(276 days)
Not Found
No
The summary describes a purely mechanical device (plates and screws) used for orthodontic anchoring. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an anchor for orthodontic procedures, which are medical treatments aimed at correcting misaligned teeth and jaws. This indicates a therapeutic intent to improve oral health and function.
No
The device is described as an anchor for orthodontic procedures, which is a therapeutic function, not a diagnostic one. It is surgically placed to facilitate treatment, not to identify a medical condition or disease.
No
The device description clearly states it includes plates, screws, and pilot drills, which are physical hardware components intended for surgical placement.
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 (in vitro).
- Device Description: The description clearly states the device is "surgically placed in the mouth" and "fixed to bone." This indicates it is an implantable or surgically placed device used within the body.
- Intended Use: The intended use is as an "anchor for orthodontic procedures," which is a mechanical function within the mouth, not a diagnostic test performed on a sample.
The information provided describes a surgical device used for mechanical support during orthodontic treatment, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only.
The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
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)
Not Found
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in bold, black letters. The word is encased in a black, oval shape that curves above and below the text. The font is sans-serif and appears to be a custom design to fit within the oval shape.
7 2006 APR
510(k) Summary
Device Proprietary Name:
OsteoMed Orthodontic Anchor Plating System
Device Common Name:
Classification Name:
DZE Implant, Endosseous, Root-Form
Name of Submitter:
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Endosseous Implant
Contact Person:
Dawn D. Tindall
Date Prepared:
January 12, 2006
Summary:
This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only.
The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041651).
Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed Orthodontic Anchor Plating System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/21 description: The image shows the logo for A Colson Associates. The logo features the word "Colson" in a stylized font, with the letters partially obscured by a dark circle. To the right of the circle, the words "A Colson Associates" are written in a bold, sans-serif font. The overall design is simple and professional.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile. The figures are arranged in a row, with their heads overlapping slightly. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2006
Ms. Dawn T. Holderman Regulatory Affairs Osteomed, L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K051798
Trade/Device Name: OsteoMed Orthodontic Anchor Plating System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: January 12, 2006 Received: January 17, 2006
Dear Ms. Holderman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Supt. y. Michael Davis
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): _ Ko Sl 798
OsteoMed Orthodontic Anchor Plating System Device Name:
Indications for Use:
Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Sver Rums
" general Hospital Hospita J. Dental Devices
KCS 1798
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