Who is the manufacturer of Zuga Dental Implant System?

Zuga Medical, Inc. filed the 510(k) submission for Zuga Dental Implant System (K171197).

What is the FDA product code for Zuga Dental Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Zuga Dental Implant System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Zuga Dental Implant System?

Zuga™ Dental Implant System (K122664); T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System (K152787); OCO Biomedical Fixed Solid O-Ball Abutment (K090174); Nobel Biocare AB NobelActive Multi-Unit Abutment (K072570); Reliadent Dental Implant System (K043428, K061323); Biomet 3i Certain System (K0100724); KAT Implants System Implants, KAT Implants System Implant Abutment (K083544); KAT Implants System Implants, KAT Implants System Straight Abutments (K101201); Southern Implants Endosseous Dental Implant System (K070841, K071161).

Who can help prepare an FDA 510(k) submission like Zuga Dental Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Zuga Dental Implant System

K171197 · Zuga Medical, Inc. · DZE · Jun 30, 2018 · Dental

Device Facts

Record ID	K171197
Device Name	Zuga Dental Implant System
Applicant	Zuga Medical, Inc.
Product Code	DZE · Dental
Decision Date	Jun 30, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2

Intended 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.

Device Story

Zuga Dental Implant System comprises endosseous dental implants, sealing/healing caps, abutments, and fixation screws. Implants are bone-level, self-tapping, root-form, threaded titanium. Components accommodate various patient anatomies for one- or two-stage surgical procedures. Implants are provided sterile; other components require sterilization by the clinician. Used by dentists/oral surgeons in clinical settings to restore chewing function. Output is a stable foundation for prosthetic devices. Benefits include restoration of dental function and aesthetics. Device is non-active, non-mechanical.

Clinical Evidence

Bench testing only. Static and dynamic fatigue testing performed per ISO 14801 and FDA guidance. Biocompatibility testing (cytotoxicity) performed per ISO 10993-5 and USP <87>. Sterility validated per ISO 11137 and ISO 17665. Bacterial endotoxin testing performed per USP <85> and <161> with acceptance criteria of <20 EU/device.

Technological Characteristics

Materials: Cold Worked Ti Grade 4 (ASTM F67), Ti-6Al-4V (ASTM F136), and Yttria-stabilized Zirconia. Design: Root-form, threaded, self-tapping endosseous implants. Surface: Al2O3 blasted and passivated. Sterilization: Gamma radiation (implants) or user-sterilized (abutments). Connectivity: Mechanical screw-retained abutment-to-implant interface (internal hex, external square).

Indications for Use

Indicated for patients requiring dental implants in maxillary or mandibular arches for support of prosthetic devices (artificial teeth, crowns, bridges, overdentures). Suitable for immediate or delayed placement and immediate loading if primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Zuga™ Dental Implant System (K122664)
T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System (K152787)
OCO Biomedical Fixed Solid O-Ball Abutment (K090174)
Nobel Biocare AB NobelActive Multi-Unit Abutment (K072570)
Reliadent Dental Implant System (K043428, K061323)
Biomet 3i Certain System (K0100724)
KAT Implants System Implants, KAT Implants System Implant Abutment (K083544)
KAT Implants System Implants, KAT Implants System Straight Abutments (K101201)
Southern Implants Endosseous Dental Implant System (K070841, K071161)

Reference Devices

Ex Feel Dental Implant System (K052369)
Nova Implants Ltd. Ball Attachment BAT (K150363)
SGS International Ltd. Overdenture Ball Attachment S3 (K133362)
Biodenta Swiss AG Multi-Use Abutment (K123491)
Biomet 3i Low Profile Abutment (K092341)
2014 InterActive/SwishActive System (K143011)

Related Devices

K173701 — Implant-One System · Implant Logistics, Inc. · Nov 29, 2018
K210220 — Kontact Dental Implant System · Biotech Dental, Sas · Jun 18, 2021
K140728 — MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR · Ditron Precision, Ltd. · Oct 17, 2014
K063364 — ALPHA BIO DENTAL IMPLANT SYSTEM · Alpha-Bio Tec , Ltd. · Mar 14, 2007
K070562 — EZ PLUS IMPLANT SYSTEM · Megagen Co., Ltd. · May 18, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 30, 2018 Zuga Medical, Inc. Chan Wang, CEO 24400 Chagrin Blvd. Suite 250 Beachwood, Ohio 44122 Re: K171197 Trade/Device Name: Zuga™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 25, 2018 Received: June 1, 2018 ### Dear Chan Wang: 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. {1}------------------------------------------------ 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### 7. Indications for Use Statement 510(k) Number: _K171197 Device Name: Zuga™ Dental Implant System Indications for 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. Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (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) {3}------------------------------------------------ ## 510(k) Summary K171197 | Date: | 29 June 2018 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Zuga Medical, Inc. 24400 Chagrin Boulevard Suite 250 Beachwood, OH 44122 Phone: 216.282.5910 Facsimile: 1.855.438.9842 | | Contact Person: | Chan Wang, CEO | | Trade Names: | Zuga™ Dental Implant System | | Device Classification: | Class II | | Classification Name: | Implant, endosseous, root-form & abutment, implant, dental, endosseous | | Regulation: | 872.3640 | | Device Product: | DZE & NHA | | Device Description: | The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, 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 blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps 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. | {4}------------------------------------------------ | Implant | Material | Cold Worked Ti Grade 4 as described in ASTM F67 | |-------------------------------|---------------------|------------------------------------------------------------------------------| | | Diameter (mm) | 3.5, 4.3, 5.0 | | | Length (mm) | 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00 | | | Angulation | - | | | Description | Endosseous Implant | | Ti Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 | | | Diameter (mm) | 4.75, 5.50, 6.25, 7.00 | | | Post Height (mm) | 4.00, 5.50, 7.00 | | | Angulation | - | | | Description | Straight Titanium Abutment | | Angled Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 or Cold Worked Ti Grade 5 | | | Diameter (mm) | 3.5, 4.3, 5.0 | | | Post Height (mm) | 8.50, 9.50, 10.50, 11.50 | | | Angulation | 15, 25 | | | Description | Angled Titanium Abutment | | Ball Abutment | Material | Titanium CP Grade 4 Cold Worked or Annealed | | | Diameter (mm) | 3.5 | | | Gum Height (mm) | 1.00, 2.00, 3.00, 4.00, 5.00 | | | Angulation | - | | | Description | Abutment for overdenture restoration | | Removable Denture Abutment | Material | Titanium CP Grade 4 Cold Worked or Annealed | | | Diameter (mm) | 3.85 | | | Gum Height (mm) | 1.00, 2.00. 3.00, 4.00, 5.00 | | | Angulation | - | | | Description | Abutment for overdenture restoration | | Hybrid Abutment | Material | ZIY and Cold Worked Ti Grade 4 as described in ASTM F67 | | | Diameter (mm) | 4.25, 4.30, 5.05, 5.50 | | | Length (mm) | 10.50 | | | Angulation | - | | | Description | Titanium and Zirconium abutment | | Multi-Unit Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 | | | Diameter (mm) | 4.00, 4.80 | | | Gum Height (mm) | 1.50, 2.50, 3.50, 4.50 | | | Angulation | 0, 17, 30 | | | Description | Titanium Abutment to be used with multiple prosthetic devices | | Healing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed | | | Diameter (mm) | 4.85, 5.65, 6.35 | | | Post Height (mm) | 3.00, 5.00, 7.00 | | | Angulation | - | | | Description | Protects implant during healing. | | Fixation Screw | Material | Titanium 6AL-4V per ASTM F136 | | | Diameter (mm) | 2.35 | | | Length (mm) | 7.50 | | | Angulation | - | | | Description | Fastens abutment to implant | | Sealing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed | | | Diameter (mm) | 2.75 | | | Length (mm) | 5.00 | | | Angulation | - | | | Description | Protects implant during healing. | Zuga Medical is making no claims regarding pyrogenicity. {5}------------------------------------------------ {6}------------------------------------------------ | Indications for 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. | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Devices: | Zuga™ Dental Implant System - K122664 T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System – K152787 OCO Biomedical Fixed Solid O-Ball Abutment – K090174 Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570 Reliadent Dental Implant System - K043428, K061323 Biomet 3i Certain System – K0100724 KAT Implants System Implants, KAT Implants System Implant Abutment – K083544 KAT Implants System Implants, KAT Implants System Straight Abutments – K101201 Southern Implants Endosseous Dental Implant System – K070841, K071161 | | Technological Characteristics: | The fundamental scientific technology of the Zuga™ Dental Implant System is the same as previously cleared devices as shown below, (i.e. the Zuga design features are common to one or more of the predicates). | | Zuga Implant System | | | | | | | |---------------------|----------------|--------------------------------|---------------------|-----------|---------------------|----------------------| | | Subject Device | Primary Predicate Device | Reference Devices | | | | | Company | Zuga Medical | Zuga Medical | Reliadent | Biomet 3i | KAT | Southern Implants | | 510(k) Number | New Device | K122664 | K043428, K061323 | K100724 | K083544, K101201 | K070841, K071161 | {7}------------------------------------------------ | | | | | | KAT Implant System Dental Implants are indicated for restoration of edentulous maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving Primary stability | The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended 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 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 Reliadent Dental Implant System is indicated for immediate or delayed surgical and restorative application for placement in maxillary and /or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures for the patient. | BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established. | | | {8}------------------------------------------------ | Material of Manufacture: | Titanium, Titanium Alloy | Titanium, Titanium Alloy | Titanium | Titanium, Titanium Alloy | Titanium Alloy | Titanium | |------------------------------|---------------------------------------|---------------------------------------|----------------------------------------|---------------------------------------|--------------------------------------------------------------------------|---------------------------------------| | Endosseous Implant | | | | | | | | Endosseous Implant Design | Root-form, Straight and tapered | Root-form, Straight | Root-form, Straight | Root-form, Straight and tapered | Root-form, Straight and tapered | Root-form, Straight and tapered | | Method of stabilization | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | | Range of Diameters | 3.5 – 5.5mm | 3.5 – 5.5mm | 3.0 – 5.5mm | 3.25 – 6mm | 2.5 – 8mm | ---- | | Range of Lengths | 8 – 17 mm | 8 – 17 mm | 8 – 16mm | 8.5 – 20mm | 6 – 14mm | ---- | | Surface Treatment | Al2O3 blasted, passivated | Al2O3 blasted, passivated | Titanium blasted and acid etched | acid etched | Al2O3 blasted, passivated | Al2O3 blasted | | Color-coding | Seating surface or None | Seating surface | Anodized seating | Seating surface | None | None | | Sterilization | Sterile, Gamma radiation | Sterile, Gamma radiation | Sterile, Gamma radiation | Sterile, Gamma radiation | Sterile, Radiation | Sterile, Gamma radiation | | Endosseous Implant Abutment | | | | | | | | Abutment Design | Standard | Standard | Standard, Angled | ---- | Standard, Angled | Standard, Angled | | Sterilization | Non-sterile | Non-sterile | Non-sterile | ---- | Non-sterile | ---- | | Connection to Implant | Hex alignment, screw attachment | Hex alignment, screw attachment | Hex alignment, screw attachment | ---- | Indexing key alignment, 1.5° locking taper, screw attachment | ---- | | Color-coding | Connection interface or none | Connection interface | Connection interface | ---- | ---- | ---- | | Angled Abutment | | | | |-----------------|----------------|------------------------------|------------------| | | Subject Device | Primary Predicate Devices | Reference Device | {9}------------------------------------------------ | System: | Zuga | T-Plus Implant Tech. Co., Ltd | MegaGen Co., Ltd | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Zuga Dental Implant System | ST Internal Fixture System | Ex Feel Dental Implant System | | 510(k) Number | New Device | K152787 | K052369 | | Intended 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 ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Fixture System is intended for use for immediate loading when good primary stability is acheived and with appropriate occlusal loading. | The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single state surgical procedure. | | Abutment Diameters, mm | 3.5, 4.3, 5.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 | | Abutment Cuff(Gum) Height, mm | 1.5, 2.5, 3.5, 4.5 | 1.0, 2.0, 3.0, 4.0, 5.0 | 2.0, 4.0 | | Angulation Range | 15°, 25° | 15°, 25° | 15°, 25° | | Implant to Abutment Connection | Internal Hexagon | Internal Hex Connection | Internal and External Hex | | Abutment Fixation | Abutment Screw | - | - | | Abutment Material | Titanium Alloy | C.P. Titanium and Titanium Alloy | C.P. Titanium and Titanium Alloy | | Sterilization | Delivered Non-Sterile | Delivered Non-Sterile | Delivered Non-Sterile | | Reusable | No | No | No | {10}------------------------------------------------ | Ball Abutment | | | | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate Device | Reference Devices | | | Company | Zuga Medical | OCO Biomedical | Nova Implants Ltd. | SGS International Ltd. | | Device Name | Zuga Dental Implant System - Ball Abutment | Fixed Solid O-Ball Abutment | Ball Attachment BAT | Overdenture Ball Attachment S3 | | 510(k) Number | New Device | K090174 | K150363 | K133362 | | Intended 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 TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. | NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. | | Abutment Heights, mm | 1, 2, 3, 4, 5 | 0, 2, 3, 4 | 1, 2, 3, 4, 5 ,6 | 1, 2, 3, 4, 5, 6 | | Implant to Abutment Connection | External Square | External Square | Internal Hex | Internal Hex, Overdenture rest. | | Abutment Fixation | Screw Retained | Screw Retained | Screw Retained | - | | Abutment Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | | Sterilization | Delivered NonSterile | - | - | - | | Reusable | No | No | No | No | {11}------------------------------------------------ | Multi-Unit Abutment | | | | | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject…