DUAL TOP ANCHOR SYSTEM SCREWS

K033767 · Jeil Medical Corporation · DZE · Feb 24, 2004 · Dental

Device Facts

• Record ID: K033767
• Device Name: DUAL TOP ANCHOR SYSTEM SCREWS
• Applicant: Jeil Medical Corporation
• Product Code: DZE · Dental
• Decision Date: Feb 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. For use in adults over the age of 12.

Device Story

Dual Top Anchor System Screws are titanium alloy bone screws used in orthodontics to provide temporary fixed anchorage for appliances like brackets, wires, and elastic bands. The device features a dual-head design; the upper head is hex-shaped with a hole for wire attachment. The tip is designed for self-drilling and self-tapping at the surgeon's option. Screws range from 1.4mm to 2.0mm in diameter and 6.0mm to 12mm in length. The device is provided non-sterile and requires steam sterilization before use. It is intended for single-use only in adult patients. The clinician implants the screw into the jawbone to serve as a stable anchor point, allowing for controlled orthodontic tooth movement. Once treatment is complete, the screw is removed. The device benefits patients by providing a stable, temporary skeletal anchorage point, potentially improving the efficiency and outcomes of orthodontic tooth movement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

Titanium alloy (ASTM F 136-98) bone screws. Dimensions: 1.4mm-2.0mm diameter, 6.0mm-12mm length. Dual-head design with hex interface and wire hole. Self-drilling/self-tapping tip. Non-sterile, requires steam sterilization. Mechanical device; no software or electronics.

Indications for Use

Indicated for adults over age 12 requiring fixed anchorage points for orthodontic appliances to facilitate tooth movement. Contraindicated for patients where temporary anchorage is not required or who are under 12 years of age.

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.

Predicate Devices

• OsteoMed Orthodontic Screw System (K031936)
• Nobel Biocare Implant Orthodontic Anchor System (K000643)

Submission Summary (Full Text)

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KO 33767

FEB 2 4 2004

### EXHIBIT 2

Jeil Medical Corporation 808. ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-Ku, Seoul, KOREA Telephone : [phone]~9 Fax: [phone] Revised February 17, 2004 Contact: N.K.Kim, R&D Director 510(k) Summary of Safety and Effectiveness

- Identification of the Device: 1. Proprietary-Trade Name: Dual Top Anchor System Screws (various models) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Bone Screw
- Equivalent legally marketed devices: OsteoMed Orthodontic Screw System, (K031936), 2. Equivancen legary manett(K982509) the Nobel Biocare Inplant Orthodontic Anchor System (K000643) ..
- Indications for Use (intended use) . This device is intended to provide a fixed anchorage point 3. for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. For use in adults over the age of 12.
- 4. Description of the Device: This device is designed for orthodontic use. The screws are made Description of alloy (ASTM F 136-98). The head of the screw is dual head type. The upper head is a hex type. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, Dual head design of screw mandible and mannia in the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The tip of the screw is designed available to self-drilling and self-tapping. (Surgeon's option) This device is comprised of screws ranging in diameter of 1.4mm to 2.0mm and in length ranging from 6.0mm to 12mm. These screws are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. Therefore, and device mast Polyethylene package. The top of packaging bag is sealed with sealing strip.
- Potential Adverse Affects and Complications: (Common to all devices of this type) 5.
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, . or oon can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Migration, bending, fracture or loosening of the implant. .
- Metal sensitivity, or allergic reaction to a foreign body. .
- Pain, discomfort, or abnormal sensation due to the presence of the device. .
- Increased fibrous tissue response around the fracture site and/or the implant. .
- Necrosis of bone. .
- . Inadequate healing.
- madequate neaming.
Apart from these adverse effects there are always possible complications of any surgical

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procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant

| Device Name | Nobel Biocare<br>Implant Orthodontic<br>Anchor System | OsteoMed<br>Orthodontic Screw<br>System, | Dual Top Anchor System<br>Screws (various models) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification<br>Name | Implant, Endosseous,<br>Product Code DZE | Implant, Endosseous,<br>Product Code DZE | Implant, Endosseous, Product<br>Code DZE |
| Applicant | Nobel BioCare | Osteomed | Jeil Medical Corporation |
| 510(K) Number | (K000643). | (K031936) | (This submission) |
| Material | Titanium | Titanium Alloy | Titanium Alloy<br>(ASTM F 136-98) |
| Intended use | This device is intended<br>to provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances<br>to facilitate the<br>orthodontic movement<br>of teeth. It is used<br>temporarily and is<br>removed after<br>orthodontic treatment<br>has been completed.<br>Screws are intended for<br>single use only. | This device is used as an<br>anchorage for orthodontic<br>treatment in the mouth. | This device is intended to<br>provide a fixed anchorage<br>point for attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of teeth. It is used<br>temporarily and is removed<br>after orthodontic treatment has<br>been completed. Screws are<br>intended for single use only.<br>For use in adults over the age<br>of 12. |
| Single Use? | YES | YES | YES |
| Supplied Sterile? | No comment | Non sterile, steam<br>sterilize before use | Non sterile, steam sterilize<br>before use |

- 6. Safety and Effectiveness, comparisons to predicate devices:
- Conclusion: In all respects, the Dual Top Anchor System Screws (various models) Bone 7. Conclusion: In an respects, the Butan of currently marked devices. They are materials Screws are the equivalent of earling markets as the consection adverse effects are identical to allu have similar difficits and enazacts manufactured from material of titanium alloy (ASTM 136-98) that is used generally in this kind of bone screw. Similar devices made from (ASTM 136-98) that is used generally in this never are manufactured and sold around the world.
titanium alloy (ASTM 136-98) to this device are manufactured and sold around to this device is substantially equivalent in design, material, intended use and function to the This device is substantially orquiral with the certified by notified body for CE.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Jeil Medical Corporation C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K033767

Trade/Device Name: Jeli Medical Corporation: Dual Top Anchor Systems Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 20, 2003 Received: December 3, 2003

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 approvisions 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 (1 Mr), it hay of badyoo in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Kamm

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 una libing (21 CF C 1 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), rt you deente 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,

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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# KO33767

## Indications for Use

510(k) Number (if known): ___K033767_

Device Name:_Jeil Medical Corporation:___Dual Top Anchor System Screws_

Indications For Use:

This device is intended to provide a fixed anchorage point for attachment of othodontic This device is intended to provide a liked anchorage point of used temoved appliances to faciliate the othroublike movement of tooth. We single use only. For use on adults over the age of 12.

Susan Russer

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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)

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