This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Device Description

The Neodent Graft Screw (Graft Screw) is an implantable device used for fixation of bone blocks in dental surgery. The design of the Graft Screw includes a tapered, self-drilling tip and a cruciform head. The Graft Screw is available in various lengths, thread diameters and head diameters.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Neodent Graft Screw, focusing on acceptance criteria and study details:

This submission (K103084) is for a dental device (Neodent Graft Screw) that is a Class II device and received a Substantial Equivalence (SE) determination from the FDA. For such devices, the primary "acceptance criteria" and "study" are typically demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. Clinical studies are often not required for this type of device unless there are novel features or concerns that cannot be addressed by non-clinical means.

Based on the provided document, the "acceptance criteria" and "study" revolve around demonstrating the device's technological characteristics are substantially equivalent to predicate devices.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Evidence from Study
Biocompatibility	Device materials are biocompatible and commonly used for implantable devices.	The device is made of "biocompatible alloys commonly used for implantable devices." (Implicitly, these meet established biocompatibility standards, likely through material specification and engineering review.)
Physical Dimensions	Device encompasses a similar range of physical dimensions (length, thread diameter, head diameter) to predicates.	"The subject and predicate devices encompass the same range of physical dimensions, including thread form, thread pitch, diameters and lengths." (Confirmed through engineering design review.)
Functional Characteristics	Device exhibits similar functional characteristics (e.g., self-drilling, self-tapping).	"Each is described as self-drilling, self-tapping and/or self-cutting." (Confirmed through engineering design review, implying the Neodent Graft Screw possesses these characteristics similar to predicates.)
Intended Use	Device shares the same intended use as predicate devices.	"This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only." This matches the implicitly acceptable intended use of the predicate devices for achieving substantial equivalence.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This submission relies on non-clinical testing which consisted of "material specification and engineering design review." There was no "test set" in the sense of patient data or a specific cohort of devices being critically evaluated against a ground truth from a study. Instead, the device's specifications and design were compared against established standards, regulatory requirements, and the characteristics of predicate devices.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from the manufacturer's own engineering and material specifications, and comparison data for predicate devices.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As noted above, there was no "test set" requiring expert-established ground truth in a clinical or imaging context. The evaluation was based on engineering and material specifications review, implying the expertise of the manufacturer's R&D team and the FDA's reviewers.
Adjudication Method for the Test Set:
- Not applicable. There was no clinical imagery or patient data requiring an adjudication method.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING: Not applicable to this device."
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- No. This device is a physical implantable medical device, not an AI/algorithm-driven one.
The Type of Ground Truth Used:
- The "ground truth" for this type of 510(k) submission, focused on substantial equivalence through non-clinical testing, is primarily:
  - Material specifications: Conforming to recognized material standards for biocompatibility and mechanical properties.
  - Engineering design parameters: Adherence to established design principles for dental implants/screws.
  - Performance characteristics of predicate devices: The "truth" of what constitutes an acceptable dental graft screw is established by the legally marketed predicate devices.
Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of an AI/machine learning model.
How the Ground Truth for the Training Set Was Established:
- Not applicable. There was no "training set."

Summary of the FDA's Review for K103084:

The FDA determined that the Neodent Graft Screw is substantially equivalent to its predicate devices based on the information provided. This determination was made because the "design, materials and functional characteristics of the Neodent Graft Screw are substantially the same as those in the predicate devices." The non-clinical testing consisted of "material specification and engineering design review," which was deemed sufficient to establish substantial equivalence without the need for clinical testing.

Summary

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K103084

510(k) Summary

FEB 1 4 201

JJGC Indústria e Comércio de Materiais Dentários SA

Neodent Graft Screw

January 25, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name:	JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Oliveira, 3291 – CICCuritiba - PR - CEP, 81270-200, Brazil
	Telephone: +55 41 2169 4071	Fax: +55 41 2169 4046
Official Contact:	Daniel Lecuona
Representative/Consultant:	David J. Collette, MD
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	11234 El Camino Real, Suite 200
	San Diego, CA 92130, USA
	Telephone: +1 (858) 792-1235
	Fax: +1 (858) 792-1236
	Email: dcollette@paxmed.com
	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Régulation: Product Code: Classification Panel: Reviewing Branch:

Neodent Graft Screw Screw, Fixation, Intraosseous 21 CFR 872.4880 DZL Dental Products Panel Dental Devices Branch

INTENDED USE

This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

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DEVICE DESCRIPTION

PREDICATE DEVICES

Salvin Dental Specialties Fixation Screw from Salvin Dental Specialties, Inc. (K073342) STOMA Bone Block Screw, Steel from Storz am Mark GmbH (K080430) Bone Block Fixation Set from Straumann USA, Inc. (K050515)

TECHOLOGICAL CHARACTERISTICS

The design, materials and functional characteristics of the Neodent Graft Screw are substantially the same as those in the predicate devices. The subject and predicate devices are made of biocompatible alloys commonly used for implantable devices. The subject and predicate devices encompass the same range of physical dimensions, including thread form, thread pitch, diameters and lengths. Each is described as self-drilling, self-tapping and/or self-cutting.

NON-CLINICAL TESTING

Non-clinical testing consisted of material specification and engineering design review.

CLINICAL TESTING

Not applicable to this device.

CONCLUSION

Based on information presented in this submission, we conclude that the Neodent Graft Screw is substantially equivalent to predicate devices with the same intended use and technological features.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three stripes above it. The eagle is facing to the left.

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

JJGC Indústria e Comércio de Materiais Dentários SA C/O Dr. David J. Collette Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

FEB 1 4 201

Re: K103084

Trade/Device Name: Neodent Graft Screw Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: January 24, 2011 Received: January 26, 2011

Dear Dr. Collette:

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 - Dr. Collette

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 reportung (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) 20); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

hh for

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number:

K103084

Device Name:

Neodent Graft Screw

Indications for Use:

This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR Over-I he-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.