3A DENTAL IMPLANT SYSTEM

K011879 · Osseco Biosource, Ltd. · DZE · Aug 27, 2002 · Dental

Device Facts

• Record ID: K011879
• Device Name: 3A DENTAL IMPLANT SYSTEM
• Applicant: Osseco Biosource, Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

Device Story

3A Dental Implant System consists of CP titanium endosseous implants; self-tapping or standard screw-type designs; available in various diameters and lengths; smooth or abrasive-blasted surface finishes. Used by dental professionals for surgical implantation in maxillary or mandibular arches to provide prosthetic support for dental restorations. Device provides structural foundation for single or multiple tooth replacements in partially or totally edentulous patients. Performance verified via bench testing of representative configurations, including angled abutments.

Clinical Evidence

Bench testing only. Performance testing was conducted on representative system configurations, including angled abutments, to ensure structural integrity and safety.

Technological Characteristics

Materials: CP titanium and titanium alloy. Design: Self-tapping or standard screw-type endosseous implant. Features: External hex and Morse taper connections; smooth or abrasive-blasted surface finishes. Dimensions: 3.75–5.5 mm diameter; 7–18 mm length. Sterilization: Provided sterile.

Indications for Use

Indicated for partially or totally edentulous individuals requiring prosthetic support for dental restorations in the maxillary or mandibular arches, including single tooth restoration.

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

• Brånemark Nobel Biocare (K993595)
• ITI Dental Implant System (K002374)

Submission Summary (Full Text)

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K011879

#### 12.0 SUMMARY OF SAFETY AND EFFECTIVENESS

| Distributor: | Osseco Biosource, Ltd.<br>64 Old Orchard, Suite 320<br>Skokie, Illinois 60077 |
|------------------------|-------------------------------------------------------------------------------|
| Regulatory Contact: | Michele H. Vovolka<br>Vantage Consulting International, Ltd |
| Telephone Number: | 847-856-0355 |
| Fax Number: | 847-856-0357 |
| Date Summary Prepared: | May 29, 2001 |
| Product Trade Name: | 3A Dental Implant System |
| Common Name: | Endosseous Implant |
| Classification: | Endosseous Implant<br>Class III per 21 CFR 872.3640 |
| Predicate Devices: | Brånemark Nobel Biocare<br>ITI Dental Implant System |

### Description:

The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters

### Intended Uses/Indications:

The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

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## Substantial Equivalence:

| Characteristic | 3A Dental<br>Implant Systems | Brånemark<br>Nobel Biocare<br>K993595 | ITI Dental<br>Implant System<br>K002374 |
|---------------------|-------------------------------------|---------------------------------------|-----------------------------------------|
| Indications for Use | Mandible and<br>Maxilla | Same | Same |
| Design: | External Hex and<br>Morse Taper | Same | Same |
| Material | Titanium and<br>Titanium Alloy | Same | Same |
| Implant Sterile | Yes | Same | Same |
| Implant Diameters | 3.75 – 5.5 mm | Equivalent | Equivalent |
| Implant Lengths | 7 – 18 mm | Equivalent | Equivalent |
| Attachments | Various abutments<br>and components | Equivalent | Equivalent |
| Product Code | DZE | Same | Same |

# COMPARISON TABLE

Summary of Testing:

Testing of a "typical" or representative, standard system configuration utilizing an "angled abutment" was conducted on samples of titanium. The testing demonstrated performance sufficient to assure both safe and efficacious use of the implant system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 7 2002

Osseco Biosource, Limited C/O Ms. Michele H. Vovolka Vantage Consulting International, Litimed P.O. Box 848 Grayslake, Illinois 60030

Re: K011879

Trade/Device Name: 3A Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 27, 2002 Received: May 29, 2002

Dear Ms. Vovolka:

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.

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.

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Page 2 - Ms. Vovolka

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski 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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KO11879 510(k) Number (if known):

3A Dental Implant System Device Name:

Indications For Use:

The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over -The-Counter Use

Susan Runner

Division Sign Off

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

510(k) Number K011879

Osseco Biosource, Ltd. 510(k) Notification