REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST

K080418 · Regeneration Technologies, Inc. · NUN · Apr 30, 2008 · Dental

Device Facts

• Record ID: K080418
• Device Name: REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
• Applicant: Regeneration Technologies, Inc.
• Product Code: NUN · Dental
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including Periodontal defects; Alveolar ridge augmentation; Extraction sockets (ridge preservation, implant preparation/ placement); Maxillary sinus floor elevation; Craniofacial augmentation; Root resection, apicoectomy and cystectomy; Tumor resection. One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Device Story

Bone grafting materials composed of human demineralized freeze-dried bone allograft (DFDBA) in inert porcine gelatin carrier; some formulations include human cortical-cancellous bone chips. Used by dentists/physicians to pack bony voids or gaps in dental, oral, and cranio-/maxillofacial sites. Provides scaffold for bone regeneration in defects like periodontal gaps, extraction sockets, and tumor resections. Osteoinductivity verified via modified athymic nude rat assay. No electronic or software components.

Clinical Evidence

Evidence includes animal model studies and clinical data. Osteoinductivity of each lot evaluated using modified athymic nude rat assay. Results demonstrate safety and effectiveness for dental bone void filling applications.

Technological Characteristics

Composition: Human demineralized freeze-dried bone allograft (DFDBA) or DFDBA with cortical-cancellous bone chips in inert porcine gelatin carrier. Osteoinductivity testing via modified athymic nude rat assay. No energy source, software, or connectivity.

Indications for Use

Indicated for filling or augmenting dental intraosseous, oral, and cranio-/maxillofacial bony voids or gaps resulting from surgical creation or traumatic injury in patients requiring bone 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

• GRAFTON PLUS® DBM Paste
• GRAFTON® DBM
• Accell Connexus
• DBX® Demineralized Bone Matrix
• RTI Allograft Paste
• RTI Allograft Paste IC

Submission Summary (Full Text)

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K080418

Image /page/0/Picture/1 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a stylized graphic on the left, followed by the word "Regeneration" in bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in a smaller font size. The logo appears to be for a technology company.

Date: February 15, 2008

Submitted by: Lisa Simpson

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

APR 3 0 2008

Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: [phone] x4326 Fax: [phone]

Trade Names:

Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with cortical cancellous chips, BioSet™, BioSet™ IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM

Classification Name and Code: bone grafting material, human source (21 CFR 872.3930, product code NUN)

### Substantial Equivalence:

The proposed devices are substantially equivalent to GRAFTON PLUS® DBM Paste, GRAFTON® DBM, Accell Connexus, and DBX® Demineralized Bone Matrix in design, function and intended use, and substantially equivalent to RTI Allograft Paste and RTI Allograft Paste IC in design, function, materials and processing.

### Description:

Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.

### Indications for Use:

These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including

- . Periodontal defects;
- . Alveolar ridge augmentation;
- Extraction sockets (ridge preservation, implant preparation/ placement); .
- . Maxillary sinus floor elevation;
- Craniofacial augmentation; .
- Root resection, apicoectomy and cystectomy; .
- Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

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K'080418

Image /page/1/Picture/1 description: The image shows the logo for Regeneration Technologies, Inc. The logo features a stylized graphic to the left of the company name. The company name is written in a bold, sans-serif font, with the word "Regeneration" appearing in a larger font size than "TECHNOLOGIES, INC." The logo is simple and modern, and it is likely used on the company's website, marketing materials, and other branding materials.

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

Summary of Technological Characteristics:

These devices are composed of demineralized and non-demineralized allograft bone in a gelatin carrier matrix. Finished product from each lot is evaluated for osteoinductivity using the modified athymic nude rat assay. These devices have the same technological characteristics (i.e., design, material, and chemical composition) as the respective predicate device as listed in the table below:

| Device Name | Predicate Name | Technological<br>Characteristics Comparison |
|-------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Regenafil®<br>Altiva DBM Paste<br>BioSet™<br>RTI Allograft Paste<br>Osteofil® | RTI Allograft Paste | Same technological<br>characteristics (i.e., design,<br>material, and chemical<br>composition) as the predicate |
| Regenaform®<br>Altiva DBM with cortical cancellous chips<br>BioSet™ IC<br>RTI Allograft Paste IC<br>Osteofil® ICM | RTI Allograft Paste IC | Same technological<br>characteristics (i.e., design,<br>material, and chemical<br>composition) as the predicate |

Performance Data Supporting Substantial Equivalence Determination:

The proposed products are equivalent to RTI Allograft Paste and RTI Allograft Paste IC, but have different specific clinical indications. Results from animal and clinical studies demonstrate that these products are safe and effective for use in dental bone void filling applications.

¹ Findings from an animal model are not necessarily predictive of human clinical results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 3 0 2008

Mr. Travis Arola Regulatory Affairs Manager Regeneration Technologies, Incorporated 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650

Re: K080418

Trade/Device Name: Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with Cortical Cancellous Chips, BioSet™, BioSet™, IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: February 15, 2008 Received: February 15 2008

Dear Mr. Arola:

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. Arola

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.

Syitte y. Michàu Oms.

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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K0804/8

# Indications for Use

510(k) Number (if known):

Device Names:

Regenafil® Regenaform® Altiva DBM Paste Altiva DBM with cortical cancellous chips BioSet™ BioSet™ IC RTI Allograft Paste RTI Allograft Paste IC Osteofil® Osteofil® ICM

#### Indications for Use:

These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including

- Periodontal defects; �
- Alveolar ridge augmentation; .
- Extraction sockets (ridge preservation, implant preparation/ placement); .
- . Maxillary sinus floor elevation:
- . Craniofacial augmentation;
- Root resection, apicoectomy and cystectomy; ●
- Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Prescription Use Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Susan Ryare

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

510(k) Number:***_***_