STRAUMANN GRANULES

K040646 · The Straumann Co. · LYC · May 3, 2004 · Dental

Device Facts

• Record ID: K040646
• Device Name: STRAUMANN GRANULES
• Applicant: The Straumann Co.
• Product Code: LYC · Dental
• Decision Date: May 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Device Story

Straumann Granules are a synthetic, resorbable bone graft substitute composed of medical-grade beta-tricalcium phosphate and hydroxylapatite. The device is intended for use by dental professionals to fill or augment osseous defects in the intraoral and maxillofacial regions. Upon implantation, the granules act as a bone void filler, providing a scaffold that is gradually resorbed and replaced by the patient's natural bone during the healing process. The device is supplied as granules for surgical placement into the defect site.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material characteristics and intended use.

Technological Characteristics

Synthetic resorbable bone graft material composed of medical grade beta-tricalcium phosphate and medical grade hydroxylapatite. Supplied as granules.

Indications for Use

Indicated for patients requiring filling or augmentation of intraoral or maxillofacial osseous defects, including periodontal defects, furcation defects, alveolar ridge defects, tooth extraction sites, and sinus elevation grafting.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Pro-Osteon® 500R Resorbable Bone Graft Filler (K990131)
• Biphasic Calcium Phosphate (K010701)
• Bone Void Filler (Sofamor Danek)
• Bio-Oss® Anorganic Bovine Bone (K970321)
• Bii-GRAFT™ (Bioresorbable Calcium Phosphate) (K960164)
• MBCP (K032268)
• OsSatura BCP Bone Void Filler (K030131)

Submission Summary (Full Text)

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**MAY - 3 2004**

K040646

## ATTACHMENT 1 - 510(k) Summary

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

#### Applicant's Name and Address 1.

| Straumann USA (on behalf of Institut Straumann AG) | |
|----------------------------------------------------|------------------------------|
| Reservoir Place | |
| 1601 Trapelo Road | |
| Waltham, MA 02451 | |
| Telephone Number: | 781-890-0001 |
| Fax Number: | 781-890-6464 |
| Contact Person: | Linda Jalbert |
| | Director, Regulatory Affairs |

#### Name of the Device 2.

| Proposed Trade Name: | Straumann Granules |
|----------------------|-----------------------------------|
| Common Name: | Synthetic Bone Graft Substitute |
| Classification Name: | LYC |
| | Bone Grafting Material, Synthetic |

### Legally Marketed Devices to which Equivalence is Claimed (Predicate ന് Devices)

| Manufacturer | Device | 510(k) | Date<br>Cleared |
|----------------------------------|--------------------------------------------------|---------|-----------------|
| Interpore Cross<br>International | Pro-Osteon® 500R Resorbable<br>Bone Graft Filler | K990131 | 3/2/1999 |
| Medtronic | Biphasic Calcium Phosphate | K010701 | 6/5/2001 |
| Sofamor Danek | Bone Void Filler | | |
| Geistlich-<br>Pharma | Bio-Oss® Anorganic Bovine<br>Bone | K970321 | 9/15/1998 |
| Bio-Interfaces,<br>Inc. | Bii-GRAFT™ (Bioresorbable<br>Calcium Phosphate) | K960164 | 4/10/1996 |
| Biomatlante | MBCP | K032268 | 12/11/2003 |
| IsoTiss NV | OsSatura BCP Bone Void Filler | K030131 | 05/20/2003 |

#### 4. Description of the Device and Intended Use

Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. filling and/or augmenting Straumann Granules are indicated for intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting. Straumann Granules

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provide a bone void filler that is resorbed and replaced with bone during the healing process.

#### 5. Basis for Substantial Equivalence

:

The Straumann Granules are substantially equivalent based on similar material characteristics and the same intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 3 2004

Institut Straumann AG C/O Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K040646

Trade/Device Name: Straumann Granules Regulation Number: Unclassified Regulation Name: Nonc Regulatory Class: None Product Code: LYC Dated: March 10, 2004 Received: March 11, 2004

Dear Ms. Jalbert:

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 prodicate 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. Jalbert

:

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" (21CFR Part 807.97). You may obtain other general information on your responsibilitics 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 vours,

Chris Lins, Ph.D.

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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K040646

# Indications for Use

510(k) Number (if known):

Device Name: Straumann Granules

Indications For Use:

Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Prescription Use (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)

Ques

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040646

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