MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM

K012299 · Basic Dental Implant Systems, Inc. · DZE · Aug 1, 2001 · Dental

Device Facts

• Record ID: K012299
• Device Name: MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
• Applicant: Basic Dental Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BASIC Dental Implant System Straight Post and Core II Attachment is intended to attach artificial teeth to a dental implant.

Device Story

The Straight Post and Core II Attachment is a three-piece dental accessory. The base is cemented into a dental implant; the top is secured to the base using a hex screw. Artificial teeth are attached to the assembly using conventional dental techniques. The device is used by dental professionals in a clinical setting to facilitate the restoration of missing teeth.

Clinical Evidence

No clinical data.

Technological Characteristics

Three-piece attachment system consisting of a base and a top component secured by a hex screw. Designed for cementation into a dental implant.

Indications for Use

Indicated for attaching artificial teeth to a dental implant.

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

• BASIC Dental Implant System 2-Piece Post and Core Attachment (K001259)

Submission Summary (Full Text)

{0}------------------------------------------------

1. 2001 AUG

## Attachment I 510(K) Summary

BASIC Dental Implant System Straight Post and Core II Attachment

This 510(K) Summary of safety and effectiveness for the BASIC Dental Implant System Straight Post and This JTQ\x) ballimary of bareer anin accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:

Address:

Contact Person:

Telephone / Fax / Email

Preparation Date:

Device Trade Name:

Common Name:

Classification:

Legally Marketed Predicate Device:

Description of the Straight 2-Piece Post and Core Attachment:

Intended use:

Performance Data:

Results of Clinical Study:

Conclusion:

BASIC Dental Implant Systems, Inc.

3321 Columbia NE Albuquerque, New Mexico 87107 USA

Dan Blacklock, Vice-President

505.881.1376 - Phone [phone] - Fax

July 19, 2001

BASIC Dental Implant System Straight Post and Core II Attachment

Accessory to a Dental Implant

DZE

BASIC Dental Implant System 2-Piece Post and Core Attachment K number K001259

The Straight Post and Core II Attachment is a three-piece attachment.

The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.

The Straight Post and Core II Attachment is intended to attach artificial teeth to a dental implant.

None

None

The Straight Post and Core II attachment is substantially equivalent to other existing Straight 2-Piece Post and Core attachments in commercial distribution.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and appears to be extracted from a document or sign.

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

**AUG 1 2001**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Blacklock Vice President Basic Dental Implant Systems, Incorporated 3321 Columbia, N.E. Albuquerque, New Mexico 87107-2001

K012299 Re : BASIC Dental Implant System Straight Trade/Device Name: 2-Piece Post and Core Attachment Regulation Number: 872.3640 Regulatory Class: III Product Code: DZE July 19, 2001 Dated: Received: July 20, 2001

Dear Mr. Blacklock :

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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

{2}------------------------------------------------

Page 2 - Mr. Blacklock

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 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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Whitehouse

Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: BASIC Dental Implant System Straight 2-Piece Post and Core Attachment

Indications for Use:

The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (per 21 CFR 801.109) | |

(Division Sign-Off)

Division of Dental, Infection Control,

a - General Hospital Devices 1. Number_KADIJ99

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________