL1P2、<br>BL1P4、BL1P5、BL2P2、BL2P4、<br>BL2P5、BL4P2、BL4P4、BL4P5 | |
| | Notched Disc: 98×30、98×35、<br>98×38 (Unit: mm) | |
| FDB-CM | A1P1、A2P1、A3P1、A3.5P1、A4P1 | Notched Disc: 98×20、98×25、 |
| | | |
| | B1P1、B2P1、C1P1、C2P1、OM1P1、<br>98×30、98×35、98×38、98×40<br>BL3P1、 A1P2、 A2P2 、 A3P2 、<br>(Unit: mm) | |
| | A3.5P2、A4P2、B1P2、B2P2、C1P2、 | |
| | C2P2、OM1P2、BL3P2、A1P3、 | |
| | A2P3、A3P3、A3.5P3、A4P3、B1P3、 | |
| | B2P3 、 C1P3 、 C2P3 、 OM1P3 、 | |
| | BL3P3、 A1P4、 A2P4、 A3P4、 | |
| | A3.5P4、A4P4、B1P4、B2P4、C1P4、 | |
| | C2P4、OM1P4、BL3P4、A1P5、 | |
| | A2P5、A3P5、A3.5P5、A4P5、B1P5、 | |
| | B2P5、C1P5、C2P5、OM1P5、 | |
| | BL3P5、 A1P6、 A2P6、 A3P6、 | |
| | A3.5P6、A4P6、B1P6、B2P6、C1P6、 | |
| | C2P6、OM1P6、BL3P6 | |
| | B3P2、B3P4、B3P5、B4P2、B4P4、 | |
| | B4P5、C3P2、C3P4、C3P5、C4P2、 | |
| | C4P4、C4P5、D2P2、D2P4、D2P5、 | |
| | D3P2、D3P4、D3P5、D4P2、D4P4、Notched Disc: 98×30、98×35、 | |
| | D4P5、OM2P2、OM2P4、OM2P5、98×38 (Unit: mm) | |
| | OM3P2、OM3P4、OM3P5、BL1P2、 | |
| | BL1P4、BL1P5、BL2P2、BL2P4、 | |
| | BL2P5、BL4P2、BL4P4、BL4P5 | |
| | Disc shape: 98×20、98×22、 | |
| | 98×25、98×28、98×30、98×35、 | |
| | 98×38、98×40、95×20、95×22、 | |
| | 95×25、95×28、95×30、95×35、 | |
| FDB-C | P1、P2、P3、P4、P5、P6<br>95×38、95×40 (Unit: mm) | |
| | Horseshoe: 101×20、101×22、 | |
| | 101×25、101×28、101×30、 | |
| | 101×35 、 101×38 、 101×40<br>(Unit: mm) | |
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#### VI. INTENED USE per 21CFR 807.92(A)(5)
Denture Base Resin is used for the fabrication of removable dentures.
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#### INDICATIONS for USE per Form FDA 3881 VII.
Denture Base Resin is used for the fabrication of removable dentures.
# VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Denture Base Resin are compared with the predicate device, IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142). The results are shown below in the Technological Characteristics Comparison Table:
| Item | Subject Device | Predicate Device | Remark |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Denture Base<br>Resin | IvoBase CAD for<br>Zenotec and<br>IvoBase CAD Bond<br>and Modelling<br>Liquid | |
| 510(k) number | K230115 | K151142 | -- |
| Regulation Number | 21 CFR PART 872.3690 | 21 CFR PART 872.3690 | SE |
| Product Code | EBI | EBI | SE |
| Common name | Denture Relining, Repairing,<br>or Rebasing Resin | Denture Relining, Repairing, or<br>Rebasing Resin | SE |
| Classification | II | II | SE |
| Manufacturer | Aidite<br>(Qinhuangdao)<br>Technology Co., Ltd | Ivoclar Vivadent, Incorporated | -- |
| Intended Use | Denture Base Resin is used for<br>the fabrication of removable<br>dentures. | IvoBase CAD for Zenotec, IvoBase<br>CAD Bond and Modelling Liquid<br>is a system used:<br><br>For the fabrication of removable<br>dentures,e.g.:<br>partial and complete<br>denture prosthetics hybrid denture prosthetics combined denture<br>prosthetics mouthguards implant-supported denture<br>prosthetics | SE |
| Type Use | Prescription (Rx Only) | Prescription (Rx Only) | SE |
| CAD CAM Technology | Denture Base Resin is<br>intended for use in the<br>fabrication of denture<br>prosthetics using CAD CAM<br>Technology. | IvoBase CAD for Zenotec is a<br>PMMA disc intended for use in<br>the fabrication of denture<br>prosthetics using CAD CAM<br>Technology. | SE |
| Monomer/polymer form | The resin block is formed<br>using CAD CAM technology.<br>The product combines the<br>prosthetic denture teeth with<br>the denture base. | The denture base is formed using<br>CAD CAM technology. The<br>prosthetic denture teeth are then<br>bonded to the denture base using<br>IvoBase CAD Bond and IvoBase<br>CAD Modelling Liquid. IvoBase<br>CAD Bond consists of a powder<br>polymer and monomer liquid<br>similar to a traditional denture<br>base device. | Similar |
| Principle of operation | Step-by-step:<br>- Design and<br>processing of<br>CAD/CAM<br>removable dentures<br>- Separate<br>After CAD/CAM<br>cutting, the<br>restoration is<br>separated from the<br>resin block with a<br>tungsten carbide or<br>diamond bur.<br>- Polishing<br>- Cleaning and<br>disinfection<br>- Insertion | Step-by-step:<br>- Anatomical impression<br>and pre- bite registration<br>- Lab makes scan of<br>impression and mills<br>individual tray<br>- Functional impression<br>and bite registration<br>- Lab makes scan and<br>mills try-in body (Tray<br>Disc for Zenotec)<br>- Try-in and esthetic,<br>functional check<br>- Lab makes final<br>denture. IvoBase CAD<br>for Zenotec can be<br>processed using the<br>Zenotec select milling<br>machine. First the lingual<br>side is milled, then the<br>teeth are bonded in<br>position using ivoBase<br>CAD Bond and then the<br>basal side is milled.<br>- After milling, the<br>denture base is separated<br>from the disc, shape | SE |
| | | adjustments are made and<br>then it is polished.<br>• Insertion | |
| Composition | The Denture Base Resin mainly<br>consist of denture base resin<br>(powder), polymethyl<br>methacrylate (PMMA), methyl<br>methacrylate, ethylene glycol<br>dimethacrylate, titanium<br>dioxide, ferric oxide, iron oxide<br>yellow and ferric tetroxide. | The chemical composition of the<br>new product and predicate are the<br>same, except for small changes in<br>pigments and the fact that the disc<br>product is industrially<br>polymerized. Therefore certain<br>ingredients (the methyl<br>methacrylate and initiators) are<br>no longer present. The result of<br>the biocompatibility assessment<br>is that the product is equivalent to<br>the predicate. | Similar |
| Biocompatibility | Biocompatibility in accordance<br>to 10993-1(Surface device in<br>contact with mucosal membrane<br>with permanent contact (>30 d)) | Biocompatibility in accordance<br>to 10993-1(Surface device in contact<br>with mucosal membrane with<br>permanent contact (>30 d)) | Same |
| Performance | Ultimate flexural strength 87<br>Mpa;<br>Flexural modulus 2340Mpa;<br>Residual methyl methacrylate<br>monomer 1.29%<br>Sorption 23.64 µg/mm3<br>Solubility 0.25 µg/mm3<br>Maximum stress intensity<br>factor for materials with<br>improved impact resistance<br>2.89MPa m1/2<br>Total fracture work 1609 J/m2 | Ultimate flexural strength82 Mpa;<br>Flexural modulus 2032Mpa;<br>Residual methyl methacrylate<br>monomer1.34%<br>Sorption 19.48 µg/mm3<br>Solubility 0.65 µg/mm3<br>Maximum stress intensity factor<br>for materials with improved<br>impact resistance<br>2.35 MPa m1/2<br>Total fracture work 1411 J/m2 | Similar |
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#### IX. SUBSTANTIAL EQUIVALENCE DISCUSSION per 21 CFR 807.92(b)
Denture Base Resin has been conducted biocompatibility studies in accordance with ISO 10993 to demonstrate the device is as safe as its predicate device. The performance bench testing was conducted to demonstrate that the subject device is as effective as its predicate device.
#### X. PERFORMANCE DATA
# Non-Clinical Performance Test Conclusion
# Biocompatibility
Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of
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International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with Surface device in contact with mucosal membrane with permanent contact (>30 d). The subject device was evaluated for: Cytotoxicity Sensitization
- Irritation Acute systemic toxicity Subchronic systemic toxicity Implantation Material-mediated pyrogenicity Genotoxicitv
# Performance Bench Testing
Performance testing were conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Dental Base Resin complies with the following standards:
- . ISO20795-1: 2013 Dentistry—Base polymers —Part 1:Denture base polymers
- ISO 4049: 2019 Dentistry Polymer-based restorative materials; ●
- ISO 7491: 2000 Dental materials-Determination of color stability. ●
The subject device and predicate device were evaluated for:
1)Surface characteristics:
2)Shape capability;
3)Colour;
4)Colour stability;
5)Translucency:
- 6)Freedom from porosity;
7)Ultimate flexural strength;
8)Flexural modulus;
9)Bonding to synthetic polymer teeth
10)Residual methyl methacrylate monomer
11)Sorption and solubility
12) Maximum stress intensity factor for materials with improved impact resistance and total fracture work
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# Clinical Test Conclusion
No clinical study is included in this submission.
#### XI. 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 IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142).
