Vista BC Sealer

K221811 · Inter-Med, Inc. · KIF · Nov 21, 2022 · Dental

Device Facts

• Record ID: K221811
• Device Name: Vista BC Sealer
• Applicant: Inter-Med, Inc.
• Product Code: KIF · Dental
• Decision Date: Nov 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent obturation of the root canal following vital pulp-extirpation. Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

Device Story

Vista BC Sealer is a premixed, ready-to-use, injectable white hydraulic cement paste for permanent root canal filling and sealing. Composed of calcium aluminates, zirconium oxide, calcium sodium phosphosilicate, fumed silica, lithium chloride, and propylene glycol; the material requires moisture from surrounding tissues to initiate a setting reaction, hardening into an insoluble, radiopaque structure. Supplied in a preloaded syringe with disposable application tips, it is used by dental professionals in clinical settings. The sealer is injected into the root canal system, filling accessory and lateral canals. By providing a permanent seal, it prevents reinfection and supports endodontic treatment success. The device is non-sterile and intended for permanent contact (>30 days) with tissue, bone, and dentin.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including ISO 6876 performance metrics (flow, set time, film thickness, solubility, radiopacity), shelf-life testing, transit testing, and biocompatibility testing (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and genotoxicity).

Technological Characteristics

Hydraulic cement paste; composition includes calcium aluminates, zirconium oxide, calcium sodium phosphosilicate, fumed silica, lithium chloride, and propylene glycol. Requires moisture to set. Dimensions: preloaded syringe with disposable tips. Standards: ISO 6876, ISO 7405, ISO 10993 series, ISO 80369-7, ISO 14971. Non-sterile, 2-year shelf life.

Indications for Use

Indicated for permanent root canal obturation in patients requiring vital pulp-extirpation or removal of infected/necrotic pulp with intracanal dressings.

Regulatory Classification

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.

Predicate Devices

• ENDOSEAL MTA (K170175)

Reference Devices

• iRootSP (K080917)

Submission Summary (Full Text)

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

November 21, 2022

Inter-Med. Inc. Alex Johnson Dir. Engineering, Regulatory & Quality 2200 South St Racine, Wisconsin 53404

Re: K221811

Trade/Device Name: Vista BC Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: October 14, 2022 Received: October 25, 2022

Dear Alex Johnson:

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.

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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 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K221811

Device Name Vista BC Sealer

Indications for Use (Describe)

· Permanent obturation of the root canal following vital pulp-extirpation.

• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font and is underlined with a thin blue line. To the right of the word is a blue globe. To the right of the globe is the word "INC." in black font.

Image /page/3/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. The logo is primarily blue and black.

K221811

## 510(k) Summary for Vista BC Sealer

#### 1. Applicant

Submitter's Name: Alex Johnson Khongchee Xiong Sara Travia

Date Summary Prepared: October 14, 2022

- Address: Inter-Med / Vista Dental Products 2200 South St. Racine, WI, USA 53404
Contact Person: Alex Johnson, MSc

Email: [e-mail]

Phone: [phone]

Fax: [phone]

- 2. Device Name
Proprietary Name: Vista BC Sealer Common Name: Root canal filling Product Code: KIF Device Class: Class 2

#### 3. Predicate Device

Primary Predicate Device ENDOSEAL MTA (K170175) by Maruchi, Inc.

- o Common Name: Root canal filling
- Product Code: KIF O
- Device Class: Class 2 O

Reference Device iRootSP (K080917) by Innovative BioCeramix, Inc.

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Image /page/4/Picture/0 description: The image shows the logos for Intermed INC. and Vista Dental Products. The Intermed INC. logo features the word "intermed" in blue, with a blue globe to the right of the word. The letters "INC." are in black and are smaller than the word "intermed". The Vista Dental Products logo features a blue mountain range above the word "VISTA" and the words "Dental Products".

#### Device Description 4.

Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.

This is the only 510(k) for these medical devices, no prior 510(k)s have been submitted.

#### ട്. Intended Use / Indication for Use

- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and ● placement of intracanal dressings.

#### 6. Technological Characteristics and Substantial Equivalence

| Characteristic | Proposed Device | Primary Predicate Device | Reference Device |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Vista BC Sealer | ENDOSEAL MTA | iRoot SP |
| 510(k) Number | Pending<br>(subject device for this<br>510(k) submission) | (K170175) | (K080917) |
| Common name | Root Canal Filling | Root Canal Filling | Root Canal Filling |
| Product Code | KIF | KIF | KIF |
| Manufacturer | Inter-Med Inc. / Vista<br>Dental Products | MARUCHI | Innovative BioCeramix, Inc. |
| Device Description | Vista BC Sealer is a ready-to-use injectable white hydraulic cement paste suitable for permanent root canal filling and sealing of the entire root canal. It is packaged in a preloaded syringe, which allows for complete filling of the root canal including accessory and lateral canals. | ENDOSEAL MTA is an endodontic sealer based on MTA, providing a root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. | iRoot SP Root Canal Sealer (IRoot SP) is a ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. |
| Characteristic | Proposed Device | Primary Predicate Device | Reference Device |
| Trade Name | Vista BC Sealer | ENDOSEAL MTA | iRoot SP |
| | | | iRoot SP is packaged in a<br>preloaded syringe and is<br>supplied with<br>disposable Intra Canal Tips. |
| Intended | Dental and Endodontic | Dental and Endodontic | Dental and Endodontic |
| Population | offices | offices | offices |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Composition (bold<br>text added to<br>highlight<br>similarities in<br>composition<br>between subject<br>device and<br>predicate /<br>reference devices) | Calcium aluminates,<br>Zirconium oxide,<br>Calcium sodium<br>phosphosilicate,<br>Thickening agent (fumed<br>silica),<br>Lithium chloride,<br>Propylene glycol | Calcium silicates,<br>Calcium aluminates,<br>Zirconium oxide,<br>Calcium sulfates,<br>Thickening agent | Zirconium oxide,<br>Calcium silicate,<br>Calcium hydroxide,<br>Calcium phosphate<br>monobasic,<br>Propylene glycol,<br>Thickening agent |
| Principle of | Vista's BC Sealer is an<br>insoluble and radiopaque<br>root canal sealer which<br>requires the presence of<br>water to set and harden.<br>Upon placement of material<br>into the root canal, the<br>moisture present from<br>surrounding tissues helps to<br>initiate a setting reaction<br>within the material and<br>eventually solidifying into a<br>hard structure. | The inside of the root canal<br>system has high humidity<br>due to residual moisture in<br>the dentinal tubules. MTA<br>solidifies into a hard<br>structure by absorbing the<br>moisture from the<br>surrounding tissue. Calcium<br>hydroxide is produced due<br>to the hydration reaction of<br>the calcium silicates<br>increasing the pH of the<br>medium. | iRoot SP is an insoluble and<br>radiopaque root canal sealer<br>which requires the presence<br>of water to set and harden. |
| operation | | | |
| Indications for use | Permanent obturation of the<br>root canal following vital<br>pulp-extirpation.<br>Permanent obturation of the<br>root canal following<br>removal of infected or<br>necrotic pulp and placement<br>of intracanal dressings. | Permanent obturation of the<br>root canal following vital<br>pulp-extirpation.<br>Permanent obturation of the<br>root canal following<br>removal of infected or<br>necrotic pulp and placement<br>of intracanal dressings. | Permanent obturation of the<br>root canal following vital<br>pulp-extirpation.<br>Permanent obturation of the<br>root canal following<br>removal of infected or<br>necrotic pulp and placement<br>of intracanal dressings.<br>iRoot SP is suitable for use<br>in the single cone and<br>lateral condensation<br>technique. |
| Delivery form | Single paste | Single paste | Single paste |
| Design | Pre-loaded syringe,<br>Disposable single use<br>application tips (i.e. | Pre-loaded syringe,<br>Disposable Intra Canal Tips | Pre-loaded syringe,<br>Disposable Intra Canal Tips |
| Characteristic | Proposed Device | Primary Predicate Device | Reference Device |
| Trade Name | Vista BC Sealer | ENDOSEAL MTA | iRoot SP |
| | identical to Intra Canal<br>Tips) | | |
| Nature of Contact | Category: External<br>communicating<br>device<br>Contact: Tissue, bone and<br>dentin<br>Contact Duration: C -<br>Permanent<br>(>30 days) | Category: External<br>communicating device<br>Contact: Tissue, bone and<br>dentin Contact Duration: C<br>- Permanent (>30 days) | Category: External<br>communicating device<br>Contact: Tissue, bone and<br>dentin Contact Duration: C<br>- Permanent (>30 days) |
| Set Time | < 90 minutes | 12.31 minutes | 240-600 minutes |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years | 2 years |
| Standards | ISO 7405<br>ISO 6876<br>ISO 10993-5<br>ISO 80369-7<br>ISO 14971<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-3 | ISO 6876 | ISO 6876 |

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Image /page/5/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a black line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black.

Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below the word "VISTA" is the phrase "Dental Products" in a smaller font. The logo is simple and clean, and the use of the mountain range suggests a sense of quality and reliability.

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Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font and is underlined with a black line. To the right of the word is a blue globe with white lines, and to the right of the globe is the word "INC." in black font.

Image /page/6/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" are the words "Dental Products".

Similarities between the subject device (Vista BC Sealer) and the predicate and reference devices (ENDOSEAL MTA and iRoot SP)

- Vista BC Sealer is classified under product code KIF and shares the identical common name "Resin, ● Root Canal Filling" as the predicate and reference devices.
- Vista BC Sealer has identical indications for use as the predicate device. ●
- Vista BC Sealer has the same contact duration (Permanent. >30 days) as the predicate and reference ● devices.
- Vista BC Sealer has identical mode of operation as the predicate and reference devices since these ● products are hydraulic cements which that require the presence of water to set and harden.
- Vista BC Sealer is used in the same target population and anatomical site as the predicate and reference devices.
- Vista BC Sealer is offered in the same configurations as the predicate and reference devices (i.e. pre-loaded syringes with disposable single use application tips / intra canal tips)
- Vista BC Sealer has an identical shelf life as the predicate and reference device (i.e. 2 years) ●
- Vista BC Sealer has identical technological characteristics to the predicate device: ●
- o Chemical composition:

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Image /page/7/Picture/0 description: The image shows the logos for Intermed INC. and Vista Dental Products. The Intermed INC. logo is in blue and features a globe graphic. The Vista Dental Products logo is also in blue and features a mountain range graphic.

- I Both devices are composed of calcium-based cement, specifically calcium aluminates
- I Both use zirconium oxide as its radiopacifying agent
- I Both use thickening agents
- Both devices have an alkaline pH. O
- Both devices are compliant with ISO 6876. O
- Both devices do not appreciably shrink while setting and hardening. O

Vista BC Sealer shares similar intended uses, technical characteristics, and methods of application to the predicate and reference devices (ENDOSEAL MTA and iRoot SP, respectively). Therefore, Vista's BC Sealer is substantially equivalent to these devices and poses no additional safety risks or efficacy concerns.

This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.

Differences between the subject device (Vista BC Sealer) and the predicate and reference devices (ENDOSEAL MTA and iRoot SP)

- Vista BC Sealer has a set time of ≤90 minutes whereas ENDOSEAL MTA and iRoot SP have a set ● time of 12 minutes and 240-600 minutes, respectively.
- o This difference does not raise any safety or efficacy concerns since the set time of Vista's BC Sealer is between the predicate and reference devices' set time.
- o Therefore, this difference does not raise any additional safety or efficacy concerns and the subject device remains substantially equivalent to the predicate device.
- Vista BC Sealer has a slightly different formulation than the predicate device ENDOSEAL MTA. ● Specifically, Vista BC Sealer contains a calcium sodium phosphosilicate as an added filler as well as an accelerator for helping speed the cementation reaction, whereas ENDOSEAL MTA contains calcium silicates and calcium sulfates which participate in the cementation reaction.
- O This difference does not raise any safety or efficacy concerns since all ingredients are safe for their intended use as evident through testing and literature references.
- Therefore, this difference does not raise any additional safety or efficacy concerns and the O subject device remains substantially equivalent to the predicate device.

Applicable Standards

- ISO 7405:2018 Dentistry Evaluation of Biocompatibility of Medical Devices Used in Dentistry ●
- ISO 6876:2012 Dentistry Root Canal Sealing Materials ●
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro ● Cytotoxicity
- ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications Part 7: ● Connectors for intravascular or hypodermic applications

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Image /page/8/Picture/0 description: The image shows the logos for Intermed INC. and Vista Dental Products. The Intermed INC. logo is on the left side of the image and features the word "intermed" in blue, with the "i" in lowercase and the rest of the letters in uppercase. To the right of the word is a blue globe. The Vista Dental Products logo is on the right side of the image and features a blue mountain range above the word "VISTA" in blue, with the trademark symbol next to it. Below the word "VISTA" is the phrase "Dental Products".

- ISO 14971:2019 Application of Risk Management to Medical Devices .
#### 7. Non-Clinical Performance Testing and Compliance

The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of Vista BC Sealer to ENDOSEAL MTA:

- Shelf-Life Testing ●
- o Through accelerated shelf life testing, Vista BC Sealer was found to have a shelf-life of two years. Real time aging is being performed on Vista BC Sealer to support shelf life during typical storage conditions.
- ISO 6876 Testing
- Flow testing, set time testing, film thickness testing, solubility and degradation testing, o and radiopacity testing were completed on Vista BC Sealer and ENDOSEAL MTA (predicate device) following methods detailed in ISO 6876.
- For all testing, Vista BC Sealer was found to be performed very similarly to the predicate O device, ENDOSEAL MTA, thereby confirming substantial equivalence.
- Transit Testing
- This test confirms that the packaging configurations are sufficient and withstand o simulated transit conditions. Moreover, the products performed satisfactory post-transit, which confirms that transit did not have a negative effect on the products themselves.
- Microbiological Testing
- Contamination risks from manufacturing are mitigated as Vista BC Sealer exhibits o bactericidal properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the syringes, as any introduced microbes will not remain viable within the medical device.
- Cytotoxicity Testing ●
- · Vista BC Sealer was found to yield equivalent, or better, cytotoxicity results compared to the predicate device, ENDOSEAL MTA.
- Sensitization Testing ●
- о Vista BC Sealer showed no evidence of causing delayed dermal contact sensitization in guinea pigs. Therefore, it is confirmed Vista BC Sealer is not considered a sensitizer. As Vista BC Sealer passed this biocompatibility test, comparison to the predicate device is not deemed necessary.
- Intracutaneous Irritation Testing
- Vista BC Sealer does not cause intracutaneous irritation and is not considered an irritant. O As Vista BC Sealer passed this biocompatibility test, comparison to the predicate device is not deemed necessary.
- Acute Systemic Toxicity Testing ●

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Image /page/9/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a line underneath it. To the right of the word is a blue globe. To the right of the globe is the word "INC." in black.

Image /page/9/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. The logo is primarily blue and black.

- All animals evaluated in this study showed no mortality or evidence of systemic toxicity o from systemic exposure to Vista BC Sealer. All animal displayed normal behaviors and displayed a positive weight gain. Therefore, Vista BC Sealer is not systemically toxic and showed no evidence of systemic toxicity. As Vista BC Sealer passed this biocompatibility test, comparison to the predicate device is not deemed necessary.
- Genotoxicity Testing ●
- Vista BC Sealer showed no signs of mutagenicity during tests. Therefore, Vista BC O sealer is confirmed as non-mutagenic. As Vista BC Sealer passed this biocompatibility test, comparison to the predicate device is not deemed necessary.

#### Clinical Performance Testing and Compliance 8.

Clinical performance is not deemed necessary.

#### 9. Conclusion

Vista BC Sealer is to be marketed by Inter-Med, Inc., 2200 South St., Racine, WI 53404, and is substantially equivalent to ENDOSEAL MTA (K170175). The subject medical device has a nearly identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predical device do not significantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, Inter-Med concludes that Vista BC Sealer is substantially equivalent to the predicate device, ENDOSEAL MTA, and the product is safe and effective for its intended use.