OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:

1. Alveolar ridge augmentation and reconstruction,
1. Alveolar ridge preservation consequent to tooth extractions,
1. Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
1. In intra bony defects around teeth,
1. Guided tissue regeneration procedures in periodontal defects.

Device Description

OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose. OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (OSSIX® Breeze) and focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. It does not describe an acceptance criteria table with reported device performance in the manner typically seen for a new AI/software device whose performance is strictly numerically quantified.

Instead, the document details a comparison of technological characteristics between the new device (OSSIX® Breeze) and a predicate device (OSSIX® Plus), supported by non-clinical testing. The "acceptance criteria" here are inherently tied to the concept of substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of studies (in vitro, in vivo animal, and biocompatibility) whose results collectively demonstrate this substantial equivalence.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as meeting the standards for substantial equivalence, which is a qualitative rather than strictly quantitative comparative goal in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a traditional medical device (bone grafting membrane), rather than a software algorithm with classic performance metrics like accuracy, sensitivity, and specificity, the "acceptance criteria" primarily revolve around demonstrating that the new device is as safe and effective as the predicate. The "reported device performance" is a comparative assessment.

Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate)	Reported Device Performance (Summary)
Composition and Material Source: Comparable materials or demonstrated biocompatibility and safety for different materials.	OSSIX® Breeze (porcine decellularized pericardia) and OSSIX® Plus (porcine tendons) are both porcine collagen. Other non-clinical tests (biocompatibility, in vitro) demonstrated comparability.
Technological Characteristics: Similar manufacturing process, cross-linking, and physical properties (porosity, water uptake, mechanical).	Both devices use a similar manufacturing process, including ribose cross-linking and ethylene oxide sterilization. Comparative bench testing found that except for minor differences, physicochemical and biochemical characteristics are comparable.
Biocompatibility: Meets established biocompatibility standards.	Biocompatibility testing performed in accordance with FDA recognized ISO 10993 series standards. All controls on animal materials followed ISO 22442 series.
Sterilization: Achieves sterility (SAL 10^-6) via validated process.	Sterilization process established and performed according to ISO 11135:2014 (Ethylene Oxide) with SAL 10^-6.
In Vivo Performance & Degradation: Performs similarly in an animal model.	In vivo animal study in a beagle mandibular guided bone regeneration model demonstrated that OSSIX® Breeze performed in a manner substantially equivalent to OSSIX® Plus regarding in vivo performance, degradation, and safety.
Safety: No new safety concerns identified compared to predicate.	Non-clinical testing (biocompatibility, in vitro, in vivo) and comparison to predicate did not raise new safety issues.
Intended Use/Indications for Use: Same intended use and similar indications.	OSSIX® Breeze has the same intended use and similar indications for use as the predicate OSSIX® Plus. Minor differences in wording are presented in the comparison table.
Mode of Action/Operating Principles: Same mechanism of action.	Both devices function as a barrier, serving as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Both are cell-occlusive, implantable, resorbable, and biocompatible.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (In vivo animal study):
- Sample Size: The document does not explicitly state the total number of animals or defects studied, only that the study design included defects of specific dimensions. It mentions "Each defect was either left untreated (negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device)." This implies multiple defects were created and treated across a number of beagle dogs, but the exact N is missing.
- Data Provenance: The study was an "in vivo animal study conducted in a beagle mandibular guided bone regeneration model." This indicates it was a prospective animal study. The country of origin for the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The ground truth in this context is established through objective scientific measurements and observations (e.g., pathology, histology, histomorphology, micro-CT) in the animal study, not through expert human interpretation of images for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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?

No, this was not done. This is a submission for a physical medical device (bone grafting membrane), not an AI/software device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

No, this was not done. This is a submission for a physical medical device.

7. The Type of Ground Truth Used

For the in vivo animal study, the "ground truth" was established through:
- Pathology
- Histology
- Histomorphology
- Micro-CT
These are objective, scientific measurements and analyses performed on tissue samples and imaging from the animal model.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device requiring no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

Datum Dental Ltd. % Janice Hogan Partner Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia, Pennsylvania 19103

7/18/2022

Re: K212509

Trade/Device Name: OSSIX® Breeze Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: June 23, 2022 Received: June 23, 2022

Dear Janice Hogan:

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-reporting-

combination-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 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 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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510(k) Number (if known)

K212509

Device Name

OSSIX® Breeze
---------------

Indications for Use (Describe)

1. Alveolar ridge augmentation and reconstruction,
1. Alveolar ridge preservation consequent to tooth extractions,
1. Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
1. In intra bony defects around teeth,
1. Guided tissue regeneration procedures in periodontal defects.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. A vertical line separates the two logos. The logos are in gray.

510(k) Summary Datum Dental Ltd.'s OSSIX® Breeze K212509

I. 510(k) Applicant

Datum Dental Ltd. 1 Bat Sheva St. Lod 7120101 Israel Phone: 1-972-8-6705400 Fax: 1-972-8-6705429

Contact person:	Lyudmila Kipnis, Director of Regulatory Affairs
Date prepared:	July 18, 2022

II. Device

Trade name:	OSSIX® Breeze
Common name:	Cross-Linked Pericardium Membrane
Classification name:	Barrier, animal source, intraoral (21 CFR 872.3930)
Regulatory class:	II
Product code:	NPL

III. Predicate Device

Primary predicate: OSSIX® Plus (K160281) Reference device: Straumann® Jason® Membrane (K173562)

IV. Device Description

OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide.

Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.

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Image /page/4/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, with a stylized leaf-like shape next to the company name in a sans-serif font. A vertical line separates the two logos, and the datum dental logo is on the right, also in a sans-serif font. The logos are all in a dark gray color.

Available in sizes: 10x12 mm, 15x20 mm, 20x30 mm and 30x40 mm.

OSSIX® Breeze is intended for use in adults and should only be used by trained dentists or oral surgeons.

V. Indications for Use

1. Alveolar ridge augmentation and reconstruction,
1. Alveolar ridge preservation consequent to tooth extractions,
1. Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
1. In intra bony defects around teeth,
1. Guided tissue regeneration procedures in periodontal defects.

VI. Comparison of Technological Characteristics with the Predicate Device

OSSIX® Breeze has similar technological characteristics as the predicate device OSSIX® Plus. Both devices are manufactured from porcine collagen that is subjected to identical cross-linking process to provide the product with better resistance to degradation. Both products are highly porous three-dimensional conductive membranes structured with a lattice network of fibrillated cross-linked collagen with a pore size that is occlusive for epithelial gingival cells. The dimensions of both products are comparable, with thickness (dry membrane) of about 0.2 mm for OSSIX® Plus and 0.1-0.2 mm for OSSIX® Breeze, and up to 30x40 mm in the length and width of both devices.

The principal difference between OSSIX® Breeze and OSSIX® Plus is that OSSIX® Plus is manufactured by reconstitution of soluble purified type I collagen derived from porcine tendons, while OSSIX® Breeze is produced from insoluble collagen of decellularized porcine pericardia. In both products, the collagen is subject to similar viral inactivation (alkaline treatment), crosslinking (glycation based), and sterilization (ethylene oxide) methods. Comparative nonclinical testing between the subject OSSIX® Breeze and predicate OSSIX® Plus demonstrates that the devices have comparable physicochemical and biochemical characteristics except for minor differences in porosity, water-uptake, microstructure and mechanical properties. Additional bench testing that compared the subject device OSSIX® Breeze to the reference device

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Image /page/5/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. The Dentsply Sirona logo consists of a stylized leaf shape and the words "Dentsply Sirona" stacked on top of each other. The datum dental logo consists of the words "datum dental" stacked on top of each other. A vertical line separates the two logos.

Straumann® Jason® membrane, which is also manufactured from acellularized porcine pericardium, demonstrated that both products are comparable in terms of these characteristics.

Regarding principles of operation, the subject device as well as the predicate and reference devices are applied and work in the same manner by adhering to the surrounding tissues and providing a barrier that guides bone and tissue regeneration.

Therefore, both the subject OSSIX® Breeze and the predicate OSSIX® Plus have the same intended use and similar indications for use, composition, structure, manufacturing process, and physicochemical characteristics. The minor technological differences between OSSIX® Breeze and its predicate devices raise no new issues of substantial equivalence. Performance data demonstrate that OSSIX® Breeze is substantially equivalent to OSSIX® Plus.

A comparison chart of OSSIX® Breeze with the predicate and reference devices is provided below:

	Subject device	OSSIX® Plus (K160281)	Straumann® Jason®Membrane (K173562)
Intended use/Indications foruse	OSSIX® Breezemembrane alone or incombination withsuitable augmentationmaterials (likeautologous bone or otherbone replacementmaterials) is indicatedfor immediate ordelayed guided boneregeneration (GBR) andguided tissueregeneration (GTR) as abiodegradablemembrane for:1) Alveolar ridgeaugmentation andreconstruction,2) Alveolar ridgepreservationconsequent to toothextractions,3) Over the window insinus elevationprocedures and forsupport of the	OSSIX® Plusbiodegradable collagenmembrane is intended foruse during the process ofguided bone regeneration(GBR) and guided tissueregeneration (GTR) as abiodegradable barrier for:• Ridge augmentation forlater implant insertions.• Simultaneous ridgeaugmentation andimplant insertions.• Ridge augmentationaround implantsinserted in delayedextraction sites.• Ridge augmentationaround implantsinserted in immediateextraction sites.• Alveolar ridgepreservation consequentto tooth (teeth)extraction(s).• Over the window inlateral window sinus	Jason Membrane alone orin combination withsuitable augmentationmaterials (likeautogenous bone,allogeneic, xenogeneic oralloplastic bonereplacement materials) isindicated for immediateor delayed guided tissueand bone regeneration.• in case of surgical bonedefects and bone walldefects• in the context of sinusfloor augmentation andfor support of theSchneiderian membrane• in the context ofmaxillary ridgeaugmentation• in the context ofmaxillary ridgereconstruction forprosthetic treatment• in the context of atreatment of
	Subject device	OSSIX® Plus (K160281)	Straumann® Jason®
			Membrane (K173562)
	Schneiderianmembrane,4) In intra bony defectsaround teeth,5) Guided tissueregenerationprocedures inperiodontal defects.	elevation procedure.• In implants withvertical bone loss due toinfection, only in caseswhere satisfactorydebridement andimplant surfacedisinfection can beachieved.• In intra bony defectsaround teeth.• For treatment ofrecession defects,together with coronallypositioned flap.• In furcation defects inmulti rooted teeth.	fenestration defects• in case of periodontalbone defects (one tothree-wall defects, classI and II furcationdefects)• in case of dehiscencedefects• after apicoectomy,cystectomy, resectionof retained teeth andresection of other bonelesions• in extraction socketsafter tooth extractions• in case of immediate ordelayed augmentationaround implants inextraction sockets
Mode of Action	Functions as a barrierwhen applied betweenbone graft material andsoft tissue.The membrane serves asa bioresorbable scaffoldthat is eventuallyremodeled, resorbed,and replaced by hosttissue.	Functions as a barrierwhen applied betweenbone graft material andsoft tissue.The membrane serves asa bioresorbable scaffoldthat is eventuallyremodeled, resorbed, andreplaced by host tissue.	Functions as a barrierwhen applied betweenbone graft material andsoft tissue.The membrane serves asa bioresorbable scaffoldthat is eventuallyremodeled, resorbed, andreplaced by host tissue.
OperatingPrinciples	• Cell-occlusive• Implantable• Resorbable• Biocompatible	• Cell-occlusive• Implantable• Resorbable• Biocompatible	• Cell-occlusive• Implantable• Resorbable• Biocompatible
Material	Porcine decellularizedpericardia	Porcine tendons	Porcine decellularizedpericardia
Collagen Source	Porcine pericardium	Porcine tendons	Porcine pericardium
Technology	Cross-linked (ribose)decellularizedpericardium	Cross-linked (ribose)reconstituted purifiedcollagen	Non-cross-linkeddecellularizedpericardium
Form	Membrane	Membrane	Membrane
Color	White to off-white	White to off-white	White to off-white
Sizes	• 10x12mm• 15x20mm• 20x30mm	• 10x12.5mm• 15x25mm• 25x30mm	• 15x20mm• 20x30mm• 30x40mm

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Image /page/6/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, with a stylized "S" shape next to the company name. A vertical line separates the two logos, with "datum dental" on the right in a similar sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for Dentsply Sirona Datum Dental. The logo consists of a stylized leaf-like shape on the left, followed by the words "Dentsply Sirona" in a sans-serif font. A vertical line separates "Dentsply Sirona" from the words "datum dental", which are also in a sans-serif font. The overall design is clean and modern.

	Subject device	OSSIX® Plus (K160281)	Straumann® Jason®Membrane (K173562)
Resorption Time	Substantially resorbedby 24 weeks	Substantially resorbed by24 weeks	Substantially resorbed by12 weeks
Single use	Yes	Yes	Yes
Packaging	Double blister pack.Two layers of sterilebarrier packaging tofacilitate the asepticdelivery of the steriledevice into the sterilesurgical field.	Double blister pack. Twolayers of sterile barrierpackaging to facilitate theaseptic delivery of thesterile device into thesterile surgical field.	Double pouch pack. Twolayers of sterile barrierpackaging to facilitate theaseptic delivery of thesterile device into thesterile surgical field.
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6	Sterile, SAL 10-6

VII. Summary of Data to Support Substantial Equivalence

The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, and biocompatibility testing of the subject device.

Non-clinical biocompatibility testing was performed in accordance with the following FDA recognized consensus standards:

ISO 10993-1:2018 Biological evaluation of medical devices- Part 1 Evaluation and . testing within a risk management process
. ISO 10993-2:2006 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
. ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO/TR10993-33:2015 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 /AC:2009 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residues
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices-Part 11-Tests for systemic . toxicity

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Image /page/8/Picture/0 description: The image shows the logos for Dentsply Sirona and datum dental. The Dentsply Sirona logo is on the left, and the datum dental logo is on the right. The Dentsply Sirona logo consists of a stylized "S" shape and the words "Dentsply Sirona" in a sans-serif font. The datum dental logo consists of the words "datum dental" in a sans-serif font, with a vertical line separating the two logos.

ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample . preparation and reference materials
The control of animal materials is performed following:
ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives Part ● 1: Application of risk management
ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Part ● 2: Controls on sourcing, collection and handling
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part . 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.

The sterilization process is established and performed according to:

. ISO 11135:2014 - Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
A series of bench tests were conducted to evaluate the biochemical and physicochemical properties of the device. In vitro product characterization testing was performed comparing the subject device to the predicate as well as to the reference devices demonstrating substantial equivalence. Specifically, the bench testing includes the following categories:
. Weight and dimensions (weight, size, thickness, expansion upon hydration and water uptake),
. Composition and purity (carbohydrates, heavy metals, endotoxins, ethanol, EtO residues, organic extractables, DNA, moisture, total organic content, minerals, amino acids and pH),
Enzymatic (collagenase and trypsin digestion),
Structural (SEM analysis, porosity, denaturing temperature, integrity upon wetting, solubility, and FT-IR spectroscopy),
. Mechanical properties (maximum load/tensile strength, suture retention, fixability).

An in vivo animal study was conducted in a beagle mandibular guided bone regeneration model to evaluate the in vivo performance, degradation and safety of OSSIX® Breeze dental membrane as compared to the predicate membrane, OSSIX® Plus. The subject device performed in a manner substantially equivalent to the cleared predicate membrane, OSSIX® Plus. The study design included defects of 10 ± 1 mm mesiodistally (z-distance), 8 ± 1 mm occlusal-apically (ydistance), and 7 ± 1 mm buccolingually (x-distance). Each defect was either left untreated

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Image /page/9/Picture/0 description: The image shows the logo for Dentsply Sirona datum dental. The Dentsply Sirona part of the logo is on the left, with a stylized leaf-like shape to the left of the text. A vertical line separates the two parts of the logo, and the datum dental part is on the right. The text is all in a gray sans-serif font.

(negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device). End points for pathology, histology, histomorphology and micro-CT were taken after 4, 12 and 24 weeks. The subject device performed in a manner substantially equivalent to the cleared predicate device.

VIII. Conclusion

Based on the data provided within these 510(k) submissions as summarized above, it is concluded that OSSIX® Breeze is substantially equivalent to the 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.