SPI EASY DENTAL IMPLANT PROTECTIVE CAP

K033346 · Thommen Medical AG · NHA · Nov 3, 2003 · Dental

Device Facts

• Record ID: K033346
• Device Name: SPI EASY DENTAL IMPLANT PROTECTIVE CAP
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Nov 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.

Device Story

SPI® EASY Dental Implant Protective Cap; endosseous dental implant component; fabricated from PEEK. Used in dental clinic setting by clinicians. Functions to maintain gingival contour; protects coronal aspect of abutment from damage; prevents tongue injury during final restoration fabrication. Placed after gingiva former removal and abutment placement; prior to final restoration. Benefits patient by protecting oral tissues and preserving site architecture during interim period.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Polyetheretherketone (PEEK) compliant with ASTM F2026. Form factor: Protective cap for dental abutments. Non-sterile. No energy source. No software.

Indications for Use

Indicated for patients requiring dental implant support for crowns, bridges, or overdentures in the maxillary or mandibular arch. Used in conjunction with SPI® System dental implants.

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

• SPI® Dental Implant System Gingiva Former (K031747)
• SPI® Dental Implant System Gingiva Former (K023645)

Submission Summary (Full Text)

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# NOV - 3 2003

#### ADMINISTRATIVE INFORMATION

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K033346

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| Manufacturer Name: | Thommen Medical AG<br>Hauptstrasse 87<br>CH-4437 Waldenburg<br>Switzerland<br>Telephone [phone]<br>FAX [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Orlando Antunes |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International<br>4329 Graydon Road<br>San Diego, CA 92130<br>Telephone: [phone]<br>FAX: [phone] |

### DEVICE NAME

| Classification Name: | Abutment, Implant, Dental, Endosseous (NHA |
|-------------------------|--------------------------------------------|
| Trade/Proprietary Name: | SPI® EASY Dental Implant Protective Cap |
| Common Name: | Endosseous Dental Implant System component |

### ESTABLISHMENT REGISTRATION NUMBER

Thommen Medical AG has submitted an Establishment Registration to FDA. The Establishment Registration number 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 "Abutment, Implant, Dental, Endosseous" is NHA.

### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implant abutments have been established by FDA. The polyetheretherketone (PEEK) raw material from which the SPI® EASY Dental Implant Protective Cap is made complies with ASTM F2026.

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#### PREDICATE DEVICE INFORMATION

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The predicate device for this modification is the SPI® Dental Implant System Gingiva Former, cleared by FDA on July 2, 2003 under K031747 and on November 13, 2002 under K023645.

#### PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI®EASY Dental Implant Protective Cap will be packaged and sold nonsterile. The device is not represented to be "pyrogen free."

#### INTENDED USE

The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.

### DEVICE DESCRIPTION

The Thommen SPI® EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated.

The Protective Cap will be offered in sizes to fitall SPI® EASY abutments and may be used with all SPI® System dental implants.

### EQUIVALENCE TO MARKETED PRODUCT

The SPI® EASY Dental Implant Protective Cap has the following similarities to the predicate SPI® Dental Implant Gingiva Former:

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

In summary, the Thommen SP1® EASY Dental Implant Protective Cap described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Public Health Service

NOV - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K033346

Trade/Device Name: SPI® EASY Dental Implant Protective Cap Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: October 17, 2003 Received: October 20, 2003

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, Druz, 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. Larson

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 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), please contact the Office of Compliance 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 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,

Pastora Cuente yfor

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

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## Special 510(k): Device Modification

- SPI® EASY Dental Implant Protective Cap
Applicant: Thommen Medical AG

510(k) Number:

Device Name: SPI® EASY Dental Implant Protective Cap

Indications for Use:

The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _V

OR

Over-The-Counter Use

Susa Rumpf
(Division Sign-Off)

510(k) Number: