(118 days)
Not Found
No
The device description focuses on the material, design, and physical characteristics of a microimplant for orthodontic anchorage, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as providing a fixed anchorage point for orthodontic appliances "to facilitate the orthodontic movement of teeth," which is a therapeutic intervention.
No
The device is described as an orthodontic microimplant used to provide a fixed anchorage point for facilitating tooth movement. Its intended use focuses on treatment (anchorage) rather than diagnosis.
No
The device description explicitly states the device is composed of Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 material and describes its physical characteristics and components (head, neck, diameter, head styles). This indicates it is a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 a physical implant made of a specific alloy, designed for surgical insertion into bone.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical anchor.
N/A
Intended Use / Indications for Use
To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth
Product codes
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
-
- Identification of the Device: Proprietary-Trade Name: AbsoAnchor (Orthodontic Microimplant) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Dental Implant
-
- Description of the Device:
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.
-
- Indications for Use:
To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth
- Indications for Use:
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
-
- Safety and Effectiveness, Comparisons to Predicate Devices:
| Device
Name | AbsoAnchor | Tomas-pin | Dual Top
Anchor
System | MDI Ortho |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | DZE | DZE | DZE | DZE |
| Applicant | Dentos, Inc | Dentaurum,
Inc | Jeil
Medical
Corp. | IMTEC Corp. |
| 510(k) # | This submission | K042965 | K033767 | K042289 |
| Material | Titanium6Aluminum-
4Vanadium ELI
Alloy Grade 5
(ASTM F136-98) | Titanium
Grade 5 | Titanium
Alloy
(ASTM
F136-98) | Titanium Alloy |
| Intended
Use | Provide a fixed
anchorage point for
attachment of
orthodontic
appliances to
facilitate the
orthodontic
movement of teeth | Provide a
fixed
anchorage
point for
attachment
of
orthodontic
appliances
to facilitate
the
orthodontic
movement
of teeth | Provide a
fixed
anchorage
point for
attachment
of
orthodontic
appliances
to facilitate
the
orthodontic
movement
of teeth | Provide a
fixed
anchorage
point for
attachment of
orthodontic
appliances to
facilitate the
orthodontic
movement of
teeth |
| Sterility | Non-sterile: steam
sterilize before use | Sterile | Non-sterile
steam
sterilize
before 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 |
2
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.
3
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
4
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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