Halley resin

K190043 · Dentsply Sirona · EBI · Apr 24, 2019 · Dental

Device Facts

• Record ID: K190043
• Device Name: Halley resin
• Applicant: Dentsply Sirona
• Product Code: EBI · Dental
• Decision Date: Apr 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Halley resin is a light-cured resin indicated for the fabrication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration. Fabrication of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer. Halley resin can be utilized as an aid in bonding denture base to denture teeth as well as repair using traditional techniques.

Device Story

Halley resin is a methacrylate-based, light-cured resin for dental laboratory use. It functions as a material for 3D additive printing of denture bases and appliances via CAD/CAM systems; it also supports traditional bonding and repair techniques. The resin is processed by dental professionals in a laboratory setting. The device is used to fabricate custom dental prostheses, which are then fitted by a dentist to improve patient oral function and aesthetics. It serves as an alternative to traditional heat-cured or autopolymerization resins.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by bench testing in accordance with ISO 20795-1:2013 (physical properties including flexural strength, modulus, water sorption/solubility, residual monomer, and color stability) and ISO 10993 series (biocompatibility).

Technological Characteristics

Methacrylate-based (mono and dimethacrylate) light-cured resin. Formulated with photoinitiators and pigments. Designed for 3D additive printing (layer-by-layer) and traditional manual application. Complies with ISO 20795-1:2013 (Type 4 material). Shelf life: 3 years.

Indications for Use

Indicated for dental laboratory fabrication of denture bases (full, partial, implant overdentures) and dental appliances. Used as try-in material for restoration evaluation. Also indicated for bonding denture teeth and traditional repair techniques. Intended for professional dental use.

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

• NextDent™ Denture / E-Denture (K162572)

Reference Devices

• Pour Acrylic (K161330)

Submission Summary (Full Text)

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April 24, 2019

Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K190043

Trade/Device Name: Halley Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 24, 2019 Received: January 25, 2019

Dear Karl Nittinger:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Srinivas Nandkumar -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K190043

Device Name Halley resin

Indications for Use (Describe)

Halley resin is a light-cured resin indication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

Halley resin can be utilized as an aid in bonding denture teeth as well as repair using traditional techniques.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract graphic on the left, resembling a curved, layered shape. To the right of the graphic are the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font.

#### K190043 SECTION 5. 510(k) SUMMARY for Halley resin

- 1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

| Contact Person: | Karl Nittinger |
|-------------------|----------------|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |

Date Prepared: 08 January 2019

- 2. Device Name:
- Proprietary Name: 0 Halley resin
- Classification Name: Resin, Denture, Relining, Repairing, Rebasing ●

- CFR Number: 21 C.F.R. 872.3760
- . Device Class: .
- Product Code: EBI 0

#### 3. Predicate Device:

| Predicate Device Name | 510(k) | Company Name |
|-----------------------------------|---------|------------------|
| NextDent™ Denture / E-<br>Denture | K162572 | Vertex-Dental BV |

#### Reference Device:

| Reference Device Name | 510(k) | Company Name |
|-----------------------|---------|----------------------|
| Pour Acrylic | K161330 | Dentsply Prosthetics |

#### 4. Description of Device:

The proposed Halley resin is a methacrylate-based, light-cured resin available in multiple shades and is intended as an alternative to traditional heat cured and autopolymerization denture base resins. The Halley resin is intended to be utilized primarily for the fabrication of dental prostheses using an additive printer and CAD/CAM techniques. The proposed Halley resin can also be used for traditional repairs and as an aid in bonding denture base to denture teeth.

In addition, Halley resin may also be utilized as an aid in bonding the printed denture to teeth as well as for repair.

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#### 5. Indications for Use:

Halley resin is a light-cured resin indicated for the fabrication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. - Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration. Fabrication of these require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

Halley resin can be utilized as an aid in bonding denture base to denture teeth as well as repair using traditional techniques.

#### 6. Substantial Equivalence:

Technological Characteristics:

For the purpose of substantial equivalence, the proposed Halley resin is compared to the predicate device. NextDent™ Denture / E-Denture (K162572). The predicate device, NextDent™ Denture / E-Denture (K162572) is being compared to the proposed device Halley resin to establish substantial equivalence to the proposed device Halley resin, specifically for performance and processing similarities related to 3D additive printing.

In addition to the primary predicate device, Pour Acrylic (K161330) is included as a reference device in support of substantial equivalence. The reason for inclusion of the reference device, Pour Acrylic (K161330), is to support similarities in technological properties and performance characteristics to the proposed device.

The proposed, predicate, and reference devices have been tested according to the requirements of ISO 20795-1:2013 (Dentistry - Base polymers - Part 1: Denture base polymers) as Type 2 or 4 materials. Table 5.1 compares the proposed device, Halley resin, the predicate device, NextDent™ Denture / E-Denture (K162572), and the reference device, Pour Acrylic (K161330).

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| Table 5.1 Similarities and differences between the proposed, predicate and reference devices. | | | | |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device | Reference Device | Similarities and |
| Element | Halley resin | NextDent™ Denture/E-Denture | Pour Acrylic | Differences |
| 510(k) | To be assigned | K162572 | K161330 | N/A |
| Indications<br>for use | Halley resin is a light-cured resin<br>indicated for the fabrication of<br>dentures bases in dental<br>laboratories, including full and<br>partial dentures as well as<br>implant overdentures, and other<br>dental appliances. Halley resin<br>can be used as a try-in material<br>for evaluation prior to fabrication<br>of the final restoration.<br>Fabrication of these prostheses<br>require a computer-aided design<br>and manufacturing (CAD/CAM)<br>system using an additive printer.<br>Halley resin can be utilized as an<br>aid in bonding denture base to<br>denture teeth as well as repair<br>using traditional techniques. | NextDent™ Denture / E-Denture is a light-<br>cured resin indicated for the fabrication of<br>denture bases fabricated in dental laboratories,<br>including full and partial removable dentures.<br>The material is an alternative to traditional heat<br>cured and auto polymerization resins.<br>NextDent™ Denture / E-Denture is intended<br>exclusively for professional dental work.<br>Fabrication of denture bases with NextDent™<br>Denture / E-Denture require a computer-aided<br>and manufacturing (CAD/CAM) system that<br>includes the following: scanner, design<br>software, additive printer and post-cure unit.<br>NextDent™ Denture / E-Denture is compatible<br>with the following CAD/CAM systems<br>components:<br>Design:<br>Brand<br>Type<br>D900<br>Scanner<br>3Shape<br>Design<br>Dental-<br>3Shape<br>Softwar<br>System<br>e<br>2016-<br>Premiu<br>m<br>Printing:<br>Type<br>Softwar<br>Brand<br>e<br>Envisio<br>DDDP 4<br>Printer<br>Perfacto<br>nTEC<br>ry<br>Rapidsh<br>D30<br>NetFab<br>ape<br>b<br>MiiUtility<br>125Y<br>Miicraft<br>MiiContr<br>oller<br>3D<br>Figure 4<br>3D<br>Sprint<br>systems<br>DWP-<br>Ver1.1<br>Roland<br>DG<br>80S<br>Post-Curing:<br>Brand<br>Type<br>LC-3D<br>Post-<br>NextDe<br>nt™<br>Cure<br>PrintBo<br>unit<br>× | Pour Acrylic resin is a self-<br>curing denture base material<br>designed for use in<br>fabrication, repair, rebasing,<br>or relining of full and partial<br>dentures including implant<br>overdentures or other dental<br>appliances. | • Both the proposed device,<br>Halley resin, and the predicate<br>device, NextDent™ Denture /<br>E-Denture (K162572), are light-<br>cured resins that utilize<br>CAD/CAM techniques to print<br>devices.<br>• The proposed Halley resin is<br>also indicated for use as an aid<br>in bonding as well as repair<br>using traditional techniques.<br>These are common uses for<br>denture materials where the<br>same materials are used for<br>bonding and repair. Similarly,<br>the reference device Pour<br>Acrylic (K161330) is also<br>indicated for repair using<br>traditional techniques.<br>• The proposed Halley resin is<br>also intended for use as a try-in<br>material for fit evaluation.<br>• Additionally, the proposed<br>Halley resin is also indicated<br>for implant overdenture and<br>dental appliances; these<br>additional terms are cleared for<br>the reference device Pour<br>Acrylic (K161330), a Type 2<br>material per ISO 20795-1<br>standard. The proposed Halley<br>resin (a Type 4 material per<br>ISO 20795-1 standard) meets<br>more stringent requirements<br>than the reference device. The<br>proposed device Halley resin is<br>supported by performance<br>characteristics to meet its<br>intended use. |
| Table 5.1 Similarities and differences between the proposed, predicate and reference devices. | | | | |
| Element | Proposed Device<br>Halley resin | Predicate Device<br>NextDent™ Denture/E-Denture | Reference Device<br>Pour Acrylic | Similarities and<br>Differences |
| CFR Section | 872.3760, FDA product code:<br>EBI | 872.3760, FDA product code: EBI | 872.3760, FDA product code:<br>EBI | All devices are classified under the<br>same regulation. |
| Composition | Methacrylate resins (mono and<br>dimethacrylate) polymerized via<br>photoinitiators in a 3D printer<br>settings. Pigments are added for<br>color of the denture. | Dimethacrylate resins polymerized via<br>photoinitiators in a 3D printer settings.<br>Pigments are added for color of the<br>denture. | polymethylmethacrylate-<br>based resins materials with<br>initiator, inhibitor and<br>pigments | Both the predicate device,<br>NextDent™ Denture / E-Denture<br>(K162572), and the proposed<br>device, Halley resin, have<br>comparable generic composition<br>description. Though the exact<br>composition of the predicate device<br>is not known; extensive<br>biocompatibility studies have been<br>conducted to verify the biological<br>safety of the proposed device<br>Halley resin in support of<br>substantial equivalence. |
| Application | Light-cured resin<br>Automated 3D printing of resin in<br>multiple layers, each light-cured<br>before printing of next layer, with<br>post curing in a light curing unit | Light-cured resin<br>Automated 3D printing of resin in<br>multiple layers, each light-cured<br>before printing of next layer, with post<br>curing in a light curing unit | Self-cured resin<br>Manual application, self-<br>polymerizing material, with<br>post curing in a curing unit. | • Both the predicate device,<br>NextDent™ Denture / E-<br>Denture (K162572), and the<br>proposed device, Halley resin,<br>are light-cured resins that<br>utilize automated 3D printing<br>technology to print dental<br>devices layer by layer.<br>• The reference device, Pour<br>Acrylic (K161330), utilizes self-<br>curing or auto-polymerizing<br>techniques to cure the dental<br>device. |
| Use | Fabricated by Dental<br>professionals in a dental<br>laboratory | Fabricated by Dental professionals in<br>a dental laboratory | Fabricated by Dental<br>professionals in a dental<br>laboratory | All devices are marketed and<br>fabricated or printed by dental<br>laboratories. |
| Element | Proposed Device<br>Halley resin | Predicate Device<br>NextDent™ Denture/E-Denture | Reference Device<br>Pour Acrylic | Similarities and<br>Differences |
| Physical<br>properties | ISO 20795-1:2013 (Dentistry –<br>Denture base polymers)<br>Type 4<br>Meets requirements of Type 2<br>materials | ISO 20795-1:2013 (Dentistry –<br>Denture base polymers)<br>Type 4 except Water Solubility which<br>meets requirements of Type 2<br>materials for Water Solubility | ISO 20795-1:2013 (Dentistry –<br>Denture base polymers)<br>Type 2 Class 2 | All devices were tested in<br>accordance with ISO 20795-1<br>standard. The proposed Halley<br>resin met the requirements of a<br>Type 4 and 2 materials. The predicate device<br>NextDent™ Denture / E-<br>Denture (K162572) did not<br>meet the requirements of Type<br>4 material for Water Solubility<br>but meets a broader<br>specification of Type 2<br>material. The performance<br>characteristics are comparable<br>for the predicate device,<br>NextDent™ Denture / E-<br>Denture (K162572), reference<br>device Pour Acrylic (K161330)<br>and proposed device Halley<br>resin. |
| Shelf life | 3 years | 2 years | 3 years | Shelf life of the proposed device<br>Halley resin is based on<br>performance testing. |

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### 7. Non-Clinical Performance Data

Physical Properties:

Data derived from testing in accordance with ISO 20795-1:2013 (Dentistry – Base polymers - Part 1: Denture base polymers) is included to support substantial equivalence. The data support a conclusion that the proposed device Halley resin, predicate device NextDent™ Denture / E-Denture (K162572) and the reference device Pour Acrylic (K161330) are comparable and meet the requirements per ISO 20795-1 standard as shown in Table 5.2 below.

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| Table 5.2 Comparison of Performance Data/Physical Properties | | | | | | | | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--|--|--|--|
| Physical Property | Standard (ISO)<br>ISO 20795-1 :2013<br>Specification Limit<br>Type 4 | Standard (ISO)<br>ISO 20795-1 :2013<br>Specification Limit<br>Type 2 | Proposed Device<br>Halley resin<br>Type 4 | Predicate Device<br>NextDent™ Denture / E-Denture<br>K162572*<br>Type 4 | Reference Device<br>Pour Acrylic<br>K161330**<br>Type 2 | | | | |
| Ultimate Flexural<br>Strength (MPa) | 65 MPa min. | 60 MPa min. | Meets ISO 20795-1:2013<br>for Type 4 material | Meets ISO 20795-1:2013 for Type<br>4 material*<br>>65 MPa | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |
| Flexural Modulus<br>(MPa) | 2000 MPa min. | 1500 MPa min. | Meets ISO 20795-1:2013<br>for Type 4 material | Meets ISO 20795-1:2013 for Type<br>4 material*<br>>2000 MPa | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |
| Water Sorption<br>(µg/mm³) | 32 µg/mm³ max. | 32 µg/mm³ max. | Meets ISO 20795-1:2013<br>for Type 4 material | Meets ISO 20795-1:2013 for Type<br>4 material*<br>≤ 32 µg/mm³ | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |
| Water Solubility<br>(µg/mm³) | 1.6 µg/mm³ max. | 8.0 µg/mm³ max. | Meets ISO 20795-1:2013<br>for Type 4 material | Exceeds ISO 20795-1:2013 for<br>Type 4 material (< 1.6 µg/mm³) but<br>meets specification for Type 2<br>material*<br>≤ 8.0 µg/mm³ | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |
| Residual methyl<br>methacrylate<br>monomer | 2.2% max. | 4.5% max. | Meets ISO 20795-1:2013<br>for Type 4 material | Meets ISO 20795-1:2013 for Type<br>4 material*<br>≤ 2.2% | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |
| UV Color Stability | The material show<br>no more than a<br>slight change in<br>color (report as<br>pass/fail) | The material show<br>no more than a<br>slight change in<br>color (report as<br>pass/fail) | Meets ISO 20795-1:2013<br>for Type 4 material | Not reported | Meets ISO 20795-<br>1:2013 for Type 2<br>material** | | | | |

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| Table 5.2 Comparison of Performance Data/Physical Properties | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------|
| Physical Property | Standard (ISO)<br>ISO 20795-1 :2013<br>Specification Limit<br>Type 4 | Standard (ISO)<br>ISO 20795-1 :2013<br>Specification Limit<br>Type 2 | Proposed Device<br>Halley resin<br>Type 4 | Predicate Device<br>NextDent™ Denture / E-Denture<br>K162572*<br>Type 4 | Reference Device<br>Pour Acrylic<br>K161330**<br>Type 2 |
| Fracture Toughness<br>- maximum stress<br>intensity work, Kmax<br>(MPa m1/2) | 1.9 MPa m $^{1/2}$ min. | 1.9 MPa m $^{1/2}$ min. | Meets ISO 20795-1:2013<br>for Type 4 material | Not reported | Meets ISO 20795-<br>1:2013 for Type 2<br>material** |
| Fracture Toughness<br>- total fracture work,<br>Wf (J/m²) | 900 J/m² min. | 900 J/m² min. | Meets ISO 20795-1:2013<br>for Type 4 material | Not reported | Meets ISO 20795-<br>1:2013 for Type 2<br>material** |
| *Data derived from predicate device K162572 510(k) Summary, Appendix A.<br>**Reference device Pour Acrylic (K161330) data is available to Dentsply Sirona. | | | | | |

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Biocompatibility:

Biocompatibility testing was conducted for the proposed Hallev resin to support device safety. The following standards were utilized to perform biocompatibility testing. In addition, Oral toxicity test was performed to support the proposed device Halley resin.

The results of the biocompatibility testing conducted on the proposed Halley resin support substantial equivalence.

- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in ● vitro cvtotoxicitv
- . ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-6, Biological evaluation of medical devices - Part 6: Tests for local effects of implantation
- ISO 10993-3. Biological evaluation of medical devices Part 3: Tests for . qenotoxicity, carcinogenicity, and reproductive toxicity

#### 8. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the proposed device. Halley resin.

#### 9. Conclusion Regarding Substantial Equivalence

The proposed device, Halley resin is a light-cured resin indicated for the fabrication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration. Fabrication of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

Halley resin can be utilized as an aid in bonding denture base to denture teeth as well as repair using traditional techniques.

The proposed device, Halley resin, has the same intended use, similar indications for use, and incorporates the same fundamental technology as the predicate device, NextDent™ Denture / E-Denture (K162572). The proposed device, Halley resin is also comparable to the reference device Pour Acrylic (K161330) for performance characteristics and meets a more stringent specification requirement of ISO 20795-1:2013 standard. Test data to verify the performance and biological safety of the proposed device. Halley resin, has been provided including physical properties in accordance with ISO 20795-1 and ISO 10993-1 standard. The results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence,