ZUGA DENTAL IMPLANT SYSTEM by ZUGA MEDICAL, INC.

The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading

Device Description

The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures.

Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing.

The implants are provided sterile, the remaining components must be sterilized prior to use.

AI/ML Overview

The Zuga™ Dental Implant System is a dental implant device, therefore no AI or algorithm performance data is available.

Here's the information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Type)	Standard/Criterion	Reported Device Performance
Mechanical Testing	ISO 14801 (Fatigue testing of dental implants)	Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: . Mechanical testing per ISO 14801." This typically means the device demonstrated acceptable fatigue strength and other mechanical properties as defined by the standard.
Cytotoxicity Testing	ISO 10993-5 (Biological evaluation of medical devices – Tests for in vitro cytotoxicity)	Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Cytotoxicity testing per ISO 10993-5." This indicates the device materials were found to be non-cytotoxic under the tested conditions.
Surface Analysis	Not a specific standard, but techniques like FTIR & SEM-EDS were used.	Not explicitly stated in quantitative terms. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Surface analysis by FTIR & SEM-EDS." This typically means the surface characteristics (e.g., elemental composition, surface topography, cleanliness) were analyzed and found to be consistent with the intended design and predicate devices.

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

Sample Size: Not explicitly stated for each test. For mechanical testing (ISO 14801), multiple samples of each implant size/design would typically be tested. For cytotoxicity, a specified number of samples or extracts would be tested.
Data Provenance: The data is "pre-clinical testing" and was conducted by Zuga Medical Inc. There is no information regarding the country of origin of the specific lab that performed the tests. This is not human data, so terms like "retrospective" or "prospective" are not applicable.

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

This information is not applicable as the studies are pre-clinical (laboratory and bench testing) and do not involve human expert assessment of outcomes or images. The "ground truth" for these tests are the established parameters and passing criteria defined by the ISO standards and accepted engineering principles.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for discrepant interpretations in human reader studies, which were not conducted here.

5. 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. The submission explicitly states: "No clinical data was used in support of this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the pre-clinical tests (mechanical, cytotoxicity, surface analysis) is defined by the established international standards (ISO 14801, ISO 10993-5) and generally accepted engineering and material science principles. These standards set the benchmarks and criteria for acceptable performance and material safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" as this is not an AI/ML device.

Summary

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K1226664

510(k) Summary

Date: Sponsor: 30 August 2012

APR 3 0 2013

Contact Person: Trade Names: Device Classification

Classification Names:

Regulation:

Device Product Codes: Device Description:

Indications for Use:

Materials:

Predicate Devices:

Zuga Medical Inc. 1163 East 40th Street, Suite 202 Cleveland, OH 44114 Phone: 216.292.5910 Facsimile: 216.292.5911

Chan Wang, CEO

Zuga™ Dental Implant System

Class II

Implant, endosseous, root-form & Abutment, implant, dental. endosseous

872.3640

DZE & NHA

The implants are provided sterile, the remaining components must be sterilized prior to use.

The Zuga Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Zuga™ Dental Implant System components including implant, abutments, sealing caps and gum shapers are manufactured from titanium (Grade 4) as described by ASTM F67. The Zuga™ Dental Implant System fixation screw is manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.

Reliadent Dental Implant System (K043428 and K061323) Biomet 3i Certain® System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071161)

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Technological Characteristics: The fundamental scientific technology of the Zuga™ system is the same as previously cleared devices as shown below, i.e., each of the Zuga design features is common to one or more of the predicates.

System:	Zuga	Reliadent	Biomet 3i	KAT	SouthernImplants
Material ofmanufacture:	Titanium	Titanium	Titanium,Titanium alloy	Titanium alloy	Titanium
Design:
Endosseous implant	Root-form,Straight	Root-form,Straight	Root-form,Straight andtapered	Root-form,Straight andtapered	Root-form,Straight andtapered
Method ofstabilization	Threadedfixation	Threadedfixation	Threadedfixation	Threadedfixation	Threaded fixation
Range of Diameters	3.5 – 5.5mm	3.0 – 5.5mm	3.25 – 6mm	2.5 – 8mm	–
Range of Lengths	8 – 17mm	8 – 16mm	8.5 – 20mm	6 – 14mm	–
Surface treatment	Yes, Al2O3blasted,passivated	Yes, Titaniumblasted andacid etched	Yes, acidetched	Yes, Al2O3blasted,passivated	Yes, Al2O3blasted
Color-coding	Seating surface	Anodizedseating	Seating surface	None	None
Sterilization	Sterile, gammaradiation	Sterile, gammaradiation	Sterile, gammaradiation	Sterile, gammaradiation	Sterile, gammaradiation
Abutments	Standard	Standard,angled	–	Standard,angled	Standard, angled
Sterilization	Non-sterile	Non-sterile	–	Non-sterile	–
Connection toimplant	Hex alignment,screwattachment	Hex alignment,screwattachment	–	Indexing keyalignment, 1.5°locking taper,screwattachment	–
Color-coding	Connectioninterface	Connectioninterface	–	–	–

Performance Data:

Pre-clinical testing of the Zuga™ Dental Implant System included:

. Mechanical testing per ISO 14801
Cytotoxicity testing per ISO 10993-5 .
. Surface analysis by FTIR & SEM-EDS

No clinical data was used in support of this submission.

Conclusion:

The Zuga™ Dental Implant System devices possess the same intended use and technological characteristics as the predicate devices. This with the information provided in the submission permit the conclusion that the Zuga™ Dental Implant System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2013

Zuga Medical, Incorporated C/O Karen E. Warden, PhD President ---BackRoads Consulting, Incorporated P.O. Box 566 CHESTERLAND OH 44026-2141

Re: K122664

Trade/Device Name: Zuga™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 16, 2013 Received: April 18, 2013

Dear Dr. Warden:

We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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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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 devicerelated 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K122664

Indications for Use Statement

510(k) Number: K122664

Device Name: Zuga™ Dental Implant System

Indications for Use:

Prescription Use _______________ OR Over-the-Counter Use_

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Mary S. Runner-5
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Susan Runner, DDSMAcn=Mary S. Runner-5.
0.9.2342.19200300.100.1.1=1300087
950
Date: 2013.04.29 15:57:18-04'00

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

510(k) Number: K122664

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.