THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
Block (Height x Length x Width)
3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

AI/ML Overview

Description of the Device

The device, "THE Graft Collagen," is a bone grafting material composed of a porcine-derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. It is designed to be trimmed and molded to fit various defect shapes and comes in block form in different sizes (e.g., 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5 x 10 mm, 7 x 7 x 7 mm). It contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The granules act as a scaffold for new bone, while the collagen helps hold the granules together and facilitates handling. The device is sterilized using gamma irradiation.

Indications for Use

THE Graft Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for "THE Graft Collagen" are based on demonstrating substantial equivalence to its predicate devices, K122894 Bio-Oss® Collagen (primary predicate) and K173188 The Graft Bone Substitute (reference predicate), through non-clinical performance testing. The reported device performance aligns with these criteria, confirming substantial equivalence.

Aspect of Performance	Acceptance Criteria	Reported Device Performance
Physicochemical Properties	To be comparable to predicate devices and acceptable for intended use. Specific tests include Ca/P ratio, residue on ignition, heavy metal content, and pH.	Bench testing performed to evaluate Ca/P ratio, residue on ignition, heavy metal, and pH, demonstrating properties consistent with satisfactory performance and substantial equivalence to predicate devices (though specific values aren't provided, the conclusion is drawn).
Compressive Strength	To be appropriate for handling and stability in the intended application (block form).	Bench testing included compressive strength, indicating the device possesses adequate mechanical properties for its intended use, comparable to predicate devices.
Biocompatibility	To meet ISO 10993-1 standards for medical devices in contact with tissue. Specific tests: Cytotoxicity (ISO 10993-5), Irritation (ISO 10093-10), Sensitization (ISO 10993-10), Genotoxicity (ISO 10993-3), Acute toxicity (ISO 10993-11), Subchronic toxicity (ISO 10993-11), Implantation (ISO 10993-6), Pyrogenicity (ISO 10993-11).	Biocompatibility evaluated per ISO 10993-1, covering all listed tests (Cytotoxicity, Irritation, Sensitization, Genotoxicity, Acute toxicity, Subchronic toxicity, Implantation, Pyrogenicity). Results demonstrated the device to be biocompatible, confirming it meets safety standards.
Pyrogenicity	To be non-pyrogenic. Specific tests: Material-mediated pyrogenicity (ISO 10993-11) and endotoxin testing (LAL, USP <85>).	Material-mediated pyrogenicity testing (ISO 10993-11) and endotoxin testing (LAL, USP <85>) were performed, demonstrating the device is non-pyrogenic.
Sterilization	To achieve a Sterility Assurance Level (SAL) of 10^-6 for terminally sterilized medical devices.	Sterilization process validation performed according to ISO 11137 demonstrated an SAL of 10^-6, confirming the device is sterile.
Shelf-Life Stability	To demonstrate product stability and packaging integrity over its intended shelf life.	Real-time aging shelf-life study performed in accordance with ISO 11607, demonstrating product stability and packaging integrity.
Control of Animal Origin Materials	To ensure safety regarding animal-derived components. Specific tests: Controls on sourcing, collection, and handling (ISO 22442-2); Viral Inactivation (ISO 22442-3).	Controls on sourcing, collection, and handling performed per ISO 22442-2, and Viral Inactivation performed per ISO 22442-3. These validations ensure the safety of the porcine-derived materials.
In-Vivo Performance	To demonstrate substantial equivalence to the primary predicate device (Bio-Oss® Collagen) in promoting bone regeneration and integration when implanted in bone defects, specifically in a mandibular intraoral model. Assessment through histology, histomorphometry, and Micro-CT analyses at various time points.	An in-vivo study comparing "THE Graft Collagen" to Bio-Oss® Collagen (primary predicate) and a negative control in a beagle mandibular intraoral model. Histology, histomorphometry, and Micro-CT analyses conducted at 4, 8, 12, 16, and 24 weeks. Results demonstrated that the performance of the subject device and the primary predicate device was substantially equivalent.
Indications for Use Alignment	The proposed indication for use (filling of extraction sockets to enhance preservation of the alveolar ridge) should be a subset of or equivalent to the predicate device's indications, proving similar technological characteristics for the specified use.	The indication for use of the subject device is "Filling of extraction sockets to enhance preservation of the alveolar ridge," which is a subset of the primary predicate device's broader indications for bone augmentation and reconstructive treatment. This similarity supports substantial equivalence for the specified indication.
Technological Characteristics	The device's material composition, form, color, size range (in context of trimmability), biocompatibility, sterilization method, sterility level, pyrogenicity, and use (prescription, single-use) should be equivalent to or demonstrate comparable safety and effectiveness to the predicate devices. Differences must be justified as not raising new questions of safety or effectiveness.	The subject device shares essential technological characteristics (e.g., product code, basic function as a scaffold, biocompatibility, gamma irradiation sterilization, SAL 10^-6, non-pyrogenic, prescription use, single use only) with the predicate devices. Differences in size range, specific proportions of bone mineral/collagen, and animal origin of bone mineral were deemed not to affect intended use or raise new safety/effectiveness concerns, due to the device's trimmability, comparable functionality of components, and robust validation of material safety (biocompatibility, viral inactivation).

Study Details

Due to the nature of this submission being a 510(k) premarket notification for a Class II medical device (Bone Grafting Material) that primarily relies on demonstrating substantial equivalence to predicate devices, the detailed information typically found in clinical trials for AI/software devices (e.g., explicit test set sample sizes, data provenance for clinical images, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or large-scale training set details) is not applicable or not provided in the document.

The "study" that proves the device meets acceptance criteria consists of:

Bench Testing: Performed on the device itself to evaluate physicochemical properties (Ca/P ratio, residue on ignition, heavy metal, pH, compressive strength).
Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including various in vitro and in vivo tests.
Sterilization Validation: Performed according to ISO 11137.
Shelf-Life Study: A real-time aging study in accordance with ISO 11607.
Control of Animal Origin Materials Validation: Performed according to ISO 22442-2 and ISO 22442-3.
Comparative In-Vivo Study: An animal study comparing the performance of the subject device to the primary predicate device in a beagle mandibular intraoral model.

Here's the breakdown of the specific points requested, based on the provided document:

A table of acceptance criteria and the reported device performance: Provided above.
Sample sized used for the test set and the data provenance:
- In-Vivo Study (Beagle Mandibular Intraoral Model): The specific number of animals (beagles) used in the study is not explicitly stated, nor is the country of origin of the study. It is an animal implant study used for performance comparison.
- Bench, Biocompatibility, Sterilization, Shelf-Life, Animal Origin Control tests: Sample sizes for these tests are not provided in this summary but would be standard for material and safety testing of medical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study. The ground truth in the animal study would be based on scientific and pathological assessments (histology, histomorphometry, Micro-CT) performed by qualified scientific personnel (e.g., veterinarians, pathologists, histotechnicians), but their specific number and qualifications are not detailed in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of animal study and material testing conducted. Data analysis would involve measurements and interpretations by individual experts or teams, rather than a consensus-based adjudication process for diagnostic labeling.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a bone grafting material, not an AI/software device involving human readers or interpretation of diagnostic images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
- In-Vivo Study: The "ground truth" was established through histology, histomorphometry, and Micro-CT analyses in a beagle mandibular intraoral model, assessing new bone formation, integration, and other tissue responses. This combines pathological assessment with quantitative imaging analysis.
- Other tests: Ground truth for bench performance, biocompatibility, sterilization, and shelf-life is based on established scientific and regulatory standards (e.g., ISO, USP) and laboratory measurements.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

Summary

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July 24, 2024

Purgo Biologics Inc. Byungsun Kim RA Team Manager #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13219 KOREA, SOUTH

Re: K230305

Trade/Device Name: THE Graft Collagen Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: June 21, 2024 Received: June 24, 2024

Dear Byungsun Kim:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-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,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230305

Device Name THE Graft Collagen

Indications for Use (Describe)

THE Graft Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other, also in purple.

510(k) Summary

07/24/2024

1. Company

	Submitter
Name	Purgo Biologics Inc.
Address	#812, 27 Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si,Gyeonggi-do, Korea 13219
Phone/Fax	Tel. +82-70-4827-0451, Fax. +82-70-8673-0660
Contact person	Byungsun Kim / RAkimbs@purgobio.com
Summary Date	07/24/2024

2. Device Name

Trade name	:	THE Graft Collagen
Regulation number	:	21 CFR 872.3930
Regulation Description	:	Bone Grafting Material
Product code	:	NPM
Classification name	:	Bone Grafting Material, Animal Source
Device class	:	Class II
Classification Panel	:	Dental

3. Predicate Device

Primary predicate device K122894 Bio-Oss® Collagen

Reference predicate device K173188 The Graft Bone Substitute

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4. Description

THE Graft Collagen is available in various sizes.

Type	Sizes
Block	(Height x Length x Width)
	3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm

THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

5. Indication for use

THE Graft Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge.

6. Summary of Data to Support Substantial Equivalence

Non-clinical performance testing of the subject device was conducted to demonstrate substantial equivalence to the predicate devices. The following performance date are provided in support of the substantial equivalence determination.

· Bench testing was performed to evaluated the physicochemical properties of the device as followings:

Ca/P ratio

510(k) Summary

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Image /page/6/Picture/0 description: The image contains the logo for Purgo Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo", the words "Dental Biologics Solution" are stacked vertically, also in purple. The overall design is clean and modern, suggesting a focus on scientific or medical solutions.

Residue on ignition
Heavy metal
pH
Compressive strength
· Biocompatibility was evaluated in accordance with ISO 10993-1 as followings:
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10093-10
- Sensitization per ISO 10993-10
- Genotoxicity per ISO 10993-3
- Acute toxicity per ISO 10993-11
- Subchronic toxicity per ISO 10993-11
- Implantation per ISO 10993-6
- Pyrogenicity per ISO 10993-11

· Material-mediated pyrogenicity testing per ISO 10993-11 and endotoxin testing (LAL, Limulus Amebocyte Lysate) per USP <85> were performed demonstrating non-pyrogenicity.

• Sterilization process validation was performed accordance with ISO 11137 demonstrating a sterility assurance level (SAL) of 10-6.

• Real time aging shelf-life study was performed accordance with ISO 11607 demonstrating product stability and packaging integrity.

· The control of animal origin materials was performed as followings:
- Controls on sourcing, collection, and handling per ISO 22442-2
- Viral Inactivation per ISO 22442-3

The in-vivo performance of the subject device in a beagle mandibular intraoral model was compared to that of the primary predicate device, Bio-Oss Collagen. Histology, histomorphometry and Micro-CT analyses were conducted for the subject device, primary predicate device and negative control at 4, 8, 12, 16 and 24 weeks. The results demonstrated that the performance of the subject and primary predicate devices was substantially equivalent.

510(k) Summary

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Image /page/7/Picture/0 description: The image shows the logo for Purgo Biologics Solution. The logo consists of a gray atom-like symbol on the left, followed by the word "Purgo" in purple. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other, also in purple. The logo is simple and modern, with a focus on the company's name and area of expertise.

No clinical data from clinical trial were included in this submission.

7. Technological Characteristics and Substantial Equivalence

The following comparison table of the technological characteristics of the subject device and the predicate device outlines and provides the substantial equivalency of the subject device and the predicate.

	Subject device	Primarypredicate device	Referencepredicate device	Discussion
Device name	THE Graft Collagen	Bio-Oss® Collagen	The Graft Bone Substitute	-
Manufacturer	Purgo Biologics Inc.	Geistlich Pharma Ag	Purgo Biologics Inc.	-
510(k) Number	K230305	K122894	K173188	-
Product Code	NPM	NPM	NPM	Same
Indication forUse	1) Filling of extractionsockets to enhancepreservation of thealveolar ridge.	1) Augmentation orreconstructive treatmentof the alveolar ridge.2) Filling of periodontaldefects.3) Filling of defects afterroot resection,apicoectomy, andcystectomy.4) Filling of extractionsockets to enhancepreservation of thealveolar ridge.5) Elevation of the maxillarysinus floor.6) Filling of periodontaldefects in conjunctionwith products intended for	1) Filling of extractionsockets to enhancepreservation of thealveolar ridge.2) Grafting of maxillarysinus floor	EquivalentThe indication forUse of the subjectdevice is a subset ofthat of the primarypredicate device.
		Guided TissueRegeneration (GTR) andGuided BoneRegeneration (GBR).7) Filling of peri-implantdefects in conjunctionwith products intended forGuided BoneRegeneration (GBR).
Function		The Graft Collagencontains 85% The GraftBone Substitute granulesand 15% porcinecollagen.Granules serve as ascaffold for new bone.Collagen holds thegranules and facilitateshandling.	Bio-Oss® Collagen contains90% Bio-Oss® granules and10% porcine collagen.Granules serve as a scaffoldfor new bone. Collagenholds the granules andfacilitates handling.	The Graft Bone Substitutegranules serve as ascaffold for new bone.	Equivalent
	MaterialComposition		• Porcine-derivedhydroxyapatite bonemineral• Porcine-derivedtype I collagen	• Bovine-derivedhydroxyapatite bonemineral• Porcine-derivedtype I collagen	• Porcine-derivedhydroxyapatite bonemineral	Equivalent
		Form		Block	Block	Granules	Equivalent
		Color		White to off-white	White to off-white	White to off-white	Same
	Size		3 x 5 x 7 mm,5 x 5 x 5 mm,5 x 5x 10 mm,7 x 7x 7 mm,	2.5 x 5 x 7.5 mm (50mg)5 x 5 x 7 mm (100mg)7 x 7 x 7 mm (250mg)10 x 10 x 7 mm (500mg)	0.15g, 0.25g, 0.5g, 1.0g,2.0g, 5.0g	Equivalent
		Biocompatibility		Biocompatible	Biocompatible	Biocompatible	Same
		Sterilization		Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Same
Sterility			Sterile, SAL 10-6	Sterile, SAL 10-6	Sterile, SAL 10-6	Same
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic	Same
Use	Prescription	Prescription	Prescription	Same
Single Use Only	Yes	Yes	Yes	Same

Comparison of Characteristics

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Image /page/8/Picture/0 description: The image contains the logo for Purgo Biologics Solution. The logo features a gray circular icon with a smaller circle inside, resembling a magnifying glass. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically, also in purple.

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Image /page/9/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in purple. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple. The logo is clean and modern, suggesting a focus on scientific and biological solutions for dental care.

The subject device is substantially equivalent to the primary predicate device K122894 in indication for use, function, material, design, biocompatibility and sterilization. Differences include the size range, composition of bone mineral and collagen, and animal origin of bone mineral.

Discussion on the differences

· Size range
The subject and primary predicate devices can be trimmed to fit the defect shapes, so the sizes do not affect usage.
Composition of bone mineral and collagen
The subject device contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The primary predicate device contains 90% Bio-Oss® granules and 10% porcine collagen. In both devices, granules serve as a scaffold for new bone and collagen is used to hold the granules. So, composition of collagen does not affect to the intended use.
· Animal origin of bone mineral
- Bone mineral of the subject device is derived from porcine and that of the predicate device is derived from bovine. The animal origin is different, but the safety of material was verified through biocompatibility tests and virus inactivation validation.

8. Conclusion

Based on the information provided, the subject device is substantially equivalent to the primary predicate device.

Regulation Number and Section

§ 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.