The SATURNO™ Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

Device Description

The SATURNO™ Overdenture Implant (SODI) System is a one-piece, self-tapping, threaded, root-form . dental implant with the abutment portion being either straight or angled for overdenture prosthetic attachment. SODI implants are provided in three diameters (2.0, 2.4 and 2.9 mm), three lengths (10, 12. and 14 mm) and two cuff heights (2.0 and 4.0 mm). Each size SODI implant has a 1.8 mm attachment ball and is available with a straight or 200 angled abutment section.

AI/ML Overview

The SATURNO™ Overdenture Implant System is a dental implant system designed to retain overdentures or partial dentures. The submission indicates that no clinical testing data was submitted, referenced, or relied upon to demonstrate substantial equivalence. Therefore, there is no study that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission states that "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to or stronger than the tested predicate device."

This means the acceptance criteria are not clinical performance measures but rather engineering and mechanical testing standards.

Here's a breakdown based on the provided text, while acknowledging the absence of a clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Engineering Analysis: Equivalence to predicate devices in design and characteristics.	The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment. Any differences in technological characteristics do not raise new issues of safety or efficacy.
Dimensional Analysis: Equivalence to predicate devices in physical dimensions.	The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment. Any differences in technological characteristics do not raise new issues of safety or efficacy.
Static and Dynamic Compression-Bending Testing: Performance according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.	Fatigue testing demonstrated the subject device to be equivalent to or stronger than the tested predicate device.

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

Since no clinical study was conducted or relied upon for this premarket notification, there is no "test set" in the context of patient data. The "test set" refers to the dental implants and materials used in the engineering and mechanical testing. The sample sizes for these non-clinical tests are not specified in the provided text. The data provenance is described as "Non-clinical testing data submitted."

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for patient outcomes. The acceptance criteria were based on established engineering standards (like ISO 14801) and comparisons to predicate devices, which would involve engineering expertise during the testing and analysis.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring adjuducation of patient outcomes.

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

No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical data were not submitted in this premarket notification." The focus was on demonstrating substantial equivalence through non-clinical testing.

6. Standalone Performance Study

No standalone performance study (in the context of an algorithm or human-in-the-loop performance) was done. The device is a physical medical device (dental implant system), and its performance was assessed through engineering and mechanical testing, not through an algorithmic or human-in-the-loop evaluation.

7. Type of Ground Truth Used

The "ground truth" for demonstrating equivalence was based on:

Established engineering standards: Specifically, ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
Comparison to predicate devices: The physical dimensions, characteristics, materials, and operating principles of the SATURNO™ Overdenture Implant System were considered "equivalent" to previously marketed and cleared devices.

8. Sample Size for the Training Set

This is not applicable. There was no "training set" in the context of machine learning. The "training" for this device involved its design and manufacturing process to meet the established engineering and safety standards.

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

This is not applicable. Since there was no "training set" in the machine learning sense, there's no ground truth establishment for it. The "ground truth" for the device's design and manufacturing revolves around adherence to established quality systems, materials science principles, and relevant engineering standards, as demonstrated through the non-clinical tests.

Summary

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510(k) Summary

SATURNOTM Overdenture Implant System

510(k) Summary

Zest Anchors, LLC

SATURNO™ Overdenture Implant System

October 28, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name

Zest Anchors, LLC 2061 Wineridge Place Escondido, CA 92029 Telephone: +1 (760) 743-7744 ext. 140 Fax: +1 (760) 743-7975

Official Contact

Representative/Consultant

Annie Wright Regulatory Affairs Manager

Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: . +1 (858) 792-1236 Email: LSchulz@paxmed.com KThomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name Common Name

Classification Name Classification Regulation Product Code

Classification Panel Reviewing Branch

SA TURNOTM Overdenture Implant System Dental implant

Implant, endosseous, root-form Class II, 21 CFR 872.3640 DZE

Dental Products Panel Dental Devices Branch

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INTENDED USE

The SATURNOTM Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Zest Anchors, LLC, LOCATOR® Overdenture, Implant System - K120198; IMTEC Corporation, IMTEC Sendax MDI and MDI Plus - K031106; IMTEC Corporation, MDI MII One-Piece Implant 2.9 - K081653;

Intra-Lock International, Inc., Mini Drive-Lock™ Dental Implant System - K070601.

Nor-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence. included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatıgue testing demonstrated the subject device to be equivalent to or stronger than the tested predicate device.

The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy ..

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Clinical data were not submitted in this premarket notification.

In conclusion, SATURNO™ Overdenture Implant System has the following similarities to the predicate devices:

has the same intended use. 。
. uses the same operating principle.
incorporates the same basic design, .
incorporates the same materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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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 stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with three curved lines forming its body and wings. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

June 25, 2014

Zest Anchors, LLC C/O Linda K. Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K133327

Trade/Device Name: SATURNO™ Overdenture Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 16, 2014 Received: June 18, 2014

Dear Ms. Schulz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Schulz

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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・・

SATURNO™ Overdenture Implant System

Indications for Use

510(k) Number: K133327

Device Name:

SATURNO™ Overdenture Implant System

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(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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Sheena
2014.06.25 11:27:59 -04'00'

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.