(89 days)
Not Found
No
The description focuses on the physical mechanism of action for sulcus retraction and bleeding control, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is used for mechanical retraction and controlling bleeding during dental procedures, which are temporary actions to facilitate other dental work (impression making, restorative dentistry). It does not treat a disease or condition, restore function in a therapeutic sense, or prevent disease other than in a very localized, procedural context where it helps prevent contamination of a restorative site. Its primary function is procedural aid rather than long-term therapeutic benefit to the patient's health.
No
The device is described as facilitating sulcus retraction and controlling bleeding/oozing, which are operative and restorative procedures, not diagnostic ones. There is no mention of the device identifying or characterizing a disease or condition.
No
The device description clearly indicates a physical device ("placement of the device into the sulcus which provides physical displacement of the gingival tissue"). The performance studies also include testing typical of a physical device (Cytotoxicity Testing, Shelf-Life Testing, Microbiological Testing, Transit Testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sulcus retraction and controlling bleeding/oozing in restorative and operative dentistry. This is a physical manipulation of tissue and management of bleeding, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical action of displacing gingival tissue and facilitating cord insertion. It does not mention analyzing any biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for a procedural use in dentistry, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VistaClear 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. Vista Clear facilitates the insertion of the cord into the sulcus.
Product codes
MVL
Device Description
Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental offices and health care offices / Health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Analytical Testing: Verified manufacturing of Vista Clear. Results were commensurate with the predicate device, supporting substantial equivalence.
- Cytotoxicity Testing: Vista Clear exhibited the same cytotoxicity result as the predicate device (ViscoStat Clear) sold for the same intended use. Confirms substantial equivalence.
- Shelf-Life Testing: Based on accelerated testing, a two-year shelf life is supported. Real-time aging is being performed.
- Microbiological Testing: Contamination risks from manufacturing are mitigated as Vista Clear exhibits bactericidal properties. Results support shelf stability and multiple use of non-patient contacting materials.
- Transit Testing: Confirmed that packaging configurations are sufficient and withstand simulated transit conditions. Products performed satisfactorily post-transit.
Clinical Performance Testing:
Clinical performance is not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.
March 4, 2020
Inter-Med / Vista Dental Products Alex Johnson Sr. Product Development Engineer 2200 South St. Ste. A Racine, Wisconsin 53404
Re: K193389
Trade/Device Name: Vista Clear Regulatory Class: Unclassified Product Code: MVL Dated: December 5, 2019 Received: December 6, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas "Nandu" Nandkumar, Ph.D. 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) K193389
Device Name Vista Clear
Indications for Use (Describe)
VistaClear 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. Vista Clear facilitates the insertion of the cord into the sulcus.
Type of Use (Select one or both, as applicable)
X 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. The word "intermed" is written in blue, with the "i" and "n" connected. There is a blue globe to the right of the word "intermed". A black line is underneath the word "intermed".
Image /page/3/Picture/2 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a blue sans-serif font, with a stylized mountain range above the letters. Below the word "VISTA" are the words "Dental Products" in a smaller, sans-serif font. There is a black line to the left of the word "VISTA".
510(k) Summary for Vista Clear
1. Applicant
| Submitter's Name: | Alex Johnson, MSc |
|---|---|
| Date Summary Prepared: | December 5, 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 |
2. Device Name
Proprietary Name: Vista Clear Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified
3. Predicate Device
ViscoStat Clear (K123215) by Ultradent Products
- Common Name: Cord, Retraction o
- Product Code: MVL O
- Device Class: Unclassified o
4. Device Description
Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating 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.
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Image /page/4/Picture/0 description: The image shows the logos for Intermed Inc. and Vista Dental Products. The Intermed Inc. logo is on the left side of the image and consists of the word "intermed" in blue, with a blue globe to the right of the word. The letters "INC." are in black to the right of the globe. A black line runs underneath the Intermed Inc. logo. The Vista Dental Products logo is on the right side of the image and consists of a blue mountain range above the word "VISTA" in blue, with the words "Dental Products" in black underneath.
5. Intended Use / Indication for Use
Vista 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. Vista Clear facilitates the insertion of the cord into the sulcus.
6. Technological Characteristics and Substantial Equivalence
| | Predicate Device: ViscoStat® Clear
(Ultradent Products) | Vista Clear
(Inter-Med / Vista Dental Products) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K123215 | Pending
(subject device for this 510(k) submission) |
| Common Name | Cord, Retraction | Cord, Retraction |
| Device
Classification | Unclassified | Unclassified |
| Product Code | MVL | MVL |
| Indication for Use | 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. | Vista 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. Vista Clear facilitates the
insertion of the cord into the sulcus. |
| Where used | Dental offices and health care offices | Dental offices and health care offices |
| Target population | Health care professionals | Health care professionals |
| Anatomical site | Oral cavity | Oral cavity |
| Chemical
characteristics | 25% Aluminum chloride | 26.6% Aluminum chloride hexahydrate |
| Mechanism of
Action | Placement of the viscous gel results in
physical displacement of gingival tissue from
the tooth. Material also facilitates insertion of
the cord into the sulcus. | Placement of the viscous gel results in
physical displacement of gingival tissue from
the tooth. Material also facilitates insertion of
the cord into the sulcus. |
| Viscosity | Viscous gel | Viscous gel |
| Packaging | 1.2mL pre-filled syringe with applicator tips | 1.2mL pre-filled syringe with applicator tips |
| Configuration | 30mL syringe with empty 1.2mL syringes and
applicator tips. | 30mL syringe with empty 1.2mL syringes and
applicator tips. |
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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 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/5/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a light blue sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller, darker font. There is a black line underneath the words "Dental Products".
| | Predicate Device: ViscoStat® Clear
(Ultradent Products) | Vista Clear
(Inter-Med / Vista Dental Products) |
|---------------------------------------|------------------------------------------------------------|----------------------------------------------------|
| Sterility | Non-sterile | Non-sterile |
| Shelf-Life | 42 months | 24 months |
| Biocompatibility
Testing Performed | Cytotoxicity | Cytotoxicity |
| Recommended
Contact Time | 1-3 minutes | 1-3 minutes |
| Prescription / OTC | Prescription | Prescription |
Similarities between the subject device (Vista Clear) and predicate device (ViscoStat Clear)
- Vista Clear has nearly identical indications for use as the predicate device, ViscoStat Clear.
- Vista Clear is classified under product code MVL and shares the identical common name "Cord, Retraction" as the predicate device.
- Vista Clear has the same recommended contact time (1-3 minutes) as the predicate, ViscoStat Clear. ●
- Vista Clear is identical to the predicate device as both products are aqueous gels which aid in the ● physical retraction of gingival tissue.
- Vista Clear is used in the same target population and anatomical site as the predicate device.
- Identical to the predicate device, Vista Clear is for prescription use only by healthcare professionals.
- Vista Clear is offered in the same configurations as the predicate device (i.e. prefilled syringes with ● applicator tips, or bulk syringes with unfilled smaller syringes and applicator tips).
- Vista Clear has identical technological characteristics to the predicate device: ●
- o Both medical devices contain an aqueous solution of a trivalent cationic salt (aluminum chlorite).
- Both medical devices have an identical pH. O
- Both medical devices exhibited identical results within cytotoxicity and microbiological O testing.
Vista Clear shares similar intended uses, technical characteristics, and methods of application to the predicate device (ViscoStat Clear). Therefore, Vista Clear is substantially equivalent to the predicate device.
This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.
Differences between the subject device (Vista Clear) and predicate device (ViscoStat Clear)
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 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/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 blue, with a trademark symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller font size. There is a horizontal line below the word "VISTA".
- . Vista Clear contains 26.6% aluminum chloride hexahydrate whereas the predicate device contains 25% aluminum chloride.
- However, this different does not raise any safety or efficacy concerns as they are analogous O materials (i.e. aluminum chloride). In fact, Vista Clear is analogously effective as the predicate device yet includes a lower amount of aluminum chloride.
- Therefore, this difference does not raise any additional safety or efficacy concerns and the O subject device remains substantially equivalent to the predicate device.
- Vista Clear has a shelf-life of 24 months, whereas the predicate device has a shelf-life of 42 months. ●
- This difference does not raise any safety or efficacy risks as the subject device has shown O safety and efficacy commensurate with the listed shelf-life and the product has labeling which adequately communicates shelf-life to the user.
Applicable Standards
- ISO 10993-1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing ●
- ISO 14971 Application of Risk Management to Medical Devices ●
- ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical ● equipment - Part 1: General requirements
- ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical ● equipment - Part 2: Lock fittings
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 Clear to ViscoStat Clear:
- Analytical Testing
- Testing verified manufacturing of Vista Clear. Results from testing are commensurate o with the predicate device, supporting substantial equivalence of the subject device to an existing commercialized device.
- Cytotoxicity Testing ●
- Vista Clear exhibited the same cytotoxicity result as the predicate device (ViscoStat O Clear) sold for the same intended use.
- This testing confirms that the subject device is substantially equivalent to the predicate o device. Combined with DHF-10043-BS and DHF-10043-CER, Inter-Med concludes that no further biocompatibility testing or clinical evaluation is needed before release of this product to the market.
- Shelf-Life Testing ●
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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 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/7/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 text.
- Based on accelerated testing, a shelf life of two years is supported for Vista Clear. Real o time aging is being performed on Vista Clear to support shelf life during typical storage conditions.
- Microbiological Testing
- Contamination risks from manufacturing are mitigated as Vista Clear exhibits O bactericidal properties. Furthermore, these results help to support shelf stability and multiple use of non-patient contacting materials, such as the syringes, as any introduced microbes will not remain viable within the medical device.
- It should be noted that Vista Dental Products is not claiming any "bactericidal" effect O of the subject medical device. This testing was performed solely to evaluate risk of contamination during manufacturing.
- 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.
8. Clinical Performance Testing and Compliance
Clinical performance is not deemed necessary.
9. Conclusion
Vista Clear is to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and is substantially equivalent to ViscoStat Clear (K123215). The subject medical device has a nearly identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predical device do not significantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, Inter-Med concludes that Vista Clear is substantially equivalent to the predicate device. ViscoStat Clear.