SPI EASY TEMPORARY CAP

K051527 · Thommen Medical AG · NHA · Jul 28, 2005 · Dental

Device Facts

• Record ID: K051527
• Device Name: SPI EASY TEMPORARY CAP
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Jul 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Thommen SPI® EASY Temporary 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. It is used to protect the coronal surface of the abutment and to serve as a base for a temporary restoration.

Device Story

SPI® EASY Temporary Cap is an endosseous dental implant component; used in conjunction with SPI® System dental implants. Device protects coronal surface of abutment from damage; prevents patient tongue injury; serves as base for temporary restoration fabrication. Used in dental clinic setting by dental professionals. Device maintains gingival contour during temporary restoration phase. Benefits patient by providing functional/protective temporary cover during final restoration fabrication.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Endosseous dental implant component; non-sterile; complies with ISO 10993-1 for biocompatibility. Sized to fit SPI® EASY abutments; compatible with SPI® System dental implants.

Indications for Use

Indicated for patients requiring temporary dental restorations supported by SPI® System dental implants in the maxillary or mandibular arch; used to protect abutment coronal surfaces and provide a base for temporary restoration fabrication.

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

• Thommen Medical AG SPI® Dental Implant System (K033346, K023645, K031747)
• Straumann USA Abutments (K041070)

Submission Summary (Full Text)

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510(k) Summary

SPI® Easy Temporary Cap

# 16051527

### Thommen Medical AG 510(k) Premarket Notification SPI® EASY Temporary Cap

#### ADMINISTRATIVE INFORMATION

Thommen Medical AG Manufacturer Name: Hauptstrasse 87 CH-4437 Waldenburg Switzerland Telephone [phone] FAX [phone]

Official Contact:

Orlando Antunes

DEVICE NAME

Classification Name: Trade/Proprietary Name: Common Name:

Abutment, Implant, Dental, Endosseous SPI® EASY Temporary Cap Endosseous Dental Implant System Component

#### ESTABLISHMENT REGISTRATION NUMBER

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

#### DEVICE CLASSIFICATION

Endosseous dental implant abutments are Class II devices (21 CFR 872.3630). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implant abutments have No performanos claindares applied the SPI® EASY Temporary Cap is made complies with ISO 10993-1.

PREDICATE DEVICE INFORMATION

The predicate devices for this modification are Thommen Medical AG SP1® Dental The production and hoto ents cleared by FDA under K033346, K023645 and K031747, and Straumann USA Abutments cleared by FDA under K041070.

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## 510(k) Summary NG/LABELING/PRODUCT INFORMATION

Thommen SPI® EASY Temporary Cap will be packaged and sold non-sterile.

#### INTENDED USE

The Thommen SPI® EASY Temporary 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. It is used to protect the coronal surface of the abutment and to serve as a base for a temporary restoration.

#### DEVICE DESCRIPTION

#### Design Characteristics

The Thommen SPI® EASY Temporary Cap is an endosseous dental implant component used for maintaining the gingival contour and as a base for a fabrication of a temporary restoration. It 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 Temporary Cap will be offered in sizes to fit all SPI® EASY abutments and may be used with all SPI® System dental implants.

#### EQUIVALENCE TO MARKETED PRODUCT

The SPI® EASY Temporary Cap has the following similarities to the predicate devices:

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

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2005

Thommen Medical, AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K051527

Trade/Device Name: SPI® Easy Temporary Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 7, 2005 Received: June 8, 2005

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 Eederal 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 (OS) 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/industry/support/index.html.

Sincerely vours.

Suvie Y. Michael Ovis.

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

Applicant: Thommen Medical AG

510(k) Number (if known): K051527

Device Name: SPI® EASY Temporary Cap

Indications for Use:

The Thommen SPT® EASY Temporary Cap is intended to be used in conjunction with She mayillars and/or The Thounnell STT ENDT Temporary Cap Is was bridges or overdentures in the maxidlary and/or dellual implans, which provide bappen les coronal surface of the abutment and to provide a base for fabrication of temporary restorations.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

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510(k) Number: K051527