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.

Device Description

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.

AI/ML Overview

The document describes the acceptance criteria and study proving the device meets them for the "Halley resin."

1. Table of Acceptance Criteria and Reported Device Performance:

Physical Property	Standard (ISO) Specification Limit (Type 4)	Standard (ISO) Specification Limit (Type 2)	Proposed Device Halley resin (Type 4) Reported Performance	Predicate Device NextDent™ Denture / E-Denture (K162572) (Type 4) Reported Performance*	Reference Device Pour Acrylic (K161330) (Type 2) Reported Performance**
Ultimate Flexural Strength (MPa)	65 MPa min.	60 MPa min.	Meets ISO 20795-1:2013 for Type 4 material	Meets ISO 20795-1:2013 for Type 4 material (>65 MPa)	Meets ISO 20795-1:2013 for Type 2 material
Flexural Modulus (MPa)	2000 MPa min.	1500 MPa min.	Meets ISO 20795-1:2013 for Type 4 material	Meets ISO 20795-1:2013 for Type 4 material (>2000 MPa)	Meets ISO 20795-1:2013 for Type 2 material
Water Sorption (µg/mm³)	32 µg/mm³ max.	32 µg/mm³ max.	Meets ISO 20795-1:2013 for Type 4 material	Meets ISO 20795-1:2013 for Type 4 material (≤ 32 µg/mm³)	Meets ISO 20795-1:2013 for Type 2 material
Water Solubility (µg/mm³)	1.6 µg/mm³ max.	8.0 µg/mm³ max.	Meets ISO 20795-1:2013 for Type 4 material	Exceeds ISO 20795-1:2013 for Type 4 material (< 1.6 µg/mm³) but meets specification for Type 2 material (≤ 8.0 µg/mm³)	Meets ISO 20795-1:2013 for Type 2 material
Residual methyl methacrylate monomer	2.2% max.	4.5% max.	Meets ISO 20795-1:2013 for Type 4 material	Meets ISO 20795-1:2013 for Type 4 material (≤ 2.2%)	Meets ISO 20795-1:2013 for Type 2 material
UV Color Stability	No more than a slight change in color	No more than a slight change in color	Meets ISO 20795-1:2013 for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2 material
Fracture Toughness - Kmax (MPa m1/2)	1.9 MPa m^(1/2) min.	1.9 MPa m^(1/2) min.	Meets ISO 20795-1:2013 for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2 material
Fracture Toughness - Wf (J/m²)	900 J/m² min.	900 J/m² min.	Meets ISO 20795-1:2013 for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2 material

*Note: Data for the predicate device, NextDent™ Denture / E-Denture (K162572), is derived from its 510(k) Summary, Appendix A.
**Note: Data for the reference device, Pour Acrylic (K161330), is available to Dentsply Sirona.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" sample size in terms of number of cases or data provenance in the way it might for a diagnostic AI. The testing described is for the physical and biocompatibility properties of the material itself.

For the physical properties, the testing was conducted in accordance with ISO 20795-1:2013 (Dentistry – Base polymers - Part 1: Denture base polymers). This standard would define the sample sizes and methodology for testing material properties. The data provenance is not explicitly stated as country of origin, but it is implied to be laboratory testing following international standards. The nature of the study is a laboratory-based, non-clinical performance evaluation, not a retrospective or prospective study on patient data.

For biocompatibility, the testing was conducted in accordance with several ISO 10993 series standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-6, ISO 10993-3). These are also laboratory-based, non-clinical tests on the material, not human or animal studies with a "test set" in the traditional sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable to the type of device and testing described. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 20795-1:2013) that define acceptable performance limits. The "ground truth" for biocompatibility is conformance to ISO 10993 series of standards. These standards do not involve expert consensus in the way a clinical image interpretation might.

4. Adjudication Method for the Test Set:

This is not applicable. The testing involves objective measurements of material properties and biological responses according to established standard protocols, rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The "Halley resin" is a dental material, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI assistance aspect or human reader performance to evaluate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done, as the device is a dental material, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is based on established international standards:

For physical properties: ISO 20795-1:2013 (Dentistry – Base polymers - Part 1: Denture base polymers)
For biocompatibility: ISO 10993 series of standards (ISO 10993-5, -10, -11, -6, -3)

These standards define the test methods and the acceptable specification limits for the relevant material properties.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. The Halley resin is a physical material whose properties are evaluated through laboratory testing against established standards, not through training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable, as there is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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

1. 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-Denture	K162572	Vertex-Dental BV

Reference Device:

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

4. Description of Device:

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
Indicationsfor use	Halley resin is a light-cured resinindicated for the fabrication ofdentures bases in dentallaboratories, including full andpartial dentures as well asimplant overdentures, and otherdental appliances. Halley resincan be used as a try-in materialfor evaluation prior to fabricationof the final restoration.Fabrication of these prosthesesrequire a computer-aided designand manufacturing (CAD/CAM)system using an additive printer.Halley resin can be utilized as anaid in bonding denture base todenture teeth as well as repairusing traditional techniques.	NextDent™ Denture / E-Denture is a light-cured resin indicated for the fabrication ofdenture bases fabricated in dental laboratories,including full and partial removable dentures.The material is an alternative to traditional heatcured and auto polymerization resins.NextDent™ Denture / E-Denture is intendedexclusively for professional dental work.Fabrication of denture bases with NextDent™Denture / E-Denture require a computer-aidedand manufacturing (CAD/CAM) system thatincludes the following: scanner, designsoftware, additive printer and post-cure unit.NextDent™ Denture / E-Denture is compatiblewith the following CAD/CAM systemscomponents:Design:BrandTypeD900Scanner3ShapeDesignDental-3ShapeSoftwarSysteme2016-PremiumPrinting:TypeSoftwarBrandeEnvisioDDDP 4PrinterPerfactonTECryRapidshD30NetFabapebMiiUtility125YMiicraftMiiController3DFigure 43DSprintsystemsDWP-Ver1.1RolandDG80SPost-Curing:BrandTypeLC-3DPost-NextDent™CurePrintBounit×	Pour Acrylic resin is a self-curing denture base materialdesigned for use infabrication, repair, rebasing,or relining of full and partialdentures including implantoverdentures or other dentalappliances.	• Both the proposed device,Halley resin, and the predicatedevice, NextDent™ Denture /E-Denture (K162572), are light-cured resins that utilizeCAD/CAM techniques to printdevices.• The proposed Halley resin isalso indicated for use as an aidin bonding as well as repairusing traditional techniques.These are common uses fordenture materials where thesame materials are used forbonding and repair. Similarly,the reference device PourAcrylic (K161330) is alsoindicated for repair usingtraditional techniques.• The proposed Halley resin isalso intended for use as a try-inmaterial for fit evaluation.• Additionally, the proposedHalley resin is also indicatedfor implant overdenture anddental appliances; theseadditional terms are cleared forthe reference device PourAcrylic (K161330), a Type 2material per ISO 20795-1standard. The proposed Halleyresin (a Type 4 material perISO 20795-1 standard) meetsmore stringent requirementsthan the reference device. Theproposed device Halley resin issupported by performancecharacteristics to meet itsintended use.
Table 5.1 Similarities and differences between the proposed, predicate and reference devices.
Element	Proposed DeviceHalley resin	Predicate DeviceNextDent™ Denture/E-Denture	Reference DevicePour Acrylic	Similarities andDifferences
CFR Section	872.3760, FDA product code:EBI	872.3760, FDA product code: EBI	872.3760, FDA product code:EBI	All devices are classified under thesame regulation.
Composition	Methacrylate resins (mono anddimethacrylate) polymerized viaphotoinitiators in a 3D printersettings. Pigments are added forcolor of the denture.	Dimethacrylate resins polymerized viaphotoinitiators in a 3D printer settings.Pigments are added for color of thedenture.	polymethylmethacrylate-based resins materials withinitiator, inhibitor andpigments	Both the predicate device,NextDent™ Denture / E-Denture(K162572), and the proposeddevice, Halley resin, havecomparable generic compositiondescription. Though the exactcomposition of the predicate deviceis not known; extensivebiocompatibility studies have beenconducted to verify the biologicalsafety of the proposed deviceHalley resin in support ofsubstantial equivalence.
Application	Light-cured resinAutomated 3D printing of resin inmultiple layers, each light-curedbefore printing of next layer, withpost curing in a light curing unit	Light-cured resinAutomated 3D printing of resin inmultiple layers, each light-curedbefore printing of next layer, with postcuring in a light curing unit	Self-cured resinManual application, self-polymerizing material, withpost curing in a curing unit.	• Both the predicate device,NextDent™ Denture / E-Denture (K162572), and theproposed device, Halley resin,are light-cured resins thatutilize automated 3D printingtechnology to print dentaldevices layer by layer.• The reference device, PourAcrylic (K161330), utilizes self-curing or auto-polymerizingtechniques to cure the dentaldevice.
Use	Fabricated by Dentalprofessionals in a dentallaboratory	Fabricated by Dental professionals ina dental laboratory	Fabricated by Dentalprofessionals in a dentallaboratory	All devices are marketed andfabricated or printed by dentallaboratories.
Element	Proposed DeviceHalley resin	Predicate DeviceNextDent™ Denture/E-Denture	Reference DevicePour Acrylic	Similarities andDifferences
Physicalproperties	ISO 20795-1:2013 (Dentistry –Denture base polymers)Type 4Meets requirements of Type 2materials	ISO 20795-1:2013 (Dentistry –Denture base polymers)Type 4 except Water Solubility whichmeets requirements of Type 2materials for Water Solubility	ISO 20795-1:2013 (Dentistry –Denture base polymers)Type 2 Class 2	All devices were tested inaccordance with ISO 20795-1standard. The proposed Halleyresin met the requirements of aType 4 and 2 materials. The predicate deviceNextDent™ Denture / E-Denture (K162572) did notmeet the requirements of Type4 material for Water Solubilitybut meets a broaderspecification of Type 2material. The performancecharacteristics are comparablefor the predicate device,NextDent™ Denture / E-Denture (K162572), referencedevice Pour Acrylic (K161330)and proposed device Halleyresin.
Shelf life	3 years	2 years	3 years	Shelf life of the proposed deviceHalley resin is based onperformance 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)ISO 20795-1 :2013Specification LimitType 4	Standard (ISO)ISO 20795-1 :2013Specification LimitType 2	Proposed DeviceHalley resinType 4	Predicate DeviceNextDent™ Denture / E-DentureK162572*Type 4	Reference DevicePour AcrylicK161330**Type 2
Ultimate FlexuralStrength (MPa)	65 MPa min.	60 MPa min.	Meets ISO 20795-1:2013for Type 4 material	Meets ISO 20795-1:2013 for Type4 material*>65 MPa	Meets ISO 20795-1:2013 for Type 2material**
Flexural Modulus(MPa)	2000 MPa min.	1500 MPa min.	Meets ISO 20795-1:2013for Type 4 material	Meets ISO 20795-1:2013 for Type4 material*>2000 MPa	Meets ISO 20795-1:2013 for Type 2material**
Water Sorption(µg/mm³)	32 µg/mm³ max.	32 µg/mm³ max.	Meets ISO 20795-1:2013for Type 4 material	Meets ISO 20795-1:2013 for Type4 material*≤ 32 µg/mm³	Meets ISO 20795-1:2013 for Type 2material**
Water Solubility(µg/mm³)	1.6 µg/mm³ max.	8.0 µg/mm³ max.	Meets ISO 20795-1:2013for Type 4 material	Exceeds ISO 20795-1:2013 forType 4 material (< 1.6 µg/mm³) butmeets specification for Type 2material*≤ 8.0 µg/mm³	Meets ISO 20795-1:2013 for Type 2material**
Residual methylmethacrylatemonomer	2.2% max.	4.5% max.	Meets ISO 20795-1:2013for Type 4 material	Meets ISO 20795-1:2013 for Type4 material*≤ 2.2%	Meets ISO 20795-1:2013 for Type 2material**
UV Color Stability	The material showno more than aslight change incolor (report aspass/fail)	The material showno more than aslight change incolor (report aspass/fail)	Meets ISO 20795-1:2013for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2material**

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Table 5.2 Comparison of Performance Data/Physical Properties
Physical Property	Standard (ISO)ISO 20795-1 :2013Specification LimitType 4	Standard (ISO)ISO 20795-1 :2013Specification LimitType 2	Proposed DeviceHalley resinType 4	Predicate DeviceNextDent™ Denture / E-DentureK162572*Type 4	Reference DevicePour AcrylicK161330**Type 2
Fracture Toughness- maximum stressintensity work, Kmax(MPa m1/2)	1.9 MPa m $^{1/2}$ min.	1.9 MPa m $^{1/2}$ min.	Meets ISO 20795-1:2013for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2material**
Fracture Toughness- total fracture work,Wf (J/m²)	900 J/m² min.	900 J/m² min.	Meets ISO 20795-1:2013for Type 4 material	Not reported	Meets ISO 20795-1:2013 for Type 2material**
Data derived from predicate device K162572 510(k) Summary, Appendix A.*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,

Regulation Number and Section

§ 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.