The subject device is fish skin medical device indicated gingiva augmentation.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:

15mm x 20mm
20mm x 30mm
30mm x 40mm
The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.
The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.

AI/ML Overview

The provided text describes the Kerecis Gingiva Graft device, a collagen membrane intended for localized gingival augmentation. This is a 510(k) submission, meaning the device seeks clearance based on its substantial equivalence to a legally marketed predicate device, not necessarily on meeting quantitative acceptance criteria established by the FDA for novel devices.

Therefore, the information typically requested in questions 1 through 9 (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) is not applicable in the context of this 510(k) summary, as it describes a different type of regulatory submission process. The study presented here aims to demonstrate equivalence, not to quantify the device's performance against pre-defined thresholds.

However, I can extract information related to the "study that proves the device meets the acceptance criteria" in the context of proving substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, reinterpreting "acceptance criteria" as "criteria for demonstrating substantial equivalence" for this 510(k) submission:

1. A table of (Substantial Equivalence) Criteria and the Reported Device Performance:

The document establishes substantial equivalence by comparing the Kerecis Gingiva Graft (subject device) to the MUCOGRAFT® Collagen Matrix (predicate device) and other reference devices across various characteristics and performance tests. Rather than explicit "acceptance criteria" with numerical thresholds, the "performance" is the demonstration of comparability or superiority to the predicate device.

Characteristic / Performance Element	Substantial Equivalence Criterion (Implicit)	Reported Device Performance
Intended Use	Same as, or subset of, predicate device.	"Subset of the intended use of the predicate device." (Kerecis: "a biocompatible, sterile collagen membrane intended for augmentation and regeneration of soft tissue in oral surgical settings." Predicate: includes broader indications like "guided tissue regeneration and multiple oral tissue defect regeneration in oral surgical settings.")
Indications for Use	Same as, or subset of, predicate device.	"Subset of the indications of the predicate device." (Kerecis: "Localized gingival augmentation to increase Keratinized tissue (KT) around teeth and implants." Predicate: includes this, plus "Covering of implants placed in immediate extraction sockets," "Alveolar ridge reconstruction for prosthetic treatment," and other GTR procedures.)
Regulation, Product Code, Class	Same as predicate.	"Same as predicate." (21 CFR 872.3930, NPL, Class II)
Biocompatibility	Meets ISO 10993 series standards. Comparable to predicate.	"Yes" (Same as predicate). Leveraged testing from applicant's own predicate devices (K190528 and K153364) for Cytotoxicity, Sensitization, Irritation, Acute/Subacute/Sub-chronic/Chronic Toxicity, Genotoxicity, Implantation, Materials-Mediated Pyrogenicity, Carcinogenicity.
NON-Pyrogenic	Yes.	"Yes" (Same as predicate). Endotoxin validation (<20 EU/device) per LAL turbidimetric kinetic method following ISO 10993-11.
Resorbable	Yes.	"Yes" (Same as predicate).
Sterilization & SAL	Validated sterilization method, SAL 10-6.	Ethylene Oxide sterilization with SAL 10-6. "Traditional Sterilization Method." Ethylene Oxide residual test following ISO 10993-7.
Shelf Life	Validated, comparable to predicate.	"3 years" (Same as predicate). Validated per ASTM F1980 and Q5C (R2)[ICH] using accelerated and real-time aged samples. Packaging per ISO 11607-series, ASTM F88 and ASTM F1886.
Animal Origin Material	Safe and suitable (via viral inactivation, etc.).	North Atlantic Cod fish: skin tissue, single layer sheet. Predicate is Porcine skin and connective tissue, double layer sheet. "Different animal source, same anatomical tissue." Viral inactivation per ISO 22422 series.
Morphology (H&E, SEM)	Rich in collagen, porous, favoring cellular infiltration, preserved collagen structure.	Both subject and predicate "rich in collagen and porous, therefore favoring cellular infiltration." SEM "shows equivalent preserved collagen structure." Cross section shows porous surfaces allowing tissue adherence and promoting cellular ingrowth.
Cellular Ingrowth	Favorable cellular infiltration in vitro.	Both materials "showed favorable cellular infiltration of fibroblasts after 14 days which is a key component for tissue augmentation and re-epithelization of defected keratinized tissue."
Tensile Strength	Comparable to predicate.	"Determined to be comparable to the predicate device measured by ultimate tensile strength."
Heavy Metal Analysis	Within ICH guidelines: Q3D Elemental Impurities.	Limits of cadmium (Cd), lead (Pb), arsenic (As), and mercury (Hg) were "acceptable under the ICH guidelines."
Stability (Simulated Physiological)	Stable in artificial saliva buffer, comparable to predicate's effect on pH/conductivity.	Buffer incubated with both products was "stable over time." Subject device "raises the pH slightly," predicate "decreases it slightly." Subject device "is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7."
Suture Pull-Out Strength	Meets or exceeds predicate with 95% confidence.	"Meets or exceeds that of the predicate with a confidence of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
Pin Pull-Out Strength	Exceeds predicate with 95% confidence.	"Exceeds that of the predicate at a confidence level of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
Compression	Compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, Energy-to-Break meet or exceed predicate with 95% confidence.	"Meet or exceed those of the predicate device, with a confidence of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
User Evaluation (Cutting/Shaping)	Favorable usability, substantially equivalent to predicate.	Evaluated by four dental clinicians using questionnaire. "Showed a favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane." Assessed ease of placement, stability, robustness, handling satisfaction.
Animal (Canine) Study - Safety	Acceptable safety profile for the subject device.	"All animals remained in good general health throughout the duration of the study and gross pathological findings suggest an acceptable safety profile for the subject device."
Animal (Canine) Study - Efficacy	No statistically significant difference from predicate in key outcomes.	For all parameters (KT thickness, KT length, root coverage, inflammation, membrane degradation), "no statistically significant difference was detected between the subject and predicate devices after 90 days of healing." Both devices "were able to increase keratinized tissue around teeth."
Clinical Study - Safety	No adverse effects or complications.	"There were no adverse effects or complications during the duration of the clinical study."
Clinical Study - Efficacy	Increased KT, similar to predicate's published results, long-term stability.	"An increased in the in the width of the KT was noticed for all treated sites. This average gain has been reported as adequate to maintain long-term periodontal health." "The device showed stability as the KT slowly replaced the piscine xenograft." Results "similar to published results reported for the predicate device."

2. Sample sizes used for the test set and the data provenance:

Bench Testing: "representative products" used for various tests. Specific numbers for each test are not provided, only statements like "with a confidence of greater than 95%" (implying statistical analysis on a certain sample size).
Animal Study: 10 canines (3 terminated at 30 days, 3 at 60 days, 4 at 90 days). Data provenance: Preclinical testing in canines (implied prospective). No country of origin specified.
Clinical Study: 6 human individuals. Data provenance: Open label, noncomparative study (prospective). No country of origin specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Bench Testing (User Evaluation): Four "dental clinicians" evaluated the device for cutting and shaping. Their specific qualifications (e.g., years of experience, specialization) are not detailed.
Animal Study: Outcomes included "Histomorphometric measurements" and "Histological analysis." This implies expert pathologists/histologists reviewed the samples, but the number and qualifications are not specified.
Clinical Study: Ground truth was the observation of clinical outcomes (KT increase) by clinicians. The number and qualifications of the clinicians performing assessments in the clinical study are not specified beyond the study being "clinical."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No specific adjudication method is mentioned for any of the studies (bench, animal, or clinical). For a 510(k) submission focused on equivalence, such detailed adjudication methods are less commonly emphasized compared to novel device approvals.

5. 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 device is a physical gingival graft, not an AI or imaging diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical gingival graft. There is no "algorithm" or standalone software component. Its performance is inherent to its physical properties and biological interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Bench Testing: Laboratory measurements (tensile strength, compression, etc.), and subjective "user evaluation" feedback from dental clinicians.
Animal Study: Histomorphometric measurements (objective), histological analysis (pathology, expert interpretation), in vivo and postmortem measurements by periodontal probe.
Clinical Study: Clinical observations of "increased in the width of the KT" and overall "stability" reported by the study investigators/clinicians as outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the traditional sense for algorithm development. The "training" here would be the manufacturing process and quality control methods to ensure consistent device properties.

9. How the ground truth for the training set was established:

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 13, 2020

Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 400 Isafjordur ICELAND

Re: K192612

Trade/Device Name: Kerecis Gingiva Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: October 9, 2020 Received: October 13, 2020

Dear Gudmundur Sigurjonsson:

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.

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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-reportingcombination-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192612

Device Name Kerecis Gingiva Graft

Indications for Use (Describe)

Kerecis Gingiva Graft is indicated for:

Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.

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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510(k) Summary

1 Submitter/510(k) Holder

Address:	Kerecis LimitedEyrargata 2400 IsafjordurIceland
Contact Person:	Gudmundur Fertram SigurjonssonPresident and CEO
Telephone:	011 354 562 2601
Date Prepared:	November 12, 2020

2 Device Name

Proprietary Name:	Kerecis Gingiva Graft
510(k) Number:	K192612
Classification Name:	Barrier, animal source, intraoral
Classification Product Code:	NPL
Regulatory Number:	872.3930
Class:	II

3 Predicate Devices

Primary Predicate: MUCOGRAFT® Collagen Matrix (K102531) Reference Devices: Kerecis MariGen Wound Extra (K190528), Kerecis SecureMesh (K153364).

4 Device Description

The subject device is fish skin medical device indicated gingiva augmentation.

The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:

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15mm x 20mm ●
20mm x 30mm
. 30mm x 40mm

The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.

The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.

5 Intended Use

Kerecis Gingiva Graft is indicated for:

Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.

6 Technological Characteristics and Substantial Equivalence

Comparisons of the subject device with the predicate device (K102531), and the reference devices (K153364 and K 190528), demonstrate that it is substantially equivalent with regards to: intended use, materials, design, and operational principles.

See Table 6.1. Kerecis Gingiva Graft in comparison with predicate and references device

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Table 6-1 Kerecis Gingiva Graft in comparison with predicate and references devices

	Subject Device	Predicate Device	Discussion
Device Name	Kerecis Gingiva Graft	Geislich MUCOGRAFT®Collagen Matrix	No discussionrequired
510(k)	Subject Device	K102531	Predicate deviceand referencedevices are cleared.
Regulation	21 CFR 872.3930	21 CFR 872.3930	Same as predicate
Product Code	NPL	NPL	Same as predicate
Device Classification	Barrier, Animal Source,Intraoral	Barrier, Animal Source,Intraoral	Same as predicate
Intended Use	Kerecis Gingiva Graft is abiocompatible, sterilecollagen membraneintended for augmentationand regeneration of softtissue in oral surgicalsettings.	MUCOGRAFT® CollagenMatrix is sterile resorbablebilayer extra cellularcollagen membrane matrixfor soft tissueaugmentation, guidedtissue regeneration andmultiple oral tissue defectregeneration in oralsurgical settings.	Subset of theintended use of thepredicate device.
Indications	Localized gingivalaugmentation to increaseKeratinized tissue (KT)around teeth and implants.	• Covering of implantsplaced in immediateextraction sockets;• Localized gingivalaugmentation toincrease keratinizedtissue (KT) aroundteeth and implants;	Subset of theindications of thepredicate device
			• Alveolar ridgereconstruction forprosthetic treatment• Guided tissueregenerationprocedures inrecession defects forroot coverage• Guided tissueregenerationprocedures inrecession defects forroot coverage.
Animal OriginMaterial	North Atlantic Cod fish: skintissue, single layer sheet	Porcine skin andconnective tissue, doublelayer sheet	Different animalsource, sameanatomical tissue
Biocompatibility	Yes	Yes	Same as predicate
NON-Pyrogenic	Yes	Yes	Same as predicate
Resorbable	Yes	Yes	Same as predicate
Sizes	15mm x 20mm20mm x 30mm30mm x 40mm	15mm x 20mm20mm x 30mm30mm x 40mm	Same as predicate
Sterilization	Ethylene Oxide	Gamma Irradiation	TraditionalSterilizationMethod
Sterility AssuranceLevel	10-6	10-6	Same as predicate
Shelf life	3 years	3 years	The shelf life of theproduct has beenvalidated

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7 Performance Testing - Bench

The following performance studies were conducted on representative products to verify that material properties remain unchanged and support the substantial equivalence determination:

7.1 Morphology Observation

The subject device and the predicate device are based on the collagen rich animal tissue, piscine and porcine, respectively. Based on H&E staining, both materials are rich in collagen and porous, therefore favoring cellular infiltration. Scanning Electron Microscope (SEM) shows equivalent preserved collagen structure of the animal origin tissues used for both devices. Cross section of both devices showed that the porous surfaces in the skin derived collagen structure of both materials allows tissue adherence and promotes tissue regeneration by favoring cellular ingrowth when applied to soft tissue defect areas.

7.2. Cellular ingrowth comparison

Both materials were tested for cellular ingrowth capability by fibroblast seeding onto the materials in vitro cellular modes. Both materials showed favorable cellular infiltration of fibroblasts after 14 days which is a key component for tissue augmentation and re-epithelization of defected keratinized tissue in the oral cavity.

7.3. Tensile Strength

The tensile strength of the subject device was determined to be comparable to the predicate device measured by ultimate tensile strength.

7.4. Heavy Metal Analysis

A heavy metal analysis was evaluated to show that the limits of cadmium (Cd), lead (Pb), arsenic (As) and mercury (Hg) contained within the subject device were acceptable under the ICH guidelines: Q3D Elemental Impurities-Guidance for Industry.

7.5. Stability of Kerecis Gingiva Graft in a simulated physiological environment

A stability test was done in a simulated physiological oral environment (artificial saliva buffer) to investigate the dissolution of both material over time and to compare the effects that the products have on the pH levels and conductivity of the buffer over 24 hours. The buffer incubated with the two products was stable over time. Incubation of the subject device to the buffer raises the pH slightly, while incubation of the predicate device decreases it slightly. The subject device is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7.

7.6. Suture Pull-Out Strength

The suture pull-out strength of the subject device meets or exceeds that of the predicate with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.

7.7. Pin Pull-Out Strength

The pin pull-out strength of the subject device exceeds that of the predicate at a confidence level of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.

Kerecis Limited Traditional 510k for Kerecis Gingiva Graft

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7.8. Compression

The compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, and Energy-to-Break of the subject device meet or exceed those of the predicate device, with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.

7.9. User Evaluation of Device for Cutting and Shaping

The subject device was evaluated in comparison to the predicate by four dental clinicians for use in the oral environment using a questionnaire to assess: ease of placement, stability over the site, robustness of the device, and satisfaction with handling the device. The questionnaire results showed a favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane.

7.10.Biocompatibility, Sterilization, Shelf-life and Animal origin.

Testing from the applicant's own predicate device (K190528 and K153364) were leveraged in support of substantial equivalence.

. Biocompatibility per ISO 10993 series
- . Cytotoxicity
- Sensitization
- . Irritation or Intracutaneous reactivity
- Acute systemic toxicity
- . Subacute/sub-chronic toxicity
- Genotoxicity
- Implantation
- Materials-Mediated Pyrogenicity
- Chronic Toxicity
- Carcinogenicity
Sterilization validation per ISO 11737-1, Ethylene Oxide residual test following ISO 10993-7
. Endotoxin validation (<20 EU/device) of sterilization method per LAL turbidimetric kinetic method following ISO 10993-11
Shelf life per ASTM F1980 and Q5C (R2)[ICH] using accelerated and real-time aged samples
Packaging per ISO 11607-series, ASTM F88 and ASTM F1886
. Animal Origin and Viral inactivation per ISO 22422 series

Based upon our assessment of the design and applicable performance data, the subject device has been determined to be substantially equivalent to the identified predicate device.

8 Performance Testing - Animal

Kerecis performed preclinical testing in canines to demonstrate the capacity of the device to facilitate guided tissue repair (GTR) in mucogingival defects in the oral environment. Each animal received four oral defects: two smaller soft tissue defects in the mandibular canines and two larger soft tissue+GTR defects on the maxillary defects. In both cases, the oral membranes (subject or predicate devices, respectively) were inserted between the exposed tooth and the soft tissue and secured by suturing the defect. Three animals were terminated at 30 days after surgery, three animals at 60 days after surgery

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and four animals at 90 days after surgery. The study endpoints were as follows:

Primary analyses outcome variable:

. Histomorphometric measurements (thickness and length of keratinized tissue (KT))
Histological analysis (inflammation, healing, remodeling)

Secondary analyses outcome variable(s):

. Thickness of keratinized tissue measured by Periodontal Probe (in vivo and postmortem).
Overall, the findings of the study support the conclusion that all animals remained in good general health throughout the duration of the study and gross pathological findings suggest an acceptable safety profile for the subject device. For all the parameters analyzed, including KT thickness, KT length, root coverage, inflammation and membrane degradation, no statistically significant difference was detected between the subject and predicate devices after 90 days of healing. In vivo measurements indicate that both the subject and predicate device were able to increase keratinized tissue around teeth for both the smaller (mandibular) and larger (maxillary) defects.

The overall conclusion is that regarding the thickness and length of keratinized tissue 90 days after the creation of a soft tissue defect, the subject device is equivalent to the predicate device.

9 Performance Testing - Clinical

The clinical study (and the respective publications) provided safety and clinical evidence supporting the device use for gingival augmentation. The device was tested in six individuals in an open label, noncomparative study. All the subjects completed the clinical investigation. There were no adverse effects or complications during the duration of the clinical study. Three patients were treated for unilateral deformities and the other three patients were treated for bilateral deformities. An increased in the in the width of the KT was noticed for all treated sites. This average gain has been reported as adequate to maintain long-term periodontal health. During the 12-month follow up, the device showed stability as the KT slowly replaced the piscine xenograft. In addition, the results with the subject device are similar to published results reported for the predicate device.

10 Conclusion

Based on the data provided within this 510(k) submission, as summarized above, it can be concluded that the subject device is substantially equivalent to the predicate device with regard to intended use, indications for use, and technological characteristics, including principles of operation and performance characteristics as shown in a series of biocompatibility, bench, and clinical testing. Thus, the subject device is substantially equivalent.

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.