RETRACTION PASTE

K130580 · Dmg USA, Inc. · MVL · Feb 25, 2014 · DE

Device Facts

• Record ID: K130580
• Device Name: RETRACTION PASTE
• Applicant: Dmg USA, Inc.
• Product Code: MVL · DE
• Decision Date: Feb 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

Device Story

Retraction Paste is a medium-viscosity, water-based kaolin clay paste containing aluminum chloride hexahydrate. Used by dental professionals in clinical settings to facilitate dental procedures. The paste is applied to the gingival sulcus via a manual dispensing syringe. The kaolin provides physical displacement of gingival tissue, while the aluminum chloride hexahydrate acts as an astringent to provide hemostasis and drying. This process temporarily shrinks and retracts gingival tissue from the tooth surface, improving visibility and access for impression materials or restorative procedures. The device is supplied in pre-filled cartridges for use with a dispensing gun.

Clinical Evidence

Bench testing only. Evidence consists of comparative physical property measurements (pH and viscosity) and chemical composition analysis demonstrating identity to the predicate device.

Technological Characteristics

Medium-viscosity paste; composition: aluminum chloride hexahydrate in water-based kaolin (clay) carrier. Delivery: pre-filled cartridge with manual dispensing gun and disposable syringe tips. No electronic components or software.

Indications for Use

Indicated for temporary gingival retraction and hemostasis during dental procedures including impressions, restoration seating, cavity restoration, and rubber dam placement.

Predicate Devices

• Expa-syl (K050180)

Submission Summary (Full Text)

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# KISOS80

# FEB 2 5 2014

# 510(k) Summary

Date:

February 10, 2014

DMG USA, Inc. Owner's Name: 23 Frank Mossberg Drive Attleboro, MA 02703 [phone] Registration # not yet assigned Owner/Operator No. 9005969 Pamela Papineau, RAC Contact Person: Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 [phone]

#### Subject Device:

Retraction Paste Trade Name: Retraction Cord Common Name: Unclassified, Product Code MVL Classification Name:

#### Predicate Device:

Trade Name: Common Name: Classification Name:

Expa-Sy! - K050180 (Sybron Dental Specialists) Retraction Cord Unclassified, Product Code MVL

#### Product Description &

The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing synnge. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.

#### Indications for Use:

For use for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

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## Substantial Equivalence:

| | DMG USA Retraction Paste<br>(current submission) | Expa-syl<br>(K050180; predicate device) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Sponsor | DMG USA | Sybron Dental Specialties, Inc. |
| Indications for<br>Use | For the temporary retraction and<br>hemostasis of the gingival<br>margin during dental procedures<br>such as, but not limited to,<br>dental impressions, seating of<br>temporary and permanent<br>restorations, restorations of<br>cavities and placement of a<br>rubber dam. | For the temporary retraction and<br>hemostasis of the gingival<br>margin during dental procedures<br>such as, but not limited to,<br>dental impressions, seating of<br>temporary and permanent<br>restorations, restorations of<br>cavities and placement of a<br>rubber dam. |
| Physical<br>Properties | pH, viscosity | pH, viscosity |
| Chemical<br>Composition | Aluminum chloride hexahydrate<br>in a water-based kaolin paste | Aluminum chloride hexahydrate<br>in a water-based kaolin paste |
| Operating<br>Principle | Kaolin-based paste physically<br>displaces gingival tissue;<br>aluminum chloride hexahydrate<br>provides gingival tissue<br>retraction, hemostasis and<br>drying of other fluids. Resulting<br>gingival sulcus exposes margin. | Kaolin-based paste physically<br>displaces gingival tissue;<br>aluminum chloride hexahydrate<br>provides gingival tissue<br>retraction, hemostasis and<br>drying of other fluids. Resulting<br>gingival sulcus exposes margin. |
| How Supplied | Pre-filled cartridge used with<br>dispensing gun; product applied<br>through disposable syringe tips<br>attached to cartridge | Pre-filled cartridge used with<br>dispensing gun; product applied<br>through disposable syringe tips<br>attached to cartridge. |

#### Conciusion:

Substantial Equivalence for the DMG USA Retraction Paste is based upon comparison to the physical properties, chemical composition, operating principle, product packaging / delivery mechanism and indications for use of the predicate device. Technological characteristics and non-ciinical performance data provided in this 510(k) consist of chemical composition, description of product packaging/delivery mechanism, and physical properties measurements (pH and viscosity). The Retraction Paste is identical to the predicate device in terms of these technological characteristics and non-clinical performance data; therefore, the Retraction Paste has been shown to be substantially equivalent to the predicate device.

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

### February 25, 2014

DGM USA, Incorporated C/O Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, MA 01432

Re: K130580

Trade/Device Name: Retraction Paste Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: December 30, 2013 Received: January 17, 2014

Dear Ms. Papineau:

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.

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## Page 2 - Ms. Papineau

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Medica]Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image contains the words "Kwame" and "Ulmers" in a bold, sans-serif font. The word "Kwame" is positioned above "Ulmers". There is a logo to the right of the words. The logo contains a circle and a triangle.

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Page 1 of of 1 a

510(k) Number (if known):

Device Name: Retraction Paste

Indications for Use:

For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

OR Prescription Use _ X

(Per 21 CFR 801 Subpart D)

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Runner

Mary S. Runner -S
DOS 04/20/2014 02.21
08:35:50 -05'00'