HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12

K060363 · Hemcon, Inc. · OLR · Jul 7, 2006 · SU

Device Facts

• Record ID: K060363
• Device Name: HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
• Applicant: Hemcon, Inc.
• Product Code: OLR · SU
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

Device Story

HemCon® Dental Dressing is a lyophilized, chitosan-based oral wound dressing. It acts as a physical barrier to protect oral mucosal tissue and provide pain relief. The device is a smaller, modified version of the HemCon® Bandage, specifically sized (10 mm x 12 mm) for use in the oral cavity and provided without a non-stick backing. It is intended for single-use application, packaged in a vacuum-sealed aluminum pouch, and sterilized via gamma radiation. The dressing is applied to the wound site to optimize mucoadhesive surface density and structural integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized chitosan-based dressing; 10 mm x 12 mm rectangular form factor; sterile, single-use; gamma radiation sterilization; mucoadhesive properties.

Indications for Use

Indicated for temporary protection of oral mucosal tissue and pain relief in patients requiring an oral wound dressing.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

• HemCon® Bandage (K023298, K043050)

Submission Summary (Full Text)

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K060363

JUL - 7 2006

14 June 2006

# HemCon® Dental Dressing 510(k) Notification

## 5. SECTION 5 - 510(K) SUMMARY

Name and Address of Sponsor:

Device Name:

HemCon. Inc. 10575 SW Cascade Avenue, Suite 103 Portland, OR 97223

Proprietary Name: Hemcon® Dental Dressing

Common Name: Oral Wound Dressing Classification Name: Dressing Product Code: Unclassified

#### Establishment Registration Number:

9053189

#### General Description:

The HemCon® Dental Dressing is identical in material, design and composition to the legally marketed HemCon® Bandage (K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). The only differences are the indication for use in the oral cavity and the reduction in size for the use in the oral cavity (10 cm x 10 cm for the legally marketed HemCon® bandage versus 10 mm x 12 mm for the dental dressing). Additionally, the HemCon® Dental Dressing is provided without the non-stick backing used on the HemCon® Bandage.

The HemCon® Dental Dressing is a lyophilized (freeze-dried) chitosan-based dressing designed to optimize the mucoadhesive surface density and structural integrity of chitosan at the wound site. The HemCon® Dental Dressing may be manufactured to any size and is currently available in 10 mm x 12 mm rectangular dressing and is packaged in a vacuum-sealed aluminum pouch and processed with gamma radiation for sterile single-use only application.

#### Indication for Use:

The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

### Contact Person(s) and Phone Number:

Kevin Hawkins Director - Quality & Regulatory Phone [phone] x114 Fax [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Mr. Kevin Hawkins Director-Quality & Regulatory HemCon, Incorporated 10575 SW Cascade Boulevard. Suite 103 Portland, Oregon 97223

Re: K060363

Trade/Device Name: HemCon® Dental Bandage Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: June 14, 2006 Received: June 15, 2006

Dear Mr. Hawkins:

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 such 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. Hawkins

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 (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.

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]. 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 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 yours,

Snite y. Michin Omp.

Chiu Lin, Ph.D. 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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14 June 2006

# 4. SECTION 4- INDICATIONS FOR USE STATEMENT

Applicant: HemCon, Inc. 510(k) Number (if known): K060363 Device Name: HemCon® Dental Bandage

Indications for Use:

The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Sivan Runor

: Sign-Off)
on of Anesthesiology, General Hospital,
Jon Control, Pental Devices

Number: 12060363

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(Posted November 13, 2003)