(153 days)
Not Found
No
The summary describes a physical dental implant made of titanium alloy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "orthodontic anchor system" intended to "facilitate the orthodontic movement of teeth." Orthodontic treatment, which involves moving teeth, is a therapeutic intervention for misaligned teeth.
No
This device is described as providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement, indicating it is a therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a dental titanium alloy used for fabricating physical dental prostheses, indicating it is a hardware device.
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 device is described as a dental titanium alloy screw used for physical anchorage.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a medical device used for orthodontic treatment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is 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
Device Description
Anchor plus / Neo Anchor plus is a dental titanium alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of titanium bearing titanium color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or the mandible
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)
Anchor plus / Neo Anchor plus has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply with applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted. Appropriate safeguards have been incorporated in the design of Orthodontic Screw.
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
Attachment A
MAY 3 1 2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: September 10, 2005
-
- Company and Correspondent making the submission:
Name - KJ MEDTECH Address - 974-3 Wolchul-dong, Buk-gu, Gwangju-city, KOREA, 500-460 Telephone - +82(62) 972-5476 Fax - +82(62) 973-2809 Contact - Mrs. Jin-Sook Kim / Manager Internet - http://www.kjmedich.co.kr
- Company and Correspondent making the submission:
- Device :
Proprietary Name - Anchor plus / Neo Anchor plus Common Name - Orthodontic Screw Classification Name – Endosseous Dental Implant
- Predicate Device :
-
- Nobel Biocare USA. Inc. Nobel Biocare's InPlant™ Orthodontic Anchor System K000643(Decision Date - 10/07/2000)
-
- Jeil Medical Corporation Dual Top Anchor Systems Screws K033767(Decision Date - 02/24/2004)
-
- Classifications Names & Citations :
1
21CFR 872.3640, DZE, Endosseous Dental Implant, Class2
-
- Description :
Anchor plus / Neo Anchor plus is a dental titanium alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of titanium bearing titanium color.
- Description :
-
- Indication for use :
It is to provide absolute Orthodontic anchorage to establish a good and stable occlusion for the patients and also to improve their facial esthetics. Orthodontic Screw is temporarily placed in either the maxilla or the mandible until Orthodontic treatment is completed successfully and is removed.
- Indication for use :
-
□ Orthodontic Screw Head Part : loading with a orthodontic element (ex: Ni-Ti coil, ligature wire).
- O Orthodontic Screw Part : It is unnecessary pilot hole and consequently provide the primary stability for orthodontic use and so be able to immediately loading .
- [ Orthodontic Screw Plate : Fixed with two Fixation Screws loading with a Orthodontic element (ex: bracket)
-
- Comparison with predicate device :
Anchor plus / Neo Anchor plus have been compared with the automatically inflated Nobel Biocare's InPlant" Orthodontic Anchor System of Nobel Biocare USA, Inc. and Dual Top Anchor Systems Screws of Jeil Medical Corporation. The intended use of this device and the predicate devices is the same. The principle of usage is identical and there are no significant differences on operating features. It is concluded that there are no technologic differences between the subject and predicate devices that raise new questions concerning either safety or effectiveness.
-
- Contra-indications :
Potential complications associated with the use of Orthodontic Screw may include, but not limited to:
- Contra-indications :
-
Allergies to metals
- Review :
2
K05 3629
Anchor plus / Neo Anchor plus has the same device characteristics as the predicate device. Material, design and use concept is similar.
Anchor plus / Neo Anchor plus has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply with applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted. Appropriate safeguards have been incorporated in the design of Orthodontic Screw.
-
10 Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, based on the information provided in this premarket notification KJ MEDITECH concludes that Anchor plus / Neo Anchor plus is safe and effective and substantially equivalent to predicate devices as described herein. -
- KJ MEDITECH will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- KJ MEDITECH will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
JK Meditech C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants 340 Groove Road Flintville, Tennessee 37335
Re: K053629
Trade/Device Name: Anchor Plus/Neo Anchor Plus Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 29, 2006 Received: April 9, 2006
Dear Mr. Mack:
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. Mack
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 (QS) 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 vours.
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
Indications for Use
510(k) Number(if known):
Device Name: Orthodontic Screw
Indications for Use:
This device is 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (Part 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)
Swen Purser
Page 1 of 1
inesthesiology, General Hospital,
053629