NEODENT GRAFT SCREW

K103084 · Jjgc Industria E Comercio DE Materiais Dentarios S · DZL · Feb 14, 2011 · Dental

Device Facts

• Record ID: K103084
• Device Name: NEODENT GRAFT SCREW
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
• Product Code: DZL · Dental
• Decision Date: Feb 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Implantable screw for fixation of bone blocks during dental surgery; facilitates bone regeneration in oral cavity. Features tapered, self-drilling tip and cruciform head; available in various lengths and diameters. Used by dental surgeons in clinical settings. Provides mechanical stabilization of bone grafts; temporary fixation until bone healing occurs. Benefits patient by securing graft material to promote successful regeneration.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing consisting of material specification and engineering design review.

Technological Characteristics

Biocompatible alloy construction; self-drilling and self-tapping design; features tapered tip and cruciform head. Available in various lengths and diameters. Mechanical fixation device.

Indications for Use

Indicated for patients requiring bone block fixation for bone regeneration in the oral cavity. Temporary use only.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Salvin Dental Specialties Fixation Screw (K073342)
• STOMA Bone Block Screw, Steel (K080430)
• Bone Block Fixation Set (K050515)

Submission Summary (Full Text)

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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 SA<br>Av. Juscelino Kubitschek de Oliveira, 3291 – CIC<br>Curitiba - PR - CEP, 81270-200, Brazil | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Telephone: [phone] | Fax: [phone] |
| 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: [phone] | |
| | Fax: [phone] | |
| | Email: [e-mail] | |
| | [e-mail] | |

### 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

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.

### 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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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 [phone] or [phone] 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)

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