INTERGRO ORAL

K070147 · Biomet 3i · NUN · May 14, 2007 · Dental

Device Facts

• Record ID: K070147
• Device Name: INTERGRO ORAL
• Applicant: Biomet 3i
• Product Code: NUN · Dental
• Decision Date: May 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InterGro® Oral is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Device Story

InterGro® Oral is a resorbable, osteoconductive, and osteoinductive bone graft substitute used in dental and oral/maxillofacial surgery. The device consists of demineralized cortical bone matrix (DBM) derived from human allograft tissue, which contains growth factors and osteoinductive proteins. Some versions incorporate calcium salt granules to enhance structural strength and osteoconduction. The DBM is granulated, lyophilized, and processed, then suspended in a biocompatible, semi-viscous lipid carrier. The product is provided ready-to-use in various physical consistencies (putty, paste, plus) for single-patient use. It is applied by clinicians to fill bone defects, where it acts as a scaffold that is gradually resorbed and replaced by the patient's own bone during the healing process.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by materials data and performance testing consistent with Class II device requirements.

Technological Characteristics

Resorbable bone graft substitute composed of demineralized cortical bone matrix (DBM) and a lipid carrier. Some versions include calcium salt granules. Manufacturing utilizes AATB and ASTM standards. Provided as a ready-to-use putty, paste, or plus formulation.

Indications for Use

Indicated for patients requiring bone grafting for dental intraosseous and oral/maxillofacial defects, including ridge augmentation, extraction sockets, cystic defects, sinus lifts, peri-implant defects, root resection/apicoectomy defects, and periodontal defects.

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

• GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch)

Submission Summary (Full Text)

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K070147

BIOMET 3i 510(k) Premarket Notification -InterGro® Oral

MAY 1 4 2007

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter: | BIOMET 3i<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 1038806 |
| Contact: | Tamara J. Nelson<br>Regulatory Affairs Supervisor<br>BIOMET 3i<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email tnelson @3implant.com |
| Date Prepared: | August 29, 2006 |
| Trade/Proprietary Name: | InterGro® Oral (Putty, Paste, Plus) |
| Common/Usual Name: | DBM Bone Graft Substitute |
| Classification Name: | Bone Grafting Material |
| Device Classification: | Class II |
| Predicate Device: | GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch) |
| Device Formulation: | InterGro® DBM (Paste, Putty, Plus) |
| Performance: | Performance standards applicable to DBM base products have not been published by the FDA. BIOMET 3i intends to contract Interpore Cross International to manufacture and package this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's, FDA Guidance Documents, AATB Standards and/or ASTM Standards are used as appropriate. |
| Device Description: | InterGro® Oral is a resorbable, osteoconductive, and<br>osteoinductive bone graft substitute that resorbs and is<br>replaced with bone during the healing process. Its<br>main component, demineralized cortical bone matrix<br>(DBM), is derived from donor human tissue (allograft<br>bone) and contains various growth factors including<br>osteoinductive proteins. The DBM has been<br>granulated, lyophilized and aseptically processed. In<br>some versions of the product, calcium salt granules<br>shall be incorporated to provide additional<br>osteoconduction and enhanced structural strength.<br>The carrier for InterGro® Oral is a resorbable,<br>biocompatible, semi-viscous lipid. InterGro® Oral is<br>provided ready-to-use in various physical<br>consistencies. It is packaged in various sizes by<br>volume for single patient use. |
| Indications for Use: | InterGro® Oral is a bone filling material indicated for |

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dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Conclusion: The safety and effectiveness of InterGro® Oral is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification. InterGro® Oral was found to be substantially equivalent to the predicate device based on the intended use, base materials, select performance properties, and use of a handling material.

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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 features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized eagle with three lines representing its wings, and a wavy line below representing water or a river.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tamara J. Nelson Regulatory Affairs Supervisor BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410

MAY 1 4 2007

Re: K070147

Trade/Device Name: InterGro® Oral Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: March 8, 2007 Received: March 12, 2007

Dear Ms. Nelson:

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. Nelson

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 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.

Sudite Y. Michais Dass.

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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## Indications for Use

510(k) Number (if known): __KO 7 Oly7

Device Name: InterGro® Oral

Indications for Use:

InterGro® Oral is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including; localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Prescription Use V Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sun Runner

Kiign-Off)
sion of Anesthesiology, General Hospital,
aon Control, Dental Devices
C(k) Number: K070147

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