MILO DENTAL IMPLANT SYSTEM

K050970 · Intra-Lock International · DZE · Oct 14, 2005 · Dental

Device Facts

• Record ID: K050970
• Device Name: MILO DENTAL IMPLANT SYSTEM
• Applicant: Intra-Lock International
• Product Code: DZE · Dental
• Decision Date: Oct 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

1. MILO™ Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. 2. MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

Device Story

Intra-Lock MILO Dental Implant System consists of machined titanium screw-form implants; 3.0mm diameter; lengths 10mm, 11.5mm, 13mm, 15mm. Used by dental professionals in clinical settings for denture stabilization or tooth rehabilitation. Implants are surgically placed into jawbone to support prosthetic restorations. Immediate function or delayed loading options available. Benefits include long-term stabilization and functional rehabilitation of specific incisor regions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Titanium-6Aluminium-4Vanadium ELI (ASTM F 136, UNS R56401). Form: Machined screw-form dental implant. Dimensions: 3.0mm diameter; 10-15mm lengths. Sterilization: Sterile packaged.

Indications for Use

Indicated for patients requiring maxillary or mandibular tissue-supported denture stabilization, or rehabilitation of single/multiple maxillary lateral incisors and mandibular central/lateral incisors. Implants may be restored after a period or placed in immediate function.

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

• Maximus™ OS (Overdenture System) Implant (K041938)
• Nobel Direct (K031345)
• XiVe® 3.0 Dental Implant System (K030639)

Submission Summary (Full Text)

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## UCT 1 4 2005

## 510(k) Summary

ー

| Establishment: | Intra-Lock International, Inc.<br>1200 North Federal Highway<br>Suite 209<br>Boca Raton, FL 33432 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Proprietary Name: | Intra-Lock MILO™ Implant |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |

- Device Classification: Class II

| | Product Name | Company | 510(k) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|
| Predicate Devices: | The Maximus™ OS<br>(Overdenture System) Implant | BioHorizons | K041938 |
| | Nobel Direct | Nobel Biocare | K031345 |
| | XiVe® 3.0 Dental Implant<br>System | FRIADENT GmbH | K030639 |
| Device Description: | The Intra-Lock MILO™ Dental Implant System consists of machined<br>titanium, screw-form dental implants 3.0mm in diameter. They are<br>available in lengths of 10mm, 11.5mm, 13mm and 15mm. The<br>implants' raw material is Titanium Alloy for Surgical Implant<br>Applications (as per ASTM F 136 Standard Specification for Wrought<br>Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy<br>(UNS) R56401).<br>The implants are sterile packaged. | | |
| Intended Use: | 1. MILO™ Implants are indicated for long-term maxillary and<br>mandibular tissue-supported denture stabilization. Multiple implants<br>may be restored after a period of time or placed in immediate<br>function. | | |

MILO" Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular lateral and/or central and incisors. The implants may be restored after a period of time or placed in immediate function.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 4 2005

Mr. Jeffrey Sakoff Director of Operations Intra-Lock International 1200 North Federal Highway Suite 209 Boca Raton, Florida 33432

Re: K050970

Trade/Device Name: MILO DENTAL IMPLANT SYSTEM Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 20, 2005 Received: September 20, 2005

Dear Mr. Sakoff:

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 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 12 ), ice 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. Sakoff

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 mean that I DT mas may Federal statutes and regulations administered by other Federal agencies. or the Act of any I outh 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 and ifsing (21 es ready in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betronic product radiation control provisions (Sections 531-542 of the Act); appread 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 m 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), If you dosite specific act 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 may octain 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/industry/support/index.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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## Indications for Use

510(K) Number (if known): K050970

Device Name: MILO™ Dental Implant System

Indications for Use:

1. MILO™ Implants are indicated for long-term maxillary and mandibular tissuesupported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function.

2. MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Ruser

(Division Sign-Off) (Civision Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoological Devices

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