(243 days)
No
The summary describes a dental implant system and its mechanical properties. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
No
This medical device is an implantable device used to support dental restorations, not for treating diseases or health conditions.
No
This device, the Implacil Implant System, is an implantable dental device used to support restorations. Its intended use is mechanical support for restorations, not for diagnosing any medical condition or disease.
No
The device description clearly states it is composed of physical implants made of titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for placement in the maxillary or mandibular arch to provide support for dental restorations. This is a surgical and mechanical function within the body.
- Device Description: The description details the physical components of a dental implant (threaded, self-tapping, root form endosseous dental implants) made of titanium. This is a physical implant, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (within the body) for a structural purpose.
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 approach is applied, the Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE
Device Description
The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants.
The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used.
The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.
HE implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths ( 7, 8, 9, 10, 11, 12, 13, 14, 15).
HI implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).
CM AR implants are available in tapered (conical) root-form design, in four diameters (3.5, 4.0, 4.5 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0, 4.5 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).
The compatible prosthetic components mate exclusively with the subject implants of the same implant-to abutment interface (HJ, HE, CM AR). All the compatible prosthetic components were cleared under K183024.
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)
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implacil de Bortoli Material Odontologico Ltda Thiago Toni Quality Manager Rua Vicente de Carvalho 178-182 Sao Paulo, Sao Paulo 01521020 BRAZIL
Re: K202832
Trade/Device Name: Implacil Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2021 Received: April 29, 2021
Dear Thiago Toni:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202832
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 approach is applied, the 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | Implacil de Bortoli Material Odontologico Ltda
Rua Vicente de Carvalho 178-182
São Paulo, São Paulo, Brazil 01521020
Telephone: +55 (11) 3342-5100 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Thiago Toni
Quality Manager
thiago@implacil.com.br |
| Date Prepared | 25/May/2021 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name
Common Name | Implacil Implant System
Dental implant and abutment |
| Regulation Number
Regulation Name
Regulation Class
Product Code | 21 CFR 872.3640
Endosseous dental implant
Class II
DZE |
| Classification Panel
Reviewing Branch | Dental Products Panel
Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K183024 - Implacil Implant System - Implacil de Bortoli Material
Odontologico Ltda |
| Reference Devices | K170392 - S.I.N. Dental Implant System - S.I.N. Sistema de Implante
Nacional S.A.
K192839 - DSP Implant System - D.S.P. Industrial Fireli |
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.
4
SUBJECT DEVICE DESCRIPTION
The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants.
The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used.
The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.
HE implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths ( 7, 8, 9, 10, 11, 12, 13, 14, 15).
HI implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).
CM AR implants are available in tapered (conical) root-form design, in four diameters (3.5, 4.0, 4.5 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0, 4.5 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).
The compatible prosthetic components mate exclusively with the subject implants of the same implant-toabutment interface (HJ, HE, CM AR). All the compatible prosthetic components were cleared under K183024.
TECHNOLOGICAL CHARACTERISTICS
The subject device and the predicate devices have the same intended use and similar technological characteristics as shown in the tables below. Differences in the design features between the subject devices and the primary predicate device K183024 are addressed by comparison to the reference devices in design and range of dimensions.
5
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Substantial Equivalence Discussion | ||
|---|---|---|---|---|---|
| Trade Name | |||||
| Information | K202832 - Implacil Implant System | ||||
| Implacil de Bortoli Material Odontologico | |||||
| Ltda | K183024 – Implacil Implant System | ||||
| Implacil de Bortoli Material Odontologico | |||||
| Ltda | K192839 - DSP Implant System | ||||
| D.S.P. Industrial Eireli | |||||
| Indication 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. | 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. | The DSP 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. | Identical |
The indication for use statement is
identical to the primary predicate device
and is within the scope of the reference
device. | |
| Implant-to-
abutment
connection | HE interface | HE interface
HI interface
Conical connection (CM AR) | HE interface | Identical
To the primary predicate and reference
devices. | |
| Raw Material | CPTi | CPTi | CPTi | Identical
To the primary predicate and reference
devices. | |
| Surface | Grit-blasted and acid-etched
Machined collar: h 1.0 mm | Grit-blasted and acid-etched
Machined collar: h 1.0 mm | Grit-blasted and acid-etched.
Machined collar: h 1.0 mm | Equivalent
Identical to the primary predicate and
reference devices. | |
| Design - presence of
chambers | Yes | No | No | Different
The presence of chambers in the external
surface is the only difference between the
subject and primary predicate device
design. The substantial equivalence is
supported by external surface area
comparison. No impact in mechanical
performance is expected | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | |
| Trade Name
Information | K202832 - Implacil Implant System | K183024 – Implacil Implant System | K192839 - DSP Implant System | Substantial Equivalence Discussion | |
| | Implacil de Bortoli Material Odontologico | Implacil de Bortoli Material Odontologico | D.S.P. Industrial Eireli | | |
| | Ltda | Ltda | | | |
| Implant diameter:
lengths (mm) | 3.5: 8, 9, 10, 11, 12, 13, 14, 15 | 3.3: 8, 10, 11.5, 13, 15 | 3.3: 8.5, 10, 11.5, 13, 15, 17 | Equivalent
Within the range of dimensions of the
primary predicate and reference devices. | |
| | | 3.5: 7, 9, 11, 13, 15 | 3.8: 8.5, 10, 11.5, 13, 15 | | |
| | 4.0: 7, 8, 9, 10, 11, 12, 13, 14, 15 | 3.75: 8, 10, 11.5, 13, 15 | | | |
| | | 4.0: 7, 8, 9, 10, 11, 11.5, 13, 15 | 4.3: 8.5, 10, 11.5, 13, 15 | | |
| | | 4.75: 8, 10, 11.5, 13, 15 | | | |
| | 5.0: 7, 8, 9, 10, 11, 12, 13, 14, 15 | 5.0: 7, 9, 11, 13, 15 | 5.0: 8.5, 10, 11.5, 13, 15 | | |
| | | | | | |
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Identical
To the primary predicate and reference
devices. | |
| | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | | |
| Trade Name
Information | K202832 - Implacil Implant System | K183024 - Implacil Implant System | K170392- S.I.N. Dental Implant
System | K192839 - DSP Implant System | Substantial Equivalence
Discussion |
| | Implacil de Bortoli Material
Odontologico Ltda | Implacil de Bortoli Material
Odontologico Ltda | S.I.N. Sistema de Implante
Nacional S.A. | D.S.P. Industrial Eireli | |
| Indication 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. | 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. | 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. | The DSP 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. | Identical
The indication for use statement
is identical to the primary
predicate device and is within the
scope of the reference devices. |
| Implant-to-
abutment
connection | HI interface | HE interface
HI interface
Conical connection (CM AR) | Conical connection (CM) | HE interface | Identical
To the primary predicate device. |
| Raw Material | CPTi | CPTi | CPTi | CPTi | Identical
To the primary predicate and
reference devices. |
| Surface | Grit-blasted and acid-etched
Machined collar: h 1.0 mm | Grit-blasted and acid-etched
Machined collar: h 1.0 mm | Grit-blasted and acid-etched | Grit-blasted and acid-etched
Machined collar: h 1.0 mm | Identical
To the primary predicate and
reference devices for the grit-
blasted and acid-etched surface
and identical to the primary
predicate and reference device
K192839 for the machined collar
height |
Table 5.1: SE comparison on Maestro HE implants
6
Page 4 of 9
K202832- Implacil Implant System
7
Table 5.2: SE comparison on Maestro HI implants
8
K202832- Implacil Implant System
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |||||
|---|---|---|---|---|---|---|---|
| Trade Name | |||||||
| Information | K202832 - Implacil Implant System | K183024 - Implacil Implant System | K170392- S.I.N. Dental Implant | ||||
| System | K192839 - DSP Implant System | Substantial Equivalence | |||||
| Discussion | |||||||
| Implacil de Bortoli Material | |||||||
| Odontologico Ltda | Implacil de Bortoli Material | ||||||
| Odontologico Ltda | S.I.N. Sistema de Implante | ||||||
| Nacional S.A. | D.S.P. Industrial Eireli | ||||||
| Design - presence of | |||||||
| chambers | Yes | No | No | No | Different | ||
| The presence of chambers in the | |||||||
| external surface is only difference | |||||||
| between the subject and primary | |||||||
| predicate device design. The | |||||||
| substantial equivalence is | |||||||
| supported by external surface | |||||||
| area comparison. No impact in | |||||||
| mechanical performance is | |||||||
| expected. | |||||||
| Implant diameter: | |||||||
| lengths (mm) | 2.9: 10, 11.5, 13 | Equivalent | |||||
| 3.3: 8, 9, 11, 13, 15 | 3.3: 8.5, 10, 11.5, 13, 15, 17 | ||||||
| 3.5: 8, 9, 10, 11, 12, 13, 14, 15 | 3.5: 8, 9, 11, 13, 15 | 3.5: 8.5, 10, 11.5, 13, 15 | Within the range of dimensions | ||||
| 3.75: 7, 9, 11, 13, 15 | 3.8: 8.5, 10, 11.5, 13, 15 | 3.8: 8.5, 10, 11.5, 13, 15 | of the primary predicate and | ||||
| 4.0: 7, 8, 9, 10, 11, 12, 13, 14, 15 | 4.0: 8, 9, 11, 13, 15 | 4.0: 5, 6, 7 | 4.3: 8.5, 10, 11.5, 13, 15 | reference devices. | |||
| 4.3: 7, 9, 11, 13, 15 | 4.3: 8.5, 10, 11.5, 13, 15 | ||||||
| 4.75: 7, 9, 11, 13, 15 | 4.5: 8.5, 10, 11.5, 13, 15 | 5.0: 8.5, 10, 11.5, 13, 15 | |||||
| 5.0: 7, 8, 9, 10, 11, 12, 13, 14, 15 | 5.0: 7, 9, 11, 13, 15 | 5.0: 5, 6, 7, 8.5, 10, 11.5, 13, 15 | |||||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Identical | ||
| To the primary predicate and | |||||||
| reference devices. |
9
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | ||
|---|---|---|---|---|
| Trade Name | ||||
| Information | K202832 - Implacil Implant System | |||
| Implacil de Bortoli Material Odontologico | ||||
| Ltda | K183024 – Implacil Implant System | |||
| Implacil de Bortoli Material Odontologico | ||||
| Ltda | K170392- S.I.N. Dental Implant System | |||
| S.I.N. Sistema de Implante Nacional S.A. | Substantial Equivalence Discussion | |||
| Indication 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. | 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. | 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. | Equivalent |
The indication for use statement is
identical to the primary predicate device
and within the scope of the reference
device. |
| Implant-to-
abutment
connection | Conical connection (CM AR) | HE interface
HI interface
Conical connection (CM AR) | Conical connection (CM) | Identical
To the primary predicate device. |
| Raw Material | CPTi | CPTi | CPTi | Identical
To the primary predicate device and
reference devices. |
| Surface | Grit-blasted and acid-etched | Grit-blasted and acid-etched | Grit-blasted and acid-etched | Identical
To the primary predicate device and
reference device. |
| Design - presence of
chambers | Yes | No | No | Different
The presence of chambers in the external
surface is only difference between the
subject and primary predicate device
design. The substantial equivalence is
supported by external surface area
comparison. No impact in mechanical
performance is expected. |
| Trade Name
Information | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Substantial Equivalence Discussion |
| | K202832 - Implacil Implant System
Implacil de Bortoli Material Odontologico
Ltda | K183024 – Implacil Implant System
Implacil de Bortoli Material Odontologico
Ltda | K170392- S.I.N. Dental Implant System
S.I.N. Sistema de Implante Nacional S.A. | |
| Implant diameter:
lengths (mm) | 3.5: 8, 9, 10, 11, 12, 13, 14, 15 | 3.3: 8, 9, 11, 13, 15
3.5: 8, 9, 11, 13, 15
3.75: 7, 9, 11, 13, 15
4.0: 8, 9, 11, 13, 15
4.3: 7, 9, 11, 13, 15
4.75: 7, 9, 11, 13, 15
5.0: 7, 9, 11, 13, 15 | 2.9: 10, 11.5, 13
3.5: 8.5,10, 11.5, 13, 15
3.8: 8.5, 10, 11.5, 13, 15
4.0: 5, 6, 7
4.3: 8.5,10, 11.5, 13, 15
4.5: 8.5, 10, 11.5, 13, 15
5.0: 5, 6, 7, 8.5,10, 11.5, 13, 15 | Equivalent
Within the range of dimensions of the
primary predicate and reference device. |
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Identical
To the primary predicate device and
reference device. |
Table 5.3: SE comparison on Maestro CM AR implants
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K202832- Implacil Implant System
11
The indication for use statement is identical to the primary predicate device.
The subject HE, HI and CM AR implants are substantially equivalent to the primary predicate device K183024, and reference devices K170392 and K192839, in designs and range of dimensions.
For all the three implant lines, there is a difference in design between subject and primary predicate device which is the presence of the chambers in the external surface of the device. The chambers do not alter the external surface area of the implants that with the bone, therefore, substantial equivalence is supported by the surface area analysis comparison. No impact in mechanical performance is expected.
PERFORMANCE DATA
The implants are made of unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The type of titanium is the same to that used for fabrication of the primary predicate devices cleared under K183024. The subject devices undergo to the same manufacturing processes, including surface treatment step to the cited predicate device.
The sterilization method, sterile barrier shelf life, package integrity, and pyrogenicity monitoring for the subject device are unchanged from the K183024 submission. Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024.
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.