(72 days)
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Not Found
No
The summary describes a mechanical device (titanium screws) and its intended use for orthodontic anchorage. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as an anchorage system for orthodontic appliances to facilitate tooth movement, providing a fixed skeletal fixation point. It does not directly treat or prevent a disease or condition, but rather serves as a mechanical aid in a treatment process.
No
The device is described as an "Anchorage System" for orthodontic movement, providing a "rigid skeletal fixation point." Its purpose is to facilitate treatment, not to diagnose a condition.
No
The device description explicitly states it consists of physical titanium screws and associated tools (screwdriver and blades), indicating it is a hardware medical 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Aarhus Anchorage System Function: The description clearly states the device is a titanium screw intended to be surgically implanted (temporarily) into bone to provide a fixed anchorage point for orthodontic appliances. It is a physical device used in vivo (within the body) to facilitate mechanical movement of teeth.
The device's function and intended use are entirely outside the scope of in vitro testing of bodily specimens.
N/A
Intended Use / Indications for Use
The Aarhus Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Aarhus Anchorage System consists of 9.6 mm to 12.2 mm in length, non-sterile, single-use titanium screws designed to aid in dental movement by providing a rigid skeletal fixation point. The "self-drilling" thread design allows for easy insertion and removal - with the use of the system`s Grip Screwdriver Replaceable F Aarhus Screw Octagonal and Blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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§ 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
AUG 1 9 2004
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Medicon eG Gänsäcker 15 78532 Tuttlingen Germany
Contact:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: June 2004
Device Name:
- . Trade Name - Aarhus Anchorage System
- Common Name - Orthodontic Implant Screw
- Classification Name -- Implant, Endosseous Dental, per 21 CFR § 872.3640 .
Devices for Which Substantial Equivalence is Claimed:
- . Medicon eG, Micro Titanium Plate System
- . KLS Martin L.P., Ortho Anchorage System
Device Description:
The Aarhus Anchorage System consists of 9.6 mm to 12.2 mm in length, non-sterile, single-use titanium screws designed to aid in dental movement by providing a rigid skeletal fixation point. The "self-drilling" thread design allows for easy insertion and removal - with the use of the system`s Grip Screwdriver Replaceable F Aarhus Screw Octagonal and Blades.
Intended Use of the Device:
The Aarhus Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
1
Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes the characters 'Koyis7' followed by 'P2'. The writing style is casual and appears to be done with a pen or marker on a white surface.
Substantial Equivalence:
Aarhus Anchorage System is substantially equivalent to other legally marketed devices in the United States. Aarhus Anchorage System Screws are composed of the same material as the Micro Titanium Plate System Screws marketed by Medcicon eG and are substantially equivalent in application and function to the Ortho Anchorage System, both marketed by KLS Martin L.P.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Medicon, E.G. C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K041527
Trade/Device Name: Aarhus Anchorage System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 4, 2004 Received: June 8, 2004
Dear Ms. Boswell:
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.
3
Page 2 - Ms. Boswell
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 (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,
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
4
Indications for Use
510(k) Number (if known):
Device Name: Aarhus Anchorage System
Indications for Use:
The Aarhus Anchorage System is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
Prescription Use (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)
Swag Purn
I Hospita Division of Anesthesiology, Ge Infection Control, Dental Devic
510(k) Number:
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