SPI ONETIME DENTAL IMPLANT

K022038 · Paxmed International · DZE · Jul 15, 2002 · Dental

Device Facts

• Record ID: K022038
• Device Name: SPI ONETIME DENTAL IMPLANT
• Applicant: Paxmed International
• Product Code: DZE · Dental
• Decision Date: Jul 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thommen SP1® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures, SP1® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

Device Story

One-piece, one-stage root form endosseous dental implant; surgically placed in maxillary or mandibular bone by dental professionals. Provides support for crowns, bridges, or overdentures. Immediate loading permitted only when splinted with bar on four (mandibular) or six (maxillary) implants. Commercially pure grade 4 titanium construction; smooth machined transgingival portion; sandblasted and acid-etched bone-contacting surface. Available in 8mm, 11mm, 14mm lengths and 4.2mm, 5.0mm diameters. Benefits include structural support for dental prosthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

Material: Commercially pure titanium Grade 4 (ASTM F67, ISO 5832-2). Form: One-piece, one-stage root form endosseous implant. Surface: Smooth machined (transgingival) and sandblasted/acid-etched (bone-contacting). Sterilization: Co60 gamma irradiation (25 kGy nominal dose) per ISO 11137. Dimensions: 8-14mm length, 4.2-5.0mm diameter.

Indications for Use

Indicated for patients requiring dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures. Immediate loading is indicated only when splinted with a bar on four implants (mandibular) or six implants (maxillary).

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 Medical AG HA-Ti Dental Implant (K003045)

Submission Summary (Full Text)

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510(k) Summary

### SPI® ONETIME Dental Implant

Page 1 of 2

### ADMINISTRATIVE INFORMATION

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

### DEVICE NAME

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

## ESTABLISHMENT REGISTRATION NUMBER

Thommen Medical AG has submitted an Establishment Registration to FDA. The Establishment Registration number has not yet been assigned. 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, Endosseous" is DZE.

# CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implants have been established by FDA. However, CP titanium Grade 4 used to manufacture the Thommen dental implant meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.

# PREDICATE DEVICE INFORMATION

The principal predicate device for this modification is the Thommen Medical AG HA-Ti Dental Implant, cleared by FDA on July 12, 2001 under K003045. Thommen Medical AG has acquired the rights to the HA-Ti system from HATI Dental AG.

# PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® ONETIME implants will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping. The sterile packs will be grouped into storage packs. Sterilization 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 Thommen Medical AG intends to meet for the SPI® ONETIME Dental Implant is 106. The device is not represented to be "pyrogen free."

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#### INTENDED USE

The Thommen SP1® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures, SP1® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

### DEVICE DESCRIPTION

The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name.

The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,

### EQUIVALENCE TO MARKETED PRODUCT

The modified SPI® ONETIME Dental Implant has the following similarities to the predicate HA-Ti Dental Implant:

- · has the same intended use.
- · uses the same operating principle,

.

- · incorporates the same basic design, (with the addition of a transqingival portion)
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### JUL 1 5 2002 . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Floyd G. Larson Consultant PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K022038

Trade/Device Name: SPI® ONETIME Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 21, 2002 Received: June 24, 2002

Dear Mr. Larson:

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.

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice

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# Page 2 - Mr. Larson ·

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timoth A. Uluturk

Timo 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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K 022 038

Applicant: Thommen Medical AG

510(k) Number: K022038

Device Name: SPI® ONETIME Dental Implant

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use ------

Susan Runn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_40000

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