K Number
K090154
Device Name
SPI DENTAL IMPLANT INICELL
Date Cleared
2009-07-27

(186 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw - Single-tooth restoration of canines and central incisors in the upper jaw - Any application involving retentive anchors
Device Description
The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.
More Information

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Not Found

No
The summary describes a dental implant with a new surface treatment. There is no mention of AI or ML in the intended use, device description, or any other section.

Yes
The device is described as an implant used for restoring chewing function and is applied through surgical procedures, which indicates a therapeutic purpose.

No

This document describes a dental implant, which is a restorative device used to replace missing teeth, not a device used to diagnose a medical condition.

No

The device description clearly states it is an "endosseous dental implant," which is a physical hardware device, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description: The description clearly states that the device is an "endosseous dental implant." This is a device surgically placed within the bone to support a dental prosthesis.
  • Intended Use: The intended use describes the surgical procedures and applications for restoring chewing function with dental implants. This is a therapeutic and restorative purpose, not a diagnostic one involving analysis of bodily specimens.

The information provided focuses on the surgical placement and function of a dental implant, which is a medical device used in vivo (within the body), not in vitro (in glass/outside the body).

N/A

Intended Use / Indications for Use

SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

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

Product codes

DZE

Device Description

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

0

510(k) Summary

1

SPI® Dental Implant, INICELL®

Kogo154

510(k) Summary

Thommen Medical AG SPI® Dental Implant, INICELL®

JUL 2-7 2009

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21

Official Contact:

Representative/Consultant:

Orlando Antunes

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code Classification Panel: Reviewing Branch:

SPI® Dental Implant, INICELL® Endosseous dental implant Implant, Endosseous, Root-Form 21 CFR 872.3640, Class II DZE Dental Products Panel Dental Devices Branch

INTENDED USE

SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

1

510(k) Summary

11090154

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

  • Restoration of posterior teeth in the upper and lower jaw ●
  • Single-tooth restoration of canines and central incisors in the upper jaw �
  • . Any application involving retentive anchors

DEVICE DESCRIPTION

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

EQUIVALENCE TO MARKETED DEVICES

Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI Dental Implant, INICELL is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices. Overall, the SPI Dental Implant, INICELL 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
  • . has similar packaging and is sterilized using the same materials and processes.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thommen Medical AG C/O Linda Schulz, RDH, BSDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

JUL 2 7 2009

Re: K090154

Trade/Device Name: SPI® Dental Implant, INICELL® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 20, 2009 Received: July 22, 2009

Dear Ms.Schulz:

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 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- Ms.Schulz

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number (if known): _ KO90154

SPI® Dental Implant, INICELL® Device Name:

Indications for Use:

SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

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

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

(Division Sign-Off)Kein Marley for HSN
------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:K090154
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