ELLIPTIC MATRIX

K040539 · Institut Straumann AG · NHA · Mar 18, 2004 · Dental

Device Facts

• Record ID: K040539
• Device Name: ELLIPTIC MATRIX
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Mar 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.

Device Story

Elliptic Matrix is a dental attachment component; functions as a spring-loaded mechanism when four internal lamellae are activated. Device features a titanium housing to provide structural support and retention for overdentures. It attaches directly to a Straumann Retentive Anchor abutment. Used by dental professionals in a clinical setting to stabilize removable dentures for patients. The device improves denture stability and retention, facilitating patient comfort and function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to the predicate device.

Technological Characteristics

Materials: Titanium housing. Mechanism: Spring-like activation of four lamellae. Form factor: Dental attachment component for overdentures. No software or electronic components.

Indications for Use

Indicated for patients requiring support and retention for an overdenture via attachment to a Straumann Retentive Anchor abutment.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Gold Matrix (K894844)

Submission Summary (Full Text)

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# MAR 1 8 2004

# ATTACHMENT 6 - 510(k) Summary

# Applicant's Name and Address 1.

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-0791 Fax Number: Contact Person: John King Regulatory Affairs

## 2. Name of the Device

| Trade Name: | Elliptic Matrix |
|----------------------|---------------------------|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| | 21 CFR 872.3640 |

# Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)

Gold Matrix (K894844)

### 4. Description of the Device

The Elliptic Matrix attaches to the retentive anchor by functioning like a spring when the four lamellae are activated. The titanium housing gives the matrix more support and retention for the denture.

### 5. Intended Use of the Device

The Elliptic Matrix is attached onto the retentive anchor abulment to provide support and retention for denture.

### റ. Basis for Substantial Equivalence

The subject device is substantially equivalent to previously cleared Gold Matrix. The intended use of the subject Elliptic Matrix is identical to the predicate Gold Matrix.

The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are similar.

510(k) Elliptic Matrix March 1, 2004 Page 16 of 20

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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 is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest wings and a body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2004

Institut Straumann AG C/O Mr. John King Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K040539

Trade/Device Name: Elliptic Matrix Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: NHA Dated: March 1, 2004 Received: March 2, 2004

Dear Mr. King:

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.

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# Page 2 -Mr. King

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 moan that I DT may must statutes and regulations administered by other Federal agencies. or the For of any I ouchar the Act's requirements, including, but not limited to: registration r od inust comply with a wart 807); labeling (21 CFR Part 801); good manufacturing practice and libang (2) es a set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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) This letter will and in yourse Finding of substantial equivalence of your device to a premaired predicate in - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rryou desire specific at 100 201 pliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Chiu Lin, Ph.D. 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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K040539

Page 1 of_1

510(k) Number (if known):

Elliptic Matrix Device Name:

Indications For Use:

The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Kein Whaley son V.S.R

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

510(k) Number: K040539

510(k) Elliptic Matrix March 1, 2004 Page 19 of 20