SPI CONTACT DENTAL IMPLANT

K034014 · Thommen Medical AG · DZE · Mar 5, 2004 · Dental

Device Facts

• Record ID: K034014
• Device Name: SPI CONTACT DENTAL IMPLANT
• Applicant: Thommen Medical AG
• Product Code: DZE · Dental
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® CONTACT implants can provide support only if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Device Story

Threaded, tapered, endosseous dental implant; manufactured from commercially pure titanium. Surgically placed by dentists into maxillary or mandibular bone to support prosthetic restorations (crowns, bridges, overdentures). Requires splinting with a bar (4 implants mandibular, 6 implants maxillary) for overdenture support. Surface features sandblasted and acid-etched threaded portion with smooth-machined 1.5 mm collar. Provided sterile via gamma irradiation. Clinical benefit includes restoration of dental function and aesthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices. Bench testing confirms compliance with ASTM F 67 and ISO 5832-2 material requirements.

Technological Characteristics

Threaded, tapered endosseous dental implant. Material: Commercially pure titanium (ASTM F 67 Grade 4 / ISO 5832-2 GR4B). Surface: Sandblasted and acid-etched threads; smooth-machined 1.5 mm collar. Dimensions: 9.5-17 mm length, 3.5-6 mm diameter. Sterilization: Co60 gamma irradiation (25 kGy), SAL 10^-6. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration via crowns, bridges, or overdentures in the maxillary or mandibular arch. Contraindicated for 3.5 mm diameter implants in areas with pronounced rotation/translation movements causing large bending moments, specifically: posterior teeth restoration in upper/lower jaw, single-tooth restoration of canines/central incisors in upper jaw, and applications involving retentive anchors.

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

• Thommen SPI Dental Implant System (K003045)
• Thommen SPI Onetime Dental Implant (K022038)
• Or Dental Implant (K030689)
• Straumann ITI TE Dental Implant (K030007)
• Steri-Oss Replace Dental Implant (K964220)
• Bränemark Replace Select Dental Implant (K022562)

Submission Summary (Full Text)

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MAR - 5 2004

K034014

#### SPI® CONTACT Dental Implant 510(k) Summary "

Page 1

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Thommen Medical AG<br>Hauptstrasse 87<br>CH-4437 Waldenburg<br>Switzerland<br>Telephone [phone]<br>FAX [phone] |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Orlando Antunes |

Floyd G. Larson Representative/Consultant: PaxMed International 4329 Graydon Road San Diego, CA 92130 Telephone [phone] FAX [phone]

#### DEVICE NAME

| Classification Name: | Implant, Dental, Endosseous (DZE) |
|-------------------------|-----------------------------------|
| Trade/Proprietary Name: | SPI® CONTACT Dental Implant |
| Common Name: | Endosseous Dental Implant |

### ESTABLISHMENT REGISTRATION NUMBER

The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.

### DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Implant, Dental, Endosseous" is DZE.

## CONFORMANCE 'WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implants have been No performanoo otandardo application Grade 4 used to manufacture Thommen outdental implants meet the chemical and mechanical requirements of ASTM F 67 and ISO 5832-2.

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### PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® CONTACT Dental Implants will be packaged in a radiation Thommen of I - OON AG+ Schulization will be accomplished by means of Co° gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization will be validated by the bioburden method, according to ISO 11137 (Sterilization of Health Care Products – Radiation Sterilization). The sterility assurance level (SAL) that Frouncts - Nation Forent Editor meet for the SPI® CONTACT Dental Implant is 10-6. The device is not represented to be "pyrogen free."

#### INTENDED USE

The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to entificalluly of dollayou, in dollayou, in an overdentures. SPI® CONTACT implants can provide oupporter. Sily if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm: Oontraindloadons in in tsuitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending moments.

- Restoration of posterior teeth in the upper or lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw 【
- Any application involving retentive anchors -

#### DEVICE DESCRIPTION

#### Design Characteristics

Thommen SPI® CONTACT Dental Implants are threaded, tapered, endosseous dental implants made of commercially pure titanium and intended for use with the System abutments and instruments. The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm.

#### Material Composition

SPI® CONTACT Dental Implants are made of pure titanium according to ASTM F 67 Grade 4/ ISO 5832-2 GR4B. The surface of the threaded portion of the SPI® Crado increating lant is sandblasted and acid etched. The 1.5 mm collar is smooth machined for subgingival and transgingival use.

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### EQUIVALENCE TO MARKETED PRODUCT

For the purposes of FDA's regulation of medical devices, the SPI® CONTACT Dental I or the purpose of the revivalent in indications and design principles to the implant is Substantially oquivalorit it in Dental Implant System, cleared by FDA on following predications and July 12, 2001 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Or | Onounts Dental Implant, cleared on March 4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on March 31, 2003 under K030007; the Steri-Oss Replace Dental Implant cleared on March 5, 1997 under K964220 and the Bränemark Replace Select Dental Implant, cleared on October 11, 2002 under K022562.

The SPI® CONTACT Dental Implant has the following similarities to the predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized 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. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

Thommen Medical, AG C/O Ms. Floyd G. Larson President Paxmed International 4329 Graydon Road San Diego, California 92130

Re: K034014

Trade/Device Name: SPI Contact dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 22, 2003 Received: December 24, 2003

Dear Ms. Larson:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we have reviewed your and have determined the device is substantially equivalent (for the If it it cations 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinent, or to arrived Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it har ob subject to case of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.

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Page 2 - Ms. Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1127 - 166aailes on that your device complies with other requirements Incall that i 27 mas made a december and regulations administered by other Federal agencies. of the Act of any I oderal bate and separements, including, but not limited to: registration r our must comply with an the Hood ing (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as sections in the quarty sion 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 w your be even finding of substantial equivalence of your device to a premarket notification. - to 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), If you desire specific at 100 to 100 loss 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,

Clus

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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# Indications for Use

510(k) Number (if known): K034014

Device Name: SP1® CONTACT Dental Implant

Indications For Use:

The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either The Thomment SFI® CONTAOT Dentar Instillation or mandibular arch to provide support for
immediately or delayed, in the bone of the maxillary or mandibular if immediately of delayed, in the bono of the makinaly opplants can be loaded immediately in the crowns, brouges of overdentures: OF IC CONTATIO Filmplants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implants Ø 3.5 mm:

Contrainalcations for the use of OF IO of to of the pronounced rotation and These Implants are not sultable for applications in threas miected to large bending moments.
translation movements occur, causing the implant to be subjected to large bendin

- ranblation of posterior teeth in the upper or lower jaw - Restoration of posterior tooth in the apper in the upper jaw
-
- Any application involving retentive anchors.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suger Rume

Division of Anesthesiology, General Hospital, Infection Control, Dental Dev

510(k) Number: K031014

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