Halley resin is a light-cured resin indicated for the fabrication of dental laboratories, including full and partial dentures as well as implant overdentures. 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.

Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base.

Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

Device Description

The proposed device, Halley resin system introduces two additional components (Halley Denture-Tooth Bonding Agent and Halley Sealer) to the Halley resin (K190043) workflow. The proposed Halley resin system consists of light-cured resins that support the modification of the Halley resin (K190043) workflow to include bonding and sealing steps using conventional techniques. The two additional components of the Halley resin system have previously been cleared under Eclipse® Bonding Agent. K051707 and TEMPEX Esthetic Provisional System. K061264. For comparison purposes, the reference device VLC Sealer (part of the TEMPFX Esthetic Provisional System, K061264) is being included. These devices are being included as reference devices (Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264) to support chemical composition and characteristics to support the Halley resin (K190043) workflow.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, the Halley Resin System. This submission establishes substantial equivalence to a predicate device (Halley resin K190043) and reference devices (Eclipse® Bonding Agent K051707 and TEMPFX Esthetic Provisional System K061264).

Crucially, this document is for a dental resin system, not an AI/ML-driven medical device for diagnosis or prognosis. Therefore, the requested information about acceptance criteria, study types (MRMC, standalone), ground truth establishment, sample sizes for training/test sets, expert adjudication, and effect sizes for human reader improvement with AI assistance do not apply to this submission.

The document discusses non-clinical performance data, specifically physical properties and biocompatibility testing of the resin system components, to demonstrate that the proposed device performs as intended and is safe. It explicitly states that "No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Halley resin system."

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional medical device submission based on material properties and established workflows using existing, cleared components.

Summary

{0}------------------------------------------------

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 26, 2019

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

Re: K191427

Trade/Device Name: Halley Resin System Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI, KLE, EBD Dated: May 23, 2019 Received: May 29, 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.

{1}------------------------------------------------

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 medical devices and radiation-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.

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191427

Device Name Halley resin system

Indications for Use (Describe)

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

Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base.

Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 leaf-like shape on the left, with a white curved line running through it. To the right of the shape are the words "Dentsply" on top and "Sirona" on the bottom, both in a simple, sans-serif font. The logo is presented in a muted gray color.

K191427

SECTION 5. 510(k) SUMMARY for

Halley resin system

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: May 23, 2019

1. Device Name:
- Proprietary Name: .
- Classification Name: .
  - CFR Number:
- 21 C.F.R. 872.3760 . Device Class: 11 ●
- Product Code: EBI .
1. Predicate Device:

Predicate Device Name	510(k)	Company Name
Halley resin	K190043	Dentsply Prosthetics

Halley resin system

Resin, Denture, Relining, Repairing, Rebasing

Reference Device:

Reference Device Name	510(k)	Company Name
Eclipse® Bonding Agent	K051707	Dentsply Prosthetics
TEMPFX EstheticProvisional System	K061264	Dentsply Prosthetics

{4}------------------------------------------------

4. Description of Device:

5. Indications for Use:

Halley resin (K190043) indications will be modified as follows (language to be added to the modified indications for use is identified in bold font):

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 computeraided 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.

Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base to denture base.

Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

1. Substantial Equivalence:
  For the purpose of substantial equivalence, the proposed device, Halley resin system is compared to the legally marketed predicate device Halley resin (K190043) manufactured by Dentsply Prosthetics. The predicate device, Halley resin received U.S. premarket clearance in April 2019 under premarket notification K190043.

The proposed Halley resin system introduces two additional components to the Halley resin (K190043) workflow. In addition to the primary predicate device. Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264 are included to support substantial equivalence based on similarities in composition and characteristics to the proposed device.

The predicate device Halley resin (K190043) has been tested in accordance with ISO 20795-1:2013 - Dentistry - Base polymers - Part 1: Denture base polymers. The proposed Halley resin system and reference devices (Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264) have been tested to support the performance characteristics contributing to the Halley resin (K190043) workflow.

Table 5.1. details similarities and differences between the proposed, predicate and reference devices

{5}------------------------------------------------

Table 5.1	Proposed DeviceHalley resin system	Predicate DeviceHalley resin	Reference DeviceEclipse® BondingAgent	Reference DeviceTEMPFX EstheticProvisional System	Similarities andDifferences
Element
510(k)	To be assigned	K190043	K051707	K061264	N/A
Indications for use	Halley resin is a light-curedresin indicated for thefabrication of dentures basesin dental laboratories,including full and partialdentures as well as implantoverdentures, and otherdental appliances. Halleyresin can be used as a try-inmaterial for evaluation prior tofabrication of the finalrestoration. Fabrication ofthese prostheses require acomputer-aided design andmanufacturing (CAD/CAM)system using an additiveprinter.Halley resin can be utilized asan aid in bonding denturebase to denture teeth as wellas repair using traditionaltechniques.Halley Denture-Tooth BondingAgent is indicated for use inenhancing the bond ofdenture base to denture base.Halley Sealer is a light-curedsealant that produces asmooth, glossy surface finishon the denture.	Halley resin is a light-cured resin indicated forthe fabrication ofdentures bases in dentallaboratories, includingfull and partial denturesas well as implantoverdentures, and otherdental appliances.Halley resin can beused as a try-in materialfor evaluation prior tofabrication of the finalrestoration. Fabricationof these prosthesesrequire a computer-aided design andmanufacturing(CAD/CAM) systemusing an additive printer.Halley resin can beutilized as an aid inbonding denture base todenture teeth as well asrepair using traditionaltechniques.	Eclipse® Bonding Agentis indicated for use inenhancing the bond ofacrylic teeth to acrylicremovable denturebases.	TEMPFX EstheticProvisional System isindicated for fabricationof provisional dentalrestorations.	-The proposed Halleyresin system is amodification of theworkflow cleared underthe predicate device,Halley resin (K190043).Two additionalcomponents areintroduced the Halleyresin (K190043)workflow.-Additional componentsproposed for the Halleyresin system have beenpreviously cleared,Eclipse® Bonding Agent(K051707) and as partof TEMPFX EstheticProvisional System(K061264) and arelisted as referencedevices.-Two additionalcomponents test reportssupport modifications tothe Halley resin(K190043) workflow toinclude a bonding agentand sealer.-Both reference devicesare currently utilized forsimilar uses in differentworkflows underK051707 and K061264.VLC Sealer is includedwithin the systemcomponents as a light-curable resin materialwhich forms a glossysurface. The identicalVLC Sealer has beenre-branded as HalleySealer to support similaruse for Halley resinsystem workflow.
Table 5.1	Proposed Device	Predicate Device	Reference Device	Reference Device
Element	Halley resin system	Halley resin	Eclipse® BondingAgent	TEMPFX EstheticProvisional System	Similarities andDifferences
Composition	Halley resin:Methacrylate (mono anddimethacrylate) resinspolymerized viaphotoinitiatorsPigments are added for colorof the denture.Halley Denture-ToothBonding Agent:Solvent vehicle containingMethacrylate (mono anddimethacrylate) resinspolymerized viaphotoinitiatorsHalley Sealer:Methacrylate (mono anddimethacrylate) resinspolymerized viaphotoinitiators	Methacrylate (monoand dimethacrylate)resins polymerized viaphotoinitiators in a 3Dprinter settings.Pigments are addedfor color of the denture.	Solvent vehiclecontainingMethacrylate (monoand dimethacrylate)resins polymerized viaphotoinitiators	Methacrylate (monoand dimethacrylate)resins polymerized viaphotoinitiators	-Composition of theproposed, predicateand reference deviceVLC Sealer (K061264)are similar. All devicesare resins polymerizedvia photoinitiators.-No pigments areadded to the proposedand reference devices.Additional colorvariations are notrequired for thesedevices.-The reference device,Eclipse Bonding Agent(K051707) uses adifferent solventvehicle, however, afterpolymerization, thedevice composition issimilar to theproposed, predicatedevices.-The predicate device,Halley resin utilizes 3Dprinting workflow fordevice fabrication. Theproposed andreference devicessupport the devicefabrication workflow.
Application	Light-cured resin	Light-cured resin	Light-cured resin	Light-cured resin	-All devices are light-cured resins.
Use	Fabricated by Dentalprofessionals in a dentallaboratory	Fabricated by Dentalprofessionals in adental laboratory	Fabricated by Dentalprofessionals in adental laboratory	Fabricated by Dentalprofessionals in adental laboratory	-All devices aremarketed andfabricated or printed bydental laboratories.
Table 5.1	Proposed Device	Predicate Device	Reference Device	Reference Device
Element	Halley resin system	Halley resin	Eclipse® Bonding	TEMPFX Esthetic	Similarities and
			Agent	Provisional System	Differences
Physicalproperties	No ISO standard availablefor these components; acombination of ISO 20795-1:2013, ISO 10477:2018 andinternal requirements weretested to confirmperformance.	ISO 20795-1:2013(Dentistry - Denturebase polymers)Type 4	No ISO standardavailable for thesecomponents: acombination of ISO20795-1:2013, ISO10477:2018 andinternal requirementswere tested to confirmperformance.	No ISO standardavailable for thesecomponents; acombination of ISO20795-1:2013, ISO10477:2018 andinternal requirementswere tested to confirmperformance.	-The predicate deviceHalley resin (K190043)complies with ISO20795-1 for Type 4materials.-The proposed Halleyresin system andreference devices areminor parts of therestorations and do nothave a uniquestandard requirement.-A combination of ISOstandards and internalrequirements wereconsidered to supportuse as bonding agentand sealer.-Performance is basedon testing.
Shelf life	3 years	3 years	Not submitted in thereference device510(k)	Not submitted in thereference device510(k)	Shelf life of theproposed deviceHalley resin system isbased on performancetesting.

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

7. Non-Clinical Performance Data

Physical Properties:

There are no specific ISO standards for supporting materials such as a bonding agent or a sealer. Performance of these proposed devices are linked to the Hallev resin (K190043) workflow. These components are minor part of the overall device and the performance testing is limited to support its characteristic as a bonding agent or a sealer. These components were added and tested to align with predicate device, Halley resin (K190043).

Data derived from testing supports conclusion that the proposed device Halley resin system support the predicate device Halley resin (K190043) workflow.

Biocompatibility:

The predicate device. Hallev resin (K190043) biocompatibility and test rationale remains unchanged from the current clearance. The patient contacting level and duration of the proposed Halley Denture-Tooth Bonding Agent and Halley Sealer are identical in material formulation and produced by the identical manufacturing methods as the reference devices. Therefore, no new biocompatibility testing was conducted for the proposed Halley resin system.

8. Clinical Performance Data

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

9. Conclusion Regarding Substantial Equivalence

The proposed device. Halley resin system testing supports the cleared predicate device, Halley resin (K190043) workflow for the following reasons:

. Both components were tested to support the modification of the cleared predicate device, Halley resin (K190043) and its workflow.
Both components have been previously cleared for similar use and the ● material composition is identical to the cleared reference devices, Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264.
The test data to verify the performance and biological safety of the proposed ● device, Halley resin system, has been provided. The results of this testing combined with the characteristics supporting the modified workflow 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.