(432 days)
No
The device description and performance studies focus on the mechanical and biological properties of the dental implant system components, with no mention of AI or ML.
Yes
The device is used to support prosthetic devices like artificial teeth, crowns, and bridges, which function to replace missing or damaged anatomical structures and restore function, thereby providing therapeutic benefit to the patient.
No
Explanation: The device is a dental implant system designed to support prosthetic devices. Its intended use does not involve diagnosing a disease or condition; rather, it is a treatment device.
No
The device description explicitly lists physical components such as endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws. The performance studies also focus on mechanical strength, cytotoxicity, and sterility of these physical components.
Based on the provided text, the Zuga™ Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical and restorative applications in the body (maxillary and/or mandibular arches) to support prosthetic devices. This is an in vivo application.
- Device Description: The description details components like endosseous dental implants, abutments, and screws, which are designed to be implanted into bone.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing samples outside the body (in vitro), such as reagents, calibrators, controls, or analysis of biological specimens.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Zuga™ Dental Implant System is a medical device used for surgical implantation and prosthetic support within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Static fatigue tests and dynamic fatigue tests were performed per ISO 14801 and FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The worst case scenarios for the Zuga™ Dental Implant System were tested. The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application.
Cytotoxicity testing was performed per ISO 10993-5 and The United States Pharmacopeia & National Formulary (USP ). The worst case scenarios for the Zuga™ Dental Implant System were tested. The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application.
Sterility tests performed under ISO 10993 yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device. Sterile subject devices were evaluated in accordance to ISO 11137-1 and 11137-2. "End-user" sterilized devices were validated according to ISO 17665-1 and 17665-2.
Further, LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests performed under ISO 10993 on the subject device yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device for medical devices not intended to contact cerebrospinal fluid.
Shelf life tests are performed under ISO 11607 for evaluating seal strength of flexible barrier materials and porous medical packaging used in the sterile packaged products in the Zuga™ Medical Dental Implant System. Test results established the shelf life to be five years provided the sterile seal is not breached. The subject device is a titanium alloy, non-mechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf-life period. Special storage conditions are not required for the device, as ambient storage conditions are not expected to adversely affect the safety or efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122664, K152787, K090174, K072570
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K043428, K061323, K100724, K083544, K101201, K070841, K071161, K052369, K150363, K133362, K123491, K092341, K143011
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Device | Primary Predicate | |||
| Device | Reference Device | |||
| Company | Zuga Medical | Nobel Biocare AB | Biodenta Swiss AG | Biomet 3i |
| Device Name | Zuga Dental | |||
| Implant System – | ||||
| Multi-Unit | ||||
| Abutment | NobelActive | |||
| Multi-Unit | ||||
| Abutment | Biodenta Dental | |||
| Implant System- | ||||
| Multi-Use | ||||
| Abutment | Low Profile Abutment | |||
| 510(k) Number | New Device | K072570 | K123491 | K092341 |
| 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 | NobelActive | |||
| Multi-Unit | ||||
| Abutment is a pre- | ||||
| manufactured | ||||
| prosthetic | ||||
| component directly | ||||
| connected to the | ||||
| endosseous | ||||
| dental implant | ||||
| and is intended | ||||
| for use as an aid in | ||||
| prosthetic | ||||
| rehabilitation. | Biodenta Dental | |||
| Implant System | ||||
| Multi-Use | ||||
| Abutments are | ||||
| intended for | ||||
| terminal or | ||||
| intermediate | ||||
| abutment support | ||||
| for fixed or | ||||
| removable crown, | ||||
| bridgework, and to | ||||
| retain | ||||
| overdentures. | Biomet 3i Low Profile Abutments are | |||
| intended for use as accessories | ||||
| to endosseous dental implant to | ||||
| support a prosthetic device in a | ||||
| partially or completely edentulous | ||||
| patient. A dental abutment is | ||||
| intended for use to support single | ||||
| and multiple tooth prosthesis, in the | ||||
| mandible or maxilla. The prosthesis | ||||
| is screw retained to the abutment. |
12
| | achieved and with
appropriate occlusal
loading. | | | |
|--------------------------------------|-------------------------------------------------------|----------------------|----------------------|-----------------------|
| Restorations | Screw Retained | Screw Retained | Screw Retained | Screw Retained |
| Abutment Type | Straight & Angled | Straight & Angled | Straight & Angled | Straight & Angled |
| Abutment Angle | 0°,17°,30° | 0°,17°,30° | 0°,18°,30° | 0°,17°,30° |
| Implant to
Abutment
Connection | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Abutment
Fixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| | 3.5mm | 3.5mm | 3.5mm | 3.25mm |
| Compatible
Implants
Diameter | 4.0mm | 4.3mm | 4.1mm | 4.0mm |
| | 4.3mm | 5.0mm | 4.8mm | 5.0mm |
| | 5.0mm | | | 6.0mm |
| Abutment
Cuff(Gum) Height | 1.5-4.5mm (0°) | 1.5-4.5mm (0°) | 2.0-5.0mm (0°) | 1.0-4.0mm (0°) |
| | 2.5-3.5mm (17°) | 2.5-3.5mm (17°) | 2.2–5.2mm (18°) | 2.0-4.0mm (17°) |
| | 3.5-4.5mm (30°) | 3.5-4.5mm (30°) | 2.0-5.0mm (30°) | 3.0-5.0mm (30°) |
| Abutment Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterilization | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered Non-Sterile |
| Reusable | No | No | No | No |
| Removable Denture Abutment | ||
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Company | Zuga Medical | Zest Anchors, Inc. |
| Device Name | Zuga Dental Implant System - | |
| Removable Denture Abutment | LOCATOR Implant Anchor Abutment for | |
| Endosseous Dental Implant | ||
| 510(k) Number | New Device | K072878 |
13
| 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 LOCATOR Implant Anchor Abutment for
Endosseous Dental Implants is appropriate for
use with overdentures or partial dentures
retained in whole or in part by endosseous
implants in the mandible or maxilla. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment Diameters, mm | 3.85 | 3.25 to 6.5 |
| Abutment Angle | Straight | Straight |
| Abutment/Implant Interface | Screw Retention | Conical, External Hex, Internal Hex, Internal Multi
Lobe |
| Divergence Allowance | Maximum 40° divergence
between two implant
constructs, with each individual
implant/abutment construct
having no more than 20°
correction. | 20°/40° |
| Prosthesis Attachment Type | Nylon Male retention cap | Nylon male retention cap |
| Abutment Material | Titanium Grade 4 | Ti-6Al-4V ELI |
| Prosthetic Retention
Component | Nylon | Nylon |
14
Hybrid Abutment
| System: | Zuga™ Dental
Implant
System -
Hybrid
Abutment | K122664
Zuga™ Dental
Implant
System -
Primary
Predicate | K143011
2014
InterActive/
SwishActive
System -
Reference
Predicate |
|------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| ENDOSSEOUS IMPLANT ABUTMENT | | | |
| Material of Manufacture: | | | |
| Abutment | NA | Titanium | NA |
| Abutment Base | Titanium | NA | Titanium |
| Abutment Upper | Yttria-stabilized
Zirconia | NA | Yttria-stabilized
Zirconia |
| Connection | Cement | NA | Cement |
| Design: | Straight | Straight | Straight,
Angled, or
Modified |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile |
| Connected to Implant | Hex alignment,
screw
attachment | Hex alignment,
screw
attachment | Hex alignment,
screw
attachment |
| Implant Platforms
it can be used with | 3.5, 4.3, 5.0,
5.5 | 3.5, 4.3, 5.0,
5.5 | Not known |
15
Performance Data: Static fatigue tests and dynamic fatigue tests were performed per ISO 14801 and FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The worst case scenarios for the Zuga™ Dental Implant System were tested. The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application.
Cytotoxicity testing was performed per ISO 10993-5 and The United States Pharmacopeia & National Formulary (USP ). The worst case scenarios for the Zuga™ Dental Implant System were tested. The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application.
Sterility tests performed under ISO 10993 yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device. Sterile subject devices were evaluated in accordance to ISO 11137-1 and 11137-2. "End-user" sterilized devices were validated according to ISO 17665-1 and 17665-2.
Further, LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests performed under ISO 10993 on the subject device yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device for medical devices not intended to contact cerebrospinal fluid.
Shelf life tests are performed under ISO 11607 for evaluating seal strength of flexible barrier materials and porous medical packaging used in the sterile packaged products in the Zuga™ Medical Dental Implant System. Test results established the shelf life to be five years provided the sterile seal is not breached. The subject device is a titanium alloy, non-mechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf-life period. Special storage conditions are not required for the device, as ambient storage conditions are not expected to adversely affect the safety or efficacy of the device.
In accordance with the United States Pharmacopeial Convention, Inc. USP , Bacterial Endotoxins Tests (BET), also known as Limulus Amebocyte Lysate (LAL) tests, is made to determine that
16
the device meets pyrogenicity limit specifications. These Bacterial Endotoxins Tests (BET) are run in accordance with the kinetic turbidimetric method as follows: Representative samples are selected from each sterilization batch. Each sterilization batch consists of multiple manufacturing lots. The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing. The Testing limit is 20 EU/device because, according to USP ,161> the limit for a device in contact with the circulatory system or lymphatic system is 20 EU/device.