Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

AI/ML Overview

The provided text describes the regulatory clearance of a dental root canal filling material, Vista BC Putty. It references non-clinical performance testing but does not include information about clinical studies, expert-based ground truth, or MRMC studies that are typically associated with AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 6876 standards for dental root canal sealing materials. The reported performance indicates compliance with these standards and comparability to predicate devices.

Acceptance Criteria (from ISO 6876)	Reported Device Performance (Vista BC Putty)	Comparison to Predicate/Reference Devices
Set Time	≤ 90 minutes	Shorter than predicate (< 240 min), similar to reference devices
Film Thickness	Tested	Confirmed substantial equivalence
Solubility and Disintegration	Tested	Confirmed substantial equivalence
Radiopacity	Tested	Confirmed substantial equivalence
Cytotoxicity	Yielded better results than reference device (Vista BC Sealer)
Shelf-Life	2 years (accelerated testing)	Similar to predicate (3 years), identical to reference devices
Transit Testing	Packaging configurations sufficient, products performed satisfactorily post-transit
Microbiological Testing	Exhibits antimicrobial properties

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

This information is not provided in the document. The document refers to "benchtop testing" and "accelerated shelf-life testing" for non-clinical performance but does not specify sample sizes or data provenance.

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)

This information is not applicable and not provided. The testing described is non-clinical (benchtop, shelf-life, etc.) for a dental material, not an AI/ML device requiring expert ground truth for interpretation of medical images or other data.

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

This information is not applicable and not provided. The testing described is non-clinical and does not involve adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. The device is a dental material, not an AI/ML-based diagnostic or assistive technology for human readers.

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

This information is not applicable. The device is a dental material, not an algorithm.

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

The "ground truth" for the non-clinical performance evaluation appears to be established by the specifications and measurement methodologies defined in the ISO 6876 standard and other relevant international standards (e.g., ISO 10993 for biocompatibility) that govern dental materials. For example, set time is measured according to a defined procedure in ISO 6876.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. The device is a dental material, not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 28, 2024

Inter-Med, Inc. Alex Johnson VP of Engineering, Regulatory & Ouality 2200 South Street Racine, Wisconsin 53404

Re: K241457

Trade/Device Name: Vista BC Putty Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: Mav 22, 2024 Received: May 23, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bobak Shirmohammadi -S

For Michael E. Adjodha. MChE, RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,

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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

Submission Number (if known)

K241457

Device Name

Vista BC Putty

Indications for Use (Describe)

· Repair of Root Perforation
· Repair of Root Resorption
· Root End Filling
· Apexification
· Pulp Capping

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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Image /page/4/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font and is underlined by a thin black line. To the right of the word is a blue globe with white lines depicting longitude and latitude. The letters "INC." are in black font to the right of the globe.

Image /page/4/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a light blue sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. There is a horizontal line to the left of the word "VISTA".

510(k) Summary for Vista BC Putty

K241457

1. Applicant

Alex Johnson Submitter's Name: Khongchee Xiong Date Summary Prepared: March 28, 2024

Address: Inter-Med, Inc. / Vista Apex 2200 South St. Racine, WI, USA 53404

Contact Person: Alex Johnson, MSc

Email: ajohnson@vista-dental.com

Phone: (262) 631-5306

Fax: (262) 636-9760

2. Device Name

Proprietary Name: Vista BC Putty Common Name: Root canal filling material Product Code: KIF Device Class: Class 2

3. Predicate Device

Primary Predicate Device MTA 2.3 (Design 2) by Avalon Biomed, Inc.

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

Reference Device #1 iRoot FS by Innovative BioCeramix, Inc.

Common Name: Root canal filling material о
O Product Code: KIF

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Image /page/5/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue font, 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 font.

Image /page/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a large, sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller font. The logo is primarily blue and black.

Device Class: Class 2 o
Reference Device #2 Vista BC Sealer (K221811) by Inter-Med, Inc.
Common Name: Root canal filling material O
Product Code: KIF o
Device Class: Class 2 O

Device Description 4.

1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

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

ನ. Intended Use / Indication for Use

Repair of Root Perforation
Repair of Root Resorption
Root End Filling ●
Apexification ●
Pulp Capping ●

Technological Characteristics and Substantial Equivalence 6.

Characteristic	Proposed Device	Predicate Device	Reference Device#1	Reference Device#2
510(k) Number	Pending(subject device forthis 510(k)submission)	(K181917)	(K102867)	(K221811)
Common Name	Root Canal Filling	Root Canal Filling	Root Canal Filling	Root Canal Filling
Product Code	KIF	KIF	KIF	KIF
Trade Name	Vista BC Putty	MTA 2.3 (Design 2)	iRoot FS	Vista BC Sealer

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

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. Below "VISTA" are the words "Dental Products" in a smaller font. The logo is in a light blue color.

Manufacturer	Inter-Med, Inc.	Avalon Biomed	InnovativeBioCeramix, Inc.	Inter-Med, Inc.
DeviceDescription	Vistas BC Putty is ahydraulic, ready-to-use injectablebioceramic, bioactiveroot repair pastedeveloped forpermanent root canalrepair of rootperforation and rootresorption, and rootend filling,apexification andpulp cappingapplications.	The MTA2.3 ROOT& PULPMATERIALS aredesigned anddeveloped for dentalclinicians touse in contact withvital pulp tissue andperiradicular tissue,including sealingandobturation of rootcanals. Thematerials can beused for dentalprocedurescontactingpulpal orperiradicular tissuesuch as: pulpcapping, cavitylining, base materialin a cavity,pulpotomies, root-end filling,apexification,perforation repair,root resorption, andobturation(pulpectomy)including root canalsealing.	iRoot FS InjectableRoot Canal RepairFilling Material is aconvenient ready-to-use fast settingwhite hydraulicpremixedbioceramic pasteddeveloped forpermanent rootcanal repair of rootperforation and rootresorption, and rootend filling,apexification andpulp cappingapplications.	Vista BC Sealer is aready-to-useinjectable whitehydraulic cementpaste suitable forpermanent rootcanal filling andsealing of the entireroot canal.
Intended	Dental and	Dental and	Dental and	Dental and
populationAnatomical Site	Endodontic officesOral Cavity - rootcanal	Endodontic officesOral Cavity - rootcanal	Endodontic officesOral Cavity - rootcanal	Endodontic officesOral Cavity - rootcanal
Composition (boldtext added tohighlightsimilarities incompositionbetween subjectdevice andpredicate /reference devices)	Cementing agents,Radiopacifier,Calcium sodiumphosphosilicate,Calcium Sulfate,TricalciumPhosphate,Thickening agent,Filler, Carrier	TantaliteTricalcium SilicateCalcium AluminateDicalcium SilicateTricalciumaluminateCalcium Sulfate,Thickening agentFiller, Carrier	Tricalcium silicateDicalcium silicateCalciumphosphatemonobasicZirconium oxideTantalum PentoxideFiller, Carrier	Calciumaluminates.Radiopacifier,Calcium sodiumphosphosilicate,Thickening agent,Accelerator,Filler, Carrier
Principle ofoperation	Vista BC Putty is aninsoluble,radiopaque,hydraulic cementmaterial that absorbsthe moisture alreadypresent in thesurrounding tissuesof the root canal toset and solidify.	The MTA 2.3ROOT & PUMPMATERIALS(design 2) is placedin the space createdby the procedure andset in vivo . Themechanism of actionis setting of theinorganic,ceramic cement inthe presence of thewater-based bodyfluids present inteeth.	iRoot FS is aninsoluble,radiopaque andaluminum freematerial based on acalcium silicatecomposition, whichrequires thepresence ofwater to set andharden.	Vista's BC Sealer isan insoluble andradiopaque rootcanal sealer whichrequires thepresence of water toset and harden.Upon placement ofmaterial into theroot canal, themoisture presentfrom surroundingtissues helps toinitiate a settingreaction within thematerial andeventuallysolidifying into ahard structure.
Indications foruse	Repair of RootPerforationRepair of RootResorptionRoot End FillingApexificationPulp Capping	Repair of RootPerforationRepair of RootResorptionRoot End FillingApexificationPulp Capping	Repair of RootPerforationRepair of RootResorptionRoot End FillingApexificationPulp Capping	Permanentobturation of theroot canal followingroot canaltreatment.
Delivery form	Single paste	Single paste	Single paste	Single paste
Design	Pre-loaded syringe	Pre-loaded syringe	Pre-loaded syringe	Pre-loaded syringe,Disposable IntraCanal Tips
Nature of Contact(ISO 7405:2018)	Category: ExternalcommunicatingdeviceContact: Tissue,bone and dentinContact Duration: C- Permanent(>30 days)	Category: ExternalcommunicatingdeviceContact: Tissue,bone and dentinContact Duration: C- Permanent(>30 days)	Category: ExternalcommunicatingdeviceContact: Tissue, bone anddentin ContactDuration: C -Permanent (>30days)	Category: ExternalcommunicatingdeviceContact: Tissue,bone and dentinContact Duration: C- Permanent(>30 days)
Set Time	≤ 90 minutes	< 240 minutes	20 minutes	≤ 90 minutes
Sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Shelf Life	2 years	3 years	2 years	2 years
Rx / OTC	Rx Only	Rx Only	Rx Only	Rx Only
Standards	ISO 7405:2018ISO 10993-1:2018ISO 10993-5:2009ISO 14971:2019ISO 15223-1:2021	Unknown	Unknown	ISO 7405:2018ISO 10993-1:2018ISO 10993-5:2009ISO 14971:2019ISO 15223-1:2021

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Image /page/7/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with the "i" extending to the top of the image. To the right of the word is a blue globe. The letters "INC." are written in black to the right of the globe.

Image /page/7/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a sans-serif font, with a stylized mountain range above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. The logo is primarily blue and white.

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Image /page/8/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written 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/8/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 large, sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".

	ISO 11014:2009ISO 20417:2021ISO 6876:2001	ISO 11014:2009ISO 20417:2021ISO 6876:2001
--	---------------------------------------------------	---------------------------------------------------

Similarities between the subject device (Vista BC Putty) and the predicate device (MTA 2.3 (Design 2)) as well as reference device #1 (iRoot FS) and reference device #2 (Vista BC Sealer).

Vista BC Putty has identical indications for use as its predicate device (MTA 2.3 (Design 2)).
. Vista BC Putty is classified under product code KIF, with respect to 21 CFR 872.3820 and the common name "Root canal filling material", which is identical to that of the predicate device (MTA 2.3 (Design 2)) and reference devices.
Vista BC Putty has identical intended population use as the predicate device (MTA 2.3 ● (Design 2)) and reference devices and is used in the same anatomical location.
. Identical to the predicate device (MTA 2.3 (Design 2)) and reference devices, Vista BC Putty is a single component product.
Vista BC Putty uses an identical mechanism of action for its indications compared to the predicate device (MTA 2.3 (Design 2)) and the reference devices, namely, all materials utilize water naturally present in the root canal / tooth to set and harden via cementation reactions.
Identical to the predicate device (MTA 2.3 (Design 2)) and the reference devices, Vista BC . Putty is classified as an external communicating device for permanent (>30 days) contact per ISO 7405:2018.
Vista BC Putty composition consists of similar ingredicate device (MTA 2.3 ● (Design 2)) and reference devices. In fact, Vista BC Putty consists of all the same ingredients at slightly different ratios, except an accelerator, as reference device #2 (Vista BC Sealer). A further detailed explanation is provided within the 510(k) Section 12 - Substantial Equivalence Discussion.
- o The differences in composition do not raise any concerns as biocompatibility testing confirms the product is biocompatible for its intended use.
Vista BC Putty's shelf life of two years is similar to the predicate device (MTA 2.3 (Design ● 2)) and identical to the reference devices.
Identical to the predicate device (MTA 2.3 (Design 2)) and reference devices, Vista BC Putty ● is a non-aqueous paste-like material that is commercialized non-sterile.
Identical to the predicate device (MTA 2.3 (Design 2)) and reference devices, Vista BC Putty ● is for prescription use (Rx) only.

Vista BC Putty shares similar intended use, technical characteristics, and composition to the predicate and reference devices. Therefore, Vista BC Putty is substantially equivalent to the predicate device and poses no additional safety or efficacy risks.

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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 blue globe to the right of the word. The letters "INC." are in black and to the right of the globe. There is a black line underneath the word "intermed".

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. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" is the phrase "Dental Products".

Discussion of Differences between the subject device (Vista BC Putty) and the predicate device (MTA 2.3 (Design 2)) as well as reference device #1 (iRoot FS) and reference device #2 (Vista BC Sealer).

The formulation of Vista BC Putty is different than the predicate device (MTA 2.3 (Design 2)) . and reference device (MTA 2.3 (Design 2)).
- o A further detailed explanation is provided within the 510(k) Section 12 Substantial Equivalence Discussion. However, the differences in composition do not raise any concerns as biocompatibility testing confirms the product is biocompatible for its intended use.
- Additionally, Vista BC Putty consists of all the same ingredients at slightly different O ratios, except an accelerator, as reference device #2 (Vista BC Sealer).
- Therefore, the subject device remains substantially equivalent to its predicate device. O
Vista BC Putty has a shorter set time compared to the predicate device (MTA 2.3 (Design 2)). ●
- This does not raise any concerns as both materials set on the order of tens to hundreds of O minutes and permanently remains within the root canal. Additionally, both reference devices have similar set times, too.
- Therefore, the subject device remains substantially equivalent to its predicate device. o

Applicable Standards

ISO 7405:2018 Dentistry Evaluation of Biocompatibility of Medical Devices Used in Dentistry ●
ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ● within a Risk Management Process
ISO 10993-5:2009 - Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 14971:2019 Application of Risk Management to Medical Devices ●
ISO 15233-1:2021 Symbols to be used with Information to be Supplied by the Manufacturer -● Part 1: General Requirements
ISO 11014:2009 Safety Data Sheet for Chemical Products ●
ISO 20417:2021 Information to be Supplied by the Manufacturer ●
ISO 6876:2001 Dental Root Canal Sealing Materials ●

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 Putty to MTA 2.3 (Design 2):

ISO 6876 Testing ●
- o Benchtop testing on Vista BC Putty was completed following ISO 6876 test protocols for set time, film thickness, solubility and disintegration, and radiopacity. Vista BC Putty was compared to the predicate device (MTA 2.3 (Design 2)) and reference device

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Image /page/10/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written 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/10/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a small "TM" symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller, darker font.

#1 (iRoot FS). Testing confirmed the substantial equivalence of the subject device to the predicate device.

Shelf-Life Testing
- O Through accelerated shelf-life testing, Vista BC Putty was found to have a shelf-life of two years. Real time aging is being performed on Vista BC Putty to support shelf life during typical storage conditions.
Transit Testing ●
- o This test confirms that the packaging configurations are sufficient and withstand 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 Putty exhibits o antimicrobial properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the svringes, as any introduced microbes will not remain viable within the medical device.
Cytotoxicity Testing ●
- Vista BC Putty was found to yield better cytotoxicity results compared to the reference O device, Vista BC Sealer.

Clinical Performance Testing and Compliance 8.

Clinical performance is not deemed necessary.

Conclusion 9.

Vista BC Putty is to be marketed by Inter-Med, Inc., 2200 South St., Racine, WI 53404, and is substantially equivalent to MTA 2.3 (Design 2) (K181917). The subject medical device has identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predicate medical device do not sigmificantly 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 Putty is substantially equivalent to the predicate device. MTA 2.3 (Design 2), and the product is safe and effective for its intended use.

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.

Indications for Use

K241457

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1. Applicant

2. Device Name

3. Predicate Device

Device Description 4.

ನ. Intended Use / Indication for Use

Technological Characteristics and Substantial Equivalence 6.

Similarities between the subject device (Vista BC Putty) and the predicate device (MTA 2.3 (Design 2)) as well as reference device #1 (iRoot FS) and reference device #2 (Vista BC Sealer).

Applicable Standards

7. Non-Clinical Performance Testing and Compliance

Clinical Performance Testing and Compliance 8.

Conclusion 9.

§ 872.3820 Root canal filling resin.

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