STATSTIX

K200764 · Centrix Incorporated · MVL · Oct 15, 2020 · DE

Device Facts

• Record ID: K200764
• Device Name: STATSTIX
• Applicant: Centrix Incorporated
• Product Code: MVL · DE
• Decision Date: Oct 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

Device Story

StatStix is a handheld dental device consisting of a polypropylene handle and a nylon polyamide applicator tip; the tip is coated with a dried 25% aluminum sulfate hydrate solution with mint flavor. Used by dentists during restorative procedures to control minor gingival bleeding. The clinician applies the wetted applicator tip to the site; the astringent solution causes tissue constriction and subsequent hemostasis. The device is intended for transient use.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation). Physical property testing included FTIR, pH, and dosage weight evaluations. Shelf-life testing performed per ASTM F1980, supporting a two-year expiration.

Technological Characteristics

Polypropylene handle; nylon polyamide applicator tip; coated with 25% aluminum sulfate hydrate solution. Dimensions: two sizes. Energy source: none (manual). Sterilization: not specified. Biocompatibility: ISO 10993-5, ISO 10993-10. Shelf-life: ASTM F1980.

Indications for Use

Indicated for control of temporary bleeding from minor cuts and abrasions on gingival tissue during dental procedures.

Predicate Devices

• Vista Clear (K193389)

Reference Devices

• BendaWedge (K140144)

Submission Summary (Full Text)

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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.

October 15, 2020

Centrix Incorporated % Roger Mastrony President MedTek LLC 2516 Kettle Creek Court Lincolnton, North Carolina 28092

Re: K200764

Trade/Device Name: Statstix Regulatory Class: Unclassified Product Code: MVL Dated: March 20, 2020 Received: March 24, 2020

Dear Roger Mastrony:

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 ([e-mail]) or phone [phone] 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):

Device Name: StatStix

Indications for Use:

StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image contains the logo for Centrix, a company that makes dentistry easier. The logo is in blue and white, with the word "centrix" in a bold, sans-serif font. Below the word "centrix" is the tagline "Making Dentistry Easier." The logo is simple and modern, and it conveys the company's mission of making dentistry more accessible.

## 510(k) SUMMARY

Premarket Notification Number K200764

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Sponsor:

Centrix Incorporated 770 River Road Shelton, CT. 06484 800.235.5862

Submitted by:

Roger Mastrony MedTek LLC 2516 Kettle Creek Court Lincolnton, N.C. 28092 203.640.5047

Date of Submission: March 20, 2020

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

Devices for Which Substantial Equivalence is Claimed:

- Primary-Vista Clear, K193389 Unclassified, Product Code MVL, Vista Dental ● Products
- Reference Device- BendaWedge, K140144 Class 1 Medical Devices, Product Code ● EJB, Centrix Incorporated

## Summary:

## Device Description

StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.

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Image /page/4/Picture/0 description: The image shows the Centrix logo. The word "centrix" is written in a blue, rounded rectangle. Below the rectangle, the text "Making Dentistry Easier" is written in a smaller font. The letters "SM" are written as a superscript.

## Indications for Use:

StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures

Comparative Indications for Use Chart:

| Device | Category | Indications for Use |
|-------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| StatStix | Subject device | StatStix is applied to control temporary<br>bleeding caused by minor cuts and abrasions<br>that may occur on gingival tissue during<br>dental procedures |
| Vista Clear | Primary device | Vista Clear is intended for sulcus retraction<br>prior to impression-making and to control<br>bleeding and gingival oozing in restorative and<br>operative dentistry used with gingival<br>retraction cord. |
| Benda Wedge | Reference device | Benda Wedge is an inter-proximal wedge<br>coated with an astringent to be used in<br>combination with other devices to temporarily<br>retain composite or amalgam restorative<br>material as well as to control gingival bleeding<br>during dental restorations. |

# Technological Characteristics Comparison:

| Primary Predicate Vista Clear K193389 | StatStix K200764 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contains 26.6% of an Aluminum Chloride<br>Astringent | Coated with dried 25% Aluminum Sulfate<br>astringent Solution with Mint flavor |
| Intended for sulcus retraction prior to<br>impression taking and to control bleeding<br>and gingival oozing in restorative and<br>operative dentistry used with gingival<br>retraction cord. Facilitates the insertion of<br>a cord into the sulcus | Substantially Equivalent in that<br>Indicated to Control Minor Gingival<br>Bleeding during dental procedures |
| Mode of Operation is to Mechanically<br>Desiccate Gingival Tissue with the<br>addition of Mechanical Pressure in<br>conjunction with cord | Substantially Equivalent in that<br>placement of the wetted StatStix<br>applicator results in tissue constriction<br>at intended site and subsequent<br>hemostasis |

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Image /page/5/Picture/0 description: The image shows the Centrix logo. The word "centrix" is written in white letters on a blue background. Below the word "centrix" is the phrase "Making Dentistry Easier."

| Used in combination with other devices to<br>temporarily retain composite or amalgam<br>restorative material during dental<br>restorations | No Equivalency Claimed |
|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------|

## Non Clinical Performance Data:

Biocompatibility testing was performed in accordance with ISO 10993-1 guidelines; specifically, biocompatibility testing was performed for cytotoxicity per ISO 10993-5 and sensitization/irritation per ISO 10993-10.

Physical property testing consisted of FTIR, pH and dosage weight evaluations and was performed according to standard laboratory benchtop practices.

### Shelf-Life Testing

Shelf-life testing was performed consistent with ASTM F1980 and the obtained results allow for a two-year expiration dating of this device

#### Clinical Testing

Clinical testing has not been performed on this product

#### Conclusion

We believe given the StatStix device is substantially equivalent to the primary device referenced in this submission.