The Spline Twist implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Device Description

Spline Twist implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Sulzer Dental Inc. Spline Twist dental implant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML medical devices.

The document focuses on comparing the Spline Twist implant's characteristics (intended use, indications, design, material, dimensions, surface, packaging, and sterilization) to existing predicate dental implants (Branemark System and ITI Implants) to establish substantial equivalence.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set size) as this information is not present in the provided text. The document is about a physical dental implant, not an AI/ML device, and thus the structure of evaluation is very different.

Summary

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JAN 1 8 2002

KOI3494

510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

Company Name:	Sulzer Dental Inc.
Address:	1900 Aston Avenue, Carlsbad, CA 92008-7308
Telephone Number:	760-929-4104
Registration Number:	2023141
Contact Person:	Foster Boop
Date Summary Prepared:	January 16, 2002
Classification Name:	Implant, Endosscous (76DZE)
Common/Usual Name:	Dental Implant
Device Trade Name:	Spline Twist

The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374).

1. Intended Use:

Sulzer Dental's implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

a) Description:

Spline Twist implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

b) Technological Characteristics:

There have been no modifications to the Spline Twist implants. There has been no change to the implant materials or to the implant/abutment interface.

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c) Comparison Analysis:

Carlos Concession Comers

The overall design of the Spline Twist implants are similar to the predicate implants. See Table 1 below for a comparison of the Advent and Swiss Plus implants and the predicate devices.

Characteristic	Branemark System	ITI Implants	Spline Twist
Intended Use	Intended to be placed in theupper or lower jaw tosupport prosthetic devices,such as artificial teeth, andto restore a patientschewing function. Thismay be accomplished usingeither a two stage surgicalprocedure or a single stagesurgical procedure.	Intended for surgicalplacement in themaxillary and/ormandibular archesto provide supportfor prostheticrestorations inedentulous orpartially edentulouspatients.	Intended for surgicalimplantation in edentulousmandibles or maxillae forattachment of completedenture prostheses, or as aterminal or intermediaryabutment for fixed orremovable bridgework, or as afreestanding single toothreplacement.
Indication	Immediate Load	Immediate Load	Immediate Load
Design	Threaded, root form implant	Threaded, root formimplant	Threaded, root form implant
Placement Method	Two or Single StageSurgery	Single StageSurgery	Two or Single Stage Surgery
Material	Commercially PureTitanium	Commercially PureTitanium	Titanium alloy
Diameter (mm)	3.75mm and 4.0mm	3.3mm, 4.1mm and4.8mm	3.75mm & 5.0mm
Lengths	10mm - 18mm	8mm - 16mm	8mm - 18mm*
ImplantSurface	MachinedRoughened - TiUnite	TPS coatedRoughened -SandblastedLargegrit Acidwashed (SLA)	HA coatedorRoughened - HA blasted
Packaging	Glass ampoule in peel-openblister pack	Ampoule	Vial inside rigid PETG tray
Sterilization	Dry heat	Gamma irradiation	Gamma irradiation

	Table 1: Summary of Comparison

The use of implants with length less than 10mm are not recommended for immediate load use

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Mr. Foster Boop Manager, Submissions & Complaints Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K013494

Trade/Device Name: 3.75MM and 5.0MM Spline Twist Implant Regulation Number: 872.3640 Regulation Name: Dental Implant or Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 19, 2001 Received: October 22, 2001

Dear Mr. Boop:

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.

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Page 2 - Mr. Boop

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: 3.75mm & 5.0mm Spline Twist

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
OR	Over-The-Counter-Use(Optional Format 1-2-96)
(Division Sign-Off)Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K013494

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.