K Number

Device Name

SPI ELEMENT DENTAL IMPLANT O 3.5 MM

Manufacturer

THOMMEN MEDICAL, AG

Date Cleared

2003-03-26

(21 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

The Thommen SPI " ELEMENT 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® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1 ELEMENT implants Ø 3.5 mm is recommended whenever possible. 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 (e.g. use of single implants for the restoration of canines). Partially edentulous lower and upper jaw: SPI® ELEMENT implants Ø 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw. Edentulous lower jaw: 4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar Edentulous lower and upper jaw: Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants

Device Description

The previously cleared SP® ELEMENT Dental Implant K003045 is not a subject of this Special 510(k). The design of this implant has been modified to make a smaller diameter (3.5 mm) implant that will be marketed as the SPP ELEMENT Dental Implant Ø 3.5 mm. Other SPY ELEMENT Dental Implant System accessories have not been modified, are suitable for use with the modified implant, and will be sold under the SPP Dental Implant System name. The Thommen SPI® ELEMENT Dental Implant is a two-stage root formendosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in four lengths (8 mm, 11 mm, 14 mm, 17 mm) with one new diameter (3.5 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K003045, K901927

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.

Therapeutic

Yes
The device is a dental implant intended to provide "support for crowns, bridges or overdentures," which are used to restore oral function and aesthetics, thus serving a therapeutic purpose.

Diagnostic

Explanation: The device description states that the product is a "Dental Implant," which is a surgically placed device intended to provide support for crowns, bridges, or overdentures. Its purpose is to replace missing teeth or provide support for dental prostheses, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a "two-stage root form endosseous dental implant made of commercially pure grade titanium," which is a physical hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is "intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures." This describes a surgical implant used in vivo (within the body) for structural support.
Device Description: The description details a "two-stage root form endosseous dental implant made of commercially pure grade titanium." This further confirms it's a physical implant for surgical placement.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Thommen SPI ELEMENT 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® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1 ELEMENT implants Ø 3.5 mm is recommended whenever possible. 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 (e.g. use of single implants for the restoration of canines).

Partially edentulous lower and upper jaw:
SPI® ELEMENT implants Ø 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.

Edentulous lower jaw:
4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:
Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

The Thommen SPI® ELEMENT Dental Implant is a two-stage root formendosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in four lengths (8 mm, 11 mm, 14 mm, 17 mm) with one new diameter (3.5 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and/or mandibular arch

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K003045, K901927

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Thommen Medical AG
Hauptstrasse 87
CH-4437 Waldenburg
Switzerland
Telephone +41 61 965 90 20
FAX +41 61 965 90 21 | MAR 2 6 2003 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | Orlando Antunes | |

DEVICE NAME

Classification Name:	Implant, Endosseous (DZE)
Trade/Proprietary Name:	SPI® ELEMENT 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, 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 manufactureThommen dental implants meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.

PREDICATE DEVICE INFORMATION

The principal predicate devices for this modification are the HA-Ti Dental Implants, cleared by FDA on July 12, 2001 under K003045 and on Jan 04, 1991 under K901927. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG and has renamed it the SP1 Dental Implant System, inclusive of the SP10 ELEMENT Dental Implant.

PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SP10 ELEMENT Ø 3.5 mm dental implants will be packaged in a radiationsterilizable 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 25kGy (2.5 Mrad). Sterlization will be validated by the bioburden method, according to ISO 11137 (Sterilization of Health Care Products - Radiation Sterilization). The sterility assurance level (SAL) thatThommen Medical AG intends to meet for the SPP ELEMENT Dental Implant Ø 3.5 mm is 10°. The device is not represented to be "pyrogen free."

INTENDED USE

The Thommen SPY ELEMENT 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.

SP® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1® ELEMENT implants Ø 3.5 mm is recommended whenever possible.

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 (e.g. use of single implants for the restoration of canines).

Partially edentulous lower and upper jaw:

SP1® ELEMENT implants Ø 3.5 mm are suitable foralloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.

Edentulous lower jaw:

4 SP1® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:

Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mmSPI implants

Contraindications for the use of SPP ELEMENT implant Ø 3.5 mm:

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

EQUIVALENCE TO MARKETED PRODUCT

The modified SP1® ELEMENT Dental Implant Ø 3.5 mm has the following similarities to the predicate SPI® ELEMENT Dental Implant:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design, (with the addition of a new diameter),
· incorporates the same materials, and
· is packaged and sterilized using the same materials and processes.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

MAR 2 6 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: K030689

Trade/Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 4, 2003 Received: March 4, 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, 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.

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Romer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Applicant: Thommen Medical AG

KO30689 510(k) Number:

Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm

Indications for Use:

Partially edentulous lower and upper jaw:

SPI® ELEMENT implants Ø 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.

Edentulous lower jaw:

4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:

Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants

Contraindications for the use of SPI® ELEMENT implant 9 3.5 mm:

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

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

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but I'm not doing that. I'm doing something else.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

Kevin Mulry for MSR

n-On)
nesthesiology, General Hospital, trol. Dental Device

lection Control, Et
510(k) Number: K030689