Sulzer Dental 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. The 3.15mm implant is recommended for use in the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

Device Description

Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. This document is a 510(k) summary for a dental implant, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request with the given input.

Summary

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SEP = 6 2001

1012055

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:	760-431-9515
Registration Number:	2023141
Contact Person:	Foster Boop
Date Summary Prepared:	September 5, 2001
Classification Name:	Implant, Endosseous (76DZE)
Common/Usual Name:	Dental Implant
Device Trade Name:	3.15mm Spline Twist

The primary device used for comparison in this summary is Sulzer Dental's existing Spline Cylinder and Spline Twist implants. All implant systems are manufactured in the same facility located in Carlsbad, California.

1. Intended Use:

The intended use of the Small Diameter Spline Twist implant is identical to the intended use of the predicate implants. Sulzer Dental 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.

Sulzer Dental recommends the Small Diameter Spline Twist implant for use in the Suizer Dental recomment the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

2. Description:

3. Technological Characteristics:

The Spline Dental Implant line has been modified to include a 3.15mm diameter The threaded design includes self-tapping capabilities. The threaded implant. implantabutiment interface remains unchanged. There has been no change to the implant materials or to the implant/abutment interface.

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4. Comparison Analysis:

The overall design of the Spline Twist implant is similar to the predicate implant. The Overal debigin of a comparison of the Spline Twist implant and the predicate device.

Feature	Small Diameter Spline Twist Implant	Predicate Device K944327 & K946311	Predicate Device K962106
Implant body geometry	Tapered, Self-Tapping Screw	Cylinder	Self-Tapping Screw Type
Implant Lengths	10, 11.5, 13, 15 & 18mm	8, 10, 13, 15 & 18mm	8, 10, 13, 15 & 18mm
Implant Body Diameter	3.15mm	3.25mm	3.75mm & 5.0mm
Implant Material	Titanium alloy	Same	Same
Implant Surface	Roughened	HA coatedTPS coated	Roughened
Implant/Abutment Interface	Spline tine anti-rotational interface	Same	Same
Abutment Options	Fixed, Preangled, Shouldered, Overdenture & Gold copings	Same	Same
Manufacturing Site	Carlsbad, CA.	Same	Same
Packaging	Vial inside PETG tray sealed with Tyvek lid	Same	Same
Sterile	Yes	Yes	Yes

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three heads, depicted in a simple, black line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 6 2001

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

Re: K012055

Trade/Device Name: 3.25mm Spline Twist Implant Regulation Number: 21 CFR 872.3640 Regulation Name: D Dental Implant Regulatory Class: Class III Product Code: DZE Dated: June 29, 2001 Received: July 2, 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. 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.

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Page 2 - Mr. Boop

This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to ocelli manetang your seubstantial equivalence of your device to 510(K) premarket nonition. "The ID: 14 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 IT you desire specific ad rice to: your for in vitro diagnostic devices), please contact the allu additionally 27 CLN Part 609110 103. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promot Office of Comphance at (301) 89 : "The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, produce in to regul 807.97). Other general information on your responsibilities under notification (21GFF Part 601197). Villion of Small Manufacturers, International and the Act may be obtained from the Briumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Timothy A. 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): _ K012055

Device Name: 3.15mm Spline Twist Implant

Indications for Use:

Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae Suizer Denal informati Bysteins the prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would use of the 5.0mm implant larger than 4.0mm. The 3.15mm implant is recommended diciale the asc or an implant surger axillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)
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	Over-The-Counter-Use(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K02055

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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.