Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, "Pulp Canal Sealer and Pulp Canal Sealer EWT." The submission aims to demonstrate substantial equivalence to a predicate device (K945244). The information focuses on non-clinical performance data and does not include details about Artificial Intelligence (AI) or machine learning algorithms. Therefore, many of the requested points related to AI studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this document.

However, I can extract information related to the acceptance criteria and non-clinical study for the device's physical and mechanical properties.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the physical and mechanical properties are implicitly derived from the predicate device's performance and the ISO 6876 standard for "Dental Root Canal Sealing materials." The reported device performance is compared against the predicate and against the ISO standard's maximum limits where specified.

Property	Acceptance Criteria (Based on Predicate and ISO 6876)	Reported Proposed Device Performance (K152956)
Pulp Canal Sealer
Consistency	Comparable to predicate (29 mm)	28 mm
Solubility	Comparable to predicate (0.09%)	0.34%
Work Time	> 45 Minutes (from predicate)	> 45 Minutes
Set Time	< 60 Minutes Max (from predicate)	< 60 Minutes Max
Film Thickness (µm)	≤ 50 µm (ISO 6876 standard) and comparable to predicate (22.6 µm)	20.66 µm
Safety	Pass (from predicate)	Pass
Pulp Canal Sealer EWT
Consistency	Comparable to predicate (28.5 mm)	25 mm
Solubility	Comparable to predicate (0.47%)	0.36%
Work Time	> 6 Hours (from predicate)	> 6 Hours
Set Time	< 2 Hours Max (from predicate)	< 2 Hours Max
Film Thickness (µm)	≤ 50 µm (ISO 6876 standard) and comparable to predicate (23.6 µm)	33.87 µm
Safety	Pass (from predicate)	Pass

Justification for Acceptance: The document states, "The data analyzed from the various tests substantiate that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate devices." Specifically for film thickness, it notes, "The sealer was tested to meet ISO 6876 standards which state that a sealer shall have a film thickness of not more than 50 um. The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT is still below the maximum 50 um allowance and will flow sufficiently to fill the voids, as the film thickness remains within the proper specifications of the ISO standard requirements."

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes used for each physical and mechanical test. It only states that "Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485:2012 Medical Devices- Quality Management Systems, and ISO 6876 Dental - Root Canal Sealing Materials."
The data provenance is from non-clinical performance data (laboratory testing) rather than human subject data. The proposed device's manufacturing location is identified as Scafati, Italy, suggesting the testing data may originate from these operations, although it's not explicitly stated. It is a prospective test in the sense that the new formulation was tested to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical, laboratory-based performance study, not involving expert interpretation of medical images or patient data. The "ground truth" is defined by the physical and mechanical properties of the materials as measured against ISO standards and the predicate device's performance.

4. Adjudication method for the test set

Not applicable. This is a non-clinical, laboratory-based performance study; therefore, no adjudication method for human interpretation was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a non-clinical study for a dental filling material, not an AI software or a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests is based on:

ISO 6876:2012 Dentistry Root canal sealing materials: This international standard specifies the requirements and test methods for root canal sealing materials.
Performance of the legally marketed predicate device (K945244): The performance characteristics of the predicate device serve as a benchmark for comparison.

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical device, and there is no "training set" as would be used in machine learning.

9. How the ground truth for the training set was established

Not applicable. As noted above, there is no training set mentioned in the context of this device's evaluation.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2016

Sybron Dental Specialties Ms. Wendy Garman VP. Regulatory Affairs 1717 W. Collins Ave. Orange, California 92867

Re: K152956

Trade/Device Name: Pulp Canal Sealer and Pulp Canal Sealer EWT Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: March 7, 2016 Received: March 8, 2016

Dear Ms. Garman:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152956

Device Name

Pulp Canal Sealer and Pulp Canal Sealer EWT

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. The logo is blue and white.

Pulp Canal Sealer and Pulp Canal Sealer EWT

Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Heather Crilly
Telephone Number:	909-962-5664
Fax Number:	909-962-5694

Date Prepared: May 05, 2016

1. Device Name:
  .

●

Proprietary Name: Pulp Canal Sealer and Pulp Canal Sealer EWT
Classification Name: Root Canal Filling Resin 872.3820
CFR Number: .
- Device Class: II
Product Code: KIF .
1. Predicate Device:

The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the legally marketed device Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) cleared on December 29, 1994, product code KIF.

1. Description of Device:
  Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.
1. Statement of Indications for Use:
  Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

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Description of Substantial Equivalence 6.
Technological Characteristics:

The powder base formulation of the Proposed Pulp Canal Sealer and the predicate device, Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244), are very similar. The only difference being the formula range of the ingredient Thymol Iodide in the Pulp Canal Sealer product. The predicate Pulp Canal Sealer contains a higher limit of Thymol Iodide, while the Proposed Pulp Canal Sealer contains a lower formula range. The Proposed Pulp Canal Sealer EWT powder base remains unchanged.

The liquid catalyst is the same formulation used for both the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT and the predicate device, Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244). The liquid catalyst remains unchanged.

Pulp Canal Sealers are intended to fill the microscopic gaps between the root canal filler/obturator product (i.e. Gutta Percha) and the root canal wall. The powder base contains Zinc Oxide and the liquid catalyst contains Eugenol. The base and catalyst are combined and mixed into a homogenous paste which is then placed directly into the root canal as a thin layer. Once the Zinc Oxide and Eugenol are mixed, the Eugenol is consumed and converted into a solid complex. The sealer paste will set due to a chelation reaction between the Zinc Oxide and Eugenol. The hardening of the thin layer occurs within the root canal in the presence of moisture.

Thymol Iodide has no significance within the chemical reaction that takes place in the actual formation of the root canal sealant. The only known effect of the addition of Thymol Iodide is that it may accelerate set times. The difference between the predicate limit and the proposed limit of Thymol Iodide is a minor change, and no effect to the formulation could be measured or recorded.

The formulation utilizing the lowered formulation range of Thymol Iodide has been on the market for a number of years in Europe. Based on post market data and design verification testing, the performance characteristics of this material results are substantially equivalent to those of the predicate. The slight variation in Thymol Iodide does not change the performance characteristics of the device.

1. Non-Clinical Performance Data:
  Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485:2012 Medical Devices- Quality Management Systems, and ISO 6876 Dental - Root Canal Sealing Materials, and the results demonstrated substantial equivalence to the predicate. The Tables 5.1 and 5.2 below depict the modifications associated with Pulp Canal Sealer and Pulp Canal Sealer EWT.

Non-clinical performance data included testing for Consistency, Solubility, Work/Set Time, Film Thickness, and Biocompatibility testing (refer to Table 6.2). The data analyzed from the various tests substantiate that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate devices. The following standard was utilized for non-clinical performance testing of the proposed:

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ISO 6876:2012 Dentistry Root canal sealing materials .

Clinical Performance Data:

Clinical performance testing has not been performed for Pulp Canal Sealer and Pulp Canal Sealer EWT.

Element	Predicate Device-Pulp Canal Sealer/Pulp CanalSealer EWT (K945244)	Proposed Pulp Canal Sealerand Pulp Canal Sealer EWT(K152956)
Trade Name	Pulp Canal Sealer/Pulp CanalSealer EWT	Pulp Canal Sealer and PulpCanal Sealer EWT
Target Users	Licensed dental professionals	Licensed dental professionals
Device Description	Pulp Canal Sealer and PulpCanal Sealer EWT are used forpermanent obturation of the rootcanal space with the aid ofobturating points in accordancewith ISO 6876 for Dental RootCanal Sealing materials.	The Proposed Pulp Canal Sealerand Pulp Canal Sealer EWT areused for permanent obturation ofthe root canal space with the aidof obturating points inaccordance with ISO 6876 forDental Root Canal Sealingmaterials.
Common Name	Root Canal Sealer	Root Canal Sealer
Classification Name	Root Canal Filling Resinper 21 CFR § 872.3820	Root Canal Filling Resinper 21 CFR § 872.3820
Class	II	II
Product Code	KIF	KIF
Powder Base Formulafor Pulp Canal Sealer(PN 24875) Only	Contains:Thymol Iodide	Contains:Decreased range of ThymolIodide
Powder Base Formulafor Pulp Canal SealerEWT(PN 24746) Only	Formula per K945244	No Change from K945244
Catalyst Formula (Samefor both products)	Formula per K945244	No Change from K945244
Manufacturing Location	Romulus, MI (USA)	Scafati, Italy
LegalManufacturer/SpecDeveloper	Kerr CorporationRomulus, MI	SybronEndoGlendora, CA
Packaging	Powder:Cap - PolypropyleneBottle – PolystyreneLiquid:Cap – Low Density PolyethyleneBottle – Polypropylene	Powder:Cap - PolypropyleneBottle – PolystyreneLiquid:Cap –Low Density PolyethyleneBottle – Polypropylene

Table 5.1: Predicate Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) and Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT Device Comparison Table

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Table 5.2: Predicate Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) and Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT Physical and Mechanical Properties Comparison

PHYSICAL & MECHANICAL PROPERTIES COMPARISON
	Predicate Device (K945244)		Proposed Device (K152956)
Element	Pulp CanalSealer	Pulp CanalSealer EWT	Pulp CanalSealer	Pulp CanalSealer EWT
Chemistry ofSetting Reaction	Chelation between zinc oxide & eugenol		Chelation between zinc oxide & eugenol
Consistency	29 mm	28.5 mm	28 mm	25 mm
Solubility	0.09%	0.47%	0.34%	0.36%
Work/Set Time	Work Time:> 45 MinutesSet Time:< 60 Minutes Max	Work Time:> 6 HoursSet Time:< 2 Hours Max	Work Time:> 45 MinutesSet Time:< 60 Minutes Max	Work Time:> 6 HoursSet Time:< 2 Hours Max
Film Thickness(µm)	22.6 µm	23.6 µm	20.66 µm	33.87 µm
Safety	Pass		Pass

Conclusion as to Substantial Equivalence:

Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) is an existing device which was granted FDA market clearance in 1994. Sybron Dental Specialties seeks only to slightly modify the existing device cleared under K945244. Additionally, the manufacturer name will change to SybronEndo, the device will be produced at a sister facility in Scafati, Italy (Kerr Italia), and the product code will be updated to KIF. Tables 5.1 and 5.2 depict the modifications associated with the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT.

The film thickness of the proposed device is roughly 10 microns thicker than the predicate device as shown in Table 5.2 above. Table 5.2 demonstrates that the difference in film thickness between the predicate and proposed devices does not affect the substantial equivalence of the subject and predicate devices. The sealer was tested to meet ISO 6876 standards which state that a sealer shall have a film thickness of not more than 50 um. The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT is still below the maximum 50 um allowance and will flow sufficiently to fill the voids, as the film thickness remains within the proper specifications of the ISO standard requirements.

The modification of Pulp Canal Sealer (PN 24875) to lower the formulation range of the ingredient Thymol Iodide, and the move of the manufacturing location to Scafati, Italy do not affect the intended use nor does it alter the fundamental scientific technology of the device. The nonclinical testing demonstrates that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT perform as well as the predicate device. The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244).

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.