STRAUMANN PREFGEL

K063812 · Straumann USA · KJJ · Jan 12, 2007 · DE

Device Facts

• Record ID: K063812
• Device Name: STRAUMANN PREFGEL
• Applicant: Straumann USA
• Product Code: KJJ · DE
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear-layer. PrefGel has been shown to effectively remove the smear-layer. PrefGel has also been shown to produce a fibrilliar collagenous meshwork on the exposed and conditioned surface by selective removal of mineral. In addition, PrefGel does not induce any detectable necrosis in the surrounding periodontal tissues.

Device Story

PrefGel is an EDTA-based root surface conditioning gel. Applied topically by a clinician during periodontal surgery to exposed root surfaces. Function: chemical removal of smear-layer and selective mineral removal to expose a fibrillar collagenous meshwork. Benefit: facilitates periodontal tissue healing without inducing necrosis. No electronic components or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on performance characteristics and biocompatibility testing.

Technological Characteristics

EDTA-based root surface conditioning gel. Chemical composition and physical properties are identical to the predicate device. No electronic, software, or mechanical components.

Indications for Use

Indicated for topical application onto exposed root surfaces during periodontal surgery to remove the smear-layer and produce a fibrillar collagenous meshwork via selective mineral removal. No specific age or gender restrictions noted.

Predicate Devices

• PrefGel (K940737)

Submission Summary (Full Text)

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K063812

## Section 9 510(K) SUMMARY

## jan 1 2 2007

| SPONSOR: | Straumann<br>60 Minuteman Road<br>Andover, MA 01810 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Lisa M. Quaglia<br>Regulatory Affairs and Clinical Research Director<br>Tel: [phone] |
| DATE OF SUBMISSION: | December 21, 2006 |
| DEVICE: | Straumann® PrefGel |
| Trade Name: | PrefGel™ |
| Common Name: | Root Surface Conditioning Gel |
| Classification: | Dental<br>Classified Under 21 CFR Part 872.3690.<br>Classified as a Class II Device. |
| PREDICATE DEVICE: | PrefGel (K940737) |
| DEVICE DESCRIPTION: | PrefGel is an EDTA gel used for topical application<br>prior to periodontal surgery to remove the smear-layer. |
| INTENDED USE: | PrefGel is intended for topical application onto exposed<br>root surfaces during periodontal surgery in order to<br>remove the smear-layer. PrefGel has been shown to<br>effectively remove the smear-layer. PrefGel has also<br>been shown to produce a fibrilliar collagenous<br>meshwork on the exposed and conditioned surface by<br>selective removal of mineral. In addition, PrefGel does<br>not induce any detectable necrosis in the surrounding<br>periodontal tissues. |
| COMPARISON OF<br>CHARACTERISTICS: | The proposed device is substantially equivalent to<br>currently marketed device. They share the same<br>intended use, same design characteristics, and the same<br>method of application. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to the<br>currently marketed PrefGel in terms of performance<br>characteristics tested and biocompatibility. |

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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 an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

JAN 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Quaglia Regulatory Affairs and Clinical Research Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K063812

Trade/Device Name: PrefGel™ Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 21, 2006 Received: December 22, 2006

Dear Ms. Quaglia:

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 - Ms. Lisa M. Quaglia

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Sincerely yours,

Susan Puon

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 Statement

510(k) Number (if known) K063812

Page 1 of 1

Device Name Straumann PrefGel™™

Indications for Use The Straumann© PrefGel™ is indicated for topical application onto
exposed root surfaces during periodontal surgery in order to selectively
remove the smear-layer PrefGel has been shown to mod

remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.

Prescription Use X (Per 21 CFR 801.109)

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OR

Over the Counter Use

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suren Ruan

General Hos
vices
K063812

Special 510(k) Premarket Notification for Straumann® PrefGel Proprietary and Confidential Information of Straumann®