(75 days)
Not Found
Not Found
No
The device description and intended use focus on the material composition (demineralized bone allograft in a gelatin carrier) and its application as a bone void filler. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are based on animal and clinical trials, not algorithmic performance metrics.
Yes
The product's intended use is to fill and/or augment bone defects, which is a therapeutic intervention, and it's described as safe and effective for bone void filling applications in performance studies.
No
The device description indicates that the products are bone grafts intended to fill and augment bony defects. There is no mention of the device being used to identify, detect, or monitor a medical condition, which are characteristics of a diagnostic device. Its purpose is therapeutic/restorative, not diagnostic.
No
The device description explicitly states that the products contain human demineralized freeze-dried bone allograft (DFDBA) and human cortical-cancellous bone chips in an inert porcine gelatin carrier, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these products are "intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects." This describes a surgical or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the composition of the products (human demineralized freeze-dried bone allograft, porcine gelatin carrier, bone chips). This is consistent with a bone graft material, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition. The purpose is to physically fill and augment bone defects.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NUN
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental intraosseous, oral and cranio-/maxillofacial defects; Periodontal defects; Alveolar ridge; Extraction sockets; Maxillary sinus floor; Craniofacial; Root; Tumor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician and/or dentist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.
0
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 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 www.rtix.com
APR 3 0 2008
Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-418-1627
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.
1
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 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 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
Characteristics Comparison |
|-------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Regenafil®
Altiva DBM Paste
BioSet™
RTI Allograft Paste
Osteofil® | RTI Allograft Paste | Same technological
characteristics (i.e., design,
material, and chemical
composition) as the predicate |
| Regenaform®
Altiva DBM with cortical cancellous chips
BioSet™ IC
RTI Allograft Paste IC
Osteofil® ICM | RTI Allograft Paste IC | Same technological
characteristics (i.e., design,
material, and chemical
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
271
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:__