STAY-PUT IMPREGNATED

K041023 · Coltene/Whaledent GmbH & Co. KG · MVL · Jun 15, 2004 · DE

Device Facts

• Record ID: K041023
• Device Name: STAY-PUT IMPREGNATED
• Applicant: Coltene/Whaledent GmbH & Co. KG
• Product Code: MVL · DE
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.

Device Story

Stay-put impregnated is a dental retraction cord consisting of a polyester cord with a metal core, impregnated with aluminium chloride hexahydrate. Used by dentists to achieve temporary retraction and haemostasis of the gingival margin during dental procedures. The metal core provides structural support to maintain the cord's position within the gingival sulcus. The chemical agent facilitates haemostasis. The device is a manual tool used in a clinical dental setting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Polyester cord with metal core; impregnated with aluminium chloride hexahydrate. Manual dental retraction device.

Indications for Use

Indicated for temporary gingival retraction and haemostasis in dental patients requiring gingival margin management.

Predicate Devices

• Ultrapak E (K041023)

Submission Summary (Full Text)

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### 510(k) Submission Stay-put impregnated 510(k) Summary

### JUN 1 5 2004

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K041023

This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR § 807.92.

1. The submitter of this premarket notification is: Coltène/Whaledent Inc. Henry Vogelstein 235 Ascot Parkway Cuyahoga Falls, OH 44223-3701 USA Tel.: [phone] Fax: [phone] This summary was prepared on February 20, 2004

2. The name of this device is Stay-put impregnated. Its common name is Stay-put impregnated and its classification is retraction cord.

3. Stay-put impregnated is substantially equivalent to Ultrapak E manufactured by Ultradent Products Inc.

4. Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.

5. The technical characteristics are similar to those found with the predicate device Ultrapak E. Both products are impregnated retraction cords for dental use. Differences are only in the compression aid.

H. Hogelster 4/19/04

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 5 2004

Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Official Correspondent Designated U.S. Agent 1349 Lexington Avenue New York, New York 10128

Re: K041023

Trade/Device Name: Stay-Put Impregnated Regulation Number: N/A Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Codes: MVL Dated: April 19, 2004 Received: April 20, 2004

Dear Mr. Vogelstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your contentially equivalent (for the indications for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass succed in also encreat date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassiriou in approval of a premarket approval application (PMA). You may, Act (Tec) market the device, subject to the general controls provisions of the Act. The general thereore, mancer me act include requirements for annual registration, listing of devices, good controle pro reserved 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 If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sam adations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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#### Page 2 - Mr. Henry J. Vogelstein

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); 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.

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 marketed predicate device 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Anthony 20. nater for

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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Image /page/3/Picture/1 description: The image shows the logo for "coltène whaledent". The word "coltène" is in lowercase letters and is stacked on top of the word "whaledent", which is also in lowercase letters. There are three diagonal lines to the right of the word "coltène".

# Indications for Use

KO41023 510(k) Number (if known):

Device Name:

Stay-put impregnated

Indications for Use:

Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.

Prescription Use (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 Ruaper

Page 1 of

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

510(k) Number: K6411023