SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Device Description

Synergy is a Xenograft of bovine origin. It contains macro and micro porous structures similar to Bio-Oss. Synergy is a purified osteoconductive mineral structure produced from bone in a multi-stage purification process. Synergy is chemically as well as structurally comparable to mineralized Bio Oss and Equimatrix. Synergy is used as an adjunctive therapy in restoring bony defects in the mouth. Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation. Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental bone grafting material called "Synergy" (K123876). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study designed to meet specific performance targets.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance or a study proving the device meets said criteria in the way a clinical trial or performance study report would.

The document primarily provides:

Device description and intended use for Synergy, the predicate devices (Bio-Oss and Equimatrix™), and a comparison table.
A statement of substantial equivalence to the predicate devices based on intended use, biocompatibility, sterility, physical and chemical testing, performance evaluation in an anatomically relevant animal model, and results of clinical cases (though the details of these cases or the animal study are not provided).
Compliance with recognized standards (ISO 10993, ASTM F1088 - 04a, USP 31, ASTM F1185 - 03, ASTM F1581 - 08, Argentine Pharmacopeia) and FDA Special Controls Guidance Document for Dental Bone Grafting Material Devices.

Since the document does not present specific acceptance criteria or a detailed study to meet them, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, etc. Those details are typically found in a dedicated performance study report, which is not part of this 510(k) summary.

Summary

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K123876

510(k) Summary

1. 510(k) Owner

Company Contact
510(k) Preparer

Odontit SA Azcuenaga 1077 4° D Buenos Aires 1115 Argentina Ph: 5411-48250221 5411-49039330 Fax: Email: info@odontit.com

Mario Gersberg President

Blix Winston ACMD Consulting, LLC. Mullinix Mill Road Mt Airy, MD 21771 USA 301-607-9185 Ph: Email: fblixwinston@aol.com

Date of Preparation

May 19, 2014

1. Device Name and Classification:
  Trade Name: Common Name: Classification Name: Synergy Anorganic Bovine Bone Grafting Material Bone Grafting Material, Animal Source
1. Predicate Devices:
  Device: 510 (k) Numbers: Manufactured by: Bio-Oss® natural bone grafting material K871773, K952617, K970321, K033815 Geistlich Pharma AG Bahnhofstrasse 40 CH-61 10 Wolhusen Switzerland

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Device: 510 (k) Number: Manufactured by: Equimatrix ™ K11816 Luitpold Pharmaceuticals, Inc. One Luitpold Drive, P0 Box 9001SE29Q1 Shirley, NY 11967SE29 Ph: 610-650-4200

7. Classification Names and Citations:

21CFR872.3930, NPM-bone grafting material, animal source, Class II

8. Compliance with Performance Standards:

The Device complies with the requirements listed in Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices

9. Device Description:

a. General:

b. Intended Use:

SYNERGY is intended for use in:

. Augmentation or reconstructive treatment of alveolar ridge
. Filling periodontal defects
. Filling defects after root resection, apicoectomy, and cystectorny
. Filling extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor .
. Filling periodontal defects in conjunction with products intended for Guided Tissue
. Regeneration (GTR) and Guided Bone Regeneration (GBR).
. Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

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c. Features:

Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation.

d. Working Principle:

Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).

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e. Device Comparison Table:

DescriptiveInformation	Synergy	Bio-OSS	EQUIMATRIX™
510(k)Number	N/A	K871773, K952617,K970321, K033815	K111816
Intended Use	SYNERGY isintended for use in:	Bio-Oss® isrecommended for:	EQUIMATRIX™cancellous andcortical granules arerecommended for:
	• Augmentation orreconstructivetreatment ofalveolar ridge	• Augmentation orreconstructivetreatment of thealveolar ridge.	• Augmentation orreconstructivetreatment of thealveolar ridge.
	• Filling periodontaldefects	• Filling of intrabony periodontaldefects.	• Filling of infrabonyperiodontal defects.
	• Filling defectsafter rootresection,apicoectomy, andcystectomy	• Filling of defectsafter rootresection,apicoectomy, andcystectomy.	• Filling of defectsafter root resection,apicoectomy, andcystectomy.
	• Filling extractionsockets toenhancepreservation ofthe alveolar ridge	• Filling ofextraction socketsto enhancepreservation ofthe alveolar ridge.	• Filling of extractionsockets to enhancepreservation of thealveolar ridge.
	• Elevation ofmaxillary sinusfloor	• Elevation of themaxillary sinusfloor.	• Elevation of themaxillary sinus floor.
	• Filling periodontaldefects inconjunction withproducts intendedfor Guided TissueRegeneration(GTR) andGuided BoneRegeneration(GBR).	• Filling ofperiodontaldefects inconjunction withproducts intendedfor Guided TissueRegeneration(GTR) andGuided BoneRegeneration(GBR).	• Filling of periodontaldefects inconjunction withproducts intendedfor Guided TissueRegeneration (GTR)and Guided BoneRegeneration(GBR).
	• Filling peri-implantdefects in		• Filling of peri-implantdefects inconjunction withproducts intendedfor Guided BoneRegeneration(GBR).
	conjunction withproducts intendedfor Guided BoneRegeneration(GBR)	• Filling of peri-implant defectsinconjunction withproducts intendedfor Guided BoneRegeneration(GBR).Bio-Oss® blocksare recommendedfor:• Filling of large oraland maxillofacialosseous cavities.
DescriptiveInformation	Synergy	Bio-Oss	EQUIMATRIX™
Device DesignForm	$0.30 - 0. 84$ mm or$0.84 - 2.0$ mmgranules	0.2 mm to 1.0 mmor 1.00mm to2.00mm granulesBio-OssCancellous- BoneBlockBlock Size1 x 1 x 2c m	0.2 mm to 1.0 mm or1.00mm to 2.00mmgranulesN/A
Source BoneSupplied as	BovineGranules suppliedin single usesterilized vial.	BovineGranules suppliedsingle use sterilizedvial	EquineGranules supplied assingle use sterilizedscrew cap containeror prefilled syringe
DescriptiveInformation	Synergy	Bio-Oss	EQUIMATRIX™
Device DesignMaterial	Anorganicosteoconductivehydroxyapatitebone mineral	Anorganic naturallyderivedosteoconductivehydroxyapatitebone mineral	Anorganic naturallyderivedosteoconductivehydroxyapatite bonemineral
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation
DescriptiveInformation	Synergy	Bio-Oss	EQUIMATRIX™
Device Design
Shelf Life	1 year	Manufacturer	3 Years
Calcium/Phoshorous (Ca/PRatio)	2.1 / 1	1.66 / 1	Similar to BioOss

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f. Substantial Equivalence

Based upon comparison of the intended use, biocompatibility, sterility, physical and chemical testing, and the performance evaluation of the subject and predicate device in an anatomically relevant animal model, and the results of clinical cases, Odontit SA concludes that Synergy is substantially equivalent to the predicate devices Bio-Oss and Equimatrix™.

g. Standards

Synergy complies with the standards listed below:

FDARecognizedStandards	Synergy	Bio-Oss	EQUIMATRIX
	ISO 10993	ISO 10993	ISO 10993
	ASTM F1088 - 04a
AdditionalStandardsUsed	Synergy	Bio-Oss	EQUIMATRIX
	USP 31
	ASTM F1185 - 03
	ASTM F1581 - 08
	ArgentinePharmacopeia
FDA SpecialControls	Synergy	Bio-Oss	Equimatrix™
	Class II SpecialControl GuidanceBone GraftingMaterial Devices	Class II SpecialControl GuidanceBone GraftingMaterial Devices	Class II SpecialControl GuidanceBone GraftingMaterial Devices

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h. Conclusion:

Based on the information provided within this submission, Odontit concludes that Synergy is substantial equivalent to Bio-Oss and Equimatrix™. .

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in a bold, black color.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2014

Odontit SA C/O Mr. Blix Winston, MPA, MS Submission Correspondent ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road Mt. Airy, MD 21771

Re: K123876

Trade/Device Name: Synergy Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material, Animal Source Regulatory Class: II Product Code: NPM Dated: May 19, 2014 Received: May 19, 2014

Dear Mr. Winston:

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. 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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Page 2 - Mr. Winston

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

MarySRunner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K123876

Device Name

Synergy, Anorganic Cancellous Bovine Bone Graft Material

Indications for Use (Describe)

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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CALL SERVED FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sheena A. Green 2014.05.21 14:36

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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.