EXPA-SYL

K050180 · Produits Dentaires Pierre Rolland · MVL · Feb 11, 2005 · DE

Device Facts

• Record ID: K050180
• Device Name: EXPA-SYL
• Applicant: Produits Dentaires Pierre Rolland
• Product Code: MVL · DE
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Expa-syl is a paste containing aluminum chloride which is intended to be used 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

Expa-syl is a gingival retraction and hemostatic paste containing aluminum chloride. It is supplied in a cartridge and applied to the gingival sulcus using a manual dispensing gun. The clinician applies the paste into the sulcus, leaves it in place for 1 to 2 minutes, and then removes it using an air/water spray with simultaneous aspiration. This process creates a dry, retracted sulcus, facilitating dental procedures such as impressions and restorations. The device is intended for use by dental professionals in a clinical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Paste formulation containing aluminum chloride; delivered via cartridge and manual dispensing gun; non-electronic, mechanical application.

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

• Stav-put Impregnated (Coltene/Whaledent)
• Ultrapak E (Ultradent Products, Inc.)

Submission Summary (Full Text)

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FEB 11 2005

sds

SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

K050180

#### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: January 2005

#### Device Name:

- . Trade Name - Expa-syl
- Common Name Gingival Retraction/Hemostatic Paste .
- Classification Name Unclassified .

# Devices for Which Substantial Equivalence is Claimed:

- . Coltene/Whaledent, Stav-put Impregnated
- Ultradent Products, Inc., Ultrapak E .

# Device Description:

Expa-syl is a paste containing aluminum chloride which is used 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. The paste is extruded through the tip attached to the cartridge and applied into the sulcus through the use of the manual dispensing gun. The paste is left in place between 1 to 2 minutes, depending upon the tonicity of the marginal gingiva, and then removed by an air and water spray with simultaneous aspiration. A dry, retracted sulcus is obtained.

#### Intended Use of the Device:

The intended use of Expa-syl is 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.

# Substantial Equivalence:

Expa-syl is substantially equivalent to other legally marketed devices in the United States. Expa-syl functions in a manner similar to and is intended for the same use as the products Stay-put Impregnated and Ultrapak E cleared for marketing for Coltene/Whaledent and Ultradent Products, Inc., respectively.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2005

Produits Dentaires Pierre Rolland C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K050180

Trade/Device Name: Expa-SylTM Regulation Number: N/A Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: January 24, 2005 Received: January 26, 2005

Dear Ms. Boswell:

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 nrior 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 n your de need it onestional 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. Colleen Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i nease be advised that I 27 r ination that your device complies with other requirements of the Act or that I Drived a deceminations administered by other Federal agencies. You must comply with all 1 caelar statutes and 16 gendarding, but not limited to: registration and listing (21 CFR Part 807); an the Ave 3 requirements) ; good manufacturing practice requirements as set forth in the quality idoceming (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally premainst noutheation " a results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Q
Shiu-S. Lien, Ph.D.

Chiu S. Lin. PhD 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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# Indications for Use

િલ્લાના નિર્માન કામાં આવેલા ગુજરાત રાજ્યના ભારત દેશના પાકની ખેત 510(k) Number (if known):

Device Name: Expa-syl

Indications For Use:

Expa-syl is a paste containing aluminum chloride which is intended to be used 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.

Prescription Use V (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)

Susan Kunze

Civision Sian-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K050180