3I CERAMIC ABUTMENT SYSTEM

K991947 · Implant Innovations, Inc. · DZE · Sep 29, 1999 · Dental

Device Facts

• Record ID: K991947
• Device Name: 3I CERAMIC ABUTMENT SYSTEM
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant's coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.

Device Story

3i Ceramic Abutment is a dental prosthetic component used to connect endosseous dental implants to oral prosthetics. It consists of a zirconium ceramic outer sleeve bonded to a machined titanium alloy core using an apatite glass-ceramic seal. The device is placed by a dental professional in a clinical setting. It functions by extending the implant's coronal aspect through mucosal tissues into the oral cavity, providing an aesthetic base for prosthetic attachment. The device is intended for use in the anterior region of the oral cavity. Clinical benefit includes improved aesthetic outcomes for dental restorations. The healthcare provider uses the abutment to support the final prosthesis, directly impacting the functional and aesthetic success of the dental implant procedure.

Clinical Evidence

Bench testing only. Testing included cyclical fatigue at 30° angle (5,000,000 cycles at 300 N), static load at 30° angle (695 N), and torsional strength (166 Ncm). Results showed the 3i ceramic abutment performed as well as or better than equivalent devices.

Technological Characteristics

Three-component assembly: zirconium ceramic outer sleeve, machined titanium alloy core, and apatite glass-ceramic bond. Sterilized via gamma irradiation to SAL 10^-6. Dimensions/form factor designed for endosseous dental implant interface. No software or electronic components.

Indications for Use

Indicated for patients requiring prosthetic attachment to endosseous dental implants to extend the coronal aspect through mucosal tissues into the oral cavity. Primarily for anterior regions requiring high aesthetics. Contraindicated in patients with insufficient jawbone width/height, lack of osseointegration, poor oral hygiene, heavy smoking/tobacco use, blood disorders, infection, vascular impairment, uncontrolled diabetes, drug/alcohol abuse, chronic high-dose steroid therapy, or metabolic bone disease.

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

• Nobel Biocare CerAdapt

Submission Summary (Full Text)

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K991947

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### 510(k) SUMMARY 3i Ceramic Abutments

To 510(k) Summary Requestor:

Information contained in this summary is from an original Pre-Market Notification [510(k)] submission, provided the United States Food and Drug Administration. No pertinent or known releasable information regarding device safety or efficacy has been intentionally or otherwise knowingly deleted from that submission, for this summary.

William G. Conety

Regulatory Affairs

CLASSIFICATION NAME: Endosseous Dental Implant

COMMON/USUAL NAMES: Abutments; transmucosal abutments/elements

PROPRIETARY NAME: No established marketing name at time of submission.

CLASSIFICATION: Class III

PERFORMANCE STANDARDS: No established performance standards for abutments

FORM and CONSTRUCTION: The 3i ceramic abutment is comprised of three basic components: An outer cylinder or sleeve constructed from zirconium ceramic bonded to an inner machined titanium alloy core with a biocompatible, water-insoluble, apatite glass-ceranic seall.

Titanium alloy cores or inserts are machined. The ceranic sleeve is molded. The two components are bonded using proprietary process. After bonding, parts are cleaned, inspected, packaged and sterilized. Sterilization is accomplished by gamma irradiation to a SAL of 10 ° The 31 ceramic abutment is equivalent in physical strength characteristics as other devices.

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Cyclical Fatigue at 30° Angle (Average result)

| Other device | 3i |
|-------------------------------------------|------------------------|
| 5000000 cycles @ 250 N | 5000000 cycles @ 300 N |
| Static load at 30° Angle (Average result) | |
| Other device | 3i |
| 517 N | 695 N |
| 03 Torsional Strength (Average result) | |
| Other device | 3i |
| 79.5 Ncm (¹) | 166 Ncm (²) |
| ¹ Abutment hex failed | ² Implant hex failed |

In all physical testing undertaken, the 3i ceramic abutment performed as well or better than equivalent other devices.

SUBSTANTIAL EQUIVALENCE: The 3i ceramic abutment is substantially equivalent to Nobel Biocare "CerAdapt" abutment in that they are similar in outward appearance, basic design configuration and indications for use do not differ between the two.

The Nobel Biocare device is a one-piece aluminum oxide ceramic device. The 3i ceramic abutment is a three component device: Inner titanium sleeve and outer ceramic body, bonded by a compatible ceramic.

INDICATIONS: Ceramic abutments are indicated for use with endosseous dental implants, to extend implant's coronal aspect through mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.

CONTRAINDICATIONS: No known (reported) or anticipated contraindications in use of ceramic abutments when used with implants that have achieved integration in alveolar bone. 3i abutments are not indicated for use in locations other than alveolar ridges.

Implants/abutments should not be used in cases where remaining jawbone is too diminished to provide adequate width/height to surround implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is insufficient available bone or poor bone quality, poor oral hygiene, heavy smoking or tobacco use or medical conditions such as blood disorders, infection(s), vascular impairment at surgical site, uncontrolled diabetes, heavy

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smoking or tobacco abuse, drug or alcohol abuse, chronic high dose steroid therapy, medical conditions such as blood clotting disorders, current or ongoing anticoagulant therapy, metabolic bone disease or other metabolic or systemic disorders which may adversely affect bone or wound healing or cases in which the available bone is too diminished to provide adequate width or height to adequately hold implants and restorative appliances.

WARNINGS: For safe and effective use of 3i implants and abutments, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized, complex procedures. Improper patient selection and technique can cause implant and/or abutment failure with possible loss of supporting bone. 3i implants are not indicated for use in sites other than alveolar ridges.

PRECAUTIONS: Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT scans and tomogram may also be beneficial.

ADVERSE EFFECTS: Ceramic abutments: No known (reported) or anticipated adverse effects.

Loss of implant anchorage (failure to integrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage.

SURGICAL COMPLICATIONS: Ceramic abutments: No known (reported) or anticipated surgical complications. The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases, the numbness has been permanent. Gingival/mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.

Summary _ End Summary _ _ _ _ _ _ _ _

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Public Hcalth Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1999

Mr. William G. Conety Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re : K991947 Trade Name: 3I Ceramic Abutment System Regulatory Class: III Product Code: DZE September 7, 1999 Dated: Received: September 8, 1999

Dear Mr. Conety:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listi prohibitions against misbranding practice, fabering, and

If your device is classified (see above) into either class II (Special Controls) or class II (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Conety

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaj.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: K

Page 1 of 1

# Device Name: Ceramic Abutment System

### INDICATIONS FOR USE:

Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant's coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number