The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

Device Description

The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.

The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)

This submission is for a modified version of an existing root canal sealer (Tubli-Seal/Tubli-Seal EWT). The core of the study is to demonstrate that the modified product line is substantially equivalent to the predicate device, essentially performing as well despite minor formula changes and a manufacturing location change.

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

The acceptance criteria are based on the international standard ISO 6876:2012 for Dental - Root Canal Sealing Materials. The reported performance of the proposed device is compared to the predicate device, with the standard as the overarching acceptance benchmark.

Criterion (ISO 6876:2012)	Predicate Device Performance	Proposed Device Performance	Acceptance Criteria (from ISO 6876:2012)	Does Proposed Device Meet Criteria?
Consistency (Flow)	29 mm	28 mm	Not explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The slight difference (1mm) is considered acceptable for substantial equivalence.	Yes (implicitly, as considered substantially equivalent)
Film Thickness	13.04 µm	17.61 µm	Not more than 50 µm	Yes (17.61 µm < 50 µm)
Solubility and Disintegration	0.70%	0.46%	Not to exceed 3.0%	Yes (0.46% < 3.0%)
Radiopacity	5 mm Al	6 mm Al	Not explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The difference (1mm Al) is considered acceptable for substantial equivalence.	Yes (implicitly, as considered substantially equivalent)

Notes on Acceptance Criteria:

For Consistency (Flow) and Radiopacity, the document does not explicitly state the numerical acceptance range from ISO 6876:2012 beyond which the device would fail. Instead, it relies on the direct comparison between the proposed and predicate devices and the conclusion of substantial equivalence based on ISO 6876:2012.
The key phrase "the proposed products meet the current product specifications and are substantially equivalent to the predicate" indicates that meeting the predicate's performance within acceptable ISO 6876:2012 deviations serves as the acceptance criterion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not explicitly state the specific number of samples for each test (Consistency, Film Thickness, Solubility, Radiopacity). It mentions "Performance testing on stability, work time, set time and slump were performed on the modified formula," indicating multiple tests were conducted. Standard quality control and testing procedures would typically involve a statistically appropriate number of samples, but the exact count is not provided.
Data Provenance: The testing was carried out as "Non-Clinical Performance Data" and "Performance Testing - Bench." This suggests the data was generated in a controlled laboratory or benchtop setting. The document also mentions that "The proposed Tubli-Seal product line (...) has successfully been on the EU market for several years without incident," suggesting real-world performance data from Europe, though the specific validation study data is laboratory-based. The manufacturing location is changing to Scafati, Italy, so it's likely the bench testing was done in relation to this manufacturing process and formulation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This study is a bench performance study comparing the physical and mechanical properties of a material (root canal sealer) against an international standard (ISO 6876:2012) and a predicate device. It does not involve human interpretation or clinical endpoints that would require expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As a bench performance study, there is no need for human adjudication of results. The measurements are objective physical properties.

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 is a bench performance study for a dental material, not an AI-assisted diagnostic device.

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

Not applicable. This does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this study is defined by the objective, measurable physical and mechanical properties of the material as specified by ISO 6876:2012 - Dentistry - Root Canal Sealing Materials. This is a standardized laboratory measurement. The predicate device's performance also serves as a comparative "truth" for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical materials performance study, not a machine learning study that requires a training set.

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

Not applicable. No training set was used.

Summary

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

July 27, 2016

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

Re: K153067

Trade/Device Name: Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: Mav 20, 2016 Received: June 7, 2016

Dear Wendy 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,

Image /page/1/Picture/8 description: The image shows a signature above the name Tina Kiang. Below the signature and name is the text '-s-'. In the background is a faded logo.

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) K153067

Device Name

Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)

Indications for Use (Describe)

The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

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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SECTION 6. 510(k) SUMMARY FOR THE TUBLI-SEAL PRODUCT LINE (TUBLI-SEAL/ TUBLI-SEAL XPRESS/TUBLI-SEAL EWT/TUBLI-SEAL EWT XPRESS)

K153067

Image /page/3/Picture/2 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized, bold, sans-serif font, stacked above the full name of the company. The letters are in a dark blue color, and there is a curved line above the letters, adding a dynamic element to the design.

Submitter Information: 1.

Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person: Wendy Garman Telephone Number: 909.962.5666 Fax Number: 909.962.5694

Date Prepared: July 14, 2016

1. Device Name:
- Proprietary Name: .
- Classification Name: ●
- CFR Number: ●
- Device Class: .
- Product Code: KIF .

3. Predicate Device:

The Proposed Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is substantially equivalent to the legally marketed devices Tubli-Seal/Tubli-Seal EWT (K942393, cleared on June 10, 1994), product code KIF.

872.3820

Resin, Root Canal Filling

Tubli-Seal product line (Tubli-Seal/Tubli-Seal

Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)

1. Description of Device:
  The Proposed Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.

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branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.

Table 6.1 Description of Accessories used with the proposed Tubli-Seal Xpress and Tubli-Seal EWT Xpress

Accessories Used with Tubli-SealXpress and Tubli-Seal EWT Xpress	Manufacturer of Accessory
Dual-barrel syringe	Sulzer Mixpac AGRuetistrasse 7Haag Sankt gallen, Switzerland9469
Auto-mix tips	Sulzer Mixpac AGRuetistrasse 7Haag Sankt gallen, Switzerland9469

5. Statement of Indications for Use:

The Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

6. Summary of Technological Characteristics:

The base formulation of the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) and the predicate devices, Tubli-Seal/Tubli-Seal EWT (K942393), remain unchanged.

The accelerator formulations of the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) and the predicate devices, Tubli-Seal/Tubli-Seal EWT (K942393), are very similar, with the only differences being the adjustment of resin and the addition of a new, yet substantially equivalent resin, the adjustment of the reactive solvent and filler, and the addition of a new filler/setting accelerator.

The resin change in the proposed device helps enhance the stability and performance. The two resin types are considered substantially equivalent. The changes in reactive solvent and filler were to accommodate the addition of a new resin type and filler/setting accelerator in the proposed accelerator formulation. The slight addition of a new filler/setting accelerator to the proposed accelerator is added during manufacturing to accelerate the set time based on in-process set-time testing to meet specification. The addition of the setting accelerator may not be necessary if in-process set-time testing meets specification. The filler and resins have no significance within the chemical reaction that takes place in the actual formation of the root canal sealant.

The mixing of the base and accelerator, in the presence of moisture that is in root canal, causes the sealer to harden. Trace amounts of water initiates the chelation reaction between the accelerator and base that results in a solid fill. The Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is intended to

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fill the microscopic gaps between root canal filler and canal walls. The slightly modified formulation for the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/ Tubli-Seal EWT/Tubli-Seal EWT Xpress) has successfully been on the EU market for several years. Performance testing on stability, work time, set time and slump were performed on the modified formula to validate that the proposed products meet the current product specifications and are substantially equivalent to the predicate.

7. Non-Clinical Performance Data:

Verification activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485 Medical Devices- Quality Management Systems, and ISO 6876:2012 Dental - Root Canal Sealing Materials, and the results demonstrated substantial equivalence to the predicate Tubli-Seal EWT (K942393). Performance testing on stability, work time, set time and slump were performed on the modified formula to validate that the proposed products meet the current product specifications and are substantially equivalent to the predicate. Table 6.2 below depicts the modifications associated with the predicate and proposed devices.

8. Summary of Performance Testing Performance Testing - Bench

Performance testing for the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) included testing for Consistency (Flow), Film Thickness, Solubility and Radiopacity per ISO 6876:2012 - Dentistry -Root Canal Sealing Materials (See Table 6.2).

The proposed accelerator formulation for Tubli-Seal was considered the "worst-case" scenario for biocompatibility and performance testing since its accelerator formulation contains two additional components that are not contained in the predicate devices or proposed Tubli-Seal EWT formulation. The "worst-case" scenario's performance and biocompatibility testing results are directly applicable to the proposed Tubli-Seal EWT since the formulation, intended use, and performance are very similar. Therefore, the predicate and proposed test results are substantially equivalent to support intended use.

In the Physical and Mechanical Properties of Table 6.2, the film thickness has a 4.57 micron (um) difference between the predicate and proposed devices. This difference does not affect the substantial equivalence of the subject and predicate devices. The sealer was tested to meet ISO 6876:2012 standard, which states that a sealer shall have a film thickness of not more than 50 um. The proposed Tubli-Seal product line (Tubli-Seal/ Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is below the maximum 50 um allowance. Therefore, the predicate and proposed sealers will flow sufficiently into the root canal and adapt to canal shape to fill voids.

The predicate and proposed devices produced Solubility and Disintegration results of 0.70% and 0.46%, respectively. According to ISO 6876:2012, the solubility may not exceed 3.0%. This data shows no substantial difference between the predicate and proposed devices according to ISO 6876:2012.

The data analyzed from the various tests substantiate that the proposed Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is substantially equivalent to the predicate Tubli-Seal/Tubli-Seal EWT (K942393).

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1. Substantial Equivalence:
  Tubli-Seal/Tubli-Seal EWT (K942393) are existing devices which were granted market clearance by FDA in 1994. Sybron Dental Specialties, on behalf of SybronEndo, seeks only to slightly modify the formula and the Indications for Use statement of the existing devices cleared under K942393. The proposed Indications for Use statement will specifically mention the use of "obturation points" to clearly describe the device's use as it is common practice for obturation points to be used with endodontic sealers.

Additionally, the device would be produced at a sister facility in Scafati, Italy (Kerr Italia); and the manufacturer name will change to SybronEndo. The proposed Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) has been on the market in the EU for a number of years without incident.

According to ISO 6876:2012, the proposed device performs as well as the legally marketed predicate device (K942393). Therefore, the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is considered to be substantially equivalent to the predicate device.

Table 6.2 depicts the comparison of performance and mechanical properties and modifications associated with the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress).

Element	Predicate Device-Tubli-Seal/Tubli-Seal EWT (K942393)	Proposed Device-Tubli-Seal product line (Tubli-Seal/ Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWTXpress)
Trade Name	Tubli-Seal/Tubli-Seal EWT	Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWTXpress
Target Users	Licensed dental professionals	Licensed dental professionals
Indications forUse	Tubli-Seal EWT, apaste/paste base and catalystformulation, is intended forpermanent obturation of pulpspace in teeth requiring rootcanal treatment.	The Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-SealEWT/Tubli-Seal EWT Xpress) isused for permanent obturation ofthe root canal space with the aid ofobturating points.
DeviceDescription	Tubli-Seal/Tubli-Seal EWT(K942393) is a Zinc OxideEugenol root canal sealer tobe used for permanentobturation of the root canalspace in conjunction withobturating points.	The Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-SealEWT/Tubli-Seal EWT Xpress) is aZinc Oxide Eugenol root canalsealer to be used for permanentobturation of the root canal space inconjunction with obturating points.
	part, base/accelerator,paste/paste system. The two-part system is packaged intubes. The product isavailable in two (2) workingtimes, Regular and ExtendedWork Time (EWT).	It is a two-part, base/accelerator,paste/paste system. The two partsystem is packaged in tubes that arehand mixed, then placed into theprepped root canal, or in a dual-barrel syringe (Tubli-Seal Xpressand Tubli-Seal EWT Xpress) thatdoes not require hand mixing. Theproduct is available in two (2)working times, Regular andExtended Work Time (EWT).
Common Name	Root Canal Sealer	Root Canal Sealer
ClassificationName	Resin, Root Canal Filling perCFR § 872.3820	Resin, Root Canal Filling per CFR§ 872.3820
Class	II	II
Product Code	KIF	KIF
Base Formula forTubli-Seal/Tubli-Seal EWT/Tubli-SealXpress	Formula per K942393	No Change from K942393
AcceleratorFormula forTubli-Seal/Tubli-SealXpress	Contains:• Resin• Solvent• Filler	Proposed formulation changes:• Decreased amount of Resin thatis currently in formation• Second resin added toformulation (total percentage oftwo (2) resins does not exceedcurrent percentage)• Decreased amount of Solventcurrently in formulation• Decreased amount of Fillercurrently in formulation• Setting Accelerator may beadded to the formulation asneeded during manufacturing tomeet set time specification
AcceleratorFormula forTubli-Seal EWT/Tubli-Seal EWTXpress	Contains:• Resin• Solvent• Matrix Fluid	Proposed formulation changes:• Decreased amount of Resin thatis currently in formulation• Second resin added toformulation (total percentage oftwo (2) resins does not exceedcurrent percentage)
LegalManufacturer/SpecificationDeveloper	Kerr Corporation28200 Wick RoadRomulus, MI 48174USA	SybronEndo1332 S. Lone Hill Ave.Glendora, CA 91740USA
ManufacturingLocation	Kerr Corporation28200 Wick RoadRomulus, MI 48174USA	Kerr Italia, S.R.L.Via Passanti, 332Scafati Salerno, I-84018ITALY
Packaging	Laminate Tubes	Laminate Tubes and Polypropylene dual-barrel syringes used with single-use automix tips.
Physical and Mechanical Properties
Form	Two Pastes(Accelerator & Base)	Two Pastes(Accelerator & Base)
Mix Ratio	Equal Volumes	Equal Volumes
Consistency(Flow)	29 mm	28mm
Film Thickness	13.04 μm	17.61 μm
Solubility andDisintegration	0.70%	0.46%
Radiopacity	5 mm Al	6 mm Al

Table 6.2: Predicate Tubli-Seal/Tubli-Seal EWT (K942393) and the proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) Comparison Table

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Conclusion as to Substantial Equivalence:

The slight modifications of the Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/ Tubli-Seal EWT/Tubli-Seal EWT Xpress) accelerator formulations, Indications for Use statement and the move of the manufacturing location to Scafati, Italy (Kerr Italia) does not affect the intended use of the device nor does it alter the fundamental scientific technology of the device.

The nonclinical testing demonstrates that the Proposed Tubli-Seal product line (Tubli-Seal/ Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) performs as well as the predicate device based on the specifications set by ISO 6876:2012 testing requirements. The Proposed Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/ Tubli-Seal EWT/Tubli-Seal EWT Xpress) is substantially equivalent to the predicate Tubli-Seal/ Tubli-Seal EWT (K942393).

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.