CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called CMFlex™, a synthetic bone grafting material. The document focuses on demonstrating the substantial equivalence of CMFlex™ to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for performance metrics that the device must meet. Instead, it compares the characteristics and performance of the CMFlex™ (subject device) to those of predicate devices to establish substantial equivalence. The "Conclusions" column in Table 1.3 effectively serves as the reported performance relative to the predicate devices for each performed test.

Purpose	Acceptance Criteria (Implied by Comparison)	Reported Device Performance (CMFlex™)
Chemical composition	Similar composition to predicate devices (majority calcium phosphate, minority biodegradable polyester).	The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component. (CMFlex™: 90% HA, 10% PLG; Primary Predicate: 78% CP, 22% PLG; Secondary Predicate: 99% β-TCP, 1% PLG).
Crystallinity (of calcium phosphate component)	Similar crystallinity (e.g., >90%) to predicate devices.	The subject and predicate devices have calcium phosphate crystallinities >90%. (CMFlex™: 96%; Secondary Predicate: 92%).
Calcium phosphate particle morphology	Similar spherical particle morphology to predicate devices.	The subject and predicate devices possess spherical calcium phosphate particles. (CMFlex™: 23 µm on average; OsteoScaf™: 27.5 µm on average).
Pore structure	Similar interconnected pores around 0.2mm and primary pores around 1mm.	The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm. (CMFlex™ and OsteoScaf™ are described as having >80% porosity with 0.25-1.20 mm pore size; Easy-Graft® also has interconnected pores).
Porosity	Porosities greater than 50%.	The subject and predicate devices have porosities greater than 50%. (CMFlex™: 85%; Primary Predicate: 80%; Secondary Predicate: 53% *reported, but noted that actual total porosity may be significantly greater and similar to CMFlex™ and OsteoScaf™. Both CMFlex™ and OsteoScaf™ exceed 80% porosity).
Mechanical strength (compressive)	Adequate handling properties and strength to ensure dimensional integrity; similar compressive properties to predicate devices.	The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties.
pH in phosphate buffered saline	Similar pH to predicate devices.	The subject and predicate device have similar pH.
Biocompatibility	Passed all relevant ISO 10993 series of standards (cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity).	Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993.
Performance in animal model (bone formation, remodeling)	Similar performance and biocompatibility to the predicate device in terms of new bone growth, residual implant material, preservation of ridge, changes to surrounding bone, and absence of significant adverse findings.	CMFlex™ was able to maintain ridge height, width, and depth and showed similar bone forming capacity and steady state inflammatory response accompanying the absorption process when compared to the predicate device. No significant adverse findings (exuberant necrosis, proliferative granulation tissue/fibrosis, extensive inflammation, or evidence of infection) were observed.
Sterilization Validation	Passed all acceptance criteria for validating the end sterilization method.	CMFlex™ passed all acceptance criteria for validating the end sterilization method.
Shelf Life	No significant mechanical property changes or clinically meaningful compositional and microstructural changes after accelerated and real-time aging.	CMFlex™ had no significant mechanical property changes or clinically meaningful compositional (ceramic and polymer component) and microstructural changes after accelerated (12-month simulation) and real-time aging (6 months and 12 months).
Package Integrity Testing (Initial and aged samples)	Passed all package integrity testing as is and after accelerated and real-time aging.	CMFlex™ packaging passed all package integrity testing as is and after accelerated (12-month simulation) and real-time aging (6 months and 12 months).

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set for Animal Model:
- The document states "Canine critical sized defect model" but does not specify the exact number of canines or defects used.
- Data Provenance: Prospective (animal model). The country of origin is not specified, but typically such studies supporting U.S. FDA submissions are conducted under GLP (Good Laboratory Practice) regulations, often in the U.S. or facilities elsewhere compliant with those standards.
Test Set for Benchtop/Material Characterization:
- For tests like mechanical strength, pH, crystallinity, porosity, etc., standard ASTM or ISO methods were used, which imply specific sample sizes for replicate testing. However, the exact sample sizes (e.g., "n=5" for each test) are not explicitly stated in this summary.
- Data Provenance: Not specified, but generally refers to laboratory testing of the manufactured device.

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

This information is not provided in the document. The animal study involves assessments (radiography, microCT, histomorphometric analysis), which would typically be performed and interpreted by qualified experts (e.g., veterinary radiologists, pathologists specialized in bone and biomaterials), but their number or specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For assessments in the animal study, it is common practice to have blinded assessments and potentially multiple reviewers, but the specific adjudication method is not mentioned.

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 document describes a traditional 510(k) submission for a physical bone grafting material, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. As stated above, this is not an AI/software device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the animal study:

Pathology/Histomorphometry: "histomorphometric analysis" was explicitly conducted, which relies on expert pathological evaluation of tissue sections.
Imaging: "radiography, microCT" implies radiological interpretation.
Outcomes Data: "new bone growth, residual implant material, preservation of ridge (height, width, depth), changes to surrounding bone, and any significant adverse findings" refer to biological outcomes assessed in the animal model.

For benchtop tests, the "ground truth" is derived from the results of the specified standard test methods.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context. The manufacturing specifications and quality control procedures ensure consistent device characteristics, which are then verified through the performance data described.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Dimension Inx Corp. Ramille Shah Chief Science Officer 3440 S Dearborn St. Suite 142S Chicago, Illinois 60616

Re: K213260

Trade/Device Name: CMFlex™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: December 19, 2022 Received: December 19, 2022

Dear Ramille Shah:

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 (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.

Andrew I. Steen -S

Andrew I. 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) K21360

Device Name CMFlex(TM)

Indications for Use (Describe)

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: 22552

· Intrabony periodontal osseous defects
· Furcation defects
· Bony defects or bony deficiencies of the alveolar ridge
· Intraoral, maxillofacial, and mandibular augmentation
· Bony defects of the upper or lower jaw
· Filling of tooth extraction sites
· Sinus elevation grafting

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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K213260 CMFlex™

510(K) Summary

DEVICE TRADE NAME CMFlex™

MANUFACTURER

Dimension Inx 3440 S. Dearborn St., Suite 142S Chicago, IL 60616 Phone: (312) 235-3510

CONTACT

Ramille Shah, Ph.D. ramilleshah(@dimensioninx.com

Consultant:

Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate Director, Regulatory Affairs, MCRA, LLC Office: (202) 552-6011 mkazemzadeh(@mcra.com

DATE PREPARED

December 30, 2022

CLASSIFICATION

Bone Grafting Material, Synthetic (21 CFR 872.3930)

PRODUCT CODE LYC

PRIMARY PREDICATE

Trade name: OsteoScaf™ Common name: Bone Grafting Material, Synthetic 510(k) number: K101827

REFERENCE DEVICE

Trade name: Easy-Graft® Common name: Bone Grafting Material, Synthetic 510(k) number: K131385

INDICATIONS FOR USE

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:

-Intrabony periodontal osseous defects
Furcation defects
Bony defects or bony deficiencies of the alveolar ridge -
-Intraoral, maxillofacial, and mandibular augmentation
Bony defects of the upper or lower jaw -
-Filling of tooth extraction sites
-Sinus elevation grafting

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DEVICE DESCRIPTION

CMFLEXTM BLOCK SIZES AND VOLUMES

Product	Dimensions (mm)	ApproximateVolume
CMFlex™ Block, 1cc	15155	1 cc
CMFlex™ Block, 6cc	38384	6 cc
CMFlex™ Block, 13cc	38389	13 cc

Table 1.1. CMFlex™ Block Sizes and Volumes

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

	Table 1.2. CMFlex™ as Compared to Predicate and Reference Devices
--	-------------------------------------------------------------------

	Subject Device	Primary PredicateDevice	Secondary PredicateDevice	Comparison
Trade Name	CMFlex™	OsteoScaf™	Easy-Graft®	N/A
Manufacturer	Dimension Inx Corp.	Texas InnovativeMedical Devices(DBA) Skeletal	Guidor®	N/A
510(k) Number	K213260	K101827	K131385	N/A
Product Code		LYC		Same product code
Device Class		Class II		Same device class
DeviceClassification		Bone grafting material, synthetic		Same device classification

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Dimension Inx

Indications for Use	Indicated for fillingand/or augmentingmaxillofacial,mandibular, andintraoral osseousdefects. Indicationsmay include:- Intrabonyperiodontal osseousdefects- Furcation defects- Bony defects or bonydeficiencies of thealveolar ridge- Intraoral,maxillofacial, andmandibularaugmentation- Bony defects of theupper or lower jaw- Filling of toothextraction sites- Sinus elevationgrafting	Indicated for fillingand/or augmentingintraoral/maxillofacialosseous defects, suchas intrabonyperiodontal osseousdefects, furcationdefects, augmentationof bony defects of thealveolar ridge, fillingof tooth extractionsites, and sinuselevation grafting.	Indicated for thetreatment of intraoral /maxillofacial osseousdefects. Dental andmaxillo-facialindications mayinclude: extractiondefects (alveolar ridgepreservation),periodontal defects,pen-implant defects,augmentation ofdeficient alveolar crest,sinus flooraugmentation, defectsafter surgicalextractions, defectsafter removal of bonycysts, defects after rootresection orapicoectomy, defectsafter removal ofautologous bone.	Intended use includeselements of the predicatedevices, supported byperformance testing in canines
---------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

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Prescription/OTC	Prescription			All require prescription
Composition	90% HA10% PLG	78% CP22% PLG	99% β-TCP1% PLGN-methyl-2-pyrrolidone	All devices comprised of amajority calcium phosphatecomponent combined with adegradable polymercomponent
PhysicalMorphology	Interconnecting pore structure			Similar pore morphology
Porosity (Nominal)	85%	80%	53%	Similar porosity to primarypredicate
Pore Size	0.20 - 0.27 mm	0.20 mm	0.23 mm	All devices have similar poresizes
Form	Block	Particulate, Cylinder,Block	Granule	Similar form factor to primarypredicate
Crystallinity	96%	Not Available	92%	Similar crystallinity tosecondary predicate
Resorption1	Resorbable	Resorbable	Resorbable	Similar resorptioncharacteristics to primarypredicate
Sterility	Sterile; One-timesingle patient use	Sterile; One-timesingle patient use	Sterile; One-timesingle patient use	All devices are sterile and forsingle use only

1Based on composition

Device Intended Use and Descriptions

CMFlex™, OsteoScaf™, and Easy-Graft® are all sterile, porous, ceramic-polymer composite single-use bone grafting materials intended for use in the filling, augmenting, or treating intraoral/maxillofacial defects. All three are class II devices and fall under the same product code, LYC.

Device Compositions and Resorption

CMFlex™, OsteoScaf™ and Easy-Graft® are comprised of discrete micro-scale, spherical calcium phosphate ceramic particles (90. 78. 99 wt.%, respectively) and the biodegradable polyester binder, poly(lactide-co-glycolide), or PLG, (10, 22, 1 wt.%, respectively). The phase of the calcium phosphate component of CMFlex™ is primarily synthetic hydroxyapatite, with minor amounts of beta tricalcium phosphate (B-TCP), while the phases of the calcium phosphate components of OsteoScaf™ and Easy-Graft® are minority hydroxyapatite, with majority di/tetra calcium phosphate and ß-TCP, respectively. The calcium phosphate components of CMFlex™ and Easy-Graft® are primarily crystalline (>90%) and the particles comprising CMFlex™ are 23 um in diameter on average, while those of OsteoScaf™ are 27.5 um on average. The difference in composition among the devices primarily affect the rate of resorption of the devices, but do not affect the substantial equivalanceof the devices for their intended use.

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Device Porositv

Like CMFlex™, OsteoScaf™, and Easy-Graft® possess interconnected micro-and macro-pores formed by overlapping fibers or bound calcium phosphate particles. While CMFlex™ and OsteoScaf™ have total porosity exceeding 80 vol. %, Easy-Graft® had a measured porosity of 53.4 vol.%; however, this value does not include the interconnected porosity within the larger calcium phosphate particles that comprise the majority of Easy-Graft® (which could not be accurately measured). Thus, the actual total porosity of Easy-Graft® may be significantly greater than 53.4 vol.%. and more similar to CMFlex™ and OsteoScaf™ (both >80% porosity with 0.25-1.20 mm pore size). Like CMFlex™, OsteoScaf™ and Easy-Graft® are flexible or moldable, absorb fluid, and are bioresorbable.

Device Form Factors and Volumes

CMFlex™ and OsteoScaf™ are comparable in form factors and sizing: CMFlex™ is available in blocks of varying volumes, while OsteoScaf™ is available in blocks, cylinders, and particulates. Like the various OsteoScaf™ form factors, the various CMFlex™ block volume options are provided as a convenience to the surgeon. Both CMFlex™ and OsteoScaf™ may be further trimmed to ensure an appropriate, custom fit to the patient's defect. Easy-Graft® is available in multiple volumes, but rather than solid form factors, it comes as a kit of PLG coated calcium phosphate particles that are mixed with solvent prior to injection into boney defect. All CMFlex™ volumes share a single "indications for use" statement, which is common to the "indications for use" statement provided for the OsteoScaf™ and Easy-Graft® predicate devices.

PERFORMANCE DATA

The following non-clinical and preclinical tests were performed to support a demonstration of substantial equivalence:

Purpose	Method	Conclusions(based on testing results and published information)
Chemical composition	Thermogravimetric analysis	The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component.
Crystallinity (of calcium phosphate component)	X-ray diffraction, ASTM F2024-10R21	The subject and predicate devices have calcium phosphate crystallinities >90%.
Calcium phosphate particle morphology	Scanning electron microscopy	The subject and predicate devices possess spherical calcium phosphate particles.
Pore structure	Scanning electron microscopy	The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm.
Porosity	Porosimetry (BET analysis)	The subject and predicate devices have porosities greater than 50%.
Mechanical strength (compressive)	Compressive mechanical testing, ASTM D695-15	The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties.
pH in phosphate buffered saline	ASTM F1635-16	The subject and predicate device have similar pH.
Biocompatibility	ISO 10993 series of standards	Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993.
Performance in animalmodel	Canine critical sizeddefect model and ISO10993-6	CMFlexTM was evaluated for performance andbiocompatibility as compared to the predicate device in aone-wall dental defect canine model at 4, 8, and 12 weeks.Assessments included radiography, microCT, andhistomorphometric analysis. Endpoints included new bonegrowth, residual implant material, preservation of ridge(height, width, depth), changes to surrounding bone, andany significant adverse findings (i.e., exuberant necrosis,proliferative granulation tissue/fibrosis, extensiveinflammation, or evidence of infection). Resultsdemonstrated that CMFlexTM was able to maintain ridgeheight, width, and depth and showed similar bone formingcapacity and steady state inflammatory responseaccompanying the absorptionprocess when compared to the predicate device.
Sterilization Validation	Pre-SterilizationBioburden (ISO 11737-1); LAL Endotoxin(USP<85>); ChamberMapping; Residualstesting; BioburdenRecovery, InactivationKinetics (ISO 11138-1);PerformanceQualification (ISO11138-1:2017, ISO11138-7:2019, ISO14937:2009)	CMFlexTM passed all acceptance criteria for validating theend sterilization method.
Shelf Life	Device properties afteraccelerated and real timeaging: Compressivemechanical testing,polymer molecularweight, ceramiccomposition andcrystallinity (ASTMF2024:2021), andmicrostructure (SEM)	CMFlexTM had no significant mechanical property changesor clinically meaningful compositional (ceramic andpolymer component) and microstructural changes afteraccelerated (12-month simulation) and real-time aging (6months and 12 months).
Package Integrity Testing(Initial and agedsamples)	ASTM F2096; ASTMF88	CMFlexTM packaging passed all package integrity testingas is and after accelerated (12-month simulation) and real-time aging (6 months and 12 months).

Table 1.3 Substantial Equivalence Performance Testing Summary

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CONCLUSIONS

CMFlex™ was compared with the identified predicate devices based on the indications for use, composition, porosity, mechanical strength, biocompatibility testing, and performance studies. CMF lex™ has similar compositional components (e.g., a combination of a biodegradable polymer and calcium phosphate particles), microstructural properties (percent porosity and pore size), pH, and compressive mechanical characteristics. Furthermore, CMFlex™ passed all biocompatibility testing per ISO 10993, and head-to-head comparison with the predicate in a canine critically sized dental defect model showed similar bone forming capacity associated with device remodeling and osteoconduction over time. Based on these studies, the subject device, CMFlex™ is found to be 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.