ABSOANCHOR MICROIMPLANT by DENTOS INC.

The intended purpose of the AbsoAnchor microimplant is to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

Device Description

The Dentos AbsoAnchor Orthodontic Microimplant is composed of Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136) material. It has been designed specifically for orthodontic use and has a button-like head and a bracket-like head with a small hole that accepts ligatures, coil springs, and elastomers. Gingival impingement by these attachments is reduced due to the slanted neck of the implant head. The smaller diameter of AbsoAnchor (1.2mm - 1.8mm) allows its insertion into many areas of the maxilla and mandible and between roots of adjacent teeth. It is classified into 2 implant groups: Taper and Cylinder. It also consists of 8 different head styles: small head, no head, long head, circle head, fixation head, bracket head, bracket head-left handed screw, OMAS mushroom.

AI/ML Overview

The provided text is a 510(k) summary for the Dentos AbsoAnchor Orthodontic Microimplant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel AI device might.

Therefore, for aspects related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness with human readers (which are typical for AI-powered medical devices), the information is not applicable or not provided in this type of submission.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly derived from demonstrating substantial equivalence to its predicate devices, rather than through quantitatively defined performance metrics (e.g., sensitivity, specificity) against a gold standard for a specific diagnostic task. The "performance" is primarily shown through direct comparison of material, intended use, and physical characteristics.

Acceptance Criterion (Implicitly Derived from Predicate Comparison)	Reported Device Performance (AbsoAnchor)
Material Composition	Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136)
Intended Use	Provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth
Product Code	DZE
Sterility	Non-sterile: steam sterilize before use
Diameter Range	1.2mm-1.8mm
Length Range	4.0mm-10mm & 12mm

The study that "proves" the device meets these acceptance criteria is the 510(k) premarket notification process itself, where the manufacturer demonstrates substantial equivalence to predicate devices. This is achieved by comparing various specifications and intended uses, as summarized in the table above. The conclusion of substantial equivalence by the FDA (as stated in the letter) indicates that these implicit criteria have been met.

Additional Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This type of 510(k) submission for a physical implantable device does not typically involve a "test set" or "data provenance" in the context of an AI/algorithm study. The evaluation relies on material science, mechanical testing, and comparison of design features to legally marketed devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. Ground truth establishment for a diagnostic AI algorithm is not relevant for this device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods for ground truth are not relevant for this device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical orthodontic microimplant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and
  effect size related to AI assistance are not applicable.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" would relate to the material properties, manufacturing quality, and biocompatibility of the implant, as well as its functional similarity to predicate devices. These are evaluated through bench testing (e.g., mechanical strength, biocompatibility tests), adherence to ASTM standards (e.g., ASTM F136 for the material), and clinical experience with similar devices, rather than expert consensus on diagnostic images or pathology. The submission relies on such technical data and comparisons to establish safety and effectiveness.
The sample size for the training set:
- Not applicable / Not provided. A "training set" is relevant for machine learning algorithms, not for physical medical implants in a 510(k) submission.
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not applicable.

Summary

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K060126

Dentos, Incorporated Dong Bu B/D 2F #22, 251,4Ga, Dong-In-Dong Jung-Gu Daugu, South Korea, 700-424 Phone: 82-53-592-5908 Fax: 82-53-592-5909 Contact: Myung Sub Kim, Assistant Manager of Quality Management Summary Preparation Date: 10/25/05

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: AbsoAnchor (Orthodontic Microimplant) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Dental Implant
1. Equivalent Legally Marketed Devices: Dentaurum Tomas-pin (K042965), Jeil Medical Dual Top Anchor System Screws (K033767), and IMTEC MDI Ortho (K042289).
1. Description of the Device:

1. Indications for Use:
  To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth

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1. Potential Adverse Affects and Complications (common to all devices of this type):
- Metal sensitivity or allergic reaction
- Pain or discomfort due to presence of device
- · Infection
- 1. Safety and Effectiveness, Comparisons to Predicate Devices:

DeviceName	AbsoAnchor	Tomas-pin	Dual TopAnchorSystem	MDI Ortho
ProductCode	DZE	DZE	DZE	DZE
Applicant	Dentos, Inc	Dentaurum,Inc	JeilMedicalCorp.	IMTEC Corp.
510(k) #	This submission	K042965	K033767	K042289
Material	Titanium6Aluminum-4Vanadium ELIAlloy Grade 5(ASTM F136-98)	TitaniumGrade 5	TitaniumAlloy(ASTMF136-98)	Titanium Alloy
IntendedUse	Provide a fixedanchorage point forattachment oforthodonticappliances tofacilitate theorthodonticmovement of teeth	Provide afixedanchoragepoint forattachmentoforthodonticappliancesto facilitatetheorthodonticmovementof teeth	Provide afixedanchoragepoint forattachmentoforthodonticappliancesto facilitatetheorthodonticmovementof teeth	Provide afixedanchoragepoint forattachment oforthodonticappliances tofacilitate theorthodonticmovement ofteeth
Sterility	Non-sterile: steamsterilize before use	Sterile	Non-sterilesteamsterilizebefore use	Sterile
Diameter	1.2mm-1.8mm	1.2mm	1.4mm-2.0mm	1.8mm
Length	4.0mm-10mm&12mm	8.0-10mm	6.0mm-12mm	6.0mm,8.0mm& 10mm

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Image /page/2/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health and Human Services. The emblem features a stylized eagle with three horizontal lines representing its wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2006

Dentos, Incorporated C/O Ms. Anna Shafto, BS, MT Health Science Research Assistant University of Michigan School of Dentistry 1011 North University Avenue Ann Arbor, Michigan 48109

Re: K060126

Trade/Device Name: AbsoAnchor Microimplant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 28, 2006 Received: May 1, 2006

Dear Ms. Shafto:

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.

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Page 2 - Ms. Shafto

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 yours,

Svette y. Michau MD

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

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K060126

Indications for Use Statement

510(k) Number (if known): ______________________________________________________________________

Device Name: AbsoAnchor Microimplant

Indications for Use:

The intended purpose of the AbsoAnchor microimplant is to provide a fixed The intendod purpose of thodontic appliances to facilitate the orthodontic movement of teeth.

Prescription Use X AND/OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (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)

Susan Runne

11 - 13- 11- 6 : 5) m of Anasthesialogy, General Hospital, on Control, Dantal Devices

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Regulation Number and Section

§ 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.