RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE

K113839 · Parkell, Inc. · MVL · Apr 12, 2012 · DE

Device Facts

• Record ID: K113839
• Device Name: RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
• Applicant: Parkell, Inc.
• Product Code: MVL · DE
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

Device Story

RETRACT is a single-part gingival retraction and hemostatic paste containing approximately 22% aluminum chloride. Supplied in 0.5 ml syringes with intra-oral tips, the paste is dispensed by a dental clinician directly into and around the sulcular area of a prepared tooth. The paste acts to temporarily displace marginal gingiva, control bleeding, and dry the gingival sulcus. After the procedure, the paste is washed away with water. By providing a dry, clear field, the device facilitates dental procedures such as impressions, preventing interference from moisture or excess soft tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material composition.

Technological Characteristics

Single-part paste containing ~22% aluminum chloride and food-grade fillers/thickening agents (clay-based). Supplied in 0.5 ml single-barrel syringes with hand plunger and intra-oral tips. Biocompatible material profile. Manual application; water-soluble for removal.

Indications for Use

Indicated for temporary gingival retraction and hemostasis of the gingival margin during dental procedures, including dental impressions, in patients requiring such procedures.

Predicate Devices

• TRAXODENT (K083695)
• EXPASYL (K050180)
• RACEGEL (K093711)

Submission Summary (Full Text)

{0}------------------------------------------------

1 KI | 3839 | Tags: 1 | 3839 | Times

# 510(k) SUMMARY

| Submitter: | Parkell, Inc.<br>300 Executive Drive<br>Edgewood, NY 11717<br>TEL: [phone]<br>FAX: [phone] |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Daniel R. Schechter, Esq.<br>VP, Regulatory Affairs<br>Parkell, Inc.<br>300 Executive Drive<br>Edgewood, NY 11717 |
| Submission Date: | 16 December 2011 |
| Trade Name: | RETRACT |
| Common Name: | Gingival Retraction/Hemostatic Paste |
| Classification Name: | None |
| Classification Product Code: | MVL |
| Predicate Devices: | TRAXODENT (K083695), EXPASYL (K050180), RACEGEL<br>(K093711) |
| Device Description: | RETRACT is a dental product capable of controlling gingival<br>bleeding, temporarily displacing the marginal gingiva and<br>temporarily drying the gingival sulcus around a tooth. The paste<br>allows the dental clinician to perform operative procedures<br>without interference from moisture or excess soft tissue.<br>RETRACT is supplied in 0.5 ml syringes with a hand plunger,<br>intra-oral tips, Instructions for Use & MSDS. |
| Intended Use: | RETRACT is a paste containing aluminum chloride which is used<br>for the temporary retraction and hemostasis of the gingival<br>margin during dental procedures such as dental impressions. |
| Tech. Characteristics: | RETRIEVE gingival retraction/hemostatic paste is a single part<br>paste and is typically supplied in a single-barrel syringe. The<br>paste is dispensed by hand into and around the sulcular area of<br>a prepared tooth for retraction and hemostasis and is then easily<br>washed away with water. The material is biocompatible based<br>on the directed usage, the known material profiles, and the<br>extensive usage history of the constituents. Other than the<br>aluminum chloride, the remaining ingredients are all food grade<br>(or better) materials. |

{1}------------------------------------------------

Substantial Equivalence:

Parkell's RETRACT gingival retraction/hemostatic paste has similar indications, principles of operation, and technological characteristics as the predicate devices. The minor differences in the device do not raise any new questions of safety or effectiveness. Thus, RETRACT is substantially equivalent to its predicate devices. For example, the three predicate devices contain aluminum chloride in concentrations ranging from 15% -25%. RETRACT has approximately 22% aluminum chloride. In addition, RETRACT, TRAXODENT and EXPASYL all use clay or similar materials as the primary fillers/thickening agent in the mixture with aluminum chloride.

{2}------------------------------------------------

### 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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Daniel R. Schechter, Esq. Vice President, Regulatory Affairs Parkell, Inc. 300 Executive Drive Edgewood, New York 11717

APR 1 2 2012

Re: K113839

Trade/Device Name: RETRACT Gingival Retraction/Hemostatic Paste Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: March 20, 2012 Received: March 26, 2012 -

Dear Mr. Schechter:

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. 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.

{3}------------------------------------------------

### Page 2 - Mr. Schechter

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 (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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hu for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: RETRACT Gingival Retraction/Hemostatic Paste

Indications for Use:

RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quinn

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

(1)3734 510(k) Number: