(294 days)
No
The summary describes a physical bone graft material and its intended uses and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a bone graft intended for augmentation, reconstructive treatment, and filling of various defects in oral, periodontal, and maxillofacial surgery, which are therapeutic medical interventions.
No
This device is a bone graft material used for reconstructive treatment and filling defects, not for diagnosis. Its intended uses involve augmenting, filling, and elevating, all of which are treatment-oriented actions rather than diagnostic procedures.
No
The device description clearly states it is a physical product composed of bone mineral and collagen matrix, provided in various sizes and supplied sterile. It is a tangible implantable material, 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 describes a device used for surgical procedures to augment and reconstruct bone in the oral and maxillofacial region. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a physical material (bone mineral and collagen matrix) implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide any kind of diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, and bone healing in an animal model, which are relevant to an implantable surgical device, not an IVD.
In summary, the DSM Biomedical Dental Bone Graft Plus is a surgical implant intended for bone regeneration, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DSM Biomedical Dental Bone Graft Plus is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
The DSM Biomedical Dental Bone Graft Plus is a non-pyrogenic porous bone mineral and collagen matrix for use in periodontal, oral, and maxillofacial surgery. The DSM Biomedical Dental Bone Graft Plus is composed of anorganic porcine bone granules combined with bovine collagen to form small cylinders. The device is provided in sizes ranging from 100 - 500mg. DSM Dental Bone Graft Plus is supplied sterile by gamma irradiation and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal defects, defects after root resection, apicoectomy, and cystectomy, extraction sockets, maxillary sinus floor, peri-implant defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Testing Data:
- Mechanical and Physical Testing: Material characterization was completed in accordance with the FDA Guidance Document, Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices. Bench testing verified that the device can be hydrated and trimmed prior to implantation. Packaging meets ISO 11607-1. Product is gamma sterilized (ISO 11137-1 and ISO 11137-2). Stability testing included evaluations of appearance, mass, collagen characterization, and simulated use, verifying no effect on device performance, collagen characterization, or package integrity over time.
- Biocompatibility Testing: Completed in accordance with ISO 10993-1 for a permanent implant device with tissue/bone contact. Included Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Genotoxicity (ISO 10993-3), Subacute Systemic Toxicity (ISO 10993-11), Chronic Systemic Toxicity (ISO 10993-6), and Implantation (ISO 10993-6). Pyrogenicity testing per USP and ISO 10993-11 confirmed non-pyrogenic. Porcine bone and bovine collagen sourced per ISO 22442-2 and FDA Guidance Document, Medical Devices Containing Materials Derived from Animal Sources. Viral inactivation studies per ISO 22442-3 and residual chemical assessment per ISO 10993-17 were conducted. Results indicate acceptable biocompatibility profile.
- Animal Testing: A canine intrabony defect animal study was performed to evaluate bone healing following treatment with the DSM Biomedical Dental Bone Graft Plus compared to the predicate device.
Key Results:
- The DSM Biomedical Dental Bone Graft Plus is substantially equivalent to the predicate device Bio-OSS® Collagen regarding indication for use, material, technological characteristics, including principles of operation, and performance characteristics as shown in an anatomically relevant animal model.
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.
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.
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.
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September 10, 2020
DSM Biomedical Susan Pileggi Senior Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19431
Re: K193212
Trade/Device Name: DSM Biomedical Dental Bone Graft Plus Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: August 17, 2020 Received: August 19, 2020
Dear Susan Pileggi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193212
Device Name
DSM Biomedical Dental Bone Graft Plus
Indications for Use (Describe)
The DSM Biomedical Dental Bone Graft Plus is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
| Type of Use (Select one or both, as applicable) | Commercial Use (including CBD extraction) Personal Use (including CBD extraction) | Commercial Use (including CBD extraction) | Personal Use (including CBD extraction) |
|---|---|---|---|
| Commercial Use (including CBD extraction) | Personal Use (including CBD extraction) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K193212
510(k) Summary
I. SUBMITTER
| Submitter: | DSM Biomedical
735 Pennsylvania Drive
Exton, PA 19341 |
|-----------------|-------------------------------------------------------------|
| Phone: | 484-713-2100 |
| Contact Person: | Susan Pileggi |
| Date Prepared: | September 10, 2020 |
II. DEVICE
| Name of Device: | DSM Biomedical Dental Bone Graft Plus |
|---|---|
| Common/Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material (21 CFR 872.3930) |
| Device Class: | II |
| Device Code: | NPM |
III. PREDICATE DEVICE
Substantial equivalence is claimed to the following device:
-
Bio-OSS® Collagen, K122894 ●
The following device is referenced within the submission: -
DSM Biomedical Dental Bone Graft, K170245 ●
IV. DEVICE DESCRIPTION
The DSM Biomedical Dental Bone Graft Plus is a non-pyrogenic porous bone mineral and collagen matrix for use in periodontal, oral, and maxillofacial surgery. The DSM Biomedical Dental Bone Graft Plus is composed of anorganic porcine bone granules combined with bovine collagen to form small cylinders. The device is provided in sizes ranging from 100 - 500mg. DSM Dental Bone Graft Plus is supplied sterile by gamma irradiation and is for single use only.
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Image /page/4/Picture/0 description: The image shows the DSM company logo. The logo consists of a colorful abstract design on the left and the letters "DSM" in blue on the right. The abstract design is made up of overlapping shapes in various colors, including blue, green, orange, and purple. The letters "DSM" are in a bold, sans-serif font.
V. Indications For USE:
DSM Biomedical Dental Bone Graft Plus is indicated for:
- . Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects .
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge ●
- Elevation of the maxillary sinus floor
- . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration (GBR)
VII. COMPARISON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICE
The DSM Biomedical Dental Bone Graft Plus is substantially equivalent in terms of indications for use, material composition, technological characteristics, and performance characteristics to the predicate device, Bio-OSS® Collagen [Geistlich-Pharma] K122894. The subject device is substantially equivalent in terms of indications for use, technological characteristics and performance characteristics to the reference device, DSM Biomedical Dental Bone Graft K170245, but differs in material composition as the subject device contains collagen in addition to the anorganic bone material of the reference device. The devices are compared in the Table 1.
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Image /page/5/Picture/0 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in blue on the right. The graphic is made up of overlapping shapes in various colors, including blue, green, orange, and purple. The letters "DSM" are in a bold, sans-serif font.
| Table | 1: | ||
|---|---|---|---|
| -- | ------- | -- | ---- |
| | DSM Biomedical Dental
Bone Graft Plus | Bio-OSS® Collagen | DSM Biomedical Dental
Bone Graft |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | (K193212: Subject Device) | (K122894: Predicate
Device) | (K170245: Reference
Device) |
| Indications for
Use | DSM Biomedical Dental Bone
Graft Plus is indicated for
augmentation or
reconstructive treatment of
the alveolar ridge; filling of
infrabony periodontal
defects; filling of defects
after root resection,
apicoectomy, and
cystectomy; filling of
extraction sockets to
enhance preservation of the
alveolar ridge; elevation of
the maxillary sinus floor;
filling of periodontal defects
in conjunction with products
intended for Guided Tissue
Regeneration (GTR) and
Guided Bone Regeneration
(GBR); filling of peri-implant
defects in conjunction with
products intended for
Guided Bone Regeneration
(GBR). | Augmentation or
reconstructive treatment of
the alveolar ridge; filling of
periodontal defects; filling
of defects after root
resection, apicoectomy, and
cystectomy; filling of
extraction sockets to
enhance preservation of the
alveolar ridge; elevation of
the maxillary sinus floor;
filling of periodontal defects
in conjunction with products
intended for Guided Tissue
Regeneration (GTR) and
Guided Bone Regeneration
(GBR); filling of peri-implant
defects in conjunction with
products intended for
Guided Bone Regeneration
(GBR). | The DSM Biomedical Dental
Bone Graft is indicated for
use in augmentation or
reconstructive treatment of
the alveolar ridge; filling of
infrabony periodontal
defects; filling of defects
after root resection,
apicoectomy, and
cystectomy; filling of
extraction sockets to
enhance preservation of the
alveolar ridge; elevation of
the maxillary sinus floor;
filling of periodontal defects
in conjunction with products
intended for Guided Tissue
Regeneration (GTR) and
Guided Bone Regeneration
(GBR); filling of peri-implant
defects in conjunction with
products intended for
Guided Bone Regeneration
(GBR). |
| Target
Population | Human, oral, periodontal | Human, oral, periodontal | Human, oral, periodontal |
| Material
Composition | Porcine-derived
osteoconductive
hydroxyapatite bone
mineral with bovine
collagen. | Bovine-derived
osteoconductive
hydroxyapatite bone
mineral with porcine
collagen | Porcine-derived
osteoconductive
hydroxyapatite bone
mineral |
| Form | Cylinder | Block | Granules |
| Dimensions | 100mg, 250mg, and 500mg | 100mg, 250mg, and 500mg | 0.5cc, 1.0cc, 2.5cc |
| Cumulative Pore
Volume | 1.6272 - 1.8329 mL/g | 0.9524 - 1.1751 mL/g | 1.3494mL/g |
| Characteristic | DSM Biomedical Dental
Bone Graft Plus
(K193212: Subject Device) | Bio-OSS® Collagen
(K122894: Predicate
Device) | DSM Biomedical Dental
Bone Graft
(K170245: Reference
Device) |
| Pore Size
Distribution | 0.003 - 360.86μm | 0.003 - 346.995μm | 0.003 - 645μm |
| Pore Size Range | Primarily macropores | Primarily macropores | Primarily macropores |
| Porosity | 73.42 - 77.26% | 53.47 - 61.34% | 65.97 - 68.74% |
| Package | Double sterile barrier
consisting of an inner and
outer tray | Double sterile barrier
consisting of an inner and
outer tray | Granules supplied in a
single use sterilized vial. |
| Performance | Bone formation | Bone formation | Bone formation |
| Biocompatible | Yes (ISO 10993-1) | Yes | Yes (ISO 10993-1) |
| Reusable | Single Use Device | Single Use Device | Single Use Device |
| Sterility | Sterile, SAL 10-6
Gamma Irradiation
(ISO 11137-1) | Sterile, SAL 10-6
Gamma Irradiation | Sterile, SAL 10-6
Gamma Irradiation
(ISO 11137-1) |
| Pyrogencity | Non-pyrogenic
(USP and ISO 10993-
11) | Non-pyrogenic | Non-pyrogenic
(USP and ISO 10993-
11) |
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Image /page/6/Picture/0 description: The image contains the logo for DSM, a global science-based company. The logo consists of a colorful, abstract swirl design on the left, with the letters "DSM" in bold, blue font on the right. The swirl design incorporates various colors, including blue, green, orange, and purple, creating a dynamic and visually appealing element.
DSM Biomedical Dental Bone Graft Plus and the predicate device have identical indications for use and are for use in the same target population. They are provided in the same sizes. Both are sterilized by gamma irradiation and supplied in a double tray configuration. The materials are shown to be an osteoconductive hydroxyapatite bone mineral with a collagen component to aid in bone formation. The DSM Biomedical Dental Bone Graft Plus is derived from porcine bone and bovine collagen while the predicate device is derived from bovine bone and porcine collagen. This does not raise questions of substantial equivalence, as chemical and physical characteristics have been shown to be substantially equivalent in benchtop and animal testing.
VII. NON-CLINICAL TESTING DATA:
The following performance data was provided in support of the substantial equivalence determination.
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Image /page/7/Picture/0 description: The image contains the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold, blue font on the right. The graphic is composed of overlapping, curved shapes in shades of blue, green, orange, and purple, creating a dynamic and modern design.
Mechanical and Physical Testing
Material characterization of the DSM Biomedical Dental Bone Graft Plus was completed in accordance with the FDA Guidance Document, Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices. Bench testing was completed to verify that the device can be hydrated and trimmed prior to implantation.
The packaging of DSM Dental Bone Graft Plus was designed to meet the requirements of ISO 11607-1. The product is gamma sterilized and has been validated per ISO 11137-1 and ISO 11137-2. Stability testing on the device included evaluations of appearance, mass, collagen characterization, and simulated use. The stability assessments verify that the passage of time did not affect the device performance, collagen characterization or package integrity.
Biocompatibility Testing
Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1 for a permanent implant device with tissue/bone contact. Biocompatibility testing included the following biological effects:
- . Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10 ●
- Irritation per ISO 10993-10
- Acute Systemic Toxicity per ISO 10993-11 ●
- Genotoxicity per ISO 10993-3 ●
- Subacute Systemic Toxicity per ISO 10993-11
- Chronic Systemic Toxicity per ISO 10993-6 .
- . Implantation per ISO 10993-6
Pyrogenicity testing per USP and Rabbit Material Mediated Pyrogenicity testing per ISO 10993-11 have been completed to verify that the device is non-pyrogenic.
The porcine bone and bovine collagen are sourced in accordance with ISO 22442-2 and per the FDA Guidance Document, Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).
Viral inactivation studies per ISO 22442-3 and a residual chemical assessment per ISO 10993-17 were conducted.
Results indicate that the device's biocompatibility profile is acceptable.
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Image /page/8/Picture/0 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping shapes in various colors, including blue, green, orange, and purple, creating a sense of dynamism and innovation. The overall design is modern and professional, reflecting the company's focus on science and technology.
Animal Testing
A canine intrabony defect animal study was performed to evaluate bone healing following treatment with the DSM Biomedical Dental Bone Graft Plus compared to the predicate device.
VIII. CONCLUSIONS
Pursuant to section 510(k), DSM Biomedical Dental Bone Graft Plus is substantially equivalent to the predicate device Bio-OSS® Collagen regarding indication for use, material, technological characteristics, including principles of operation, and performance characteristics as shown in an anatomically relevant animal model.