(118 days)
Not Found
No
The summary describes a mechanical implantable device for bone fixation and explicitly states that AI/ML mentions, image processing, and performance studies related to AI/ML are not found or applicable.
No
The device is used for fixation of bone blocks for bone regeneration, which is a supportive role in a surgical procedure, not directly treating a disease or condition.
No
This device is described as an "implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity." Its function is structural (fixation) and therapeutic (regeneration), not diagnostic.
No
The device description clearly states it is an "implantable device" and describes physical components like a "tapered, self-drilling tip and a cruciform head," indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Neodent Graft Screw is an implantable device used for fixation of bone blocks in the oral cavity. This is a surgical device that is placed inside the body.
The intended use and device description are entirely focused on a surgical procedure and the physical placement of a device within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
Non-clinical testing consisted of material specification and engineering design review.
Clinical testing is Not applicable to this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
Av. Juscelino Kubitschek de Oliveira, 3291 – CIC
Curitiba - 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.
1
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.
2
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.
3
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
4
Indications for Use
510(k) Number:
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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