Predicate Devices

Reference Devices

K163349, K101732, K072570, K132125, K112440, K120530

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is a dental implant system used to provide support for prosthetic devices to restore a patient's chewing function, which addresses a medical condition and improves body function.

Diagnostic

No

This device is a dental implant system used for surgical and restorative applications to provide support for prosthetic devices (like artificial teeth) and restore chewing function. It is a treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components like endosseous dental implants, cover screws, healing caps, and abutment systems, which are hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the UNIQA® Dental Implants System is for surgical and restorative applications, placed in the bone to support prosthetic devices and restore chewing function. This involves direct interaction with the patient's body.
Device Description: The description details physical components like implants, cover screws, healing caps, and abutment systems, along with their materials and surface treatments. These are all physical devices implanted into the body.
IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on bodily specimens.

The UNIQA® Dental Implants System is a medical device intended for surgical implantation and restoration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

UNIQA® 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. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Product codes

DZE, NHA

Device Description

UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design: (a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;

Dental Implants:

Conical Implant, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Dental Abutments:

Dental Abutments Internal Hex Connection: Locator Abutments, Angled Anatomic Abutments 15°, 25°, Angled Abutments 15°, 25°, Angled Multi Unit Abutments D-type 179,300 (provided also as set), Temporary Sleeves for Multi Unit D-type, Straight Multi Unit Abutments D-type, Ball attachment abutments, Healing Caps (Narrow, Regular, Wide), Straight anatomic abutment, Straight abutments (Regular, Wide), Straight abutment with shoulder( Reqular, Wide), Snap on Transfer abutments, Straight Multi Unit Abutments D-type.

Dental Abutments Conical Connection: Healing Caps (Mini, Regular), Transfer Abutments (Mini, Regular), Transfer Abutment Regular, Straight Multi Unit Abutments C-type, Sleeves for Multi Unit C-type.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw

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)

Clinical Testing - No clinical data is included in this submission.

Sterilization Validation Test was carried out with accordance to ISO 11137 in order to ensure safety and effectiveness related to UNIQA® Dental Implants - Test results have demonstrated that the SAL of 10-® was achieved and all testing requirements were met. Shelf Life Test was carried out with accordance to ASTM F-1980 in order to validate the claimed shelf life of 5 years.

Steam Sterilization Test was carried out with accordance to ISO 17665 in order to ensure safety and effectiveness related to UNIQA® Dental Abutments - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Biocompatibility - UNIQA Dental Implants are made of Ti6AI4V ELI using the conventional manufacturing process. Cytotoxicity testing was carried out with accordance to ISO 10993-5 in order to demonstrate that the manufacturing process did not change the biocompatibility profile. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality raw material which conforms the international standard ASTM F-136 Eli used for human implant applications.

Fatigue test was carried out with accordance to ISO 14801 in order to verify the mechanical connection strength of implant/abutment, results have demonstrated the performance with the use of UNIQA® Dental Implants / Abutments.

Surface Test was carried out to ensure the cleanness of the implant surface, surface results were met UNIQA requirements.

Risk Assessment was carried out with accordance to ISO 14971 and has demonstrated no new safety and/or effectiveness issues.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sterilization Assurance Level (SAL) of 10-6 was achieved.

Predicate Device(s)

K040807

Reference Device(s)

K163349, K101732, K072570, K132125, K112440, K120530

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 8, 2018

UNIQA DENTAL LTD. % Daniela Levy Regulatory Consultant Sterling Medical Registration 22815 Ventura Blvd. Woodland Hills, California 91364

Re: K180598

Trade/Device Name: UNIOA® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 14, 2018 Received: May 23, 2018

Dear Daniela Levy:

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

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Image /page/2/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The logo is simple and clean, with a focus on the company name.

SECTION 4

Indication for Use Statement

510(k) Number (if known): K180598 Device Name: UNIQA® Dental Implants System Indications for Use (Describe)

Indications for Use:

UNIQA® 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. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use(21 CFR 801 Subpart

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

3

Image /page/3/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The overall design is simple and modern.

SECTION 5 -

510(k) Number K180598

1 Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional

2	Submission Owner	UNIQA DENTAL LTD.
		Dima Goberman - CEO
		26 Tom Lantos blvd., Alon Center
		Netanya 4276001
		Israel
		Tel : 972-77-7827367
		Fax : 972-73-7372636
3	Official Correspondent
Contact Person	Sterling Medical Registration
Daniela Levy - Regulatory Consultant
		22815 Ventura blvd.
		Woodland Hills, CA 91364
		Phone: 1-213-787-3027
		Email: sterlingmedical2017@gmail.com
4	Date Prepared	Tuesday, August 7, 2018
5	Device Trade Name	UNIQA® Dental Implants System
6	Regulation Description	Endosseous Dental Implants Abutment
7	Classification	Primary Product Code: DZE
		Device Name : Implant, endosseous, root-form
		Regulation No : 872.3640
		Class : II
		Panel : Dental
		Secondary Product Code: NHA
8	Reason for the Premarket Notification Submission	: New Device
9	Identification of Legally Marketed Predicate Devices :

Primary Predicate:
MIS Implant Technologies Ltd Implants System K040807;

4

Reference Devices:

MIS Implant Technologies Ltd Implants System K163349; Astra Tech AB OsseoSpeed TX K101732 Nobel Biocare Multi Unit Abutment K072570; A.B. Dental Devices Ltd K132125, K112440; Dentin Dental Implants System K120530; in terms of intended use, indication for use, raw material, technological characteristics and performance. The primary predicate and referenced devices are Class II medical devices.

10 Device Description:
UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design:(a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;

Dental Implants:

Conical Implant, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Dental Abutments:

Dental Abutments Internal Hex Connection: Locator Abutments, Angled Anatomic Abutments 15°, 25°, Angled Abutments 15°, 25°, Angled Multi Unit Abutments D-type 179,300 (provided also as set), Temporary Sleeves for Multi Unit D-type, Straight Multi Unit Abutments D-type, Ball attachment abutments, Healing Caps (Narrow, Regular, Wide), Straight anatomic abutment, Straight abutments (Regular, Wide), Straight

5

abutment with shoulder( Reqular, Wide), Snap on Transfer abutments, Straight Multi Unit Abutments D-type.

Dental Abutments Conical Connection: Healing Caps (Mini, Regular), Transfer Abutments (Mini, Regular), Transfer Abutment Regular, Straight Multi Unit Abutments C-type, Sleeves for Multi Unit C-type.

11 Indication for Use:
UNIQA® 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. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

12 Performance Standards or Special Controls
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
- . ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.
- . ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

6

ISO 11737-2: 2009 Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ASTM F-1980 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems . for Medical Devices
. ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
. ISO 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1
. ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
Chemical and SEM analysis performed on implants per Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
Endotoxin batch testing protocol per FDA Guidance Document Submission and . Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

7

13 Substantial Equivalence

| Characteristic | Conical Implant, Pure
& Porous, P&P Cat #
UCI | MIS - SEVEN Implants | MIS V3 Conical
Connection implants | OsseoSpeed TX S | A.B. Dental
Implant system | DENTIN Dental
Implant system |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Primary Predicate | Reference Device | Reference Device | Reference
Device | Reference Device |
| 510(k) number | K180598 | K040807 | K163349 | K101732 | K132125 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants
Technologies Itd | MIS Implants
Technologies Itd | Astra Tech AB | A.B. Dental
Device Itd | DENTIN Implants
Technologies Ltd |
| Product Name | Conical Implant, Pure &
Porous, P&P | SEVEN Implants | MIS V3 Conical
Connection Dental
Implant System | OsseoSpeed TX S | 15 Conical
Implant | RAPID Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double
Thread | Tapered, Double
Thread | Cylindrical tapered
apex, threaded | Tapered, Double
Thread | Tapered |
| Measurements:
Ø / Length mm | 3.3 Ø: 8 ,10, 11.5, 13,
16
3.75 Ø: 8 ,10, 11.5, 13,
16
4.2 Ø: 8 ,10, 11.5, 13,
16
5.0 Ø: 8 ,10, 11.5, 13,
16 | 3.75 Ø: 8 ,10, 11.5,
13,16
4.2 Ø: 8 ,10, 11.5, 13,
16
5.0 Ø: 8 ,10, 11.5, 13,
16 | 3.3 Ø: 10, 11.5, 13, 16
4.3 Ø: 8 ,10, 11.5, 13,
16
4.9 Ø: 8 ,10, 11.5, 13,
16
5.0 Ø: 8 ,10, 11.5, 13,
16 | 3.0 Ø: 11, 13, 15
3.5 Ø: 8, 9, 11, 13, 15,
17
4.0 Ø: 6, 8, 9, 11,
13,15, 17
5.0 Ø: 9, 11, 13, 15, 17 | 3.5 Ø: 8 ,10,
11.5, 13, 16 | 3.3 Ø: 8 ,10, 11.5, 13,
16
3.75 Ø: 8 ,10, 11.5,
13, 16
4.2 Ø: 8 ,10, 11.5, 13,
16
5.0 Ø: 7, 8 ,10, 11.5,
13
6.0 Ø: 7, 8 ,10, 11.5,
13 |
| Connection
Type | Internal conical
connection, cone
angulation 22° | Internal hex | Internal conical
connection, cone
angulation 12° | Internal conical
connection, cone
angulation 21º | Internal Hex | Internal Hex |
| Material | Titanium Alloy Ti6Al4V
ELI | Titanium Alloy Ti6Al4V
ELI | Titanium Alloy Ti6Al4V
ELI | Titanium grade 4 | Titanium Alloy
Ti6Al4V ELI | Titanium Alloy Ti6Al4V
ELI |
| Surface
Treatment | Clean&Porous, P&P
(Hydroxyapatite and
Calcium Phosphates) | Sand Blast and acid-
etched | Sand Blast and acid-
etched | TiO2-blasted
fluoridemodified surface | Hydroxyapatite
and Calcium
Phosphates | Sand Blast & Acid
Etched |
| Self tapping | Yes | Yes | Yes | Yes | Yes | Yes |
| Indication for Use | UNIQA Dental ® Dental Implants | The MIS Dental Implant System | MIS V3 Connection Dental Implant System | The OsseoSpeed Implants | A.BDENTAL DEVICES® | DENTIN® Dental Implants System |
| | 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. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or | 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 masticatory function. | 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. | are intended to be used: to replace missing teeth in single or multiple unit applications within the mandible or maxillafor immediate placement in extraction sites and partially or completely healed alveolar ridge situationsfor both one- and two stage surgical proceduresespecially well in soft bone applications where implants with other implant surface treatments may be less effectivetogether with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriatetogether with immediate loading protocol for single tooth restorations on implants 8 mm or longerwith its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors. | 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. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: I2,I5,I6BI. One Stage: I6, I6b, I6B. One Stage & One-Piece 3.0 mm diameter implants: I6, I6B, I6BI, are intended for | 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. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID, PRESTIGE. One Stage Implants: ONE PIECE DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants. |
| Indication for
Use | | | | | placement at the
mandibular
central and
lateral incisors
and maxillary
and lateral
incisors.
Indicated also
for denture
stabilization
using multiple
implants. One
stage & One-
Piece 2.4 mm
diameter
implants for
temporary use or
long term use:
I6, I6b, permit
immediate splint
stability and long
term fixation of
new or existing
crown, bridge
and prosthesis.
P14 Angulated
Abutment
Adapter is to be
used with
implant diameter
4.2mm and
higher. | |
| Self tapping | ✓ | Gamma Ray | ✓ | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Double packaging | Gamma Ray | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | | Double packaging | Double packaging | Double
packaging | Double packaging |

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Image /page/9/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small maroon square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The logo is simple and modern.

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| Characteristic | Conical Implant, SBA
Cat # UC7 | MIS - SEVEN Implants | MIS V3 Conical
Connection implants | OsseoSpeed TX S | DENTIN Dental Implant
system |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Primary Predicate | Reference Device | Reference Device | Reference Device |
| 510(k) number | K180598 | K040807 | K163349 | K101732 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants
Technologies Itd | MIS Implants
Technologies Itd | Astra Tech AB | DENTIN Implants
Technologies Ltd |
| Product Name | Conical Implant, SBA | SEVEN Implants | MIS V3 Conical
Connection Dental
Implant System | OsseoSpeed TX S | RAPID Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread | Tapered, Double Thread | Cylindrical tapered apex,
threaded | Tapered |
| Measurements:
Ø / Length mm | 3.3 Ø: 8, 10, 11.5, 13, 16
3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 8, 10, 11.5, 13, 16 | 3.3 Ø: 10, 11.5, 13, 16
4.3 Ø: 8, 10, 11.5, 13,
16
4.9 Ø: 8, 10, 11.5, 13,
16 | 3.0 Ø: 11, 13, 15
3.5 Ø: 8, 9, 11, 13, 15, 17
4.0 Ø: 6, 8, 9, 11, 13, 15,
17
5.0 Ø: 9, 11, 13, 15, 17 | 3.3 Ø: 8, 10, 11.5, 13, 16
3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 7, 8, 10, 11.5, 13
6.0 Ø: 7, 8, 10, 11.5, 13 |
| Connection
Type | Internal conical connection,
cone angulation 22° | Internal hex | Internal conical
connection, cone
angulation 12° | Internal conical
connection, cone
angulation 21° | Internal Hex |
| Material | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V
ELI | Titanium grade 4 | Titanium Alloy Ti6Al4V ELI |
| Surface
Treatment | Sand Blast and acid-etched | Sand Blast and acid-etched | Sand Blast and acid-etched | TiO2-blasted
fluoridemodified surface | Sand Blast & Acid Etched |
| Self tapping | Yes | Yes | Yes | Yes | Yes |

11

Indication for	UNIQA Dental ® Dental	The MIS Dental Implant	MIS V3 Conical	The OsseoSpeed implants	DENTIN® Dental Implants
Use	Implants
System	System is intended to be	Connection Dental	are intended to be used:	System is indicated for use
	indicated for use in surgical	surgically placed in the	Implant System	• to replace missing teethin	in surgical and restorative
	and restorative applications	bone of the upper or	intended to be surgically	single or multiple unit	applications for placement
	for placement in the bone of	lower jaw arches to	placed in the bone of	applications within the	in the bone of the upper or
	the upper or lower jaw to	provide support for	the upper or lower jaw	mandible or maxilla • for	lower jaw to provide support
	provide support for	prosthetic devices, such	arches to provide	immediate placement in	for prosthetic devices, such
	prosthetic devices, such as	as artificial teeth, in order	support for prosthetic	extraction sites and	as artificial teeth, in order to
	artificial teeth, in order to	to restore masticatory	devices, such as	partially or completely	restore the patient's
	restore the patient's	function.	artificial teeth, in order	healed alveolar ridge	chewing function. DENTIN®
	chewing function. UNIQA		to restore masticatory	situations •for both one-	Dental Implants System is
	Dental ® Dental Implants		function. When a one-	and two stage surgical	indicated also for immediate
	System is indicated also for		stage surgical	procedures • especially	loading when good primary
	immediate loading when		procedure is applied,	well in soft bone	stability is achieved and
	good primary stability is		the implant may be	applications where	with appropriate occlusal
	achieved and with		immediately loaded	implants with other implant	loading.
	appropriate occlusal		when good primary	surface treatments may be	Two Stage Implants:
	loading.		stability is achieved and	less effective • together	CLASSIC, RAPID,
	UNIQA Conical Connection		the occlusal load is	with immediate loading	PRESTIGE.
	Implants: #UCI & #UC7 are		appropriate. Narrow	protocol in all indications,	One Stage Implants: ONE
	to be used only with straight		implants (Ø3.3mm) are	except in single tooth	PIECE
	abutments.		indicated for use in	situations in soft bone	DENTIN® ONEPIECE
	Conical Mini implants		surgical and restorative	(type IV) where implant	Implants 3.0 mmd are
	(Ø3.3mm) are indicated for		applications for	stability may be difficult to	intended for placement at
	use in surgical and		placement only in the	obtain and immediate	the mandibular central and
	restorative applications for		mandibular central,	loading may not be	lateral incisors and
	placement only in the		lateral incisor and	appropriate • together with	maxillary and lateral
	mandibular central, lateral		maxillary lateral incisor	immediate loading protocol	incisors. Indicated also for
	incisor and maxillary lateral		regions of partially	for single tooth restorations	denture stabilization using
	incisor regions of partially		edentulous jaws, to	on implants 8 mm or	multiple implants.
	edentulous jaws, to provide		provide support for	longer • with its 3.0 S
	support for prosthetic		prosthetic devices such	product line for maxillary
	devices such as artificial		as artificial teeth, in	lateral incisors and
	teeth, in order to restore the		order to restore the	mandibular lateral and
	patient chewing function.		patient chewing	central incisors.
	Mandibular central and		function. Mandibular
	lateral incisors must be		central and lateral
	splinted if using two or		incisors must be
	more narrow implants		splinted if using two or
	adjacent to one another.		more narrow implants
			adjacent to one another.

12

Self tapping	✓	✓	✓	✓	✓
Sterilization	Gamma Ray	Gamma Ray	Gamma Ray	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging	Double packaging	Double packaging	Double packaging

| Characteristic | Conical Implant, Internal Hex, Pure
& Porous, P&P
Cat# USI | MIS - SEVEN Implants | A.B. Dental Devices Ltd | DENTIN Dental Implant
system |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K180598 | K040807 | K132125 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants Technologies Itd | A.B. Dental Device Itd | DENTIN Implants
Technologies Ltd |
| Product Name | Conical Implant, Internal Hex, Pure &
Porous, P&P | SEVEN Implants | I5 Conical Implant | RAPID Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread | Tapered, Double Thread | Tapered |
| Measurements:
Ø / Length mm | 3.3 Ø: 8 ,10, 11.5, 13, 16
3.75 Ø: 8 ,10, 11.5, 13, 16
4.2 Ø: 8 ,10, 11.5, 13, 16
5.0 Ø: 8 ,10, 11.5, 13, 16 | 3.75 Ø: 8 ,10, 11.5, 13,16
4.2 Ø: 8 ,10, 11.5, 13, 16
5.0 Ø: 8 ,10, 11.5, 13, 16 | 3.5 Ø: 8 ,10, 11.5, 13, 16 | 3.3 Ø: 8 ,10, 11.5, 13, 16
3.75 Ø: 8 ,10, 11.5, 13, 16
4.2 Ø: 8 ,10, 11.5, 13, 16
5.0 Ø: 7, 8 ,10, 11.5, 13
6.0 Ø: 7, 8 ,10, 11.5, 13 |
| Connection Type | Internal hex | Internal hex | Internal Hex | Internal Hex |
| Material | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI |
| Surface Treatment | Clean&Porous, P&P
(Hydroxyapatite and Calcium)
Phosphates) | Sand Blast and acid-etched | Hydroxyapatite and Calcium
Phosphates | Sand Blast & Acid Etched |
| Self tapping | Yes | Yes | Yes | Yes |

13

| Indication for Use | UNIQA Dental ® 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. UNIQA
Dental ® Dental Implants System is
indicated also for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading.
UNIQA Conical Connection Implants:
#UCI & #UC7 are to be used only
with straight abutments.
Conical Mini implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral
incisor and maxillary lateral incisor
regions of partially edentulous jaws,
to provide support for prosthetic
devices such as artificial teeth, in
order to restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if
using two or more narrow implants
adjacent to one another. | The MIS Dental Implant System 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
masticatory function. | A.BDENTAL DEVICES® 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. A.B. DENTAL DEVICES® Dental Implants
System is indicated also for immediate loading when good
primary stability is achieved and with appropriate occlusal
loading. Two Stage Implants:
I2,I5,I6BI. One Stage: I6, I6b, I6B. One Stage & One-Piece
3.0 mm diameter implants: I6, I6B, I6BI, are intended for
placement at the mandibular central and lateral incisors and
maxillary and lateral incisors. Indicated also for denture
stabilization using multiple implants. One stage & One-Piece
2.4 mm diameter implants for temporary use or long term use: I6, I6b, permit
immediate splint stability and long term fixation of new or
existing crown, bridge and prosthesis. P14 Angulated
Abutment Adapter is to be used with implant diameter
4.2mm and higher. | DENTIN® 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. DENTIN® Dental
Implants System is indicated also for immediate loading
when good primary stability is achieved and with
appropriate occlusal loading. Two Stage Implants:
CLASSIC, RAPID, PRESTIGE.
One Stage Implants: ONE PIECE DENTIN® ONEPIECE
Implants 3.0 mmd are intended for placement at the
mandibular central and lateral incisors and maxillary
and lateral incisors. Indicated also for denture stabilization
using multiple implants |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Self tapping | ✓ | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging | Double packaging | Double packaging |
| Characteristic | Conical Implant, Internal Hex, SBA
Cat# US7 | MIS - SEVEN Implants | DENTIN Dental Implant system | |
| | | Primary Predicate | Reference Device | |
| 510(k) number | K180598 | K040807 | K120530 | |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants Technologies Itd | DENTIN Implants Technologies Ltd | |
| Product Name | Conical Implant, Internal Hex, SBA | SEVEN Implants | RAPID Implant | |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread | Tapered | |
| Measurements:
Ø / Length mm | 3.3 Ø: 8, 10, 11.5, 13, 16
3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 8, 10, 11.5, 13, 16 | 3.3 Ø: 8, 10, 11.5, 13, 16
3.75 Ø: 8, 10, 11.5, 13, 16
4.2 Ø: 8, 10, 11.5, 13, 16
5.0 Ø: 7, 8, 10, 11.5, 13
6.0 Ø: 7, 8, 10, 11.5, 13 | |
| Connection Type | Internal hex | Internal hex | Internal Hex | |
| Material | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | |
| Surface Treatment | Sand Blast and acid-etched | Sand Blast and acid-etched | Sand Blast & Acid Etched | |
| Self tapping | Yes | Yes | Yes | |

14

15

| Indication for Use | UNIQA Dental ® 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. UNIQA Dental ® Dental Implants
System is indicated also for immediate
loading when good primary stability is
achieved and with appropriate occlusal
loading.
UNIQA Conical Connection Implants: #UCI &
#UC7 are to be used only with straight
abutments.
Conical Mini implants (Ø3.3mm) are indicated
for use in surgical and restorative applications
for placement only in the mandibular central,
lateral incisor and maxillary lateral incisor
regions of partially edentulous jaws, to
provide support for prosthetic devices such as
artificial teeth, in order to restore the patient
chewing function. Mandibular central and
lateral incisors must be splinted if using two or
more narrow implants adjacent to one
another. | The MIS Dental Implant System 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
masticatory function. | DENTIN® 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. DENTIN® Dental Implants System
is indicated also for immediate loading when
good primary stability is achieved and with
appropriate occlusal loading.
Two Stage Implants: CLASSIC, RAPID,
PRESTIGE.
One Stage Implants: ONE PIECE
DENTIN® ONEPIECE Implants 3.0 mmd
are intended for placement at the
mandibular central and lateral incisors and
maxillary and lateral incisors. Indicated also
for denture stabilization using multiple
implants. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Self tapping | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging | Double packaging |

16

Image /page/16/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL", also in green, sans-serif font, but smaller than "UNIQA". The logo is simple and modern.

Dental Abutments

	UNIQA Dental Abutments
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
Product Name	Locator Abutments # ULAR	Locator Abutments
Indication for Use	UNIQA Dental ®
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. UNIQA Dental ®
Dental Implants System is indicated also for
immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI & #UC7
are to be used only with straight abutments.
Conical Mini implants (Ø3.3mm) are indicated for
use in surgical and restorative applications for
placement only in the mandibular central, lateral
incisor and maxillary lateral incisor regions of
partially edentulous jaws, to provide support for
prosthetic devices such as artificial teeth, in order to
restore the patient chewing function. Mandibular
central and lateral incisors must be splinted if using
two or more narrow implants adjacent to one
another.	The MIS Dental Implant System 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
masticatory function.
Dimensions mm	Height 1, 2, 3, 4, 5	Height 0,1,2,3,4,5,6
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Related accessories	Silicon caps (Cat#ULCR)- soft, standard, strong;
Metal cap(Cat#ULMR);	Silicon caps: soft, standard, strong; Metal cap (MM-
LFA50)
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
Product Name	Angled Anatomic Abutments# UAAR	Esthetic Angulated Abutment
Dimensions mm	Height 1,2,3,4 - Angle 15
Height 1,2,3,4 - Angle 25	Height 1,2,3 - Angle 15
Height 1,2,3 - Angle 25
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Company / 510k	UNIQA Dental Itd #UABR	MIS K040807
		Primary Predicate
Product Name	Angled Abutment	Angulated Cement Abutment
Dimensions mm	Length 9,12 - Angle 15, 25	Length 9,11 - Angle 15, 25
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex

17

Company / 510k	UNIQA Dental Itd K180598	MIS K040807	Nobel Biocare K072570
		Primary Predicate	Reference device
Product Name	Angled Multi Unit Abutment, MUA, D-type
#UAMD	Esthetic Angulated Abutment	Multi-Unit Abutment
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ® Dental Implants
System is indicated also for immediate
loading when good primary stability is
achieved and with appropriate occlusal
loading.

UNIQA Conical Connection Implants: #UCI &
#UC7 are to be used only with straight
abutments.

Conical Mini implants (Ø3.3mm) are
indicated for use in surgical and restorative
applications for placement only in the
mandibular central, lateral incisor and
maxillary lateral incisor regions of partially
edentulous jaws, to provide support for | The MIS Dental Implant System 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
masticatory function. | 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. |

18

Image /page/18/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL", also in green, sans-serif font, but smaller than "UNIQA". The logo is simple and modern.

| | prosthetic devices such as artificial teeth, in
order to restore the patient chewing function.
Mandibular central and lateral incisors must
be splinted if using two or more narrow
implants adjacent to one another. | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Dimensions | Height 1,2,3 - Angle 17
Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15
Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5
Angles 17, 30 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex/Conical |
| Related Components | Sleeve for Multi Unit Abutment, MUA,
Temporary, D-type#USTD
Sleeve for Multi Unit Abutment, MUA,
Temporary, V-type#USTV

screw (#UMSD) | | Sleeve=Temporary copying
(29046) + screw, plastic cap,
MU screw#29285
Related tools are applicable |

Company / 510k	UNIQA Dental Itd K180598	MIS K040807	MIS K163349
		Primary Predicate	Reference device
Product Name	Straight Multi Unit Abutment, MUA,
D-type # USMD	Anatomic transgingival
Abutment	Straight Multi Unit Abutments
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated
also for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading.
UNIQA Conical Connection Implants:
#UCI & #UC7 are to be used only
with straight abutments.
Conical Mini implants (Ø3.3mm) are	The MIS Dental Implant System 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 masticatory
function.	MIS V3 Conical Connection Dental
Implant System 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
masticatory function. When a one-
stage surgical procedure is applied,
the implant may be immediately
loaded when good primary stability is
achieved and the occlusal load is
appropriate. Narrow implants
(Ø3.3mm) are indicated for use in
surgical and restorative applications
for placement only in the mandibular
central, lateral incisor and maxillary
	indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral
incisor and maxillary lateral incisor
regions of partially edentulous jaws,
to provide support for prosthetic
devices such as artificial teeth, in
order to restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if
using two or more narrow implants
adjacent to one another.		lateral incisor regions of partially
edentulous jaws, to provide support
for prosthetic devices such as
artificial teeth, in order to restore the
patient chewing function. Mandibular
central and lateral incisors must be
splinted if using two or more narrow
implants adjacent to one another.
Dimensions mm	Diameter: Regular
Heights 1,2,3,4	Height 1,2,3,4	Diameter: Regular
Heights 1,2,3,4,5
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Conical Hex
Related Components	Sleeve, Healing Cap, plastic cap		Sleeve, Healing Cap, plastic cap

Company / 510k	UNIQA Dental Itd K180598	MIS K040807	Nobel Biocare K072570
		Primary Predicate	Reference device
Product Name	Set Angled Multi Unit Abutment,
MUA, D-type, Castable Sleeve

UAMC | Esthetic Angulated Abutment | Multi-Unit Abutment |

| Indication for Use | UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated
also for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading.
UNIQA Conical Connection Implants:
#UCI & #UC7 are to be used only | The MIS Dental Implant System 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 masticatory
function. | 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. |
| Dimensions mm | Diameter: Regular
Height 1,2,3 - Angle 17
Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15
Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5
Angles 17, 30 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex/Conical |
| Related Components | The set is available with a Plastic sleeve + Sleeve screw + instrument + Multi unit screw (#UMSD) | | Sleeve=Temporary copying (29046) + screw, plastic cap, MU screw#29285
Related tools are applicable |
| Company / 510k | UNIQA Dental Itd K180598 | MIS K040807 | Nobel Biocare K072570 |
| Product Name | Set Angled Multi Unit Abutment, MUA, D-type, Temporary Sleeve # UAMT | Esthetic Angulated Abutment | Reference device
Multi-Unit Abutment |
| Dimensions mm | Diameter: Regular
Height 1,2,3 - Angle 17
Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15
Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5
Angles 17, 30 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex/Conical |
| Related Components | The set is available with a Transfer sleeve + Sleeve screw + instrument + Multi unit screw (#UMSD) | | Sleeve=Temporary copying (29046) + screw, plastic cap, MU screw#29285 |
| | | | Related tools are applicable |
| Company / 510k | UNIQA Dental Itd K180598 | MIS K040807 | Nobel Biocare K072570 |
| | | Primary Predicate | Reference device |
| Product Name | Healing cap for MUA, D-type #UMHD | Healing Caps | Multi-Unit Abutment / Healing cap#31145 |
| Indication for Use | UNIQA Dental ® 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. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. | The MIS Dental Implant System 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 masticatory function. | 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. |
| Dimensions mm | Height 4.0 | Wide -
Diameter. 5.0, 6.5; Height 3,4,5,6
Narrow -
Diameter 3.3, 4.3 - Height 2, 3, 4, 6,8 | Heights 4.1, 5.5 |
| | | Standard -
Diameter 4.0, 4.8, 5.5; Height
2,3,4,5,6 | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| | | | |

19

Image /page/19/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "i". Below "UNIQA" is the word "DENTAL", also in green, sans-serif font, but smaller than "UNIQA". The logo is simple and clean, with a focus on the company name.

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Image /page/20/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The logo is simple and clean, with a focus on the company name.

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Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
Product Name	Ball Attachment #UBAR	Ball Attachment
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated also for
immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI & #UC7
are to be used only with straight abutments.
Conical Mini implants (Ø3.3mm) are indicated for
use in surgical and restorative applications for
placement only in the mandibular central, lateral
incisor and maxillary lateral incisor regions of
partially edentulous jaws, to provide support for
prosthetic devices such as artificial teeth, in order to
restore the patient chewing function. Mandibular
central and lateral incisors must be splinted if using
two or more narrow implants adjacent to one
another.	The MIS Dental Implant System 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
masticatory function.
Dimensions mm	Height 0.5,1,2,3,4,5,6, 7	Height 1,2,3,4,5
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Related Components	Metal Caps(#UBMR-0001), Silicon Caps(#UBSR-

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Metal Caps, Silicon Caps                                                                                                                                                                                                                  |

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| Product Name | # USAR
Straight Anatomic Abutment | Anatomic transgingival
Abutment |
|---------------|--------------------------------------|------------------------------------|
| Dimensions mm | Height 1,2,3,4 | Height 1,2,3,4 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex |
| | | |

Company / 510k	UNIQA Dental Itd K180598	MIS K040807	A.B.Dental Devices Ltd K112440
		Primary Predicate	Reference device
Product Name	Straight Abutment #USBX	Cemented Abutment	P3 Abutment Anti rotation
Indication for Use	UNIQA Dental® 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. UNIQA
Dental® Dental Implants System is
indicated also for immediate loading when
good primary stability is achieved and with
appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI
& #UC7 are to be used only with straight
abutments.
Conical Mini implants (Ø3.3mm) are
indicated for use in surgical and restorative
applications for placement only in the
mandibular central, lateral incisor and
maxillary lateral incisor regions of partially
edentulous jaws, to provide support for
prosthetic devices such as artificial teeth,
in order to restore the patient chewing
function. Mandibular central and lateral
incisors must be splinted if using two or
more narrow implants adjacent to one
another.	The MIS Dental Implant System 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
masticatory function.	The AB Dental Devices implants are
intended for surgical placement in the
maxillary and/or mandibular arch to
support crowns, bridges, or
overdentures in edentulous or partially
edentulous patients. 17 Integra
implant, 15 Conical implant, P15
Temporary abutment, P12-T,L
Temporary flat connection abutment,
and P16 Straight adaptor are
appropriate for immediate loading
when good primary stability is achieved
and with appropriate occlusal loading.
Dimensions mm	Diameter : Regular (#USBR)	Diameter : Regular, Wide	Diameter : 3.0, 3.75, 5

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| | Length 5, 7, 9, 11, 13, 15 mm
Diameter : Wide (# USBW) | Length 5, 7, 9, 12 mm (=Heights
1,2,3,4) | Length 5, 7, 9, 11, 12, 15 |
|------------|-----------------------------------------------------------|---------------------------------------------|-------------------------------|
| | Length 5, 7, 9, 11, 13, 15 mm | | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| | | | |

Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
Product Name	Straight Abutment with shoulder #USSX	Cemented Abutment
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated also for
immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI & #UC7
are to be used only with straight abutments.
Conical Mini implants (Ø3.3mm) are indicated for
use in surgical and restorative applications for
placement only in the mandibular central, lateral
incisor and maxillary lateral incisor regions of
partially edentulous jaws, to provide support for
prosthetic devices such as artificial teeth, in order to
restore the patient chewing function. Mandibular
central and lateral incisors must be splinted if using
two or more narrow implants adjacent to one
another.	The MIS Dental Implant System 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
masticatory function.
Dimensions mm	Diameter :
Heights 1,2,3,4	Diameter : Regular, Wide
Heights 1,2,3,4
Material	Titanium alloy Ti-6AI-4V-ELI.	Titanium alloy Ti-6AI-4V-ELI.
Connection	Internal Hex	Internal Hex
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
	Snap on transfer #UTSR	Cemented Abutment
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated also for
immediate loading when good primary stability is
achieved and with appropriate occlusal loading.
UNIQA Conical Connection Implants: #UCI & #UC7
are to be used only with straight abutments.
Conical Mini implants (Ø3.3mm) are indicated for
use in surgical and restorative applications for
placement only in the mandibular central, lateral
incisor and maxillary lateral incisor regions of
partially edentulous jaws, to provide support for
prosthetic devices such as artificial teeth, in order to
restore the patient chewing function. Mandibular
central and lateral incisors must be splinted if using
two or more narrow implants adjacent to one
another.	The MIS Dental Implant System 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
masticatory function.
	Diameter: Regular,
Heights 1,2,3,4,5	Diameter : Regular, Slim, Wide
Heights 1,2,3,4
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI. or gold
Connection	Internal Hex	Internal Hex
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
		Primary Predicate
Product Name	Screw for Abutment #USXX	Ti Base
Dimensions mm	Measurements:
Length 8.3 mm #USWR
Length 8.1 mm #USWL	Diameter: Narrow, Regular, wide
Length 8.1 mm
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Company / 510k	UNIQA Dental Itd K180598	MIS K040807	MIS K163349
		Primary Predicate	Reference device
Product Name	Straight Multi Unit Abutment, MUA,	Esthetic Angulated Abutment	Straight Multi Unit Abutments
	V-type# USMV
Indication for Use	UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated
also for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading.
UNIQA Conical Connection Implants:
#UCI & #UC7 are to be used only
with straight abutments.
Conical Mini implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral
incisor and maxillary lateral incisor
regions of partially edentulous jaws,
to provide support for prosthetic
devices such as artificial teeth, in
order to restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if	The MIS Dental Implant System 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 masticatory
function.	MIS V3 Conical Connection Dental
Implant System 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
masticatory function. When a one-
stage surgical procedure is applied,
the implant may be immediately
loaded when good primary stability is
achieved and the occlusal load is
appropriate. Narrow implants
(Ø3.3mm) are indicated for use in
surgical and restorative applications
for placement only in the mandibular
central, lateral incisor and maxillary
lateral incisor regions of partially
edentulous jaws, to provide support for
prosthetic devices such as artificial teeth, in order to restore the
patient chewing function. Mandibular
central and lateral incisors must be
splinted if using two or more narrow
implants adjacent to one another.
	using two or more narrow implants
	adjacent to one another.
Dimensions mm	Diameter: Regular	Height 1,2,3 - Angle 15	Diameter: Regular
	Heights 1,2,3,4	Height 1,2,3 - Angle 25	Heights 1,2,3,4,5
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Conical Hex
Related components
(L=length)	Screw for Multi Unit Abutment
sleeve, V-type (#UMSV-0002) -
measurement 3.9 L mm ;
Healing cap for Multi Unit Abutment,
MUA, V-type (#UMHV-0004) - 3.1 L
mm		Multi unit screw measurement 3.8 L
mm;
Healing Cap measurement 4.3 L mm
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
Primary Predicate	MIS K163349
Reference device
Product Name	Healing Cap # UOHX	Healing Caps	Healing Cap
Dimensions mm	Diameter: Mini (#UOHM) - Diameter
4.0, 4.5 Heights 3, 4, 5,7
Regular (#UOHR) -
Diameter 4.0, 4.5, 5.0, 6.0, 7.0
Heights 3, 4, 5, 7	Wide -
Diameter. 5.0, 6.5; Height 3,4,5,6
Narrow -
Diameter 3.3, 4.3 - Height 2, 3, 4, 6,8
Standard -
Diameter 4.0, 4.8, 5.5; Height
2,3,4,5,6	Diameter: Slim
Diameter 3.3, 4.0, 4.8, Heights
3,4,5,6,8
Regular, Diameter 3.9, 4.3, 5.0,
Heights 3,4,5,6,8
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Conical Hex	Internal Hex	Conical Hex
Company / 510k	UNIQA Dental Itd K180598	MIS K040807
Primary Predicate	MIS K163349
Reference device
Product Name	Transfer Abutment #UOTX	Cemented Abutment	Cementing Abutment
Dimensions mm	Mini Diameter: 4.5 mm, Height 1, 2,
3, 4, 5 mm Lengths: 5.5, 7 mm
(#UOTM)
Regular Diameter: 4.5, 5.0, 6.0 mm,
Height 1, 2, 3, 4, 5 mm, Lengths:
4.0(not for 4.5), 5.5, 7 mm(#UOTR)
Provided with:
Screw Mini Conical (#UOSM-0001)
Screw Regular Conical (#UOSR-0001	Diameter : Regular, Wide
Heights 1,2,3,4	Narrow Diameter: 4.0 Length 1, 3
Narrow Diameter: 4.8 Length 1,2, 3

Standard Diameter: 4.8 Length
1,2,3,4 Height 4,6,8.

Provided with:
Screw MN-S0160 (mini)
MD-S0200, MD-S0222 (standard) |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Conical Hex | Internal Hex | Conical Hex |
| | | | |
| Company / 510k | UNIQA Dental Itd K180598 | MIS K040807 | MIS K163349 |
| | | Primary Predicate | Reference device |
| Product Name | Straight Multi Unit Abutment, MUA,
C-type (#UOMX) | Anatomic transgingival
Abutment | Multi Unit |
| Indication for Use | UNIQA Dental ® 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. UNIQA Dental ®
Dental Implants System is indicated
also for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading.
UNIQA Conical Connection Implants:
#UCI & #UC7 are to be used only
with straight abutments.
Conical Mini implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral
incisor and maxillary lateral incisor
regions of partially edentulous jaws,
to provide support for prosthetic
devices such as artificial teeth, in
order to restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if
using two or more narrow implants
adjacent to one another. | The MIS Dental Implant System 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 masticatory
function. | MIS V3 Conical Connection Dental
Implant System 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
masticatory function. When a one-
stage surgical procedure is applied,
the implant may be immediately
loaded when good primary stability is
achieved and the occlusal load is
appropriate. Narrow implants
(Ø3.3mm) are indicated for use in
surgical and restorative applications
for placement only in the mandibular
central, lateral incisor and maxillary
lateral incisor regions of partially
edentulous jaws, to provide support
for prosthetic devices such as
artificial teeth, in order to restore the
patient chewing function. Mandibular
central and lateral incisors must be
splinted if using two or more narrow
implants adjacent to one another. |
| Dimensions mm | Mini Diameter: 4.0 Height 1, 2,3,4
(#UOMM) | Height 1,2,3,4 | Narrow Diameter: Heights 1,2,3,5
Standard Diameter: Heights 1,2,3,4 |
| | Regular Diameter: 4.0, 5.0, 6.0
Height 1, 2,3,4,5 (5mm not for 4Ø)
(#UOMR) | | 5
(also available Angulated 17, 30 with
height 1,2) |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Conical Hex | Internal Hex | Conical Hex |
| Related Components | Sleeve for Multi Unit Abutment, MUA,
Rotation, C-type (#USTC-Rx)
Diameter Regular : 4.0, 5.0, 6.0
Length: 7.
Sleeve for Multi Unit Abutment, MUA,
Fixed, C-type (#USTC-Fx) Diameter
Regular : 4.0, 5.0, 6.0 Length: 7.
Screw for MUA sleeve, C-type
(#UMSC-0002) | | Temporary cylinder (#MU-TO480)
Screw (#MU-S0220) |
| | | | |

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Connection	Internal Hex	Internal Hex

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Image /page/30/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "Q". Below "UNIQA", the word "DENTAL" is in a smaller, green, sans-serif font. The overall design is clean and modern.

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14 Summary of Equivalence:

UNIQA® Dental Implants System share the same indication for use with its Primary Predicate MIS SEVEN Implant K040807; with two differences UNIQA Conical Implants (#UCI and #UC7) are to be used only with straight abutments, and that the Conical Mini implants (Ø3.3mm) indications are similar to the Reference Device MIS V3 Conical Connection Dental Implant System K163349 the Narrow Implants. The differences do not raise different safety or effectiveness issues as verified by Fatigue testing per ISO 14801:2007.

UNIQA® Dental Implants System, line of Conical Connection Implants (#UCI and #UC7) share similarity with its Reference Device MIS V3 Conical Connection Dental Implant System K163349 and its Reference Device Astra Tech OsseoSpeed TX K101732 in terms of intended use, technological characteristics, conical connection, sterilization method, surgical procedure. The differences are as follow: UNIQA Conical Implants are available in two options of surface treatment (1) SBA - Sand Blast with acid etched in similar to its Reference Device MIS K163349; and (2) Pure & Porous, P&P which is similar to its Reference Device A.B.DENTAL DEVICES LTD K132125; UNIQA line of Conical Hex Implants 3.30 are also provided with 8 mm length, whereas with its Reference Device MIS K163349 3.3Ø implants are provided only from 10 mm length. However, UNIQA share similar implant measurement 3.3Øx8 mm length with its other Reference Device DENTIN K120530; UNIQA conical connection cone angulation is 22° whereas with its Reference Device MIS K163349 introduces 12°, and its other Reference Device OsseoSpeed TX K101732 introduces 21º; The cone angulation is very similar to the OsseoSpeed TX K101732 with a minor difference; UNIQA conical connection implants currently are not distributed with angled abutments thus raise no new and/or different risks. UNIQA implant diameter range is slightly different (3.3, 3.75, 4.2, 5.0) but still is within the range of the Reference Device (3.3, 4.9, 4.3, 5.0); The differences do not raise different safety or effectiveness issues as verified by Fatigue testing per ISO 14801:2007.

UNIQA® Dental Implants System, line of Conical Implant Internal Hex (#USI and #US7) share similarity with its Primary Predicate MIS SEVEN Implant K040807 in terms of intended use, technological characteristics, conical body design, internal hex connection, sterilization method, surgical procedure. The differences are as follow: UNIQA Conical

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Implants Internal Hex are available in two options of surface treatment (1) SBA - Sand Blast with acid etched in similar to its Primary Predicate MIS K040807; and (2) Pure & Porous, P&P which is similar to its Reference Device A.B.DENTAL DEVICES LTD K132125; UNIQA line of Conical Implant Internal Hex is available in 3.3Ø, whereas with its Primary Predicate MIS K040807 is available from 3.5Ø. However, this difference doesn't raise any new risk since the same measurements are exist in the Reference Device K120530;

15 Performance Testing:
Clinical Testing - No clinical data is included in this submission.

Sterilization Validation Test was carried out with accordance to ISO 11137 in order to ensure safety and effectiveness related to UNIQA® Dental Implants - Test results have demonstrated that the SAL of 10-® was achieved and all testing requirements were met. Shelf Life Test was carried out with accordance to ASTM F-1980 in order to validate the claimed shelf life of 5 years.

Steam Sterilization Test was carried out with accordance to ISO 17665 in order to ensure safety and effectiveness related to UNIQA® Dental Abutments - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Biocompatibility - UNIQA Dental Implants are made of Ti6AI4V ELI using the conventional manufacturing process. Cytotoxicity testing was carried out with accordance to ISO 10993-5 in order to demonstrate that the manufacturing process did not change the biocompatibility profile. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality raw material which conforms the international standard ASTM F-136 Eli used for human implant applications.

Fatigue test was carried out with accordance to ISO 14801 in order to verify the mechanical connection strength of implant/abutment, results have demonstrated the performance with the use of UNIQA® Dental Implants / Abutments.

Surface Test was carried out to ensure the cleanness of the implant surface, surface results were met UNIQA requirements.

Risk Assessment was carried out with accordance to ISO 14971 and has demonstrated no new safety and/or effectiveness issues.

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16 Conclusion:

As verified by substantial equivalence, risk assessment and bench testing UNIQA® Dental Implants System shares similarity to its predicated devices in terms of intended use, indication for use, raw material, technological characteristics and performance. Therefore, UNIQA® Dental Implants system is considered to be substantially equivalent to its predicate devices.