CORDCAP

K091380 · Centrix, Inc. · MVL · Jul 30, 2009 · DE

Device Facts

• Record ID: K091380
• Device Name: CORDCAP
• Applicant: Centrix, Inc.
• Product Code: MVL · DE
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CordCap is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means. Compression of gingival tissue over several minutes is commonly known to widen the sulcus. In addition, mechanical pressure on the tissue can effect hemostasis, and is enhanced through the natural action of salts.

Device Story

CordCap is a compression roll made of wicking paper impregnated with natural salts (sodium chloride and/or aluminum chloride). Used in dental settings by clinicians to temporarily retract gingival tissue and achieve hemostasis. The device is placed in the gingival sulcus; mechanical pressure widens the sulcus while impregnated salts enhance hemostasis. The device provides a physical, non-automated method for tissue management during dental procedures.

Clinical Evidence

No clinical data. Bench testing only. Safety and effectiveness are supported by the use of common, low-concentration salts (sodium chloride/aluminum chloride) and the mechanical nature of the device, which is consistent with legally marketed predicate devices.

Technological Characteristics

Mechanical device; absorbent wicking paper; impregnated with sodium chloride and/or aluminum chloride salts. Salt concentration <6mg per 1" x 0.5" paper (approx. 0.06g-0.09g per device). Non-electronic; no software; no energy source.

Indications for Use

Indicated for temporary retraction and hemostasis of the gingival margin in patients requiring gingival sulcus widening.

Predicate Devices

• Ultrapak NEHA (K010070)
• Stay-Put Impregnated (K041023)

Submission Summary (Full Text)

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K091380

າງປະ ຊັ່ງປະ ຊົນ 2009

## April 24, 2009

## 510(k) SUMMARY

- 1) Submission Applicant & Correspondent:
Name: Centrix Incorporated Address: 770 River Road. Shelton, Connecticut 06484 USA Establishment Registration Number 1281412 Phone [phone] Contact Person: John Discko, Executive VP Extension 206

- 2) Name of Device: Cord, Retraction Trade/Proprietary/Model Name: CordCap™ Classification Product Code: MVL
- 3) Devices to Which New Device is Substantially Equivalent: Ultrapak NEHA (K010070) Stay-Put Impregnated (K041023)
- 4) Device Description: CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
- 5) Intended Use of the Device: The CordCap is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means. Compression of gingival tissue over several minutes is commonly known to widen the sulcus. In addition, mechanical pressure on the tissue can effect hemostasis, and is enhanced through the natural action of salts.
- 6) Summary of Technological Characteristics of the Device Compared to the Predicate Devices:

CordCap is substantially equivalent to other legally marketed devices in the United States. CordCap™ functions in a physical manner similar to and is intended for the same use as the products Ultrapak NEHA (K010070) and Stay-Put Impregnated (K041023) cleared for marketing for Ultradent Products and Coltene/Whaledent, respectively.

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## 510(k) Summary Page 2

In summary, CordCap ™ as described in this submission is, in our opinion, substantially equivalent to the predicate devices by meeting the following standards set by FDA:

>It has the same intended use as the predicate devices; and

>It has the same technological characteristics as the predicate devices; or >the sponsor demonstrates that the device is as safe and effective as the legally marketed device.

## 7) Tests and Conclusions:

CordCap™ is a mechanical device, made of absorbent paper, and infused with sodium chloride and/or aluminum chloride salts. Salt level is less than 6mg per 1" x ½" of paper. Typically, this amounts to .06g - .09g of salt per device, depending on size. Based on the low concentrations of the above common salts, the CordCap can be considered safe and effective for the temporary retraction of gingival tissue.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# IJUL 3 0 2009

Mr. John Discko Executive, Vice President Centrix, Incorporated 770 River Road Shelton, Connecticut 06484

Re: K091380

Trade/Device Name: CordCap™ Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: April 24, 2009 Received: May 11, 2009

#### Dear Mr. Discko:

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. 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.

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.

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Page 2 - Mr. Discko

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runner

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Centrix Inc

510(k) Notification CordCap™

| <strong>Labels</strong> | <strong>Values</strong> |
|--------------------------|-------------------------|
| 510(k) number (if known) | K091380 |

CordCap™ Device Name:

Indications for Use: CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <div style="display:inline-block;">✓</div> </div> | or | Over-The-Counter Use | |
|---------------------------------------|---------------------------------------------------------|----|----------------------|--|
|---------------------------------------|---------------------------------------------------------|----|----------------------|--|

| (Division Sign-Off) | <div> <div style="display:inline-block;"></div> <div><i>Susan Runner</i></div> </div> |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K911380 |