(469 days)
No
The 510(k) summary describes a dental implant system composed of physical components (implants, abutments, screws) made of titanium. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical properties, sterilization, and biocompatibility, not computational performance.
Yes
The device is described as an "Implacil Implant System" intended for placement in the maxillary or mandibular arch to provide support for dental restorations, which is a therapeutic function in healthcare.
No
The device is described as an implant system for supporting dental restorations in the mouth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components made of titanium and titanium alloy, including implants and prosthetic components. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the Implacil Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for placement in the maxillary or mandibular arch to provide support for dental restorations. This is a surgical and prosthetic application within the body.
- Device Description: The description details the physical components of the implant system (implants, abutments, screws) made of titanium. These are physical devices implanted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The Implacil Implant System is a medical device intended for surgical implantation within the body.
N/A
Intended Use / Indications for Use
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).
HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.
HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.
CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).
lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).
The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
Sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-2. Sterile barrier shelf life testing (accelerated aging according to ASTM F1980); package integrity according to ASTM F1929 and ASTM F88/F88M; sterility of the package content according to ISO 11737-2. The biocompatibility of the subject devices materials was supported by cytotoxicity testing according to ISO 10993-12. Pyrogenicity monitoring according to AAMI/ANSI ST72. Mechanical performance demonstrated through dynamic fatigue testing according to ISO 14801 and static torsional loading test according ISO/TS 13498:2011. No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K062931, K072642, K090452, K101207, K101945, K133510, K140440, K163060, K163634, K170392, K170608, K173819, K173902, K180282
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2020
Implacil de Bortoli Material Odontologico Ltda c/o Janine Treter Regulatory Affairs Specialist PR Serviços Regulatórios Administrativos Ltda Rua Alice Além Saadi, 855/ 2402 Ribeirão Preto, São Paulo 14096-570 BRAZIL
Re: K183024
Trade/Device Name: Implacil Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 13, 2020 Received: January 16, 2020
Dear Janine Treter:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183024
Device Name
Implacil Implant System
Indications for Use (Describe)
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | |
|---|---|
| --------- | -- |
| Sponsor | Implacil de Bortoli Material Odontologico Ltda |
|---|---|
| Rua Vicente de Carvalho 178-182 | |
| São Paulo, São Paulo, Brazil 01521020 |
Contact Person and Preparer Janine Treter, PhD Regulatory Affairs Specialist Passarini Regulatory Affairs PR Serviços Regulatórios Administrativos Ltda E-Mail: janine@rapassarini.com.br Telephone +55 (47) 3804 0075
Date Prepared
13/Feb/2020
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Implacil Implant System |
|---|---|
| Common Name | Dental implant and abutment |
| Primary Classification Name | Endosseous dental implant |
| Primary Classification Regulation | 21 CFR 872.3640, Class II |
| Primary Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
|---|---|
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate Device
Reference Devices
K170398 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A. K062931 – IMPLUS - LEADER Italia S.R.O K072642 - BIOMET 3i Dental Abutments and Restorative Components - Biomet 3i, Inc.
K090452 - Neoss Implant System 03,25 - Neoss Limited
K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A.
K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.
4
K133510 - Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.
K140440 - Noris Medical Dental Implants System - Noris Medical, Ltd.
K163060 -Deep Conical (DC) Implants and Accessories - Southern Implants (Pty) Ltd
K163634 - External Hex Implants - Southern Implants (Pty) Ltd
K170392 - S.I.N. Dental Implant System - S.I.N. Sistema de Implante Nacional S.A.
K170608 - UF(II) Implant System - DIO Corporation
K173819 – MyPlant II Implant System Hager & Meisinger GmbH
K173902 - Neodent Implant System - GM Line - JJGC Industria e Comercio de Materiais Dentarios S.A.
K180282 - MIS Internal Hex Dental Implant System -MIS Implants Technologies Ltd.
INDICATIONS FOR USE
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SUBJECT DEVICE DESCRIPTION
Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).
HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.
HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.
5
CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).
lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).
The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).
TECHNOLOGICAL CHARACTERISTICS
The subject device and the predicate devices have the same intended use as and technological characteristics as shown in the tables below. Differences in the design features between the subject devices and the primary predicate device K170398 are addressed by comparison to the reference devices.
6
| Table 5.1: Comparison on indication for use statement | ||
|---|---|---|
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | |
| SUBJECT DEVICE | K183024 – Implacil Implant System | |
| Implacil de Bortoli Material Odontologico | ||
| Ltda | Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit | |
| restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good | ||
| primary stability is achieved and with appropriate occlusal loading. | ||
| PRIMARY PREDICATE | ||
| DEVICE | K170398 - S.I.N. Dental Implant System | |
| S.I.N. Sistema de Implante Nacional S.A | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit | |
| restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good | ||
| primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading | ||
| only. | ||
| REFERENCE DEVICES | K062931 – IMPLUS | |
| LEADER Italia S.R.O | IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide | |
| support for fixed and/or removal prosthetics in order to restore original features and masticatory functions. | ||
| Implus implant fixtures are indicated for permanent use. | ||
| Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized. | ||
| K072642 – BIOMET 3i Dental Abutments and | ||
| Restorative Components | ||
| Biomet 3i, Inc. | BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or | |
| completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or | ||
| maxilla. The prosthesis can be screw retained or cement retained. | ||
| Restorative Components |
- Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
- Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental
prosthetics. - Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the
dental implant. |
| | K090452 – Neoss Implant System 03,25
Neoss Ltd | The Neoss Implant System 03,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neoss Implant System 03,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient
bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Neoss Implant 03,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic
rehabilitation. |
| | K101207 - Neodent Implant System
JJGC Industria e Comercio de Materiais
Dentarios S.A. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic
devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple
unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple
tooth applications may be rigidly splinted. |
| | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT |
| REFERENCE DEVICES | K101945- Neodent Implant System
JJGC Industria e Comercio de Materiais
Dentarios S.A. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic
devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple
unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple
tooth applications may be rigidly splinted. |
| | K133510 - Neodent Implant System
JJGC Industria e Comercio de Materiais
Dentarios S.A. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lowerjaw to provide support for prosthetic
devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple
unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple
tooth applications may be rigidly splinted. |
| | K163060 -Deep Conical (DC) Implants and
Accessories
Southern Implants (Pty) Ltd | Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the
following clinical protocols:
• replacing single and multiple missing teeth in the mandible and maxilla,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where
implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors |
| | K163634 - External Hex Implants
Southern Implants (Pty) Ltd | Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower
jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Southern Implants' External Hex Implants are intended for immediate function when good primary
stability with appropriate occlusal loading is achieved. |
| | K170608 - UF(II) Implant System
DIO Corporation | The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or
multiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System (Ø3.8 ~ Ø5.5) can be placed with a
conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for
immediate loading when good primary stability is achieved with appropriate occlusal loading. |
| | K170392 - S.I.N. Dental Implant System
S.I.N. Sistema de Implante Nacional S.A | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit
restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading
only. |
| | K173819 – MyPlant II Implant System
Hager & Meisinger GmbH | The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous
patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic
restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for
the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary
stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be performed. |
| | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT |
| REFERENCE DEVICES | K173902 - Neodent Implant System - GM
Line | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic
devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple
unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. |
| | JJGC Industria e Comercio de Materiais
Dentarios S.A. | |
| | K180282 - MIS Internal Hex Dental Implant
System | MIS dental implant systems are 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. |
| | MIS Implants Technologies Ltd. | Narrow implants (Ø3.3mm & UNO) 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only. |
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| Table 5.2: SE comparison on HE implants | |||||
|---|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |||
| Trade Name | K183024 - Implacil Implant | ||||
| System | |||||
| Implacil de Bortoli Material | |||||
| Odontologico Ltda | K170398 - S.I.N. Dental Implant | ||||
| System | |||||
| S.I.N. Sistema de Implante | |||||
| Nacional S.A. | K101207 – Neodent Implant | ||||
| System | |||||
| JJGC Industria e Comercio de | |||||
| Materiais Dentarios S.A. | K062931 - IMPLUS | ||||
| LEADER Italia S.R.O. | K163634 – External Hex Implant | ||||
| Southern Implants (Pty) Ltd. | |||||
| November 6, 2017 | |||||
| Information | |||||
| Implant-to-abutment connection | HE interface | HE interface | HE interface | HE interface | HE interface |
| Raw Material | CPTi | CPTi | CPTi | CPTi | CPTi |
| Surface | Grit-blasted and acid-etched | Acid-etched and HA | Grit-blasted and acid-etched | Sand-blasted and acid-etched | Grit-blasted and acid-etched |
| Machine collar versions | |||||
| available | |||||
| Root type design | Cylindrical | Cylindrical | Cylindrical | Cylindrical | Cylindrical |
| Tapered | Tapered | Tapered | Tapered | ||
| Implant diameter (mm) | Cylindrical: | ||||
| 3.3: 8, 10, 11.5, 13, 15 | |||||
| 3.75: 8, 10, 11.5, 13, 15 | |||||
| 4.0: 8, 10, 11.5, 13, 15 | |||||
| 4.75: 8, 10, 11.5, 13, 15 |
Tapered:
3.5: 7, 9, 11, 13, 15
4.0: 7, 9, 11, 13, 15
5.0: 7, 9, 11, 13, 15 | Cylindrical:
3.25: 8.5, 10, 11.5, 13, 15
3.5: 7, 8.5, 10, 11.5, 13, 15
3.75: 7, 8.5, 10, 11.5, 13, 15
4.0: 6, 7, 8.5, 10, 11.5, 13, 15
4.5: 8.5, 10, 11.5, 13, 15
5.0: 6, 7, 8.5, 10, 11.5, 13, 15 | Cylindrical:
3.3: 9, 11, 13, 15, 17
3.75: 9, 11, 13, 15, 17, 19
4.0: 9, 11, 13, 15, 17, 19
4.5: 9, 11, 13
5.0: 7, 9, 11, 13
Tapered:
3.5: 10, 13, 16
4.3: 10, 13, 16
5.0: 10, 13, 16 | Cylindrical:
3.3: 10, 11.5, 13, 15
3.75: 8, 10, 11.5, 13, 15, 18, 20
5.0: 8, 10, 11.5, 13
Tapered:
4.0: 8, 10, 11.5, 13, 15
5.0: 8, 10, 11.5, 13 | Cylindrical:
3.75: 7, 8.5, 10, 11.5, 13, 15, 18,
20
5.0: 6, 7, 8.5, 10, 11.5, 13, 15
6.0: 7, 8.5, 10, 11.5, 13, 15
Tapered:
3.25: 8.5, 10, 11.5, 13, 15, 18
4.0: 6, 8.5, 10, 11.5, 13, 15
4.7: 10, 11.5, 13, 15, 18
5.0: 6, 8.5, 10, 11.5, 13, 15
5.7: 10, 11.5, 13, 15, 18 |
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
10
Page 8 of 22
| Table 5.3: SE comparison on HI implants | ||||
|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | ||
| Trade Name | ||||
| Information | K183024 – Implacil Implant System | K170398 - S.I.N. Dental Implant System | K062931 - IMPLUS | K180282 - MIS Internal Hex Dental Implant |
| System | ||||
| Implacil de Bortoli Material Odontologico | ||||
| Ltda | S.I.N. Sistema de Implante Nacional S.A. | LEADER Italia S.R.O. | MIS Implants Technologies Ltd. | |
| Implant-to-abutment | ||||
| connection | HI interface | HI interface | HI interface | HI interface |
| Raw Material | CPTi | CPTi | CPTi | Ti alloy (TI-6AI-4V ELI) |
| Surface | Grit-blasted and acid-etched | Acid-etched and HA | Sand-blasted and acid-etched | Anodized, sand blasted and acid etched |
| Sand blasted and acid etched | ||||
| Root type design | Cylindrical | |||
| Tapered | Cylindrical | Cylindrical | ||
| Tapered | Cylindrical | |||
| Tapered | ||||
| Diameter: length (mm) | Cylindrical | |||
| 3.3: 8, 9, 11, 13, 15 | ||||
| 3.75: 7, 9, 11, 13, 15 | ||||
| 4.3: 7, 9, 11, 13, 15 | ||||
| 4.75: 7, 9, 11, 13, 15 | ||||
| Tapered: | ||||
| 3.5: 8, 9, 11, 13, 15 | ||||
| 4.0: 8, 9, 11, 13, 15 | ||||
| 5.0: 7, 9, 11, 13, 15 | Cylindrical | |||
| 3.8: 8.5, 10, 11.5, 13, 15 | ||||
| 4.5: 8.5, 10, 11.5, 13, 15 | ||||
| 5.0: 8.5, 10, 11.5, 13, 15 | Cylindrical | |||
| 3.3: 8, 10, 11.5, 13, 16 | ||||
| 3.75: 8, 10, 11.5, 13, 16 | ||||
| 4.5: 8, 10, 11.5, 13, 16 | ||||
| 5.5: 8, 10, 11.5, 13 | ||||
| Tapered: | ||||
| 4.0: 8, 10, 11.5, 13, 16 | ||||
| 5.0: 8, 10, 11.5, 13, 16 | ||||
| 6.0: 8, 10, 11.5, 13 | Cylindrical | |||
| 3.3: 10, 11.5, 13, 16 | ||||
| 3.75: 8, 10, 11.5, 13, 16, 18, 20 | ||||
| 4.2: 6, 8, 10, 11.5, 13, 16, 18, 20 | ||||
| 5.0: 6, 8, 10, 11.5, 13, 16 | ||||
| 6.0: 6, 8, 10, 11.5, 13 | ||||
| Tapered: | ||||
| 3.3: 10, 11.5, 13, 16 | ||||
| 3.75: 8, 10, 11.5, 13, 16, 18, 20 | ||||
| 4.2: 8, 10, 11.5, 13, 16, 18, 20 | ||||
| 5.0: 8, 10, 11.5, 13, 16 | ||||
| 6.0: 8, 10, 11.5, 13 | ||||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
11
Page 9 of 22
| Table 5.4: SE comparison on CM AR implants | ||||
|---|---|---|---|---|
| SUBJECT DEVICES | REFERENCE DEVICES | |||
| Trade Name | ||||
| Information | K183024 – Implacil Implant System | K101945 – Neodent Implant System | K170608 – UF(II) Implant System | K163060 -Deep Conical (DC) Implants and |
| Accessories | ||||
| Implacil de Bortoli Material Odontologico | ||||
| Ltda | JJGC Industria e Comercio de Materiais | |||
| Dentarios S.A. | DIO Corporation | Southern Implants (Pty) Ltd | ||
| Implant-to-abutment | ||||
| connection | Conical connection (CM AR) | Conical connection (CM) | Conical connection (CM) | Conical connection (Deep Conical) |
| Raw Material | CPTi | CPTi | CPTi | CPTi |
| Surface | Grit-blasted and acid-etched | Grit-blasted and acid-etched | Hybrid Sand-blasted and acid-etched | Roughened surface |
| Root type design | Tapered | Cylindrical | ||
| Tapered | Tapered | Cylindrical | ||
| Tapered | ||||
| Implant-to-abutment | ||||
| indexation feature | Dodecagon (double-hexagon) | Hexagon | Hexagon | Dodecagon (double-hexagon) |
| Implant diameter: lenghts (mm) | Tapered: | |||
| 3.5: 7, 9, 11, 13, 15 | ||||
| 4.0: 7, 9, 11, 13, 15 | ||||
| 4.5: 7, 9, 11, 13, 15 | ||||
| 5.0: 7, 9, 11, 13, 15 | Cylindrical: | |||
| 3.5: 7, 8, 9, 11, 13, 15, 17 | ||||
| 3.75: 7, 8, 9, 11, 13, 15, 17 | ||||
| 4.0: 7, 8, 9, 11, 13, 15, 17, 19 | ||||
| 5.0: 7, 8, 9, 11, 13 | ||||
| Tapered: | ||||
| 3.5: 8, 10, 11.5, 13, 16 | ||||
| 4.3: 8, 10, 11.5, 13, 16 | ||||
| 5.0: 8, 10, 11.5, 13, 16 | Tapered: | |||
| 3.8: 8.5, 10, 11.5, 13, 15, 16 | ||||
| 4.0: 8.5, 10, 11.5, 13, 15, 16 | ||||
| 4.5: 7, 8.5, 10, 11.5, 13, 15, 16 | ||||
| 5.0: 7, 8.5, 10, 11.5, 13, 15, 16 | ||||
| 5.5: 7, 8.5, 10, 11.5, 13, 15, 16 | Cylindrical: | |||
| 3.0: 11, 13, 15 | ||||
| 3.5: 8, 9, 11, 13, 15 | ||||
| 4.0: 6, 8, 9, 11, 13, 15 | ||||
| 5.0: 9, 11, 13, 15 | ||||
| Tapered: | ||||
| 3.0: 9, 11, 13, 15 | ||||
| 3.5: 8, 9, 11, 13, 15 | ||||
| 4.0: 6, 8, 9, 11, 13, 15 | ||||
| 5.0: 9, 11, 13, 15 | ||||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
12
Page 10 of 22
| Table 5.5: SE comparison on Covers | |||||
|---|---|---|---|---|---|
| SUBJECT DEVICES | REFERENCE DEVICES | ||||
| Trade Name | K183024 - Implacil Implant System | K101207 - Neodent Implant | |||
| System | K180282 - MIS Internal Hex | ||||
| Dental Implant System | K101945 – Neodent Implant | ||||
| System | K170608 - UF(II) Implant System | ||||
| Information | Implacil de Bortoli Material | ||||
| Odontologico Ltda | JJGC Industria e Comercio de | ||||
| Materiais Dentarios S.A. | MIS Implants Technologies Ltd. | JJGC Industria e Comercio de | |||
| Materiais Dentarios S.A. | DIO Corporation | ||||
| Implant-to-abutment connection | |||||
| (Implant line) | HE interface | ||||
| HI interface | |||||
| Conical interface (CM AR) | HE interface | HI interface | Conical interface (CM) | Conical interface (CM) | |
| Diameter (mm) | HE: 3.5, 4.0, 5.0 | ||||
| HI: 3.5, 4.0, 5.0 | |||||
| CM AR: 2.5 | HE: 3.3, 4.1, 4.3, 5.0 | HI: 3.3, 3.75, 4.7 | CM: 2.5 | CM: 2.7, 2.794, 3.6, 3.8 | |
| Gingival Height (mm) | HE: 0 | ||||
| HI: 0 | |||||
| CM AR: 2 | HE: 0 | HI: 0 | CM: 0, 2 | CM: 0, 1, 2, 3 | |
| Raw material | CPTi | Ti alloy | Ti alloy | Ti alloy | CPTi |
| Surface | Machined | Machined | Machined and Anodized | Machined | Machined and anodized |
| Angulation | 0° | 0° | 0° | 0° | 0° |
| Load | No occlusal load | No occlusal load | No occlusal load | No occlusal load | No occlusal load |
| Sterility | Provided sterile by irradiation. | Provided sterile by ethylene | |||
| oxide. | Provided sterile by irradiation | Provided sterile by ethylene | |||
| oxide. | Provided sterile by irradiation. |
13
Page 11 of 22
| Table 5.6: SE comparison on Healing Abutments | |||||
|---|---|---|---|---|---|
| Trade Name Information | SUBJECT DEVICES | PRIMARY PREDICATE DEVICES | REFERENCE DEVICES | ||
| K183024 – Implacil Implant System | |||||
| Implacil de Bortoli Material | |||||
| Odontologico Ltda | K170398 – S.I.N. Dental Implant System | ||||
| S.I.N. Sistema de Implante | |||||
| Nacional S.A. | K101207 – Neodent Implant System | ||||
| JJGC Industria e Comercio de | |||||
| Materiais Dentarios S.A. | K180282 – MIS Internal Hex Dental | ||||
| Implant System | |||||
| MIS Implants Technologies Ltd. | K101945 – Neodent Implant System | ||||
| JJGC Industria e Comercio de | |||||
| Materiais Dentarios S.A. | |||||
| Implant-to-abutment connection | HE interface | ||||
| HI interface | |||||
| Conical interface (CM AR) | HE interface | ||||
| HI interface | HE interface | HI interface | Conical interface (CM) | ||
| Diameter (mm) | HE: 3.5, 4.0, 5.0 | ||||
| HI: 3.5, 4.0, 5.0 | |||||
| CM AR: 3.5, 4.5 | HE: 3.6, 4.1, 5.0 | HE: 3.3, 4.1, 4.3, 5.0 | HI: 4.0, 4.3, 4.8, 5.0, 5.5, 6.5 | CM: 3.5, 4.0 | |
| Gingival Height (mm) | HE: 2, 3, 4, 5, 6, 7 | ||||
| HI: 2, 3, 4, 5, 6, 7 | |||||
| CM AR: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 | HE: 1, 2, 4, 6, 8 | HE: 2, 3, 4, 5, 6 | HI: 2, 3, 4, 5, 6, 8 | CM: 0.8, 3.5, 4.5, 5.5, 6.5 | |
| Raw material | CPTi | Ti alloy | Ti alloy | Ti alloy | Ti alloy |
| Surface | Machined | Machined | Machined | Machined and Anodized | Machined |
| Angulation | 0° | 0° | 0° | 0° | 0° |
| Load | No occlusal load | No occlusal load | No occlusal load | No occlusal load | No occlusal load |
| Sterility | Provided sterile by irradiation. | Provided sterile by irradiation. | Provided sterile by ethylene | ||
| oxide. | Provided sterile by irradiation | Provided sterile by ethylene | |||
| oxide. |
Table 5.6: SE comparison on Healing Abutments
14
Table 5.7: SE comparison on Healing Abutment Covers
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICES | REFERENCE DEVICES | ||
|---|---|---|---|---|
| Trade Name | ||||
| Information | K183024 – Implacil Implant System | |||
| Implacil de Bortoli Material Odontologico | ||||
| Ltda | K170398 - S.I.N. Dental Implant System | |||
| S.I.N. Sistema de Implante Nacional S.A. | K180282 – MIS Internal Hex Dental | |||
| Implant System | ||||
| MIS Implants Technologies Ltd. | K170392 - S.I.N. Dental Implant System | |||
| S.I.N. Sistema de Implante Nacional S.A. | ||||
| Implant-to-abutment connection | Not applicable | |||
| (is mounted on the abutment) | Not applicable | |||
| (is mounted on the abutment) | Not applicable | |||
| (is mounted on the abutment) | Not applicable | |||
| (is mounted on the abutment) | ||||
| Diameter (mm) | 3.8, 4.5, 4.8 | 4.8 | 4.8 | 3.3 |
| Total height (mm) | 5.5, 5.8, 7.5 | 5 | 4.3 | Unknown |
| Raw material | CPTi | Ti alloy | CPTi | Ti alloy |
| Surface | Machined | Machined | Machined | Machined |
| Angulation | 0° | 0° | 0° | 0° |
| Load | No occlusal load | No occlusal load | No occlusal load | No occlusal load |
| Sterility | Provided non-sterile. Steam sterilized | |||
| prior use. | Provided sterile by irradiation. | Provided sterile by irradiation | Provided sterile by irradiation. |
15
Page 13 of 22
| SUBJECT DEVICES | REFERENCE DEVICE | |||||||
|---|---|---|---|---|---|---|---|---|
| Trade Name | ||||||||
| Information | K183024 - Implacil | |||||||
| Implant System | K101207 – Neodent | |||||||
| Implant System | K133510 - Neodent | |||||||
| Implant System | K062931 - IMPLUS | K072642 - BIOMET 3i | ||||||
| Dental Abutments | ||||||||
| and Restorative | ||||||||
| Components | K180282 - MIS | |||||||
| Internal Hex Dental | ||||||||
| Implant System | K101945 - Neodent | |||||||
| Implant System | K170608 - UF(II) | |||||||
| Implant System | ||||||||
| Implacil de Bortoli | ||||||||
| Material | ||||||||
| Odontologico Ltda | JJGC Industria e | |||||||
| Comercio de | ||||||||
| Materiais Dentarios | ||||||||
| S.A. | JJGC Industria e | |||||||
| Comercio de | ||||||||
| Materiais Dentarios | ||||||||
| S.A. | LEADER Italia S.R.O. | Biomet 3i, Inc. | MIS Implants | |||||
| Technologies Ltd. | JJGC Industria e | |||||||
| Comercio de | ||||||||
| Materiais Dentarios | ||||||||
| S.A. | DIO Corporation | |||||||
| Implant-to- | ||||||||
| abutment | ||||||||
| connection | HE interface | |||||||
| HI interface | ||||||||
| Conical interface | ||||||||
| (CM AR) | HE interface | HE interface | HE interface | HI interface | HI interface | Conical interface | ||
| (CM) | Conical interface | |||||||
| (CM) | ||||||||
| Diameter (mm) | HE: 3.5, 4.0, 5.0 | |||||||
| HI: 3.5, 4.0, 5.0 | ||||||||
| CM AR: 4.8 | HE: 4.1, 4.3, 5.0 | HE: 3.3 | HE: 4.1 | HI: 3.4, 5.0, 6.0 | HI: 4.8 | CM: 4.8 | CM: 4.8 | |
| Gingival height (mm) | HE: 1, 2, 3 | |||||||
| HI: 1, 2, 3 | ||||||||
| CM: 0.8, 1.5, 2.5, 3.5, | ||||||||
| 4.5, 5.5 | HE: 1, 2, 3 | HE: 1, 2, 3 | HE: 1, 2, 3 | HI: 1, 2, 3, 4, 5.5 | HI: 1, 2, 3, 4, 5 | CM: 0.8, 1.5, 2.5, | ||
| 3.5, 4.5, 5.5, 6.5 | Unknown | |||||||
| Anti-rotational | ||||||||
| feature | Yes | No | No | No | No | No | No | No |
| Raw material | CPTi | Ti alloy | Ti alloy | Ti alloy | Ti alloy | Ti alloy | Ti alloy | CPTi |
| Surface | Machined | Machined | Machined | Machined/TiN | Machined | Machined | Machined | Machined |
| Angulation | 0, 17, 30° | 0° | 0° | 0, 17° | 0, 17, 25° | 0, 15, 25° | 0, 17, 30° | 0° |
| Sterility | Provided non- | |||||||
| sterile, to be steam | ||||||||
| sterilized prior use. | Provided sterile by | |||||||
| ethylene oxide. | Provided sterile by | |||||||
| ethylene oxide. | Unknown | Provided sterile. | ||||||
| Unknown method | Provided non- | |||||||
| sterile, to be steam | ||||||||
| sterilized prior use. | Provided sterile by | |||||||
| ethylene oxide. | Provided non- | |||||||
| sterile, to be steam | ||||||||
| sterilized prior use. |
16
Table 5.9: SE comparison on Mini Tapered and Mini Tapered Fit Abutments
| SUBJECT DEVICES | REFERENCE DEVICE | |||||
|---|---|---|---|---|---|---|
| Trade Name | ||||||
| Information | K183024 – Implacil Implant | |||||
| System | K101207 – Neodent Implant | |||||
| System | K180282 – MIS Internal Hex | |||||
| Dental Implant System | K072642 – BIOMET 3i Dental | |||||
| Abutments and Restorative | ||||||
| Components | K101945 – Neodent Implant | |||||
| System | K170608 – UF(II) Implant | |||||
| System | ||||||
| Implacil de Bortoli Material | ||||||
| Odontologico Ltda | JJGC Industria e Comercio de | |||||
| Materiais Dentarios S.A. | MIS Implants Technologies | |||||
| Ltd. | Biomet 3i, Inc. | JJGC Industria e Comercio de | ||||
| Materiais Dentarios S.A. | DIO Corporation | |||||
| Implant-to-abutment | ||||||
| connection | HE interface | |||||
| HI interface | ||||||
| Conical interface (CM AR) | HE interface | HI interface | HI interface | Conical interface (CM) | Conical interface (CM) | |
| Diameter (mm) | HE: 3.5, 4.0, 5.0 | |||||
| HI: 3.5, 4.0, 5.0 | ||||||
| CM AR: 4.8 | HE: 4.1, 4.3, 5.0 | HI: 4.8 | HI: 3.4, 5.0, 6.0 | CM: 4.5 | CM: 4.8 | |
| Gingival height (mm) | HE: 1, 2, 3 | |||||
| HI: 1, 2, 3 | ||||||
| CM AR: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 | HE: 1, 2, 3, 4, | HI: 1, 2, 3 | HI: 1, 2, 3, 4, 5.5 | CM: 1.5, 2.5, 3.5 | Unknown | |
| Anti-rotational feature | Yes | No | No | No | Yes | No |
| Raw material | CPTi | |||||
| Ti alloy | Ti alloy | Ti alloy | Ti alloy | Ti alloy | CPTi | |
| Surface | Machined | Machined | Machined/ Anodized | Machined | Machined | Machined |
| Angulation | 0, 17, 30° | 0° | 0, 17, 30° | 0, 15° | 0, 17, 30° | 0° |
| Sterility | Provided non-sterile, to be | |||||
| steam sterilized prior use. | Provided sterile by | |||||
| ethylene oxide. | Provided non-sterile, to be | |||||
| steam sterilized prior use. | Provided sterile. Unknown | |||||
| method | Provided sterile by | |||||
| ethylene oxide. | Provided non-sterile, to be | |||||
| steam sterilized prior use. |
17
Page 15 of 22
Table 5.10: SE comparison on Abutments and Abutment with Collar
| | SUBJECT DEVICES | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICES | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| Trade Name
Information | K183024 – Implacil Implant
System
Implacil de Bortoli Material
Odontologico Ltda | K170398 – S.I.N. Dental
Implant System
S.I.N. Sistema de Implante
Nacional S.A. | K133510 – Neodent Implant
System
JJGC Industria e Comercio de
Materiais Dentarios S.A. | K180282 – MIS Internal Hex
Dental Implant System
MIS Implants Technologies
Ltd. | K090452 – Neoss Implant
System 03,25
Neoss Limited | K140440 – Noris Medical,
Ltd.
Noris Medical, Ltd. |
| Implant-to-abutment
connection | HE interface
HI interface | HE interface
HI interface | HE interface | HI interface | HI interface | HI interface |
| Diameter (mm) | HE: 3.3, 4.0, 5.0
HI: 3.3, 4.0, 5.0 | HE: 3.6, 4.1, 5.0
HI: 3.8, 4.5 | HE: 3.3, 4.1, 4.3, 5.0 | HI: 3.75, 4.0, 5.5, 6.0, 6.5 | HI: 3.25 | HI: 3.8, 4.0, 5.4 |
| Gingival height (mm) | HE: 1, 2, 3, 4, 5
HI: 1, 2, 3, 4, 5 | HE: 1, 2, 3, 4
HI: 1, 2, 3, 4 | HE:1, 2, 3 | HI: 1, 2, 3 | HI: 1 | HI: 1, 2, 3, 4 |
| Post Height (mm) | 9, 10 | 5, 5.5 | 4, 6 | 4, 6 | 8 | 9.5, 10.5, 11.5, 12.5 |
| Anti-rotational feature | Yes | No | No | No | Yes | No |
| Raw material | CPTi | Ti alloy | Ti alloy | Ti alloy | CPTi | Ti alloy |
| Surface | Machined | Machined/ Anodized | Machined | Machined/Anodized | Machined | Machined |
| Angulation | 0, 15, 25° | 0° | 0, 17, 30° | 0, 10, 15, 20, 25° | 0, 20° | 0, 15, 25° |
| Sterility | Provided non-sterile, to
be steam sterilized prior
use. | Provided sterile for
irradiation. | Provided sterile by
ethylene oxide. | Provided non-sterile, to be
steam sterilized prior use. | Provided sterile by
irradiation | Provided non-sterile, to be
steam sterilized prior use. |
18
Table 5.11: SE comparison on Smart and Ideale abutment
| Trade Name Information | SUBJECT DEVICES | REFERENCE DEVICES |
|---|---|---|
| K183024 – Implacil Implant System | K101945 – Neodent Implant System | |
| Implacil de Bortoli Material Odontologico Ltda | JJGC Industria e Comercio de Materiais Dentarios S.A. | |
| Implant-to-abutment connection | Conical interface | Conical interface |
| Diameter (mm) | 3.3, 4.5 | 3.3, 4.5 |
| Gingival height (mm) | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 |
| Cementable Height | 4, 6 | 4, 6 |
| Anti -rotational feature | Yes | Yes |
| Raw material | CPTi | |
| Ti alloy | Ti alloy | |
| Surface | Machined/Anodized | Machined |
| Angulation | 0°, 17°, 30° | 0°, 17°, 30° |
| Sterility | Provided non-sterile, to be steam sterilized prior use. | Provided sterile by ethylene oxide. |
19
Page 17 of 22
Table 5.12: SE comparison on O'ring Abutment
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||||
|---|---|---|---|---|---|---|
| K183024 - Implacil Implant | K170398 - S.I.N. Dental | K101207 - Neodent Implant | K180282 - MIS Internal Hex | K101945 - Neodent Implant | K173819 - MyPlant II | |
| Trade Name | ||||||
| Information | System | Implant System | System | Dental Implant System | System | Implant System |
| Implacil de Bortoli Material | S.I.N. Sistema de Implante | JJGC Industria e Comercio de | MIS Implants Technologies | JJGC Industria e Comercio de | Hager & Meisinger GmbH | |
| Odontologico Ltda | Nacional S.A. | Materiais Dentarios S.A. | Ltd. | Materiais Dentarios S.A. | ||
| Implant-to-abutment | ||||||
| connection | HE interface | HE interface | HE interface | |||
| HI interface | HI interface | HI interface | ||||
| Conical interface (CM AR) | Conical interface (CM) | Conical interface (CM) | ||||
| Diameter (mm) | HE: 3.5, 4.0, 5.0 | HE: 3.4, 4.1, 5.0 | HE: 4.1, 4.3, 5.0 | |||
| HI: 3.5, 4.0, 5.0 | HI: 3.8, 4.5 | HI: 4.0, 5.0 | ||||
| CM AR: 4.0 | CM: 3.5 | Snap Attachment Sphere: | ||||
| 2.25 | ||||||
| Height (mm) | HE: 1, 2, 3, 4, 5 | HE: 2, 3 | HE: 2, 3, 4, 5 | |||
| HI: 1, 2, 3, 4, 5 | HI: 2, 3 | HI: 1, 2, 3, 4, 5 | ||||
| CM AR: 0.8, 1.5, 2.5, 3.5, | CM: 1.5, 2.5, 3.5, 4.5, 5.5 | CM: 1.5, 3.0, 4.5 | ||||
| 4.5, 5.5 | ||||||
| Anti-rotational feature | No | No | No | No | No | No |
| Raw material | CPTi | Ti alloy | Ti alloy | Ti alloy | Ti alloy | CPTi |
| Surface | Machined | Machined | Machined | Machined | Machined | Machined |
| Machined/TiN | ||||||
| Angulation | 0° | 0° | 0° | 0, 15, 25° | 0° | 0° |
| Sterility | Provided non-sterile, to be | Unknown | Provided sterile by | Provided non-sterile, to be | Provided sterile by | Provided non-sterile, to be |
| steam sterilized prior use. | ethylene oxide. | steam sterilized prior use. | ethylene oxide. | steam sterilized prior use. |
20
Table 5.13: SE comparison on UCLA abutments
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |||
|---|---|---|---|---|---|
| Trade Name | |||||
| Information | K183024 – Implacil Implant System | K170398 – S.I.N. Dental Implant System | K101207 – Neodent Implant System | K180282 – MIS Internal Hex Dental | |
| Implant System | K173902 – Neodent Implant | ||||
| System – GM Line | |||||
| Implacil de Bortoli Material | |||||
| Odontologico Ltda | S.I.N. Sistema de Implante | ||||
| Nacional S.A. | JJGC Industria e Comercio de | ||||
| Materiais Dentarios S.A. | MIS Implants Technologies Ltd. | JJGC Industria e Comercio de | |||
| Materiais Dentarios S.A. | |||||
| Implant-to-abutment | |||||
| connection | HE interface | ||||
| HI interface | |||||
| Conical interface | HE interface | ||||
| HI interface | HE interface | HI interface | Conical interface | ||
| Diameter (mm) | 3.5, 4.0, 5.0 | 3.6, 4.1 | 4.1, 4.3, 5.0 | 3.75, 5.0 | 3.5/3.75, 4.0/4.3, 5.0/6.0 |
| Gingival Height (mm) | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Anti-rotational feature | Yes | Yes | Yes | Yes | Yes |
| Raw material | CPTi | ||||
| CoCr/POM | Ti alloy | ||||
| CoCr/POM | Ti alloy | ||||
| Noble/POM | |||||
| Zirconia | Gold/POM | CoCr/POM | |||
| Surface | Machined | Machined | Machined | Machined | Machined |
| Angulation | 0° | 0° | 0° | 0° | 0° |
| Sterility | Provided non-sterile, to be | ||||
| steam sterilized prior use. | Unknown | Provided sterile by ethylene | |||
| oxide. | Provided non-sterile, to be steam | ||||
| sterilized prior use. | Provided non-sterile, to be steam | ||||
| sterilized prior use. |
21
Page 19 of 22
Table 5.14: SE comparison on Copings
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |||
|---|---|---|---|---|---|
| Trade Name | |||||
| Information | K183024 – Implacil Implant System | K170398 – S.I.N. Dental Implant | |||
| System | K101207 – Neodent Implant | ||||
| System | K101945 - Neodent Implant | ||||
| System | K170608 - UF(II) Implant System | ||||
| Implacil de Bortoli Material | |||||
| Odontologico Ltda | S.I.N. Sistema de Implante Nacional | ||||
| S.A. | JJGC Industria e Comercio de | ||||
| Materiais Dentarios S.A. | JJGC Industria e Comercio de | ||||
| Materiais Dentarios S.A. | DIO Corporation | ||||
| Implant-to-abutment | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| connection | (is mounted on the abutment) | (is mounted on the abutment) | (is mounted on the abutments) | (is mounted on the abutments) | (is mounted on the abutments) |
| Diameter (mm) | 3.3, 3.5, 4.0, 4.5, 4.8, 5.0 | 3.8, 4.5 | 4.1, 5.0 | 3.3, 4.1, 4.5 | 4.95, 5.8, 6.4, 6.9 |
| Gingival Height (mm | Not applicable | Not applicable | Not applicable | Not applicable | Not applicable |
| Cementable height (mm) | 4, 6 | Unknown | Unknown | 4, 6 | Unknown |
| Anti-rotational feature | Yes | Yes | Yes | Yes | No |
| Raw material | CPTi | ||||
| CoCr/POM | Ti alloy | ||||
| CoCr/POM | Ti alloy | ||||
| Noble/POM | |||||
| Zirconia | Ti alloy | ||||
| Noble/POM | |||||
| POM | CPTi | ||||
| Surface | Machined | Machined | Machined | Machined | Machined |
| Angulation | 0° | 0° | 0° | 0° | 0° |
| Sterility | Provided non-sterile, to be steam | ||||
| sterilized prior use. | Not informed | Provided sterile by ethylene | |||
| oxide. | Provided sterile by ethylene | ||||
| oxide. | Provided non-sterile, to be | ||||
| steam sterilized prior use. |
22
Page 20 of 22
| Table 5.15: SE comparison on Screws | ||||
|---|---|---|---|---|
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
| K183024 – Implacil Implant System | K170398 – S.I.N. Dental Implant System | K101207 – Neodent Implant System | K101945 – Neodent Implant System | |
| Trade Name | ||||
| Information | Implacil de Bortoli Material Odontologico | |||
| Ltda | S.I.N. Sistema de Implante Nacional S.A. | JJGC Industria e Comercio de Materiais | ||
| Dentarios S.A. | JJGC Industria e Comercio de Materiais | |||
| Dentarios S.A. | ||||
| Implant-to-abutment connection | HE interface | |||
| HI interface | ||||
| Conical interface | HE interface | |||
| HI interface | HE interface | Conical interface | ||
| Implant/Abutment diameter (mm) | 3.5, 4.0 | Unknown | 3.3, 4.1, 4.3, 5.0 | 4.1, 5.0 |
| Implant/Abutment gingival height | ||||
| (mm) | 2, 3 | Unknown | 1, 2, 3 | Unknown |
| Cementable height (mm) | Not applicable | Not applicable | Not applicable | Not applicable |
| Anti-rotational feature | Not applicable | Not applicable | Not applicable | Not applicable |
| Raw material | Ti alloy | Ti alloy | Ti alloy | Ti alloy |
| Surface | Machined | Machined | ||
| Machined/ Anodized | Machined | Machined | ||
| Angulation | 0° | 0° | 0° | 0° |
| Sterility | Provided non-sterile, to be steam | |||
| sterilized prior use. | Unknown | Provided sterile by ethylene oxide. | Provided sterile by ethylene oxide. |
23
The indication for use of subject and primary predicate device K170398 are identical except for two slight changes.
-
Inclusion of "and/" in order that the indication for use statement is applicable to all the subject devices instructions for use and not misleading in any way. Currently, the subject devices are divided in 16 instructions for use. For example, many of the subject abutment are indicated for both, single-unit and also multi-unit restorations. The proposed inclusion brings clarity to the cases where both indications are recommended and is also applicable for cases where just one of them is indicated.
-
The current submission do not have subject implants with length below 7 mm, therefore, the last sentence of the primary predicate instructions for use is not applicable.
The indication for use of subject device is within the scope of the reference devices indications for use.
The subject HE Implants are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K062931 and K163634, in designs and range of dimensions. The subject HI Implants are substantially equivalent to the primary predicate device K170398, and reference devices K062931 and K180282, in designs and range of dimensions. The subject CM AR Implants are substantially equivalent to the reference devices K101945, K170608 and K163060, in designs and range of dimensions.
The subject Covers are substantially equivalent to the reference devices K101207, K180282, K101945 and K170608, in designs and range of dimensions. The subject Healing Abutments are substantially equivalent to the primary predicate K170398 and to the reference devices K101207, K180282 and K101945, in designs and range of dimensions. The subject Healing Abutment Covers are substantially equivalent to the primary predicate K170398 and to the reference devices K180282 and K170392, in designs and range of dimensions.
The subject Tapered Aesthetic Abutments are substantially equivalent to the reference devices K101207, K133510, K062931, K072642, K101945 and K170608, in designs and range of dimensions. The subject Mini Tapered and Mini Tapered Fit Abutments are substantially equivalent to the reference devices K101207, K180282, K072642, K101945 and K170608, in designs and range of dimensions. The subject Abutments are substantially equivalent to the primary predicate device K170398, and reference devices K133510, K180282, K090452 and K140440, in designs and range of dimensions. The subject Smart and Ideale Abutments are substantially equivalent to the reference device K101945, in designs and range of dimensions.
The subject O'ring Abutment is substantially equivalent to the primary predicate device K170398, and reference devices K101207, K180282, K101945 and K173819, in designs and range of dimensions. The reference device K101207 is for the HE connection in the heights not encompassed by the primary predicate device.
The subject UCLA abutment are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K180282 and K173902 in raw material, designs and range of dimensions. The subject Copings are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K101945 and K170608 in raw material, designs and range of dimensions.
The subject Screws are substantially equivalent to the primary predicate device K170398, and reference devices K101207 and K101945 in raw material, designs and range of dimensions.
24
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
Sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-2. Sterile barrier shelf life testing (accelerated aging according to ASTM F1980); package integrity according to ASTM F1929 and ASTM F88/F88M; sterility of the package content according to ISO 11737-2. The biocompatibility of the subject devices materials was supported by cytotoxicity testing according to ISO 10993-12. Pyrogenicity monitoring according to AAMI/ANSI ST72. Mechanical performance demonstrated through dynamic fatigue testing according to ISO 14801 and static torsional loading test according ISO/TS 13498:2011. No clinical data were included in this submission.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified primary predicate and reference devices.