(96 days)
Not Found
No
The document describes a physical orthodontic screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "orthodontic fixation screw system" intended to provide a "fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth." This indicates a direct role in medical treatment, specifically correcting dental alignment, which falls under the definition of a therapeutic device.
No
The device, "Alpha Bio Orthodontic Fixation Screw System®," is described as mini thread self-tapping implants intended to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. Its function is to physically assist in orthodontic treatment, not to diagnose a condition or disease.
No
The device description explicitly states it consists of titanium alloy screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium alloy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is an implant used inside the body for a mechanical purpose.
N/A
Intended Use / Indications for Use
Alpha Bio Orthodontic Fixation Screw System (OFS, OFSR) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
DZE, OAT
Device Description
Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
| Alpha-Bio Tec
| 03/06 | RA Department | FDA Traditional 510k | Page 29 of 33 | |
|---|---|---|---|---|
| ------------------------ | --------------- | ---------------------- | --------------- | -- |
בס"ד
510(K) SUMMARY
Alpha-Bio Tec® Orthodontic Fixation Screw System
510(k) Number K_________________
MAR 26 2007
| A. Applicant's Name: | Alpha-Bio Tec Ltd |
|---|---|
| 7, Embar st. | |
| Industrial Zone Kiryat Arie | |
| POB 3936 ZIP 49130 | |
| Petach-Tikva, Israel | |
| Tel: +972-3-9291000 / 9390668 | |
| Fax: +972-3-9235055 | |
| e-mail: ophir@alpha-bio.net; Daniela@alpha-bio.net | |
| Web site: www.alpha-bio.net | |
| B. Contact Person: | Daniela Ben Shabat |
| Alpha-Bio Tec Ltd | |
| 7, Embar st. | |
| Industrial Zone Kiryat Arie | |
| POB 3936 ZIP 49130 | |
| Petach-Tikva, Israel | |
| Tel: +972-3-9291000 / 9390668 | |
| Fax: +972-3-9235055 | |
| e-mail: Daniela@alpha-bio.net | |
| Web site: www.alpha-bio.net | |
| C. Date Prepared: | March 2006 |
| D. Trade Name: | Alpha-Bio Tec® |
| E. Classification: | Name: implant, endosseous, root-form |
| Product Code: DZE | |
| Regulation No: 872.3640 | |
| Class: II | |
| Panel: Dental |
F. Predicate Devices: The Alpha Bio Orthodontic Fixation Screw System ® is substantially equivalent to Osteomed Orthodontic Screw System L.P. K031936 in terms of intended use, indications for use, technological characteristics, performance and user interface.
The predicate device is Class II medical devices.
.
1
| Alpha-Bio Tec
| 03/06 | RA Department |
|---|---|
| FDA Traditional 510k | Page 30 of 33 |
Alpha Bio
A discussion of substantial equivalence is provided in Section 3 of this submission.
- G. Device Description: Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
- H. Intended Use / Indication for Use: Alpha Bio Orthodontic Fixation Screw System (OFS, OFSR) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
- I. Performance Standards: No performance standards have been established for such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act.
The device complies with the following recognized standards:
- . ISO 7405:1997, Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental
- . F136-02a: 2004 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (ÜNS R56401).
- . ASTM F1350-02, 2002 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673).
- ISO 13402:1995, Surgical and dental hand instruments -� - Determination of resistance against autoclaving, corrosion and thermal exposure.
- . UL 544 (1998):, Standard for Medical and Dental Equipment - Ed. 4.0.
- J. Substantial Equivalence: There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- · The Alpha-Bio Tec® intended use and indications for use were previously cleared by FDA for the predicate device.
- · The technical characteristics of the Alpha-Bio Tec® are similar to those of the predicate device.
2
| Alpha-Bio Tec
| 03/06 | RA Department |
|---|---|
| FDA Traditional 510k | Page 31 of 33 |
- · Safety and performance testing.
Therefore, the Alpha-Bio Tec® System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
:
. . . . . . .
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha-Bio Tec Limited C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue, NW Suite 440 Washington, DC 20015
MAR 2 6 2007
Re: K063770
Trade/Device Name: The Alpha Bio Tec® Orthodontic Fixation Screw System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: March 22, 2007 Received: March 23, 2007
Dear Mr. Manelli:
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.
4
Page 2 - Mr. Manelli
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Clair Lise, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| Alpha-Bio Teq
| 03/06 | RA Department | FDA Traditional 510k | Page 33 of 33 |
|---|---|---|---|
| ------------------------ | --------------- | ---------------------- | --------------- |
בס"ד
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: The Alpha Bio Tec® Orthodontic Fixation Screw System
Indications for Use:
Indication for use :-
Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Susan Runge
an agn-Off) Asian of Anesthesiology, General Hospital, in rotion Control, Dental Devices
5 : 0(k) Number: _____________________________________________________________________________________________________________________________________________________________