(154 days)
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.
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;
The provided text describes UNIQA® Dental Implants System and its comparison to predicate devices, but it does not contain information about acceptance criteria for a study or the study details to prove the device meets acceptance criteria related to a diagnostic or AI-assisted product.
The document is a 510(k) premarket notification for a medical device (dental implants and abutments). It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of:
- Intended Use and Indications for Use: The UNIQA® system has the same general indications as its primary predicate, with some specific details for certain implant types (e.g., mini implants for specific jaw regions, use with straight abutments) matching reference devices.
- Technological Characteristics: This includes thread design, measurements (diameter/length), connection type, material (Titanium Alloy Ti6Al4V ELI), surface treatment (Pure & Porous, P&P or SBA), self-tapping feature, sterilization method (Gamma Ray), and packaging (Double packaging).
- Performance Testing: Bench tests like fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), shelf life (ASTM F-1980), biocompatibility (ISO 10993-5), and surface cleanliness are mentioned. These tests are performed to ensure the device's safety and effectiveness in relation to its physical and material properties, rather than its diagnostic performance.
Therefore, I cannot provide the requested information about acceptance criteria and study details for a diagnostic or AI-assisted device, as this information is not present in the provided text.
The document explicitly states: "Clinical Testing - No clinical data is included in this submission." This confirms that no studies involving human subjects were conducted or reported for this submission to establish a clinical performance metric.
To reiterate, the provided text does not contain:
- A table of acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).
- Reported device performance values for diagnostic tasks.
- Sample size used for a test set in a diagnostic study.
- Data provenance for a diagnostic study.
- Number of experts or their qualifications for establishing ground truth in a diagnostic study.
- Adjudication methods for ground truth in a diagnostic study.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone performance (algorithm only without human-in-the-loop performance) for a diagnostic algorithm.
- Type of ground truth used for a diagnostic study (expert consensus, pathology, etc.).
- Sample size for a training set of a diagnostic algorithm.
- How ground truth for a training set of a diagnostic algorithm was established.
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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)
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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 CorrespondentContact Person | Sterling Medical RegistrationDaniela 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;
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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
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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
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- 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.
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13 Substantial Equivalence
| Characteristic | Conical Implant, Pure& Porous, P&P Cat #UCI | MIS - SEVEN Implants | MIS V3 ConicalConnection implants | OsseoSpeed TX S | A.B. DentalImplant system | DENTIN DentalImplant system |
|---|---|---|---|---|---|---|
| Primary Predicate | Reference Device | Reference Device | ReferenceDevice | Reference Device | ||
| 510(k) number | K180598 | K040807 | K163349 | K101732 | K132125 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS ImplantsTechnologies Itd | MIS ImplantsTechnologies Itd | Astra Tech AB | A.B. DentalDevice Itd | DENTIN ImplantsTechnologies Ltd |
| Product Name | Conical Implant, Pure &Porous, P&P | SEVEN Implants | MIS V3 ConicalConnection DentalImplant System | OsseoSpeed TX S | 15 ConicalImplant | RAPID Implant |
| Thread Design | Tapered, Double Thread | Tapered, DoubleThread | Tapered, DoubleThread | Cylindrical taperedapex, threaded | Tapered, DoubleThread | Tapered |
| Measurements:Ø / Length mm | 3.3 Ø: 8 ,10, 11.5, 13,163.75 Ø: 8 ,10, 11.5, 13,164.2 Ø: 8 ,10, 11.5, 13,165.0 Ø: 8 ,10, 11.5, 13,16 | 3.75 Ø: 8 ,10, 11.5,13,164.2 Ø: 8 ,10, 11.5, 13,165.0 Ø: 8 ,10, 11.5, 13,16 | 3.3 Ø: 10, 11.5, 13, 164.3 Ø: 8 ,10, 11.5, 13,164.9 Ø: 8 ,10, 11.5, 13,165.0 Ø: 8 ,10, 11.5, 13,16 | 3.0 Ø: 11, 13, 153.5 Ø: 8, 9, 11, 13, 15,174.0 Ø: 6, 8, 9, 11,13,15, 175.0 Ø: 9, 11, 13, 15, 17 | 3.5 Ø: 8 ,10,11.5, 13, 16 | 3.3 Ø: 8 ,10, 11.5, 13,163.75 Ø: 8 ,10, 11.5,13, 164.2 Ø: 8 ,10, 11.5, 13,165.0 Ø: 7, 8 ,10, 11.5,136.0 Ø: 7, 8 ,10, 11.5,13 |
| ConnectionType | Internal conicalconnection, coneangulation 22° | Internal hex | Internal conicalconnection, coneangulation 12° | Internal conicalconnection, coneangulation 21º | Internal Hex | Internal Hex |
| Material | Titanium Alloy Ti6Al4VELI | Titanium Alloy Ti6Al4VELI | Titanium Alloy Ti6Al4VELI | Titanium grade 4 | Titanium AlloyTi6Al4V ELI | Titanium Alloy Ti6Al4VELI |
| SurfaceTreatment | Clean&Porous, P&P(Hydroxyapatite andCalcium Phosphates) | Sand Blast and acid-etched | Sand Blast and acid-etched | TiO2-blastedfluoridemodified surface | Hydroxyapatiteand CalciumPhosphates | Sand Blast & AcidEtched |
| 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 forUse | placement at themandibularcentral andlateral incisorsand maxillaryand lateralincisors.Indicated alsofor denturestabilizationusing multipleimplants. Onestage & One-Piece 2.4 mmdiameterimplants fortemporary use orlong term use:I6, I6b, permitimmediate splintstability and longterm fixation ofnew or existingcrown, bridgeand prosthesis.P14 AngulatedAbutmentAdapter is to beused withimplant diameter4.2mm andhigher. | |||||
| Self tapping | ✓ | Gamma Ray | ✓ | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray | Double packaging | Gamma Ray | Gamma Ray | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging | Double packaging | Doublepackaging | 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, SBACat # UC7 | MIS - SEVEN Implants | MIS V3 ConicalConnection implants | OsseoSpeed TX S | DENTIN Dental Implantsystem |
|---|---|---|---|---|---|
| Primary Predicate | Reference Device | Reference Device | Reference Device | ||
| 510(k) number | K180598 | K040807 | K163349 | K101732 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS ImplantsTechnologies Itd | MIS ImplantsTechnologies Itd | Astra Tech AB | DENTIN ImplantsTechnologies Ltd |
| Product Name | Conical Implant, SBA | SEVEN Implants | MIS V3 ConicalConnection DentalImplant 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, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 16 | 3.3 Ø: 10, 11.5, 13, 164.3 Ø: 8, 10, 11.5, 13,164.9 Ø: 8, 10, 11.5, 13,16 | 3.0 Ø: 11, 13, 153.5 Ø: 8, 9, 11, 13, 15, 174.0 Ø: 6, 8, 9, 11, 13, 15,175.0 Ø: 9, 11, 13, 15, 17 | 3.3 Ø: 8, 10, 11.5, 13, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 7, 8, 10, 11.5, 136.0 Ø: 7, 8, 10, 11.5, 13 |
| ConnectionType | Internal conical connection,cone angulation 22° | Internal hex | Internal conicalconnection, coneangulation 12° | Internal conicalconnection, coneangulation 21° | Internal Hex |
| Material | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4VELI | Titanium grade 4 | Titanium Alloy Ti6Al4V ELI |
| SurfaceTreatment | Sand Blast and acid-etched | Sand Blast and acid-etched | Sand Blast and acid-etched | TiO2-blastedfluoridemodified surface | Sand Blast & Acid Etched |
| Self tapping | Yes | Yes | Yes | Yes | Yes |
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| Indication for | UNIQA Dental ® Dental | The MIS Dental Implant | MIS V3 Conical | The OsseoSpeed implants | DENTIN® Dental Implants |
|---|---|---|---|---|---|
| Use | ImplantsSystem | 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. | |||||
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| 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&PCat# USI | MIS - SEVEN Implants | A.B. Dental Devices Ltd | DENTIN Dental Implantsystem |
|---|---|---|---|---|
| 510(k) number | K180598 | K040807 | K132125 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants Technologies Itd | A.B. Dental Device Itd | DENTIN ImplantsTechnologies 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, 163.75 Ø: 8 ,10, 11.5, 13, 164.2 Ø: 8 ,10, 11.5, 13, 165.0 Ø: 8 ,10, 11.5, 13, 16 | 3.75 Ø: 8 ,10, 11.5, 13,164.2 Ø: 8 ,10, 11.5, 13, 165.0 Ø: 8 ,10, 11.5, 13, 16 | 3.5 Ø: 8 ,10, 11.5, 13, 16 | 3.3 Ø: 8 ,10, 11.5, 13, 163.75 Ø: 8 ,10, 11.5, 13, 164.2 Ø: 8 ,10, 11.5, 13, 165.0 Ø: 7, 8 ,10, 11.5, 136.0 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 CalciumPhosphates | Sand Blast & Acid Etched |
| Self tapping | Yes | Yes | Yes | Yes |
{13}------------------------------------------------
| Indication for Use | UNIQA Dental ® Dental ImplantsSystem is indicated for use insurgical and restorative applicationsfor placement in the bone of theupper or lower jaw to provide supportfor prosthetic devices, such asartificial teeth, in order to restore thepatient's chewing function. UNIQADental ® Dental Implants System isindicated also for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading.UNIQA Conical Connection Implants:#UCI & #UC7 are to be used onlywith straight abutments.Conical Mini implants (Ø3.3mm) areindicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateralincisor and maxillary lateral incisorregions of partially edentulous jaws,to provide support for prostheticdevices such as artificial teeth, inorder to restore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another. | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such asartificial teeth, in order to restoremasticatory function. | A.BDENTAL DEVICES® Dental Implants System isindicated for use in surgical and restorative applications forplacement in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, in orderto restore the patient's chewingfunction. A.B. DENTAL DEVICES® Dental ImplantsSystem is indicated also for immediate loading when goodprimary stability is achieved and with appropriate occlusalloading. Two Stage Implants:I2,I5,I6BI. One Stage: I6, I6b, I6B. One Stage & One-Piece3.0 mm diameter implants: I6, I6B, I6BI, are intended forplacement at the mandibular central and lateral incisors andmaxillary and lateral incisors. Indicated also for denturestabilization using multiple implants. One stage & One-Piece2.4 mm diameter implants for temporary use or long term use: I6, I6b, permitimmediate splint stability and long term fixation of new orexisting crown, bridge and prosthesis. P14 AngulatedAbutment Adapter is to be used with implant diameter4.2mm and higher. | DENTIN® Dental Implants System is indicated for use insurgical and restorative applications for placement inthe bone of the upper or lower jaw to provide supportfor prosthetic devices, such as artificial teeth, in order torestore the patient's chewing function. DENTIN® DentalImplants System is indicated also for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading. Two Stage Implants:CLASSIC, RAPID, PRESTIGE.One Stage Implants: ONE PIECE DENTIN® ONEPIECEImplants 3.0 mmd are intended for placement at themandibular central and lateral incisors and maxillaryand lateral incisors. Indicated also for denture stabilizationusing 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, SBACat# 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, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 16 | 3.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 16 | 3.3 Ø: 8, 10, 11.5, 13, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 165.0 Ø: 7, 8, 10, 11.5, 136.0 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 isindicated for use in surgical and restorativeapplications for placement in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth, inorder to restore the patient's chewingfunction. UNIQA Dental ® Dental ImplantsSystem is indicated also for immediateloading when good primary stability isachieved and with appropriate occlusalloading.UNIQA Conical Connection Implants: #UCI &#UC7 are to be used only with straightabutments.Conical Mini implants (Ø3.3mm) are indicatedfor use in surgical and restorative applicationsfor placement only in the mandibular central,lateral incisor and maxillary lateral incisorregions of partially edentulous jaws, toprovide support for prosthetic devices such asartificial teeth, in order to restore the patientchewing function. Mandibular central andlateral incisors must be splinted if using two ormore narrow implants adjacent to oneanother. | The MIS Dental Implant System is intendedto be surgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, such asartificial teeth, in order to restoremasticatory function. | DENTIN® Dental Implants System isindicated for use in surgical and restorativeapplications for placement in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth, inorder to restore the patient's chewingfunction. DENTIN® Dental Implants Systemis indicated also for immediate loading whengood primary stability is achieved and withappropriate occlusal loading.Two Stage Implants: CLASSIC, RAPID,PRESTIGE.One Stage Implants: ONE PIECEDENTIN® ONEPIECE Implants 3.0 mmdare intended for placement at themandibular central and lateral incisors andmaxillary and lateral incisors. Indicated alsofor denture stabilization using multipleimplants. |
|---|---|---|---|
| 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 isindicated for use in surgical and restorativeapplications for placement in the bone of the upperor lower jaw to provide support for prostheticdevices, such as artificial teeth, in order to restorethe patient's chewing function. UNIQA Dental ®Dental Implants System is indicated also forimmediate loading when good primary stability isachieved and with appropriate occlusal loading.UNIQA Conical Connection Implants: #UCI & #UC7are to be used only with straight abutments.Conical Mini implants (Ø3.3mm) are indicated foruse in surgical and restorative applications forplacement only in the mandibular central, lateralincisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support forprosthetic devices such as artificial teeth, in order torestore the patient chewing function. Mandibularcentral and lateral incisors must be splinted if usingtwo or more narrow implants adjacent to oneanother. | The MIS Dental Implant System is intended to besurgically placed in the bone of the upper or lowerjaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory 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 15Height 1,2,3,4 - Angle 25 | Height 1,2,3 - Angle 15Height 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 isindicated for use in surgical and restorativeapplications for placement in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth, inorder to restore the patient's chewingfunction. UNIQA Dental ® Dental ImplantsSystem is indicated also for immediateloading when good primary stability isachieved and with appropriate occlusalloading.UNIQA Conical Connection Implants: #UCI &#UC7 are to be used only with straightabutments.Conical Mini implants (Ø3.3mm) areindicated for use in surgical and restorativeapplications for placement only in themandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support for | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restoremasticatory function. | NobelActive Multi UnitAbutment is a pre-manufacturedprosthetic component directlyconnected to the endosseousdental implant and is intendedfor use as an aid in prostheticrehabilitation. |
{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, inorder to restore the patient chewing function.Mandibular central and lateral incisors mustbe splinted if using two or more narrowimplants adjacent to one another. | |||
|---|---|---|---|
| Dimensions | Height 1,2,3 - Angle 17Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5Angles 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#USTDSleeve for Multi Unit Abutment, MUA,Temporary, V-type#USTV+ screw (#UMSD) | Sleeve=Temporary copying(29046) + screw, plastic cap,MU screw#29285Related 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 transgingivalAbutment | Straight Multi Unit Abutments |
| Indication for Use | UNIQA Dental ® Dental ImplantsSystem is indicated for use in surgicaland restorative applications forplacement in the bone of the upper orlower jaw to provide support forprosthetic devices, such as artificialteeth, in order to restore the patient'schewing function. UNIQA Dental ®Dental Implants System is indicatedalso for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.UNIQA Conical Connection Implants:#UCI & #UC7 are to be used onlywith straight abutments.Conical Mini implants (Ø3.3mm) are | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restore masticatoryfunction. | MIS V3 Conical Connection DentalImplant System is intended to besurgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, suchas artificial teeth, in order to restoremasticatory function. When a one-stage surgical procedure is applied,the implant may be immediatelyloaded when good primary stability isachieved and the occlusal load isappropriate. Narrow implants(Ø3.3mm) are indicated for use insurgical and restorative applicationsfor placement only in the mandibularcentral, lateral incisor and maxillary |
| indicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateralincisor and maxillary lateral incisorregions of partially edentulous jaws,to provide support for prostheticdevices such as artificial teeth, inorder to restore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another. | lateral incisor regions of partiallyedentulous jaws, to provide supportfor prosthetic devices such asartificial teeth, in order to restore thepatient chewing function. Mandibularcentral and lateral incisors must besplinted if using two or more narrowimplants adjacent to one another. | ||
| Dimensions mm | Diameter: RegularHeights 1,2,3,4 | Height 1,2,3,4 | Diameter: RegularHeights 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 ImplantsSystem is indicated for use in surgicaland restorative applications forplacement in the bone of the upper orlower jaw to provide support forprosthetic devices, such as artificialteeth, in order to restore the patient'schewing function. UNIQA Dental ®Dental Implants System is indicatedalso for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.UNIQA Conical Connection Implants:#UCI & #UC7 are to be used only | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restore masticatoryfunction. | NobelActive Multi Unit Abutment is apre-manufactured prostheticcomponent directly connected to theendosseous dental implant and isintended for use as an aid inprosthetic rehabilitation. |
| Dimensions mm | Diameter: RegularHeight 1,2,3 - Angle 17Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5Angles 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#29285Related 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 deviceMulti-Unit Abutment |
| Dimensions mm | Diameter: RegularHeight 1,2,3 - Angle 17Height 1,2,3 - Angle 30 | Height 1,2,3 - Angle 15Height 1,2,3 - Angle 25 | Height 1.5, 2.5, 3.5, 4.5Angles 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 3,4,5,6Narrow -Diameter 3.3, 4.3 - Height 2, 3, 4, 6,8 | Heights 4.1, 5.5 |
| Standard -Diameter 4.0, 4.8, 5.5; Height2,3,4,5,6 | |||
| 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.
{20}------------------------------------------------
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.
{21}------------------------------------------------
{22}------------------------------------------------
| 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 isindicated for use in surgical and restorativeapplications for placement in the bone of the upperor lower jaw to provide support for prostheticdevices, such as artificial teeth, in order to restorethe patient's chewing function. UNIQA Dental ®Dental Implants System is indicated also forimmediate loading when good primary stability isachieved and with appropriate occlusal loading.UNIQA Conical Connection Implants: #UCI & #UC7are to be used only with straight abutments.Conical Mini implants (Ø3.3mm) are indicated foruse in surgical and restorative applications forplacement only in the mandibular central, lateralincisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support forprosthetic devices such as artificial teeth, in order torestore the patient chewing function. Mandibularcentral and lateral incisors must be splinted if usingtwo or more narrow implants adjacent to oneanother. | The MIS Dental Implant System is intended to besurgically placed in the bone of the upper or lowerjaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory 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-0001) | Metal Caps, Silicon Caps |
| Company / 510k | UNIQA Dental Itd K180598 | MIS K040807 |
| Primary Predicate | ||
| Product Name | Healing Caps #UHXX | Healing Caps |
| Indication for Use | UNIQA Dental ® Dental Implants System is | The MIS Dental Implant System is intended to be |
| indicated for use in surgical and restorative | surgically placed in the bone of the upper or lower | |
| applications for placement in the bone of the upper | jaw arches to provide support for prosthetic | |
| or lower jaw to provide support for prosthetic | devices, such as artificial teeth, in order to restore | |
| devices, such as artificial teeth, in order to restore | masticatory function. | |
| 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. | ||
| Dimensions mm | Wide (# UHCW) - | Wide - |
| Diameter 5.5, 6.3 Height 2,3,4,5,6,7 | Diameter. 5.0, 6.5; Height 3,4,5,6 | |
| Narrow (# UHCN) -Diameter 3.5; Height 3, 5,7 | Narrow -Diameter 3.3, 4.3 - Height 2, 3, 4, 6,8 | |
| Regular (#UHCR) - | Standard - | |
| Diameter 4.6, Height 2,3,4,5,6,7 | Diameter 4.0, 4.8, 5.5; Height 2,3,4,5,6 | |
| 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 |
{23}------------------------------------------------
{24}------------------------------------------------
| Product Name | # USARStraight Anatomic Abutment | Anatomic transgingivalAbutment |
|---|---|---|
| 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 Systemis indicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function. UNIQADental® Dental Implants System isindicated also for immediate loading whengood primary stability is achieved and withappropriate occlusal loading.UNIQA Conical Connection Implants: #UCI& #UC7 are to be used only with straightabutments.Conical Mini implants (Ø3.3mm) areindicated for use in surgical and restorativeapplications for placement only in themandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support forprosthetic devices such as artificial teeth,in order to restore the patient chewingfunction. Mandibular central and lateralincisors must be splinted if using two ormore narrow implants adjacent to oneanother. | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such asartificial teeth, in order to restoremasticatory function. | The AB Dental Devices implants areintended for surgical placement in themaxillary and/or mandibular arch tosupport crowns, bridges, oroverdentures in edentulous or partiallyedentulous patients. 17 Integraimplant, 15 Conical implant, P15Temporary abutment, P12-T,LTemporary flat connection abutment,and P16 Straight adaptor areappropriate for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading. |
| Dimensions mm | Diameter : Regular (#USBR) | Diameter : Regular, Wide | Diameter : 3.0, 3.75, 5 |
{25}------------------------------------------------
| Length 5, 7, 9, 11, 13, 15 mmDiameter : Wide (# USBW) | Length 5, 7, 9, 12 mm (=Heights1,2,3,4) | 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 ImplantsSystem isindicated for use in surgical and restorativeapplications for placement in the bone of the upperor lower jaw to provide support for prostheticdevices, such as artificial teeth, in order to restorethe patient's chewing function. UNIQA Dental ®Dental Implants System is indicated also forimmediate loading when good primary stability isachieved and with appropriate occlusal loading.UNIQA Conical Connection Implants: #UCI & #UC7are to be used only with straight abutments.Conical Mini implants (Ø3.3mm) are indicated foruse in surgical and restorative applications forplacement only in the mandibular central, lateralincisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support forprosthetic devices such as artificial teeth, in order torestore the patient chewing function. Mandibularcentral and lateral incisors must be splinted if usingtwo or more narrow implants adjacent to oneanother. | The MIS Dental Implant System is intended to besurgically placed in the bone of the upper or lowerjaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory function. | |
| Dimensions mm | Diameter :Heights 1,2,3,4 | Diameter : Regular, WideHeights 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 isindicated for use in surgical and restorativeapplications for placement in the bone of the upperor lower jaw to provide support for prostheticdevices, such as artificial teeth, in order to restorethe patient's chewing function. UNIQA Dental ®Dental Implants System is indicated also forimmediate loading when good primary stability isachieved and with appropriate occlusal loading.UNIQA Conical Connection Implants: #UCI & #UC7are to be used only with straight abutments.Conical Mini implants (Ø3.3mm) are indicated foruse in surgical and restorative applications forplacement only in the mandibular central, lateralincisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support forprosthetic devices such as artificial teeth, in order torestore the patient chewing function. Mandibularcentral and lateral incisors must be splinted if usingtwo or more narrow implants adjacent to oneanother. | The MIS Dental Implant System is intended to besurgically placed in the bone of the upper or lowerjaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory function. | |
| Diameter: Regular,Heights 1,2,3,4,5 | Diameter : Regular, Slim, WideHeights 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 #USWRLength 8.1 mm #USWL | Diameter: Narrow, Regular, wideLength 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 ImplantsSystem is indicated for use in surgicaland restorative applications forplacement in the bone of the upper orlower jaw to provide support forprosthetic devices, such as artificialteeth, in order to restore the patient'schewing function. UNIQA Dental ®Dental Implants System is indicatedalso for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.UNIQA Conical Connection Implants:#UCI & #UC7 are to be used onlywith straight abutments.Conical Mini implants (Ø3.3mm) areindicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateralincisor and maxillary lateral incisorregions of partially edentulous jaws,to provide support for prostheticdevices such as artificial teeth, inorder to restore the patient chewingfunction. Mandibular central andlateral incisors must be splinted if | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restore masticatoryfunction. | MIS V3 Conical Connection DentalImplant System is intended to besurgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, suchas artificial teeth, in order to restoremasticatory function. When a one-stage surgical procedure is applied,the implant may be immediatelyloaded when good primary stability isachieved and the occlusal load isappropriate. Narrow implants(Ø3.3mm) are indicated for use insurgical and restorative applicationsfor placement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to provide support forprosthetic devices such as artificial teeth, in order to restore thepatient chewing function. Mandibularcentral and lateral incisors must besplinted if using two or more narrowimplants 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 Abutmentsleeve, V-type (#UMSV-0002) -measurement 3.9 L mm ;Healing cap for Multi Unit Abutment,MUA, V-type (#UMHV-0004) - 3.1 Lmm | Multi unit screw measurement 3.8 Lmm;Healing Cap measurement 4.3 L mm | |
| Company / 510k | UNIQA Dental Itd K180598 | MIS K040807Primary Predicate | MIS K163349Reference device |
| Product Name | Healing Cap # UOHX | Healing Caps | Healing Cap |
| Dimensions mm | Diameter: Mini (#UOHM) - Diameter4.0, 4.5 Heights 3, 4, 5,7Regular (#UOHR) -Diameter 4.0, 4.5, 5.0, 6.0, 7.0Heights 3, 4, 5, 7 | Wide -Diameter. 5.0, 6.5; Height 3,4,5,6Narrow -Diameter 3.3, 4.3 - Height 2, 3, 4, 6,8Standard -Diameter 4.0, 4.8, 5.5; Height2,3,4,5,6 | Diameter: SlimDiameter 3.3, 4.0, 4.8, Heights3,4,5,6,8Regular, 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 K040807Primary Predicate | MIS K163349Reference 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, WideHeights 1,2,3,4 | Narrow Diameter: 4.0 Length 1, 3Narrow Diameter: 4.8 Length 1,2, 3Standard Diameter: 4.8 Length1,2,3,4 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 transgingivalAbutment | Multi Unit |
| Indication for Use | UNIQA Dental ® Dental ImplantsSystem is indicated for use in surgicaland restorative applications forplacement in the bone of the upper orlower jaw to provide support forprosthetic devices, such as artificialteeth, in order to restore the patient'schewing function. UNIQA Dental ®Dental Implants System is indicatedalso for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.UNIQA Conical Connection Implants:#UCI & #UC7 are to be used onlywith straight abutments.Conical Mini implants (Ø3.3mm) areindicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateralincisor and maxillary lateral incisorregions of partially edentulous jaws,to provide support for prostheticdevices such as artificial teeth, inorder to restore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another. | The MIS Dental Implant System isintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restore masticatoryfunction. | MIS V3 Conical Connection DentalImplant System is intended to besurgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, suchas artificial teeth, in order to restoremasticatory function. When a one-stage surgical procedure is applied,the implant may be immediatelyloaded when good primary stability isachieved and the occlusal load isappropriate. Narrow implants(Ø3.3mm) are indicated for use insurgical and restorative applicationsfor placement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to provide supportfor prosthetic devices such asartificial teeth, in order to restore thepatient chewing function. Mandibularcentral and lateral incisors must besplinted if using two or more narrowimplants adjacent to one another. |
| Dimensions mm | Mini Diameter: 4.0 Height 1, 2,3,4(#UOMM) | Height 1,2,3,4 | Narrow Diameter: Heights 1,2,3,5Standard Diameter: Heights 1,2,3,4 |
| Regular Diameter: 4.0, 5.0, 6.0Height 1, 2,3,4,5 (5mm not for 4Ø)(#UOMR) | 5(also available Angulated 17, 30 withheight 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, 6.0Length: 7.Sleeve for Multi Unit Abutment, MUA,Fixed, C-type (#USTC-Fx) DiameterRegular : 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.
§ 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.