Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS Liguid facilitate the insertion of the cord into the sulcus.

Device Description

Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

AI/ML Overview

The provided text does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, or F1 score) or detailed results from a clinical study that would allow a direct comparison to such criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and non-clinical performance testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information available, here's what can be provided:

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

The document does not explicitly state quantitative acceptance criteria in terms of clinical performance metrics. The evaluation is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" in this context refers to the results of non-clinical testing confirming manufacturing, cytotoxicity, shelf-life, microbiological properties, and transit resilience.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance
Manufacturing quality and consistency	Testing verified manufacturing, commensurate with predicate devices.
Biocompatibility (Cytotoxicity)	No differences in cytotoxicity compared to predicate device (ViscoStat Clear); same result at all dilutions.
Shelf-life stability (interim)	All test data for 18-month time point significantly within test acceptance criteria.
Microbiological safety (bactericidal properties)	Exhibit bactericidal properties, mitigating contamination risks and supporting shelf stability.
Packaging integrity during transit	Packaging configurations sufficient, product performed satisfactorily post-transit.
Clinical performance (equivalent to predicates)	Clinical performance is not deemed necessary given substantial equivalence demonstration based on other factors.

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

The document describes non-clinical laboratory testing. It does not refer to a "test set" in the context of clinical data or a patient population. The samples for testing were likely materials from the manufactured devices themselves (e.g., aliquots for analytical testing, cell cultures for cytotoxicity). No information on the country of origin of data or whether it was retrospective or prospective is provided, as these are not relevant to the described non-clinical tests.

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

Not applicable. This information is relevant for studies relying on expert-derived ground truth, typically in image analysis or diagnostic scenarios. The provided document concerns non-clinical testing of a dental product.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not described in this document for the evaluation of this dental product.

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 device is a dental product (sulcus retraction material) and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental product and not an algorithm.

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

The "ground truth" for the non-clinical tests described would be the established scientific standards and methods for analytical chemistry, cytotoxicity assessment, stability testing, and microbiological evaluation. For example, for cytotoxicity, the "ground truth" is typically determined by observing cell viability and growth inhibition according to standardized protocols (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this document describes non-clinical testing of a physical medical device, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant to the provided document.

Summary

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

June 10, 2019

Inter-Med / Vista Dental Products Alex Johnson Sr. Product Development Engineer 2200 South St. Ste. A Racine, Wisconsin 53404

Re: K190220

Trade/Device Name: Vista FS, Vista FS Liquid Regulatory Class: Unclassified Product Code: MVL Dated: March 7, 2019 Received: March 12, 2019

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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Srinivas Nandkumar, PhD Acting Assistant Director DHT1B: Division of Dental 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) K190220

Device Name Vista FS and Vista FS Liquid

Indications for Use (Describe)

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/3/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath it. 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/3/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 blue, sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller font size. A horizontal line is to the left of the words "Dental Products".

K190220

510(k) Summary for Vista FS and Vista FS Liquid

1. Applicant

Submitter's Name:	Alex Johnson, MScJohn Baeten, MSc	Date Summary Prepared:	March 7, 2019
Address:	Inter-Med / Vista Dental Products2200 South St. Ste ARacine, WI, USA 53404	Contact Person:	Alex Johnson, MSc
Phone:	(262) 631-5306	Email:	ajohnson@vista-dental.com
Fax:	(262) 636-9760
Device Name:

Proprietary Name: Vista FS and Vista FS Liquid Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified

3. Primary Predicate Device

ViscoStat Clear (K123215) by Ultradent Products

Common Name: Cord, Retraction O
Product Code: MVL o
O Device Class: Unclassified

Additional Predicate Device

Astringedent Clear (K152064) by Ultradent Products

Common Name: Cord, Retraction O
O Product Code: MVL
Device Class: Unclassified O

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Image /page/4/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath it. 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/4/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 simple and clean, with a focus on the company name and the products they offer.

Reference Devices

ViscoStat (pre-amendment device) by Ultradent Products

Common Name: Cord, Retraction o
Product Code: MVL O
O Device Class: Unclassified

Astringedent (pre-amendment device) by Ultradent Products

Common Name: Cord, Retraction O
Product Code: MVL O
Device Class: Unclassified O

4. Device Description

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

5. Intended Use / Indication for Use

Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. These devices facilitate the insertion of the cord into the sulcus.

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

Image /page/5/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 horizontal line underneath. Above the word "VISTA" is a stylized mountain range. Below the word "VISTA" is the text "Dental Products".

6. Technological Characteristics and Substantial Equivalence

	Subject Device:	Subject Device:	Primary PredicateDevice:	Predicate Device:	Reference Device:	Reference Device:
	Vista FS	Vista FS Liquid	ViscoStat Clear	Astringedent Clear	ViscoStat	Astringedent
Manufacturer	Inter-Med / VistaDental Products	Inter-Med / VistaDental Products	Ultradent Products	Ultradent Products	Ultradent Products	Ultradent Products
510(k) Number	K190220	K190220	K123215	K152064	Not applicable; pre-amendment device	Not applicable; pre-amendment device
Common Name	Cord, Retraction	Cord, Retraction	Cord, Retraction	Cord, Retraction	Cord, Retraction	Cord, Retraction
DeviceClassification	Unclassified	Unclassified	Unclassified	Unclassified	Not applicable	Not applicable
Product Code	MVL	MVL	MVL	MVL	Not applicable	Not applicable
Indication forUse	Vista FS and Vista FSLiquid are intendedfor sulcus retractionprior to impressionmaking and to controlbleeding and gingivaloozing in restorativeand operativedentistry used withgingival retractioncord. These devicesfacilitate the insertionof the cord into thesulcus.	Vista FS and Vista FSLiquid are intendedfor sulcus retractionprior to impressionmaking and to controlbleeding and gingivaloozing in restorativeand operativedentistry used withgingival retractioncord. These devicesfacilitate the insertionof the cord into thesulcus.	ViscoStat Clear isintended for sulcusretraction prior toimpression makingand to controlbleeding and gingivaloozing in restorativeand operativedentistry used withgingival retractioncord and/or the DentoInfusor. These gelsfacilitate the insertionof the cord into thesulcus.	Astringedent Clear isintended for sulcusretraction prior toimpression makingand to controlbleeding and gingivaloozing in restorativeand operativedentistry used withgingival retractioncord and/or the DentoInfusor. The solutionfacilitate the insertionof the cord into thesulcus.	Pre-amendmentdevice; FDA Form3881 does not existfor this product.*	Pre-amendmentdevice: FDA Form3881 does not existfor this product.*
	Subject Device:	Subject Device:	Primary PredicateDevice:	Predicate Device:	Reference Device:	Reference Device:
	Vista FS	Vista FS Liquid	ViscoStat Clear	Astringedent Clear	ViscoStat	Astringedent
Where used	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices andhealth care offices	Dental offices andhealth care offices
Targetpopulation	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals
Anatomical site	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity
TrivalentCationic Salt	20% ferric sulfate inaqueous-based gel	15.5% ferric sulfatein aqueous liquid	25% aluminumchloride in aqueous-based gel	25% aluminumchloride in aqueousliquid	20% ferric sulfate inaqueous-based gel	15.5% ferric sulfatein aqueous liquid
Viscosity	Viscous gel	Liquid	Viscous gel	Liquid	Viscous gel	Liquid
Mechanism ofAction	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.	Placement of thematerial results inphysical displacementof gingival tissuefrom the tooth.Material alsofacilitates insertion ofthe cord into thesulcus.
PackagingConfiguration	1.2mL pre-filledsyringe withapplicator tips30mL syringe withempty 1.2mLsyringes andapplicator tips.	30mL bottle30mL syringe	1.2mL pre-filledsyringe withapplicator tips30mL syringe withempty 1.2mLsyringes andapplicator tips.	30mL bottle30mL syringe	1.2mL pre-filledsyringe withapplicator tips30mL syringe withempty 1.2mLsyringes andapplicator tips.	30mL bottle30mL syringe
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile
	Subject Device:	Subject Device:	Primary PredicateDevice:	Predicate Device:	Reference Device:	Reference Device:
	Vista FS	Vista FS Liquid	ViscoStat Clear	Astringedent Clear	ViscoStat	Astringedent
Shelf-Life	18 months	18 months	42 months	Unknown	48 months	48 months
BiocompatibilityTestingPerformed	Cytotoxicity	Cytotoxicity	Cytotoxicity	None	Unknown	Unknown
RecommendedContact Time	1-3 minutes	1-3 minutes	1-3 minutes	1-3 minutes	1-3 minutes	1-3 minutes
Prescription /OTC	Prescription	Prescription	Prescription	Prescription	Prescription	Prescription

Inter-Med, Inc. | 2200 South Street, Racine, WI 53404

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Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with the "i" and "n" connected. To the right of the word is a blue globe. To the right of the globe is the word "INC." in black.

Image /page/6/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" are the words "Dental Products" in a smaller font. The logo is simple and clean, and the mountain range suggests a sense of stability and reliability.

Inter-Med, Inc. | 2200 South Street, Racine, WI 53404

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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 a blue globe to the right of the word. To the right of the globe is the word "INC" in blue. There is a black line underneath the word "intermed".

Image /page/7/Picture/1 description: The image contains the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized blue 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 simple and clean, with a focus on the company name and its association with dental products.

*An FDA Form 3881 does not exist for these reference devices are pre-amendment medical devices. As such, the indications for use for these devices is not explicitly known by Inter-Med / Vista Dental Products. Regardless are only incorporated for reference only and represent pre-amendment devices.

Inter-Med, Inc. | 2200 South Street, Racine, WI 53404

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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 blue globe to the right of the word. The letters "INC." are written in black to the right of the globe.

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 sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".

Similarities between the subject devices (Vista FS Liquid) and predicate devices (ViscoStat Clear and Astringedent Clear)

Vista FS and Vista FS Liquid have nearly identical indications for use as the predicate devices; the ● only differences are the medical device names and removal of the "Dento Infusor" as this is not a Vista Dental product.
Vista FS and Vista FS Liquid are classified under product code MVL and share the identical ● common name "Cord, Retraction" as the predicate devices.
Vista FS and Vista FS Liquid have the same recommended contact time (1-3 minutes) as the ● predicates, ViscoStat Clear and Astringedent Clear.
Vista FS and Vista FS Liquid are identical to the predicate devices as all products are aqueous ● materials (i.e gels or liquids) which aid in the physical retraction of gingival tissue, and can be used with retraction cord.
Vista FS and Vista FS Liquid are used in the same target population and anatomical site as the ● predicate devices.
Identical to the predicate device, Vista FS and Vista FS Liquid are for prescription use only by ● healthcare professionals.
Vista FS is offered in the same configurations as the predicate device, ViscoStat Clear (i.e. prefilled syringes with applicator tips, or bulk syringes with unfilled smaller syringes and applicator tips).
Vista FS Liquid is offered in the same configurations as the predicate device, Astringedent (i.e. a bulk syringe, or a bottle).
Vista FS and Vista FS Liquid have identical technological characteristics as the predicate devices, ViscoStat Clear and Astringedent Clear.
- o All medical devices contain an aqueous solution of a trivalent cationic salt. ViscoStat Clear and Astringedent Clear contain aluminum chloride, and Vista FS and Vista FS Liquid contain ferric sulfate
- All medical devices have an identical pH. o
- All medical devices exhibit identical results within cytotoxicity testing. O
- All medical devices exhibit identical results within microbiological testing. O
Identical to the predicate devices, Vista FS and Vista FS Liquid represent a viscous gel device and ● a liquid device compared to ViscoStat Clear and Astringedent Clear, respectively, for nearly identical indications for use.

Vista FS and Vista FS Liquid share similar intended uses, technical characteristics, and method of application to the predicate devices (ViscoStat Clear and Astringedent Clear). Therefore, Vista FS and Vista FS Liquid are substantially equivalent to the predicate devices and pose no additional safety risks.

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

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Image /page/9/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a line underneath it. 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/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 blue sans-serif font. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" are the words "Dental Products" in a smaller, dark gray sans-serif font.

Differences between the subject devices (Vista FS Liquid) and predicate device (ViscoStat Clear and Astringedent Clear)

Vista FS and Vista FS Liquid contain ferric sulfate, whereas the predicate devices, ViscoStat Clear ● and Astringedent Clear, contain aluminum chloride.
- However, this difference does not raise any safety or efficacy concerns as ferric sulfate and O aluminum chloride are both trivalent cationic salts.
- Furthermore, ViscoStat and Astringedent represent commercialized medical devices that O contain ferric sulfate at identical concentrations to the subject devices, for use in the same dental procedures as the subject device, and for similar indications for use as the subject devices. ViscoStat and Astringedent have been on the market for over 40 years and are wellknown safe and biocompatible retraction cord medical devices.
- Therefore, this difference does not raise any additional safety or efficacy concerns and the O subject devices remain substantially equivalent.
Vista FS and Vista FS Liquid have a shelf-life of 18 months, whereas the predicate device ● (ViscoStat Clear) has a shelf-life of 42 months.
- o This difference does not raise any safety or efficacy risks as the subject devices have shown safety and efficacy commensurate with the listed shelf-life and have labeling which adequately communicates shelf-life to the user.
- Ongoing accelerated and real-time shelf-life testing will determine the most appropriate O shelf-life constraints for Vista FS and Vista FS Liquid. The labeling and user manual for Vista FS and Vista FS Liquid will be updated accordingly to communicate the most appropriate shelf-life constraints to users.
- Therefore, the subject devices remain substantially equivalent to the predicate devices. o

Applicable Standards

ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1 - Evaluation and Testing
ISO 14971:2007 - Application of Risk Management to Medical Devices
ISO 14971:2012 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 FS and Vista FS Liquid to ViscoStat Clear and Astringedent Clear:

. DHF10011-TR001 – Analytical Testing
- o Testing verified manufacturing of Vista FS and Vista FS Liquid. Results from testing are commensurate with the predicate devices and reference devices, supporting substantial equivalence of the subject devices to existing commercialized devices.

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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 with white lines.

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 a sans-serif font. Below the word "VISTA" is the phrase "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".

DHF10011-TR002 Cvtotoxicity Testing ●
- Vista FS and Vista FS Liquid do not exhibit any differences in cytotoxicity when o compared to the currently marketed and sold product for the same intended use (i.e. the predicate device - ViscoStat Clear). All products in this testing were found to have the same result at all dilutions evaluated.
- This testing confirms that the subject devices are substantially equivalent to the o predicate devices in safety for their intended use. Combined with DHF10011-BS and DHF10011-CER, Inter-Med concludes that no further biocompatibility testing or clinical evaluation is needed before release of this product to the market.
DHF10011-TR003 - Shelf-Life Testing
- This test report represents an interim analysis of the accelerated shelf-life testing o performed to-date. All test data for the 18 month time point were significantly within test acceptance criteria, so accelerated shelf-life testing will continue through 36 months of accelerated testing to provide a suggested shelf-life for Vista FS and Vista FS Liquid.
- An additional test report will be written to summarize the completed accelerated shelf- O life testing. Real-time shelf-life testing will be run in parallel to confirm actual shelf-life parameters for these medical devices.
DHF10011-TR004 Microbiological Testing ●
- o Contamination risks from manufacturing are mitigated as Vista FS and Vista FS Liquid exhibit 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.
- It should be noted that Vista Dental Products is not claiming any "bactericidal" effect O of the subject medical devices. This testing was performed solely to evaluate risk of contamination during manufacturing.
DHF10011-TR005 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.

Clinical Performance Testing and Compliance 8.

Clinical performance is not deemed necessary.

9. Conclusion

Vista FS and Vista FS Liquid are to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and are substantially equivalent to ViscoStat Clear (K123215) and Astringedent Clear (K152064). The subject medical devices have a nearly identical intended use and technological characteristics, and all devices are substantially equivalent in safety and effectiveness when used for the described indications.

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Image /page/11/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 a blue globe next to it, followed by "INC." in black. 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 words "Dental Products" in black below it.

Any differences between the subject medical devices and predical devices are substantiated from reference devices (ViscoStat and Astringedent), which represent commercially available medical devices of identical technical characteristics.

Regulation Number and Section

N/A