Who is the manufacturer of Vista FS, Vista FS Liquid?

Inter-Med/Vista Dental Products filed the 510(k) submission for Vista FS, Vista FS Liquid (K190220).

What is the FDA product code for Vista FS, Vista FS Liquid?

MVL. as a Class U device in the DE panel.

What is the regulatory pathway for Vista FS, Vista FS Liquid?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Vista FS, Vista FS Liquid?

ViscoStat Clear (K123215); Astringedent Clear (K152064).

Who can help prepare an FDA 510(k) submission like Vista FS, Vista FS Liquid?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Vista FS, Vista FS Liquid

K190220 · Inter-Med/Vista Dental Products · MVL · Jun 10, 2019 · DE

Device Facts

Record ID	K190220
Device Name	Vista FS, Vista FS Liquid
Applicant	Inter-Med/Vista Dental Products
Product Code	MVL · DE
Decision Date	Jun 10, 2019
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Vista FS (gel) and Vista FS Liquid (liquid) are dental agents containing ferric sulfate; used to facilitate gingival sulcus retraction and control bleeding/oozing during restorative procedures. Applied in dental offices by healthcare professionals; used in conjunction with gingival retraction cord to provide physical tissue displacement and a chemical barrier. The trivalent cationic salt (ferric sulfate) acts as a hemostatic agent. Output is the physical retraction of gingival tissue and hemostasis, allowing for accurate dental impressions. Benefits include improved visualization and tissue management for the clinician and reduced bleeding for the patient.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including analytical testing, cytotoxicity testing (ISO 10993-1), microbiological testing, and transit testing. Results demonstrate performance commensurate with predicate devices.

Technological Characteristics

Aqueous-based formulations containing trivalent cationic salt (20% ferric sulfate gel or 15.5% ferric sulfate liquid). Non-sterile. Packaged in syringes or bottles. Designed for 1-3 minute contact time. Complies with ISO 10993-1 (biocompatibility) and ISO 14971 (risk management).

Indications for Use

Indicated for sulcus retraction prior to dental impression making and control of bleeding/gingival oozing in restorative and operative dentistry, used in conjunction with gingival retraction cord. For use by healthcare professionals in the oral cavity.

Predicate Devices

ViscoStat Clear (K123215)
Astringedent Clear (K152064)

Reference Devices

ViscoStat
Astringedent

Related Devices

K211420 — Stasis Gel · Belport Company, Inc., Gingi-Pak · Mar 14, 2022
K193389 — Vista Clear · Inter-Med/Vista Dental Products · Mar 4, 2020
K123215 — VISCOSTAT CLEAR · Ultradent Products, Inc. · Feb 5, 2013
K211419 — Gingi-Aid Gel · Belport Company, Inc., Gingi-Pak · Jan 10, 2022
K243910 — Retraxil · Kulzer, LLC · Sep 24, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K190220 Device Name Vista FS and Vista FS Liquid ### Indications for Use (Describe) 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. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 2. | Submitter's Name: | Alex Johnson, MSc John Baeten, MSc | Date Summary Prepared: | March 7, 2019 | |-------------------|------------------------------------------------------------------------------------|------------------------|---------------------------| | Address: | Inter-Med / Vista Dental Products 2200 South St. Ste A Racine, 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 {4}------------------------------------------------ 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 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. 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. {5}------------------------------------------------ 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 Predicate Device: | Predicate Device: | Reference Device: | Reference Device: | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Vista FS | Vista FS Liquid | ViscoStat Clear | Astringedent Clear | ViscoStat | Astringedent | | Manufacturer | Inter-Med / Vista Dental Products | Inter-Med / Vista Dental 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 | | Device Classification | Unclassified | Unclassified | Unclassified | Unclassified | Not applicable | Not applicable | | Product Code | MVL | MVL | MVL | MVL | Not applicable | Not applicable | | 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. | 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. | ViscoStat Clear is 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 and/or the Dento Infusor. These gels facilitate the insertion of the cord into the sulcus. | Astringedent Clear is 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 and/or the Dento Infusor. The solution facilitate the insertion of the cord into the sulcus. | Pre-amendment device; FDA Form 3881 does not exist for this product.* | Pre-amendment device: FDA Form 3881 does not exist for this product.* | | | Subject Device: | Subject Device: | Primary Predicate Device: | Predicate Device: | Reference Device: | Reference Device: | | | Vista FS | Vista FS Liquid | ViscoStat Clear | Astringedent Clear | ViscoStat | Astringedent | | Where used | Dental offices and health care offices | Dental offices and health care offices | Dental offices and health care offices | Dental offices and health care offices | Dental offices and health care offices | Dental offices and health care offices | | Target population | Healthcare professionals | Healthcare professionals | Healthcare professionals | Healthcare professionals | Healthcare professionals | Healthcare professionals | | Anatomical site | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity | | Trivalent Cationic Salt | 20% ferric sulfate in aqueous-based gel | 15.5% ferric sulfate in aqueous liquid | 25% aluminum chloride in aqueous- based gel | 25% aluminum chloride in aqueous liquid | 20% ferric sulfate in aqueous-based gel | 15.5% ferric sulfate in aqueous liquid | | Viscosity | Viscous gel | Liquid | Viscous gel | Liquid | Viscous gel | Liquid | | Mechanism of Action | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | Placement of the material results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. | | Packaging Configuration | 1.2mL pre-filled syringe with applicator tips 30mL syringe with empty 1.2mL syringes and applicator tips. | 30mL bottle 30mL syringe | 1.2mL pre-filled syringe with applicator tips 30mL syringe with empty 1.2mL syringes and applicator tips. | 30mL bottle 30mL syringe | 1.2mL pre-filled syringe with applicator tips 30mL syringe with empty 1.2mL syringes and applicator tips. | 30mL bottle 30mL syringe | | Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | | Subject Device: | Subject Device: | Primary Predicate Device: | 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 | | Biocompatibility Testing Performed | Cytotoxicity | Cytotoxicity | Cytotoxicity | None | Unknown | Unknown | | Recommended Contact 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ 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. {11}------------------------------------------------ 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.

Vista FS, Vista FS Liquid

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Device Story

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Reference Devices

Related Devices

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Vista FS, Vista FS Liquid

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Device Story

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