(89 days)
No
The document describes a light-cured resin system for dental prosthetics and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition, or alleviate symptoms. This device is a resin system used for fabricating dental prostheses and enhancing the bond and surface finish of dentures, which are restorative and cosmetic functions, not therapeutic.
No
The device is a light-cured resin system used for fabricating and modifying dental prostheses, not for diagnosing medical conditions.
No
The device description clearly states it consists of "light-cured resins" and "two additional components (Halley Denture-Tooth Bonding Agent and Halley Sealer)", which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental prostheses (dentures, overdentures) and related materials (bonding agent, sealer) used in dental laboratories. This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is described as light-cured resins used in a dental laboratory workflow. It's a material used to create a physical object.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is a material used in the creation of a dental prosthesis, which is a medical device itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBI, KLE, EBD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Fabricated by Dental professionals in a dental laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Halley resin system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Halley resin (K190043)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Eclipse® Bonding Agent, K051707, TEMPFX Esthetic Provisional System, K061264
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
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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 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.
| 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.
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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.
SECTION 5. 510(k) SUMMARY for
Halley resin system
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
Contact Person: Karl Nittinger Telephone Number: 717-849-4424 Fax Number: 717-849-4343
Date Prepared: May 23, 2019
-
- Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Number:
- 21 C.F.R. 872.3760 . Device Class: 11 ●
- Product Code: EBI .
-
- 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 Esthetic | ||
| Provisional System | K061264 | Dentsply Prosthetics |
4
4. Description of Device:
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.
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.
-
- 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.
- Substantial Equivalence:
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 Device
Halley resin system | Predicate Device
Halley resin | Reference Device
Eclipse® Bonding
Agent | Reference Device
TEMPFX Esthetic
Provisional System | Similarities and
Differences |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | | | | | |
| 510(k) | To be assigned | K190043 | K051707 | K061264 | N/A |
| 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 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.
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. | 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. | Eclipse® Bonding Agent
is indicated for use in
enhancing the bond of
acrylic teeth to acrylic
removable denture
bases. | TEMPFX Esthetic
Provisional System is
indicated for fabrication
of provisional dental
restorations. | -The proposed Halley
resin system is a
modification of the
workflow cleared under
the predicate device,
Halley resin (K190043).
Two additional
components are
introduced the Halley
resin (K190043)
workflow.
-Additional components
proposed for the Halley
resin system have been
previously cleared,
Eclipse® Bonding Agent
(K051707) and as part
of TEMPFX Esthetic
Provisional System
(K061264) and are
listed as reference
devices.
-Two additional
components test reports
support modifications to
the Halley resin
(K190043) workflow to
include a bonding agent
and sealer.
-Both reference devices
are currently utilized for
similar uses in different
workflows under
K051707 and K061264.
VLC Sealer is included
within the system
components as a light-
curable resin material
which forms a glossy
surface. The identical
VLC Sealer has been
re-branded as Halley
Sealer to support similar
use for Halley resin
system workflow. |
| Table 5.1 | Proposed Device | Predicate Device | Reference Device | Reference Device | |
| Element | Halley resin system | Halley resin | Eclipse® Bonding
Agent | TEMPFX Esthetic
Provisional System | Similarities and
Differences |
| Composition | Halley resin:
Methacrylate (mono and
dimethacrylate) resins
polymerized via
photoinitiators
Pigments are added for color
of the denture.
Halley Denture-Tooth
Bonding Agent:
Solvent vehicle containing
Methacrylate (mono and
dimethacrylate) resins
polymerized via
photoinitiators
Halley Sealer:
Methacrylate (mono and
dimethacrylate) resins
polymerized via
photoinitiators | Methacrylate (mono
and dimethacrylate)
resins polymerized via
photoinitiators in a 3D
printer settings.
Pigments are added
for color of the denture. | Solvent vehicle
containing
Methacrylate (mono
and dimethacrylate)
resins polymerized via
photoinitiators | Methacrylate (mono
and dimethacrylate)
resins polymerized via
photoinitiators | -Composition of the
proposed, predicate
and reference device
VLC Sealer (K061264)
are similar. All devices
are resins polymerized
via photoinitiators.
-No pigments are
added to the proposed
and reference devices.
Additional color
variations are not
required for these
devices.
-The reference device,
Eclipse Bonding Agent
(K051707) uses a
different solvent
vehicle, however, after
polymerization, the
device composition is
similar to the
proposed, predicate
devices.
-The predicate device,
Halley resin utilizes 3D
printing workflow for
device fabrication. The
proposed and
reference devices
support the device
fabrication workflow. |
| Application | Light-cured resin | Light-cured resin | Light-cured resin | Light-cured resin | -All devices are light-
cured resins. |
| Use | Fabricated by Dental
professionals in a dental
laboratory | Fabricated by Dental
professionals in a
dental laboratory | Fabricated by Dental
professionals in a
dental laboratory | Fabricated by Dental
professionals in a
dental laboratory | -All devices are
marketed and
fabricated or printed by
dental 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 |
| Physical
properties | No ISO standard available
for these components; a
combination of ISO 20795-
1:2013, ISO 10477:2018 and
internal requirements were
tested to confirm
performance. | ISO 20795-1:2013
(Dentistry - Denture
base polymers)
Type 4 | No ISO standard
available for these
components: a
combination of ISO
20795-1:2013, ISO
10477:2018 and
internal requirements
were tested to confirm
performance. | No ISO standard
available for these
components; a
combination of ISO
20795-1:2013, ISO
10477:2018 and
internal requirements
were tested to confirm
performance. | -The predicate device
Halley resin (K190043)
complies with ISO
20795-1 for Type 4
materials.
-The proposed Halley
resin system and
reference devices are
minor parts of the
restorations and do not
have a unique
standard requirement.
-A combination of ISO
standards and internal
requirements were
considered to support
use as bonding agent
and sealer.
-Performance is based
on testing. |
| Shelf life | 3 years | 3 years | Not submitted in the
reference device
510(k) | Not submitted in the
reference device
510(k) | Shelf life of the
proposed device
Halley resin system is
based on performance
testing. |
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.