K Number

Device Name

SYNERGY

Manufacturer

ODONTIT SA

Date Cleared

2014-05-22

(521 days)

Product Code

NPM

Regulation Number

872.3930

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 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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K871773, K952617, K970321, K033815, K11816

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and physical properties of a xenograft bone substitute. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as an "adjunctive therapy in restoring bony defects in the mouth," and its intended uses include "augmentation or reconstructive treatment of alveolar ridge," "filling periodontal defects," and "filling defects after root resection, apicoectomy, and cystectomy," all of which are considered therapeutic actions.

Diagnostic

The device description clearly states "Synergy is used as an adjunctive therapy in restoring bony defects in the mouth." Its intended use is for augmentation, filling, and regeneration of bone defects, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly states that Synergy is a Xenograft of bovine origin, a physical material used for bone grafting. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as a material for augmenting and reconstructing bone defects in the mouth. This is a surgical/implantable device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details the material composition (bovine xenograft), physical properties (porous structure, granule sizes), and sterilization method. It focuses on its function as an osteoconductive material for bone regeneration.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

Therefore, Synergy is a medical device used for surgical procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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)

Product codes

NPM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

alveolar ridge, periodontal, root, apicoectomy, cystectomy, extraction sockets, maxillary sinus floor, peri-implant

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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™.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K871773, K952617, K970321, K033815, K11816

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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)

c. Features:

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).

e. Device Comparison Table:

| Descriptive

Information	Synergy	Bio-OSS	EQUIMATRIX™
510(k)
Number	N/A	K871773, K952617,
K970321, K033815	K111816
Intended Use	SYNERGY is
intended for use in:	Bio-Oss® is
recommended for:	EQUIMATRIX™
cancellous and
cortical granules are
recommended for:
	• Augmentation or
reconstructive
treatment of
alveolar ridge	• Augmentation or
reconstructive
treatment of the
alveolar ridge.	• Augmentation or
reconstructive
treatment of the
alveolar ridge.
	• Filling periodontal
defects	• Filling of intra
bony periodontal
defects.	• Filling of infrabony
periodontal defects.
	• Filling defects
after root
resection,
apicoectomy, and
cystectomy	• Filling of defects
after root
resection,
apicoectomy, and
cystectomy.	• Filling of defects
after root resection,
apicoectomy, and
cystectomy.
	• Filling extraction
sockets to
enhance
preservation of
the alveolar ridge	• Filling of
extraction sockets
to enhance
preservation of
the alveolar ridge.	• Filling of extraction
sockets to enhance
preservation of the
alveolar ridge.
	• Elevation of
maxillary sinus
floor	• Elevation of the
maxillary sinus
floor.	• Elevation of the
maxillary sinus floor.
	• Filling periodontal
defects in
conjunction with
products intended
for Guided Tissue
Regeneration
(GTR) and
Guided Bone
Regeneration
(GBR).	• Filling of
periodontal
defects in
conjunction with
products intended
for Guided Tissue
Regeneration
(GTR) and
Guided Bone
Regeneration
(GBR).	• Filling of periodontal
defects in
conjunction with
products intended
for Guided Tissue
Regeneration (GTR)
and Guided Bone
Regeneration(GBR).
	• Filling peri-implant
defects in		• Filling of peri-implant
defects in
conjunction with
products intended
for Guided Bone
Regeneration
(GBR).
	conjunction with
products intended
for Guided Bone
Regeneration
(GBR)	• Filling of peri-
implant defects
inconjunction with
products intended
for Guided Bone
Regeneration
(GBR).
Bio-Oss® blocks
are recommended
for:
• Filling of large oral
and maxillofacial
osseous cavities.
Descriptive
Information	Synergy	Bio-Oss	EQUIMATRIX™
Device Design
Form	$0.30 - 0. 84$ mm or
$0.84 - 2.0$ mm
granules	0.2 mm to 1.0 mm
or 1.00mm to
2.00mm granules
Bio-Oss
Cancellous- Bone
Block
Block Size1 x 1 x 2
c m	0.2 mm to 1.0 mm or
1.00mm to 2.00mm
granules
N/A
Source Bone
Supplied as	Bovine
Granules supplied
in single use
sterilized vial.	Bovine
Granules supplied
single use sterilized
vial	Equine
Granules supplied as
single use sterilized
screw cap container
or prefilled syringe
Descriptive
Information	Synergy	Bio-Oss	EQUIMATRIX™
Device Design
Material	Anorganic
osteoconductive
hydroxyapatite
bone mineral	Anorganic naturally
derived
osteoconductive
hydroxyapatite
bone mineral	Anorganic naturally
derived
osteoconductive
hydroxyapatite bone
mineral
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation
Descriptive
Information	Synergy	Bio-Oss	EQUIMATRIX™
Device Design
Shelf Life	1 year	Manufacturer	3 Years
Calcium/Phos
horous (Ca/P
Ratio)	2.1 / 1	1.66 / 1	Similar to BioOss

f. Substantial Equivalence

g. Standards

Synergy complies with the standards listed below:

| FDA
Recognized

Standards	Synergy	Bio-Oss	EQUIMATRIX
	ISO 10993	ISO 10993	ISO 10993
	ASTM F1088 - 04a
Additional
Standards
Used	Synergy	Bio-Oss	EQUIMATRIX
	USP 31
	ASTM F1185 - 03
	ASTM F1581 - 08
	Argentine
Pharmacopeia
FDA Special
Controls	Synergy	Bio-Oss	Equimatrix™
	Class II Special
Control Guidance
Bone Grafting
Material Devices	Class II Special
Control Guidance
Bone Grafting
Material Devices	Class II Special
Control Guidance
Bone Grafting
Material Devices

h. Conclusion:

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

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,

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

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

Sheena A. Green 2014.05.21 14:36

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