The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Description

Euroteknika's range of implants refer to sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.

AI/ML Overview

Here's an analysis of the provided text regarding the dental implants' acceptance criteria and study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K083670 is a 510(k) summary for dental implants. 510(k) submissions primarily focus on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for novel device functions like an AI algorithm. Therefore, explicit, quantitative acceptance criteria and corresponding performance metrics are not present in the provided document.

Instead, the "performance" demonstrated is that the Euroteknika dental implants (AESTHETICA, UNIVERSAL, NATURA, NATEA) were found to be substantially equivalent to their listed predicate devices. This equivalence is based on:

Identical Intended Use: All devices share the same intended use: "surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients."
Similar Design and Material: The devices are described as "sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement." This description aligns with the common materials and forms for dental implants, implicitly similar to the predicate devices.
Laboratory Testing: The document states, "Laboratory testing was conducted to determine device functionality and conformance to design requirements." While the specific tests and their passing criteria are not detailed, the conclusion drawn is that the devices are "Substantially equivalent to the cited predicate devices."

Therefore, the "acceptance criteria" is implicitly that the new devices perform comparably to predicate devices in terms of safety and effectiveness for their intended use, as demonstrated through laboratory testing.

Acceptance Criteria (Implicit from 510(k) process)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Achieved; "Substantially equivalent to the cited predicate devices"
Conformance to Design Requirements (via lab tests)	Achieved; "Laboratory testing was conducted to determine device functionality and conformance to design requirements."
Identical Intended Use	Achieved; Intended Use for all devices is identical to predicate device's presumed use.
Similar Materials and Design	Achieved; Made of pure titanium (grade iv) and titanium alloy (TA6V).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of an AI algorithm or a clinical study with a specific patient sample size. The testing mentioned is "Laboratory testing" for functionality and conformance. Therefore, there is no information provided regarding a sample size for a test set, data provenance (country of origin, retrospective/prospective), or any human subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since this is not an AI or diagnostic device requiring human interpretation for a "ground truth" test set, there is no information provided regarding the number or qualifications of experts for establishing ground truth.

4. Adjudication Method for the Test Set

As there is no "test set" or human subject data requiring adjudication, there is no information provided regarding an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported. This submission is for a medical device (dental implant), not a diagnostic or AI-driven imaging device that would typically involve an MRMC study. Therefore, no effect size for human reader improvement with AI assistance is applicable or provided.

6. Standalone (Algorithm Only) Performance Study

This device is a physical dental implant, not an algorithm. Therefore, no standalone algorithm performance study was conducted or reported.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI or diagnostic studies (e.g., pathology, expert consensus) does not apply to this submission. The "truth" for this device rests on its physical and mechanical properties demonstrated through laboratory testing and engineering principles, showing it functions as intended and is comparable to existing, legally marketed devices.

8. Sample Size for the Training Set

This submission is for a physical medical device, not an AI algorithm. Therefore, there is no "training set" or sample size mentioned in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned (this being a physical device), this question is not applicable.

Summary

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K083670

1872

510(k) Summary

JUL 2 3 2009

Name/Address of Submitter: 1. Euroteknika
656 rue du Général de Gaulle 74700, Salanches, France

Contact Person: Emmanuel Montini Consultant, BCF Certification inc. Phone: (514) 397-6705 Fax: (514) 397-8515

1. Date Summary Prepared: October 22td, 2008
  Devices Name: AESTHETICA, UNIVERSAL, NATURA and NATEA 4.
ડ. Predicate Devices:

AESTHETICA	ITI Wide DiameterImplant(K 031055)	Zimmer (Sulzer Dental / Sulzer Medica)Swiss Plus Conical(K 011245)
UNIVERSAL	(Nobel Bränemark MkIII)(K 040643)	Innova Life 5.0x 5MM endopore Endosseousdental implant system(K 032140)
NATURA	Astra TechMicro-thread Fixtures(K 024111)	Zimmer (Sulzer Dental / Sulzer Medica) SwissPlus Conical(K 011245)
NATEA	Astra TechMicro-thread Fixtures(K 024111)	Zimmer (Sulzer Dental / Sulzer Medica) SwissPlus Conical(K 011245)

1. Devices Description: Euroteknika's range of implants refer to sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.

7. Intended Use:

Device Name: AESTHETICA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.

Device Name: UNIVERSAL

The device is intended for surgical placement in maxillary and/or Indication for Use: mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Name: NATURA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Name: NATEA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

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K083670

20g

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1 1 20

Brief Description of Clinical and Non-clinical Testings: Laboratory testing was 8. conducted to determine device functionality and conformance to design requirements.

Conclusion Drawn: Substantially equivalent to the cited predicate devices. 9.

· .......

. . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2-3 2009

Euroteknika C/O Mr. Emmanuel Montini Senior Consultant BCF Certification, Incorporated 1100 Rene-Levesque- Boulevard West-25th floor Montreal, Quebec Canada H3B 5C9

Re: K083670

Trade/Device Name: AESTHETICA, UNIVERSAL, NATURA and NATEA Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 13, 2009 Received: July 15, 2009

Dear Mr. Montini:

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- Mr. Montini

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 yours,

th toc

Susan Runner, D.D.S., M.A. Acting 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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K083670

Indication for Use

Device Name: AESTHETICA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Name: UNIVERSAL

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Name: NATURA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Device Name: NATEA

Indication for Use: The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Concurrence of CDRH Office of Device Evaluation

Prescription Use (per 21CFR 801.109) Over-the-counter Use

Ke. Mulay for WSE.

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

510(k) Number: K083670

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.