NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)

K993595 · Nobel Biocare Uas, Inc. · DZE · Jan 28, 2000 · Dental

Device Facts

• Record ID: K993595
• Device Name: NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Device Story

Threaded, hex-lock root-form dental implant; 3.75-mm diameter; 7-mm to 20-mm lengths. Features titanium oxide surface layer. Used by dental surgeons in clinical settings to support prosthetic devices (artificial teeth). Implanted into upper or lower jaw via single or two-stage surgical procedures. For single-stage, immediate loading requires minimum four implants in anterior mandible, splinted with bar, to ensure stability. Restores patient chewing function.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate devices.

Technological Characteristics

Threaded, hex-lock root-form dental implant; 3.75-mm diameter; 7-20-mm length. Material: Commercially pure titanium with thin titanium oxide surface layer (mean <10μ). Sterile, glass vial in blister pack packaging.

Indications for Use

Indicated for patients requiring prosthetic support for artificial teeth in the upper or lower jaw to restore chewing function. Suitable for two-stage or single-stage surgical procedures. Single-stage immediate loading requires placement of at least four implants in the anterior mandible (between mental foramina) splinted with a bar, ensuring good initial stability.

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

• Cylindro-Blade Implant (K930071)
• ITI "One Part" Implant (K984104)

Submission Summary (Full Text)

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K993595

## Section 8 510(k) Summary

# Nobel Biocare USA Letterhead

## 510(k) Summary

## A. Manufacturer Information:

| Submitter's Name: | Nobel Biocare USA, Inc. |
|--------------------------------------------------------|---------------------------------------------------------------------------|
| Submitter's Address (U.S. Representative/Distributor): | 22825 Eastpark Drive<br>Yorba Linda, CA 92887 USA |
| Contact's Name: | Jeff Hausheer, Ph.D., Regulatory Affairs Specialist |
| Contact's Telephone No.: | 714-282-4800, extension 7832 |
| Date Prepared: | October 1999 |
| Address (Manufacturer): | Nobelpharma Production AB<br>Dimbovagen 2<br>Karlskoga S-691-51<br>SWEDEN |
| Manufacturer's Registration No. | 9611993 |

## B. Device Name:

- Common Name: Dental Implant Trade Name: Nobel Biocare's Modified Surface Implant
# C. Classification:

Classification Name: Endosseous Dental Implant Classification Number: DZE Classification Citation: 21 CFR 872.3640

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## Nobel Biocare USA - October 1999

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# Section 8 510(k) Summary (continued)

## D. Device Description:

Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ, range = 3μ to 10μ).

## E. Intended Use:

Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

## F. Comparison to the Predicate Device(s):

The following table provides a comparison of the technological characteristics of the predicate devices and Nobel Biocare's Modified Surface Implant

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Nobel Biocare USA - October 1999

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# Section 8 510(k) Summary (continued)

## Table 8.1 Identification of the Predicate Devices and the Submitted Device, Nobel Biocare's Modified Surface Implant

| Implant<br>Product | 510(k) #<br>(and Manufacturer) |
|--------------------------|--------------------------------|
| Modified Surface Implant | K # pending |
| Cylindro-Blade Implant | K930071 (Sargon) |
| ITI "One Part" Implant | K984104 (Straumann) |

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# Section 8 510(k) Summary (continued)

## Table 8.2

Technology: Comparison of the Predicate Devices and the Submitted Device, Nobel Biocare's Modified Surface Implant

| Attribute/ Characteristic | Predicate No. 1<br>Sargon Cylindro-Blade Implant | Predicate No. 2 Strau-<br>mann ITI Implant | Nobel Biocare's Modified<br>Surface Implant<br>(Submitted Product) |
|----------------------------|----------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------------------------|
| Design | Threaded, tapered, non-solid (hollow),<br>flanged root-form implant | Threaded, root-form | SAME predicate #2) |
| Placement Method | Single stage surgery, immediate load | Single stage surgery,<br>immediate load | SAME |
| Body Material | Titanium alloy | Commercially pure tita-<br>nium | SAME (predicate #2) |
| Coating | None | None | SAME |
| Length (mm, min.-<br>max.) | 10 mm to 18 mm | Unknown | 7 mm to 20 mm* |
| Diameter (mm) | Available in 1 tapered design only; its di-<br>ameter ranges from 3.8 to 4.1 mm. | Unknown | 3.75 mm |
| Packaging | Vial | Unknown | Glass vial in blister pack |
| Sterility | Unknown | Unknown | Sterile |

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Nobel Biocare USA - October 1999

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

ﺔ ﺑﻠﺪﻳ

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 8 2000

Jeff Hausheer, Ph.D. Requlatory Affaris Specialist Nobel Biocare USA, Incorporated 22895 Eastpark Drive 92887 Yorba Linda, California

Re: K993595 Nobel Biocare's Modified Surface Implant Trade Name: Requlatory Class: III Product Code: DZE Dated: October 22, 2000 Received: October 25, 2000

#### Dear Dr. Hausheer:

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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation may result in requlatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Dr. Hausheer

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 one rogalable. Choroson, (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.fda.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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K93595

## Section 1 Indications for Use

Page 1 of 1

1171

## 510(k) Number (if known): K9XXXXX

Device Name: Nobel Biocare's Modified Surface Implant

## Indications For Use:

Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
| Prescription Use <span style="text-decoration: overline;"><b>✓</b></span> | OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
| <span style="text-decoration: overline;"></span><br>(Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices<br><span style="text-decoration: overline;">K993595</span><br>510(k) Number | NOBEL BIOCARE USA - | CTOBER 1999 |