ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR

K061266 · Ortho Organizers, Inc. · OAT · Jul 31, 2006 · Dental

Device Facts

• Record ID: K061266
• Device Name: ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
• Applicant: Ortho Organizers, Inc.
• Product Code: OAT · Dental
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodonic movement of teeth.

Device Story

Temporary orthodontic anchor; single-piece titanium alloy implant; threaded shaft for bone anchorage; low-profile proximal head with undercut and transverse circular opening for appliance attachment; vertical flats for tool-assisted implantation. Used in dental clinic by orthodontists; implanted into alveolar ridge. Provides stable anchorage for orthodontic appliances; facilitates tooth movement; benefits patient by enabling controlled orthodontic treatment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium alloy (ASTM F136). Design: Single-piece, threaded shaft, tapered conical section, proximal head with attachment points. Energy: None (mechanical). Connectivity: None. Sterilization: Non-sterile, intended for sterilization prior to use.

Indications for Use

Indicated for patients requiring fixed anchorage points for orthodontic appliances to facilitate tooth movement.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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510(k) Summary

# 510(k) Summary

KOLO1266

# Ortho Organizers, Inc. Temporary Orthodontic Anchor

JUL 3 1 2006

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Ortho Organizers, Inc.<br>1619 S. Rancho Santa Fe Road<br>San Marcos, CA 92078<br>Telephone [phone]<br>FAX [phone] |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Robert Riley<br>Vice President of Operations |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone [phone]<br>FAX [phone] |

#### DEVICE NAME

| Classification Name: | Implant, Endosseous, Root-Form |
|-------------------------|-----------------------------------------------|
| Trade/Proprietary Name: | Ortho Organizers Temporary Orthodontic Anchor |
| Common Name: | Orthodontic Anchor |

#### DEVICE CLASSIFICATION

Implant, Endosseous, Root-Form is classified as Class II (21 CFR 872.3640). The product code is DZE. This device classification is reviewed by the Dental Devices Branch.

#### INTENDED USE

The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodonic movement of teeth.

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## 510(k) Summary

## DEVICE DESCRIPTION

The Ortho Organizers Temporary Orthodontic Anchor is a device that is temporarily implanted in the alveolar ridge to provide a fixed anchorage point for various orthodontic tooth movements.

## Design

It is a single-piece design that features a threaded shaft and a low profile proximal head. The it is a smere preso dosign that romation and undercut that serves as an attachment point. The tapered conical section below the button incorporates a transverse circular opening which also serves as an attachment point. Vertical flats below the conical section enable use of tools to turn the device into its fully implanted position. The head terminates in a collar that separates the attachment points from the threaded portion of the device. The device is soparates the attactinent program or a long collar to accommodate variations in soft tissue thickness.

### Material

The Ortho Organizers Temporary Orthodontic Anchor is made of titanium alloy conforming to the requirements of ASTM F 136 Standard Specification for Wrought Titaniumto the require. Wanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

### Sterilization

The Ortho Organizers Temporary Orthodontic Anchor will be sold non-sterile and is intended to be sterilized prior to use.

# EQUIVALENCE TO MARKETED DEVICE

Ortho Organizers, Inc. demonstrated that, for the purposes of FDA's regulation of medical Ortho Organizers Temporary Orthodontic Anchor is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

The intended use, design, materials and functional characteristics of the Ortho Organizers The micention ass, accirent inte predicate devices are substantially the same. All are r villportuly Ofthodontio Fixed anchorage of orthodontic appliances and accessories used in the movement of teeth. The basic design of each consists of a threaded shaft for bone anchorage and a contoured head for attachment of various orthodontic appliances and accessories. Each is made of Ti-6A1-4V titanium alloy, a well-proven material for implantable devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2007

Ortho Organizers, Incorporated C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K061266

:

Trade/Device Name: Ortho Organizers Temporary Orthodontic Anchor Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: July 26, 2006 Received: July 27, 2006

Dear Mr. Larson:

This letter corrects our substantially equivalent letter of July 31, 2006.

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 (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 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 - Mr. Larson

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 continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Chris S. Liang, Ph.D.

Chiu S. Lin, PhD 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): Kobi 266

Device Name:

Ortho Organizers Temporary Orthodontic Anchor

Indications for Use:

The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

RohutSBatz DDS for Dr SusanRunner

Concurrence of CDRH, Office of Device Evaluation (ODE)

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