SARGON IMMEDIATE LOAD IMPLANT, MODEL D

K981141 · Sargon Ent., Inc. · DZE · Jun 23, 1999 · Dental

Device Facts

• Record ID: K981141
• Device Name: SARGON IMMEDIATE LOAD IMPLANT, MODEL D
• Applicant: Sargon Ent., Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

Device Story

Endosseous dental implant; used for prosthetic attachment in partially or fully edentulous mandibles and maxillae. Features longer collar design allowing direct fixation of prosthesis to implant, with or without abutment. Implanted by dental professionals in clinical settings. Provides structural support for fixed or detachable dental restorations; enables immediate loading. Benefits patient by facilitating dental reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design comparison and material specifications.

Technological Characteristics

Endosseous dental implant; material: titanium 6Al-4V alloy (ASTM F136). Features longer collar design for direct prosthesis fixation. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients with partially or fully edentulous mandibles and maxillae requiring fixed or detachable dental prostheses or support for free-standing restorations, with or without adjacent dentition involvement.

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

• K930071
• K961005

Submission Summary (Full Text)

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KAS1141

EXHIBIT 6

## 510(k) Summary

Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 1233 20th Street, NW (Suite 700) Washington, DC 20036 202-261-1000

> On behalf of Sargon Enterprises, Inc. 510(k) Submission: Sargon Immediate Load Implant Alternate collar design March 27, 1998

The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment.

The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications." The indications for use are likewise identical: For use in either partially or fully edentulous mandibles and maxillae as a final or intermediary abutment for fixed or detachable prosthesis, and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines that suggest a head and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Sargon Enterprises, Incorporated c/o Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street North West 7th Floor Washington, DC 20036-3307

Re : K981141 Sargon Immediate Load Implant Model D Trade Name: Requlatory Class: III Product Code: DZE March, 25 1999 Dated: Received: Maarch 29, 1999

Dear Mr. Manelli:

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 regulations 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.

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Page 2 - Mr. Manelli

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.

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 requlation (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 requlation entitled, "Misbranding by reference to ene regaration 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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## EXHIBIT A

Page 1 of 1

K981141 510(k) Number (if known):

Sargon Immediate Load Implant - Ultratooth Model Device Name:

Indications for use:

For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription use | <div style="display:inline-block;">✓</div> |
|----------------------|--------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

Susan Pearson
(Division Sign-Off)
Division of Dental, Infection Control
and General Hospital Devices

| 510(k) Number | 198191 |
|---------------|--------|
|---------------|--------|