An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Device Description

The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.

AI/ML Overview

This 510(k) submission (K040946) for the ANKYLOS® Dental Implant System does not contain a study to prove the device meets acceptance criteria related to performance metrics, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study. This submission is primarily focused on presenting additional instructions for use sheets for a device that has already been cleared (predicate 510(k) K012681).

Therefore, many of the requested elements for describing a study are not applicable to this particular submission. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through a new study.

Here's an breakdown based on the provided text, indicating what is present and what is not:

Acceptance Criteria and Device Performance

Acceptance Criteria (for 510(k) Clearance)	Reported Device Performance (as claimed for Substantial Equivalence)
Substantially equivalent in design	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of design.
Substantially equivalent in materials	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of materials.
Substantially equivalent in coatings	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of coatings.
Substantially equivalent in mechanical strength	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of mechanical strength.
Substantially equivalent in prosthetic options	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of prosthetic options.
Substantially equivalent in indications for use	The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of indications for use. The specific indications are for surgical placement in upper or lower jaw arches, to provide a root form for single or multiple unit prosthetic appliance attachment to restore chewing function. Implants can use 2-stage or single-stage (immediate loading) processes, with immediate loading restricted to the anterior mandible (4 interforaminal placed implants, not single, unsplinted).
No change in system and methodology of implantation	The system and methodology of implantation has not changed with the new labeling.
No change in technological characteristics	The technological characteristics of the ANKYLOS® Dental Implant System have not changed with the addition of the new labeling.

Summary of the "Study" (or basis for clearance):

This submission is a "Special 510(k)" or a similar type where the changes are minimal and do not impact safety or effectiveness. The "study" here is a comparison to a predicate device (Dentsply Ceramco ANKYLOS® Dental Implant System, K012681) to demonstrate substantial equivalence, particularly because the primary purpose of this specific application is to present "additional instructions for use sheets." The manufacturer asserts that design, materials, coatings, mechanical strength, prosthetic options, indications for use, system and methodology of implantation, and technological characteristics have not changed.

Non-Applicable or Not Provided Information from the Text:

Due to the nature of this 510(k) (updates to labeling for an already cleared device), the following information, which would typically be present for a clinical or performance study, is not provided in the given text:

Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
Adjudication method for the test set: Not applicable. No test set needing adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-based device, and no standalone algorithm performance is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There's no performance evaluation generating new data that would require a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
The sample size for the training set: Not applicable. This is not an AI-based device, and no training set is mentioned.
How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary

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K040946

JUL 0 1 2004

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 15.1

a.	Company Name:	FRIADENT GmbH.
b.	Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c.	Company Phone:Company Facsimile:	(011) 49 06 21 4 86 1549(011) 49 06 21 4 86 1866
d.	Contact Person:	Heike DietzlerRegulatory Affairs Manager
e.	Date Summary Prepared:	April 7, 2004
	DEVICE IDENTIFICATION
a.	Trade/Proprietary Name:	ANKYLOS® Dental Implant System

b. Classification Name:	Endosseous Dental Implants21 CFR 872.3640
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15.3 IDENTIFICATION OF PREDICATE DEVICES

Company	Device	510(k) No.	Date Cleared
Dentsply Ceramco	ANKYLOS® Dental ImplantSystem	K012681	08/22/2003

15.4 DEVICE DESCRIPTION

15.2.

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K040946

SUBSTANTIAL EQUIVALENCE ાર્સ્ડ

The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and indications for use.

15.6 INTENDED USE

The ANKYLOS® dental implant is an endosseous dental implant that is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient's must be subject for dental treatment with endosseous implants.

15.7 TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the ANKYLOS® Dental Implant System have not changed with the additional of the new labeling.

15.8 CLASS III CERTIFICATION AND SUMMARY

This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.

15.9 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewers Checklist is provided in this submission. Comparison of the ANKYLOS dental implant systems to the predicate device show that the device is substantially equivalent.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes above a wavy line, representing water or movement.

JUL 0 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FRIADENT GmbH C/O Ms. Carol Patterson President Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630

Re: K040946

Trade/Device Name: ANKYLOS® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 7, 2004 Received: April 12, 2004

Dear Ms. Patterson:

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.

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Page 2 - Ms. Patterson

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,

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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INDICATION FOR USE

K040946 510(k) Number:

Device Name:

ANKYLOS® Dental Implant System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Penner

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

510(k) Number:	K040946
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Prescription Use	✓	OR	Over-The-Counter Use
------------------	--------------	----	----------------------	--

(Per 21 CFR 801.109)CONFIDENTIAL

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.