(94 days)
The Orthodontic Temporary Anchorage Implant Screws are intended to provide a fixed anchorage point for the attachment of intraoral orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The Orthodontic Temporary Anchorage Implant Screws are available in three sizes, 6mm, 8mm and 10mm. The head of the screw allows insertion by either a screwdriver type instrument mated with a slot head or a socket driver type instrument matched with the dual socket design. The neck is long enough, with a .022 hole, to engage auxiliaries and short enough to maintain a low profile. The screws are intended for immediate loading and are highly polished to prevent osseointegration. The screws are made from the same materials, 100% biocompatible titanium ASTM F136, as most of the predicate devices and are sold as non-sterile with instructions to use steam sterilization methods or other accepted techniques used by the orthodontist.
This 510(k) summary describes a medical device submission for orthodontic temporary anchorage implant screws and does not include information about acceptance criteria or a study proving device performance against such criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Information on experts used to establish ground truth or adjudication methods.
- Details of an MRMC comparative effectiveness study or related effect sizes.
- Results of a standalone algorithm performance study.
- The type of ground truth used (expert consensus, pathology, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) submission process is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical studies if technological characteristics and intended use are similar. In this case, the manufacturer asserts substantial equivalence based on material, design, and function compared to existing devices.
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K08/393
510(k) Summary G&H Wire Orthodontic Temporary Anchorage Implant Screw
AUG 2 1 2008
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)1)
Submitter Information
Carri Graham, Consultant The Anson Group 11460 N. Meridian St., Suite 150 Carmel, IN 46032
| Phone: | 317 569 9500 x 103 |
|---|---|
| Facsimile: | 317 569 9520 |
Contact Person: Carri Graham
Date: May 16, 2008
807.92(a)2)
Trade Name: Orthodontic Temporary Anchorage Implant Screw
Common Name: Temporary Anchoring Device
Classification Name(s): Implant, Endosseous, Orthodontic
Classification Number: OAT -- 21CFR 872.3640
807.92(a)3)
Predicate Device(s)
| Ortho Organizers | Ancor Pro TemporaryOrthodontic AnchorageSystem | K061266 |
|---|---|---|
| Dentaurum | Tomas Temporary MicroAnchorage | K042965 |
| T.O.A.D.S. | Temporary AnatomicalAnchor Device | K063149 |
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510(k) Summary G&H Wire Orthodontic Temporary Anchorage Implant Screw 807.92 (a)(4)
Device Description
The Orthodontic Temporary Anchorage Implant Screws are available in three sizes, 6mm, 8mm and 10mm. The head of the screw allows insertion by either a screwdriver type instrument mated with a slot head or a socket driver type instrument matched with the dual socket design. The neck is long enough, with a .022 hole, to engage auxiliaries and short enough to maintain a low profile. The screws are intended for immediate loading and are highly polished to prevent osseointegration. The screws are made from the same materials, 100% biocompatible titanium ASTM F136, as most of the predicate devices and are sold as non-sterile with instructions to use steam sterilization methods or other accepted techniques used by the orthodontist.
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807.92(a)5)
Intended Use(s)
The Orthodontic Temporary Anchorage Implant Screws are intended to provide a fixed anchorage point for the attachment of intraoral orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.
807.92(a)6)
Technological Characteristics
The Orthodontic Temporary Anchorage Implant Screws have the same intended use and indications, are made from the same or similar materials, and are very similar in design as the predicate devices: Ancor Pro Temporary Orthodontic Anchorage System (Ortho Organizers), Tomas Temporary Orthodontic Micro Anchorage (Dentaurum, Inc.) and the Temporary Anatomical Anchor Device System, TADDS, (T.O.A.D.S, LLC).
The Orthodontic Temporary Anchorage Implant Screw is equivalent to the predicate devices both by material and overall design and function. All screws have self tapping threads and multiple sizes to accommodate the orthodontist needs.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle faces to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2008
G & H Wire Company C/o Ms. Carri Graham Consultant The Anson Group, LLC 11460 North Meridian Street, Suite 150 Carmel, Indiana 46032
Re: K081393
Trade/Device Name: Orthodontic Temporary Anchorage Implant Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: August 15, 2008 Received: August 18, 2008
Dear Ms. Graham:
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. Graham
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu S. Lin, Ph. D.
Chiu S. Lin, Ph. D Division 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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Indications for Use
510(k) Number (if known):
Device Name: Orthodontic Temporary Anchorage Implant Screw
Temporary anchorage screws are intended to provide a fixed anchorage Indications for Use: point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The screw is used temporarily and is removed after orthodontic treatment has been completed.
Prescription Use X (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 Runner
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: (0)
§ 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.