(504 days)
No
The summary describes a physical implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties, sterilization, and biocompatibility.
Yes
The device is surgically placed to provide support for prosthetic devices to restore chewing function, which addresses a medical condition (chewing impairment).
No
The device is described as an "Implant System" 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." This description indicates it is a therapeutic or restorative device, not one designed to diagnose a condition.
No
The device description clearly states the device is composed of physical implants and prosthetic components made of titanium and cobalt-molybdenum alloy, which are hardware. The performance studies also focus on hardware-related testing like sterilization, shelf life, biocompatibility, and surface analysis.
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 surgically placed in the bone to support prosthetic devices for restoring chewing function. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The description details the materials and components of a dental implant system, which are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing. The performance studies focus on sterilization, biocompatibility, and material analysis, which are relevant to implanted devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs.
DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136).
The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants.
The subject device abutments components mate exclusively with the subject implants of the same line.
COCR BASE UCLA
The CoCr Base UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr Base UCLAs are composed of two parts: the CoCr alloy part that interfaces directly to the implant and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromium-based alloy. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136.
COCR UCLA
The CoCr UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr UCLAs interfaces directly to the implant and the top portion is cast out of CoCr metal using the lost-wax technique. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The CoCr UCLA is a multi-unit abutment intended to be hand-milled to a patient-matched shape with a bridge or bar cast onto it.
TITANIUM ABUTMENTS
The Titanium Abutments are intermediary prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The Titanium Abutments it is the bottom half of a two-piece abutment. The second piece of this two-piece abutment is cast out of CoCr metal using the lost-wax technique. The two pieces are then cemented together. For the cementation, it is recommended to use dual resinous cement Panavia F (Kuraray Co Ltd Tokyo-Japan).
COCR BASE COPINGS
The CoCr Base Copings are prosthetic components to be installed over the Mini Conical Abutment to support the definitive prosthesis. The CoCr Base Coping are composed of two parts: the CoCr alloy part that interfaces to the abutment and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromiumbased alloy. They are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136.
MINI CONICAL ABUTMENTS
The Mini Conical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be screw-retained over the Mini Conical Abutment.
Mini Conical Abutments are indicated multi-unit restorations only. They are to be used exclusively with a coping extending the abutment portion to a minimum of 4.9 mm.
ONE STEP HYBRID TECHNIQUE
The One Step Hybrid Titanium Coping is a definitive prosthetic component intended for the One Step Hybrid Technique. It is made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The One Step Hybrid Titanium Coping is compatible with the HE Mini Conical Abutment. The prosthesis is to be cement-retained over the One Step Hybrid Titanium Coping.
COVER
The Cover is a device intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. In one end have fitting for a manual screwdriver that allows its installation and in the other, presents the interface for HE implants line coupling.
HEALING ABUTMENT
The Healing Abutments are straight devices intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in standard or anatomical shapes to be installed over the implant. In one end have fitting for its manual installation driver and in the other, present the interface compatible with the implant line (HE).
PROTECTION CYLINDER
The Protection Cylinders are prosthetic components intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in a cap shape to be installed over the Conventional Abutment (Mini Conical Abutment). In one of the ends it has a fit for the manual driver that allows its installation and in the other end the compatible geometry for installation over the abutment. It has a coupled screw for attachment on the corresponding abutment.
TEMPORARY ABUTMENT
The Temporary Abutments are temporary prosthetic components to be installed onto DSP HE implants) to support provisional prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Temporary Abutment.
ANATOMICAL ABUTMENTS
The Anatomical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Anatomical Abutments.
O'RING ABUTMENT
The O'ring abutments are straight ball-type intermediary prosthetic components to be installed onto DSP HE implants to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67.
The O'ring is indicated for the attachment of full or partial overdentures for multi-unit restorations.
TEMPORARY COPINGS
The Temporary Copings are temporary coping-type prosthetic components to be installed over a Conventional Abutment (HE), specifically, the Temporary Copings are screw-retained on the Mini Conical Abutments. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement over the Temporary Copings.
ABUTMENT SCREW
The Abutment Screws (Temporary Abutment, UCLA-type Abutment or Conventional Abutment) are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are composed of two different parts: head and body. The head has a geometry for the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.
PROSTHETIC SCREWS
The Prosthetic Screws are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are intended to connect the prosthesis in the Conventional Abutments, specifically, the Mini Conical Abutments. The Prosthetic Screws are composed of two different parts: head and body. The head has a geometry for the fitting of the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. SO 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 testing according to ISO 10993-5. Pyrogenicity monitoring according to AAMI/ANSI ST72, The method selected to determine pyrogen limit specifications is the Bacterial Endotoxin Test (BET) performed according to USP using the photometric technique. Representative samples are selected for testing based upon the raw material, manufacturing processes, and sterilization process. No clinical data were included in this submission.
In order to analyze the blasted and acid etched surface and verify if some residual contaminants substances used during implant surface treatment remains over the implant, a scanning electron microscopy (SEM) coupled with Energy Dispersive Spectroscopy (EDS) was performed. The implant surface (modified surface) was analyzed. The elements were quantified by EDS no presence of contaminating metal particles was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K023113, K083561, K925762, K101945, K150669, K163634, K170398, K183024
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image shows 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.
D.S.P Industrial Eireli % Graziela Brum Regulatory Affairs Specialist PR Servicos Regulatorios Administrarivos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 BRAZIL
Re: K192839
Trade/Device Name: DSP Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 8, 2021 Received: January 12, 2021
Dear Graziela Brum:
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 (OS) 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 Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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) K192839
Device Name
DSP Implant System
Indications for Use (Describe)
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 procedures, for single or multiple unit restorations, and may be loaded immediately 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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510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | D.S.P. Industrial Eireli |
|---|---|
| Rua Marechal Floriano Peixoto 303 -Ouro Verde II | |
| Campo Largo, Paraná, Brazil 83606-290 | |
| Telephone +55 (41) 3291-2200 | |
| Prepared by | Janine Treter and Graziela Brum |
| Passarini Regulatory Affairs | |
| PR Serviços Regulatórios Administrativos Ltda | |
| Email:graziela@rapassarini.com.br | |
| Telephone +55 (16) 3421-8488 | |
| Date prepared | 10/Feb/2021 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | DSP Implant System |
| Common Name | Dental implant and dental implant abutment |
| Primary Classification Name | Endosseous dental implant |
| Primary Classification Regulation | 21 CFR 872.3640, Class II |
| Primary Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais |
| Dentarios S.A | |
| Reference Devices | |
| K023113 - Replace TiUnite Endosseous Implant - Nobel Biocare USA Inc | |
| K083561- Neoss ProActive Implant - Neoss Limited | |
| K925762 - Branemark System Self-Tapping Fixture - Nobelpharma USA, Inc | |
| K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais | |
| Dentarios S.A. | |
| K150669 - Neoss TiBase and CoCr Abutments-Neoss Ltd. | |
| K163634 - - External Hex Implants - Southern Implants (Pty) Ltd. | |
| K170398 - Σ.Ι.N. Dental Implant System - S.I.N. Sistema de Implante Nacional | |
| S.A | |
| K183024 - Implacil Implant System -Implacil de Bortoli Material | |
| Odontologico Ltda |
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INDICATIONS FOR USE
The DSP Implant System is intended to be surgically placed in 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.
SUBJECT DEVICE DESCRIPTION
DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs.
DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136).
The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants.
The subject device abutments components mate exclusively with the subject implants of the same line.
COCR BASE UCLA
The CoCr Base UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr Base UCLAs are composed of two parts: the CoCr alloy part that interfaces directly to the implant and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromium-based alloy. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136.
COCR UCLA
The CoCr UCLAs are prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. The CoCr UCLAs interfaces directly to the implant and the top portion is cast out of CoCr metal using the lost-wax technique. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The CoCr UCLA is a multi-unit abutment intended to be hand-milled to a patient-matched shape with a bridge or bar cast onto it.
TITANIUM ABUTMENTS
The Titanium Abutments are intermediary prosthetic components to be installed onto DSP HE implants to support the definitive prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The Titanium Abutments it is the bottom half of a two-piece abutment. The second piece of this two-piece abutment is cast out of CoCr metal using the lost-wax technique. The two pieces are
5
then cemented together. For the cementation, it is recommended to use dual resinous cement Panavia F (Kuraray Co Ltd Tokyo-Japan).
COCR BASE COPINGS
The CoCr Base Copings are prosthetic components to be installed over the Mini Conical Abutment to support the definitive prosthesis. The CoCr Base Coping are composed of two parts: the CoCr alloy part that interfaces to the abutment and a polymer cylinder part for fabrication of a cast prosthesis by a burnout technique. The cylinder part is made of polyoxymethylene polymer (POM) and the CoCr part is made of a Cobalt-Chromiumbased alloy. They are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136.
MINI CONICAL ABUTMENTS
The Mini Conical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be screw-retained over the Mini Conical Abutment.
Mini Conical Abutments are indicated multi-unit restorations only. They are to be used exclusively with a coping extending the abutment portion to a minimum of 4.9 mm.
ONE STEP HYBRID TECHNIQUE
The One Step Hybrid Titanium Coping is a definitive prosthetic component intended for the One Step Hybrid Technique. It is made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The One Step Hybrid Titanium Coping is compatible with the HE Mini Conical Abutment. The prosthesis is to be cement-retained over the One Step Hybrid Titanium Coping.
COVER
The Cover is a device intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. In one end have fitting for a manual screwdriver that allows its installation and in the other, presents the interface for HE implants line coupling.
HEALING ABUTMENT
The Healing Abutments are straight devices intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in standard or anatomical shapes to be installed over the implant. In one end have fitting for its manual installation driver and in the other, present the interface compatible with the implant line (HE).
PROTECTION CYLINDER
The Protection Cylinders are prosthetic components intended for temporary use, made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are available in a cap shape to be installed over the Conventional Abutment (Mini Conical Abutment). In one of the ends it has a fit for the manual driver that
6
allows its installation and in the other end the compatible geometry for installation over the abutment. It has a coupled screw for attachment on the corresponding abutment.
TEMPORARY ABUTMENT
The Temporary Abutments are temporary prosthetic components to be installed onto DSP HE implants) to support provisional prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Temporary Abutment.
ANATOMICAL ABUTMENTS
The Anatomical Abutments are intermediary prosthetic components to be installed onto DSP implants (HE) to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67. They are supplied with a removable abutment screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement-retained over the Anatomical Abutments.
O'RING ABUTMENT
The O'ring abutments are straight ball-type intermediary prosthetic components to be installed onto DSP HE implants to support the final prosthesis. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67.
The O'ring is indicated for the attachment of full or partial overdentures for multi-unit restorations.
TEMPORARY COPINGS
The Temporary Copings are temporary coping-type prosthetic components to be installed over a Conventional Abutment (HE), specifically, the Temporary Copings are screw-retained on the Mini Conical Abutments. They are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are supplied with a removable prosthetic screw made of titanium alloy in accordance with standard ASTM F136. The prosthesis is to be cement over the Temporary Copings.
ABUTMENT SCREW
The Abutment Screws (Temporary Abutment, UCLA-type Abutment or Conventional Abutment) are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are composed of two different parts: head and body. The head has a geometry for the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.
PROSTHETIC SCREWS
The Prosthetic Screws are manufactured in titanium alloy in accordance with ASTM F136 - Ti6Al4V-ELI. They are intended to connect the prosthesis in the Conventional Abutments, specifically, the Mini Conical Abutments. The Prosthetic Screws are composed of two different parts: head and body. The head has a geometry for the fitting of the Driver/Connection which enable its use; and the body has a thread with a geometry which allow its fixation.
TECHNOLOGICAL CHARACTERISTICS
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The subject devices indications for use statement is equivalent to the primary predicate device K101207. The phrase "multiple tooth application may be rigidly splinted" was suppressed since it is up to the professional in charge to select proper technique for multi-unit restoration. The indication for use of the subject device is within the scope of the reference devices. Refer to table 5.1.
Differences in the design features between the subject devices and primary predicate devices K101207 are addressed by comparison to the reference devices in the tables 5.2 to 5.17 below.
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| Table 5.1: SE comparison on Indication for Use Statements | ||
|---|---|---|
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | |
| SUBJECT DEVICE | K192839 - DSP Implant System | |
| D.S.P. Industrial Eireli | 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. | ||
| PRIMARY PREDICATE | ||
| DEVICE | 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. | ||
| REFERENCE DEVICES | K023113 - Replace TiUnite Endosseous | |
| Implant | ||
| Nobel Biocare USA Inc | The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in theupper or lower jaw to support prosthetic devices | |
| such as artificial teeth, and to restore patient's chewing function, This may be accomplished using a two stage surgical procedure or a | ||
| single stage surgical procedure. If the single stage surgical procedure is used, these implants may be loaded immediately following | ||
| insertion - provided - at least four implants are placed and splinted with a bar. These implants must be placed predominantly in the | ||
| anterior mandible (between the mental foraminae) where good initial stability of the implants with or without bi-cortical anchorage, can | ||
| most often be obtained. | ||
| K083561- Neoss ProActive Implant | ||
| Neoss Limited | The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. | |
| The Neoss ProActive Implant are intended for immediate placement and function 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. | ||
| K925762 - Branemark System Self-Tapping | ||
| Fixture | ||
| Nobelpharma USA, Inc | The Nobelpharma Branemark System® - Self-Tapping Fixture is intended to be used in edentulous and partially edentulous patients to restore | |
| chewing functions of those patients. | ||
| K101945- Neodent Implant System | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support fqr prosthetic | |
| devices such as artificial teeth, to restore chewing function It may be used with single-stage or two-stage procedures for single or | ||
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | |
| JJGC Industria e Comercio de Materiais | ||
| Dentarios S.A. | 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. | ||
| K150669 - Neoss TiBase and CoCr | ||
| Abutments | Neoss TiBase: | |
| Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. | ||
| Neoss Ltd. | The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use | |
| with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System. | ||
| Neoss CoCr Abutments: | ||
| Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. | ||
| K170398 - S.I.N. Dental Implant System | 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. | ||
| S.I.N. Sistema de Implante Nacional S.A | ||
| K163634 - - External Hex Implants | 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. | ||
| Southern Implants (Pty) Ltd | ||
| K183024 – Implacil Implant System | Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support forsingle-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 de Bortoli Material Odontologico | ||
| Ltda |
9
Page 7 of 20
10
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | ||
|---|---|---|---|---|
| Trade Name | ||||
| Information | K192839 - DSP Implant System | K101207 – Neodent Implant System | K023113 - Replace TiUnite Endosseous | |
| Implant | K170398 - S.I.N. Dental Implant System | |||
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais | |||
| Dentarios S.A. | Nobel Biocare USA Inc | S.I.N. Sistema de Implante Nacional S.A. | ||
| HE SLIM | ||||
| Implant-to-abutment | ||||
| connection | HE | HE | Internal tri-channel | HE |
| Root-type design | Cylindrical | Cylindrical | ||
| Tapered | Tapered | Cylindrical | ||
| Prosthesis attachment | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | ||||
| Restoration | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | ||||
| Implant diameter: Length | ||||
| (mm) | Cylindrical | |||
| 3.3: 8.5, 10, 11.5, 13, 15, 17 | 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 | Tapered: | |||
| 3.5: 10, 13, 16 | ||||
| 4.3: 10, 13, 16 | ||||
| 5.0: 10, 13, 16 | ||||
| 6.0: 10, 13, 16 | 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 | ||||
| Raw Material | CPTi Gr4 | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched. | |||
| Machined collar: h 1.0 mm | Treated. Grit-blasted and acid-etched. | Treated, TiUnite | ||
| Machined collar: h 1.5 mm | Treated. Acid-etched and HA | |||
| Machined collar: h 0.7 mm | ||||
| Treated collar : | ||||
| h unknown | ||||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
| Table 5.3: SE comparison on HE BIOFIT implants | ||||
| SUBJECT DEVICE | REFERENCE DEVICES | |||
| Trade Name | ||||
| Information | K192839 - DSP Implant System | K083561- Neoss ProActive Implant | K023113 - Replace TiUnite Endosseous | |
| Implant | K170398 - S.I.N. Dental Implant System | |||
| D.S.P. Industrial Eireli | Neoss Limited | Nobel Biocare USA Inc | S.I.N. Sistema de Implante Nacional S.A. | |
| HE BIOFIT | ||||
| Implant-to-abutment | ||||
| connection | HE | Internal Hex (NeoLoc) | Internal tri-channel | HE |
| Root-type design | Cylindrical | Cylindrical | Tapered | Cylindrical |
| Prosthesis attachment | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Cement-retained | Cement-retained | Cement-retained | Cement-retained | |
| Overdenture | Overdenture | Overdenture | Overdenture | |
| Restoration | Single-unit | Single-unit | Single-unit | Single-unit |
| Multi-unit | Multi-unit | Multi-unit | Multi-unit | |
| Implant diameter: Length | ||||
| (mm) | Cylindrical: | |||
| 3.5: 8.1, 9.6, 11.1, 12.6, 14.6, 16.6 | ||||
| 3.75: 7, 8.1, 9.6, 11.1, 12.6, 14.6, 16.6 | ||||
| 4.0:, 7, 8.1, 9.6, 11.1, 12.6, 14.6 | ||||
| 4.5: 7, 8.1, 9.6, 11.1, 12.6, 14.6, 16.6 | ||||
| 5.0: 7, 8.1, 9.6, 11.1, 12.6 | Cylindrical: | |||
| 3.5: 7, 9, 11, 13, 15, 17 | ||||
| 4.0: 7, 9, 11, 13, 15, 17 | ||||
| 4.5: 7, 9, 11, 13, 15, 17 | ||||
| 5.0: 7, 9, 11, 13, 15 | ||||
| 5.5: 7, 9, 11, 13 | Tapered: | |||
| 3.5: 10, 13, 16 | ||||
| 4.3: 10, 13, 16 | ||||
| 5.0: 10, 13, 16 | ||||
| 6.0: 10, 13, 16 | 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 | ||||
| Raw Material | CPTi Gr4 | Not informed | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched | Treated. Grit-blasted and acid-etched | Treated, TiUnite | Acid-etched and HA |
| Machined collar: h 0.3 mm | Treated collar: h unknown | Machined collar: h 1.5 mm | Machined collar: h 0.7 mm | |
| Sterilization | Provided sterile by irradiation | Provided sterile. Method not informed. | Provided sterile by irradiation | Provided sterile by irradiation |
| Table 5.4: SE comparison on HE SOULFIT implants | ||||
| SUBJECT DEVICE | REFERENCE DEVICES | |||
| Trade Name | ||||
| Information | K192839 - DSP Implant System | K023113 - Replace TiUnite Endosseous | ||
| Implant | K925762 - Branemark System Self- | |||
| Tapping Fixture | K170398 - S.I.N. Dental Implant System | |||
| D.S.P. Industrial Eireli | Nobel Biocare USA Inc | Nobelpharma USA, Inc | S.I.N. Sistema de Implante Nacional S.A. | |
| HE SOULFIT | ||||
| Implant-to-abutment | ||||
| connection | HE | Internal tri-channel | HE | HE |
| Root-type design | Cylindrical | Tapered | Cylindrical | Cylindrical |
| Prosthesis attachment | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | Screw-retained | |||
| Cement-retained | ||||
| Overdenture | ||||
| Restoration | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | ||||
| Implant diameter: Length | Cylindrical: | |||
| 3.5: 8.5, 10, 11.5, 13, 15 | ||||
| 3.75: 7, 8.5, 10, 11.5, 13, 15, 17 | ||||
| 4.0: 7, 8.5, 10, 11.5, 13, 15, 17 | ||||
| 5.0: 7, 8.5, 10, 11.5, 13 | Tapered: | |||
| 3.5: 10, 13, 16 | ||||
| 4.3: 10, 13, 16 | ||||
| 5.0: 10, 13, 16 | ||||
| 6.0: 10, 13, 16 | Cylindrical: | |||
| 3.3: 10, 11.5, 13, 15 | ||||
| 3.75: 7, 8.5, 10, 11.5, 13, 15, 18 | ||||
| 4.0: 7, 8.5, 10, 11.5, 13, 15, 18 | ||||
| 5.0: 7, 8.5, 10, 11.5, 13, 15, 18 | 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 | ||||
| Raw Material | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched | |||
| Machined collar: h max 0.8 mm | Treated, TiUnite | |||
| Machined collar: h 1.5 mm | Treated. Grit-blasted and acid-etched. | |||
| Machined collar: h 0.8 mm | Acid-etched and HA | |||
| Machined collar: h 0.7 mm | ||||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation | Provided sterile by irradiation |
11
12
13
| Table 5.5: SE comparison on HE WAYFIT implants | |||
|---|---|---|---|
| SUBJECT DEVICE | REFERENCE DEVICE | ||
| Trade Name | |||
| Information | K192839 - DSP Implant System | K023113 - Replace TiUnite Endosseous Implant | K163634 - External Hex Implants |
| D.S.P. Industrial Eireli | Nobel Biocare USA Inc | Southern Implants (Pty) Ltd. | |
| HE WAYFIT | |||
| Implant-to-abutment connection | HE | Internal tri-channel | HE |
| Root-type design | Tapered | Tapered | Cylindrical |
| Tapered | |||
| Prosthesis attachment | Screw-retained | ||
| Cement-retained | |||
| Overdenture | Screw-retained | ||
| Cement-retained | |||
| Overdenture | Screw-retained | ||
| Cement-retained | |||
| Overdenture | |||
| Restoration | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | |||
| Implant diameter: Length (mm) | Tapered | Tapered: | Tapered: |
| 3.8 : 8.5, 10, 11.5, 13, 15, | |||
| 4.3 : 8.5, 10, 11.5, 13, 15 | 3.5 : 10, 13, 16 | ||
| 4.3 : 10, 13, 16 | 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 : 8.5, 10, 11.5, 13, 15 | 5.0 : 10, 13, 16 | ||
| 6.0 : 10, 13, 16 | 5.0 : 6, 8.5, 10, 11.5, 13, 15 | ||
| 5.7 : 10, 11.5, 13, 15, 18 | |||
| 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 | |||
| Raw Material | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched | Treated, TiUnite | Grit-blasted and acid-etched |
| Sterilization | Machined collar : h max 0.7 mm | ||
| Provided sterile by irradiation | Machined collar: h 1.5 mm | ||
| Provided sterile by irradiation | Provided sterile by irradiation | ||
| Table 5.6: SE comparison on HE PROPFIT implants | |||
| Trade Name Information | SUBJECT DEVICE | REFERENCE DEVICES | |
| HE PROPFIT | K192839 - DSP Implant System | ||
| D.S.P. Industrial Eireli | K023113 - Replace TiUnite Endosseous Implant | ||
| Nobel Biocare USA Inc | K163634 -- External Hex Implants | ||
| Southern Implants (Pty) Ltd. | |||
| Implant-to-abutment connection | HE | Internal tri-channel | HE |
| Root-type design | Tapered | Tapered | Cylindrical |
| Tapered | |||
| Prosthesis attachment | Screw-retained | ||
| Cement-retained | |||
| Overdenture | Screw-retained | ||
| Cement-retained | |||
| Overdenture | Screw-retained | ||
| Cement-retained | |||
| Overdenture | |||
| Restoration | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | |||
| Implant diameter: Length (mm) | Tapered | ||
| 3.8 : 8.5, 10, 11.5, 13, 15, | |||
| 4.3 : 8.5, 10, 11.5, 13, 15 | |||
| 5.0 : 8.5, 10, 11.5, 13, 15 | Tapered: | ||
| 3.5 : 10, 13, 16 | |||
| 4.3 : 10, 13, 16 | |||
| 5.0 : 10, 13, 16 | |||
| 6.0 : 10, 13, 16 | 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 | |||
| Raw Material | CPTi Gr4 | CPTi Gr4 (cold worked titanium) | CPTi Gr4 |
| Surface | Treated. Grit-blasted and acid-etched | Treated, TiUnite | Grit-blasted and acid-etched |
| Machined collar: h 1.0 mm. | Machined collar: h 1.5 mm | ||
| Sterilization | Provided sterile by irradiation | Provided sterile by irradiation |
14
15
Table 5.7: SE comparison on Covers, Healing Abutments and Protection Cylinders
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K101207 - Neodent Implant System |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | |
| COVER, HEALING ABUTMENT, PROTECTION CYLINDER | ||
| Implant-to-abutment connection | HE | HE |
| Diameter (mm) | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.3, 5.0 |
| Gingival Height (mm) | 2, 3, 4, 5, 6 | 2, 3, 4, 5, 6 |
| Raw material | CPTI Gr4 | Ti alloy |
| Surface | Machined | Machined |
| Angulation | 0° | 0° |
| Load | No occlusal load | No occlusal load |
| Sterility | Provided sterile by irradiation. | Provided sterile by ethylene oxide. |
Table 5.8: SE comparison on Temporary Abutment
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | |
| D.S.P. Industrial Eireli | K101207 - Neodent Implant System | |
| JJGC Industria e Comercio de Materiais Dentarios S.A. | ||
| TEMPORARY ABUTMENT | ||
| Compatibility | HE | HE |
| Application | Provisional prosthesis over the implant | Provisional prosthesis over the implant |
| Temporary timeframe | Up to 180 days | Up to 180 days |
| Diameter (mm) | 3.3, 4.1 | 3.3, 4.1, 4.3, 5.0 |
| Gingival height (mm) | 1, 2, 3 | 1, 2, 3, 4 |
| Prosthesis retention | Cement-retained | Cement-retained |
| Raw material | CPTi Gr 4 | Ti alloy |
| Surface | Machined | Machined |
| Angulation | 0° | 0° |
| Sterility | Provided sterile for irradiation | Provided sterile by ethylene oxide. |
16
Table 5.9: SE comparison on CoCr Base UCLA
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K101207 – Neodent Implant System |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | |
| COCR BASE UCLA | ||
| Compatibility | HE | HE |
| Application | Definitive prosthesis over the implant | Definitive prosthesis over the implant |
| Diameter (mm) | 3.3, 4.1 | 4.1, 5.0 |
| Prosthesis retention | Casted retained | Casted retained |
| Raw material | CoCr/ POM | CoCr/ POM |
| Surface | Machined/ Cast | Machined/ Cast |
| Angulation | 0° | 0° |
| Sterility | Provided non-sterile, to be steam sterilized prior use. | Provided non-sterile, to be steam sterilized prior use. |
Table 5.10: SE comparison on CoCr UCLA
| SUBJECT DEVICE | REFERENCE DEVICES | ||
|---|---|---|---|
| Trade Name | |||
| Information | K192839 - DSP Implant System | K150669 - Neoss TiBase and CoCr Abutments | K183024 - Implacil Implant System |
| D.S.P. Industrial Eireli | Neoss Ltd. | Implacil de Bortoli Material Odontologico Ltda | |
| COCR UCLA | |||
| Compatibility | HE | Internal Hex (NeoLoc) | HE, Internal Hex, Conical |
| Application | Definitive prosthesis over the implant | Definitive prosthesis over the implant | Definitive prosthesis over the implant |
| Diameter (mm) | 3.3, 4.1 | 4.5 | 3.5, 4.0, 5.0 |
| Gingival height (mm) | 1.0 | 0.7 | Unknown |
| Prosthesis retention | Casted retained | Casted retained | Casted retained |
| Raw material | CoCr | CoCr | CoCr/ POM |
| Surface | Machined/Cast | Machined/Cast | Machined/ Cast |
| Angulation | 0° | 0° | 0° |
| Sterility | Provided non-sterile, to be steam sterilized prior use. | Provided non-sterile, to be steam sterilized prior use. | Provided non-sterile, to be steam sterilized prior use. |
17
Table 5.11: SE comparison on Anatomical Abutments
| Trade Name
| Information | SUBJECT DEVICE | REFERENCE DEVICE |
|---|---|---|
| K192839 - DSP Implant System | K183024 - Implacil Implant System | |
| D.S.P. Industrial Eireli | Implacil de Bortoli Material Odontologico Ltda | |
| ANATOMICAL ABUTMENTS | ||
| Implant-to-abutment connection | HE | HE, Internal Hex, Conical |
| Diameter (mm) | 3.3, 3.6, 4.0, 4.1 | 3.3, 3.5, 4.0, 4.5, 5.0 |
| Gingival height (mm) | 1, 2, 3 | 0.8, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5 |
| Prosthesis retention | Cement-retained | Cement-retained |
| Prosthetic height (mm) | 6 | 4,6 |
| Raw material | CPTi Gr 4 | CPTi Gr 4 |
| Surface | Machined | Machined |
| Machined/Anodized | ||
| Angulation | 0° | 0, 15, 17, 25, 30° |
| Sterility | Provided sterile for irradiation. | Provided non-sterile, to be steam sterilized prior use. |
Table 5.12: SE comparison on Titanium Abutments
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K101207 - Neodent Implant System |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | |
| TITANIUM ABUTMENTS | ||
| Implant-to-abutment connection | HE | HE |
| Diameter (mm) | 3.3, 3.6, 4.1 | 4.1, 5.0 |
| Gingival height (mm) | 1, 2, 3 | Not applicable |
| Prosthesis retention | Cement-retained | Casted retained |
| Prosthetic height (mm) | 4.7, 6.0 | Unkown |
| Raw material | CPTi Gr 4/ CoCr Alloy | CoCr/ CoCr Alloy |
| Surface | Machined/Cast | Machined/ Cast |
| Angulation | 0° | 0° |
| Sterility | Provided sterile for irradiation. | Provided non-sterile, to be steam sterilized prior use |
18
Table 5.13: SE comparison on Mini Conical Abutments
| Trade Name
| Information | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| K192839 - DSP Implant System | K101207 - Neodent Implant System | K183024 – Implacil Implant System | |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | Implacil de Bortoli Material Odontologico Ltda | |
| MINI CONICAL ABUTMENTS | |||
| Implant-to-abutment connection | HE | HE | HE, Internal Hex, Conical |
| Diameter (mm) | 3.3, 4.1 | 3.3, 4.3, 5.0 | 3.5, 4.0, 4.8, 5.0 |
| Gingival height (mm) | 1, 2, 3, 4, 5.5 | 1, 2, 3, 4 | 0.8, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5 |
| Prosthesis retention | Screw-retained | Screw-retained | Screw-retained |
| Raw material | CPTi Gr 4 | Titanium alloy | CPTi Gr 4 |
| Surface | Machined | Machined | Machined |
| Angulation | 0° | 0, 17, 30° | 0, 17, 30° |
| Sterility | Provided sterile for irradiation. | Provided sterile by ethylene oxide. | Provided non-sterile, to be steam sterilized prior use. |
Table 5.14: SE comparison on O'ring Abutment
| SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K101207 – Neodent Implant System |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | |
| O'RING ABUTMENT | ||
| Compatibility | HE | HE |
| Diameter (mm) | 3.3, 4.1 | 4.1, 4.3, 5.0 |
| Gingival height (mm) | 1, 2, 3, 4, 5 | 2, 3, 4, 5 |
| Raw material | CPTi Gr 4 | CPTi Gr 4 |
| Surface | Machined | Machined/TiN |
| Angulation | 0° | 0° |
| Sterility | Provided sterile for irradiation. | Provided sterile by ethylene oxide. |
19
Table 5.15: SE comparison on Temporary Coping
| SUBJECT DEVICE | REFERENCE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K183024 - Implacil Implant System |
| D.S.P. Industrial Eireli | Implacil de Bortoli Material Odontologico Ltda | |
| TEMPORARY COPING | ||
| Compatibility | HE | HE, HI |
| Application | Provisional prosthesis over the abutment | Provisional prosthesis over the abutment |
| Diameter (mm) | 4.8 | 4.8 |
| Prosthesis retention | Cement-retained | Cement-retained |
| Raw material | CPTi Gr 4 | CPTi Gr 4 |
| Surface | Machined | Machined |
| Angulation | 0° | 0° |
| Sterility | Provided sterile for irradiation. | Provided non-sterile, to be steam sterilized prior use. |
Table 5.16: SE comparison on CoCr Base Coping
| SUBJECT DEVICE | REFERENCE DEVICE | |
|---|---|---|
| Trade Name | ||
| Information | K192839 - DSP Implant System | K183024 – Implacil Implant System |
| D.S.P. Industrial Eireli | Implacil de Bortoli Material Odontologico Ltda | |
| COCR BASE COPING | ||
| Compatibility | HE | HE, HI |
| Application | Definitive prosthesis over the abutment | Definitive prosthesis over the abutment |
| Diameter (mm) | 4.8 | 3.5, 4.0, 5.0 |
| Prosthesis retention | Cement-retained | Cement-retained |
| Raw material | CoCr/ POM | CoCr/ POM |
| Surface | Machined/Cast | Machined/Cast |
| Angulation | 0° | 0° |
| Sterility | Provided non-sterile, to be steam sterilized prior use. | Provided non-sterile, to be steam sterilized prior use. |
20
| Table 5.17: SE comparison on One Step Hybrid Coping | |||
|---|---|---|---|
| Trade Name | |||
| Information | SUBJECT DEVICE | REFERENCE DEVICE | |
| K192839 - DSP Implant System | K101945- Neodent Implant System | K183024 - Implacil Implant System | |
| D.S.P. Industrial Eireli | JJGC Industria e Comercio de Materiais Dentarios S.A. | Implacil de Bortoli Material Odontologico Ltda | |
| ONE STEP HYBRID COPING | |||
| Compatibility | HE | Conical Connection | HE, HI |
| Application | Definitive prosthesis over the abutment | Definitive prosthesis over the abutment | Definitive prosthesis over the abutment |
| Diameter (mm) | 4.0, 4.2, 4.8 | 4.1, 5.0 | 3.5, 4.0, 5.0 |
| Prosthesis retention | Cement-retained | Cement-retained | Cement-retained |
| Raw material | CPTi Gr 4 | CPTi Gr 4 | CoCr/ POM |
| Surface | Machined | Machined | Machined |
| Angulation | 0° | 0° | 0° |
| Sterility | Provided non-sterile, to be steam sterilized prior use | Provided non-sterile, to be steam sterilized prior use | Provided non-sterile, to be steam sterilized prior use |
21
DSP Implant System
The subject HE SLIM implants are substantially equivalent to the primary predicate device K101207 and reference devices K023113 and K170398. The primary predicate device K101207 is for substantial equivalence of the length 17 mm while other dimensions are covered by K170398. Both K101207 and K170398 are also for body geometrical features. The K023113 is for substantial equivalence of the height of the machined collar.
Considering all the subject implants, the machined collar is implantable as the reference device K023113.
The subject HE BIOFIT implants are substantially equivalent to the reference devices K083561, K023113 and K170398. The K083561 is for substantial equivalence of the length 16,6 mm for diameters 3.5 mm. The remain dimensions are covered by K170398. Both K083561 and K170398 are also for body geometrical features. The K023113 is for substantial equivalence of the machined collar.
The subject HE SOULFIT implants are substantially equivalent to the reference devices K023113, K925762 and K170398. K170398 is for body geometrical features and range of dimensions while K023113 is for substantial equivalence of the height of the machined collar. The K925762 is for substantial equivalence of the dimensions not encompassed by K170398 which are the length 17 mm for diameters 3.75 and 4.0 mm. The K023113 is for substantial equivalence of the height of the machined collar.
The subject HE WAYFIT and PROPFIT implants are substantially equivalent to the reference devices K123022 and K163634. The K163634 is for substantial equivalence of the range of dimensions (diameter and length). The K023113 is for substantial equivalence of the height of the machined collar.
The subject HE PROPFIT implants are substantially equivalent to the reference devices K023113, K062931 and K163634. The K163634 is for substantial equivalence of the range of dimensions (diameter and length). The K023113 is for substantial equivalence of the height of the machined collar.
The subject Covers, Healing Abutments, Protection Cylinders, Temporary Abutments and CoCr Base UCLA are substantially equivalent to the primary predicate device K101207 in design and range of dimensions.
The subject CoCr UCLAs are substantially equivalent to the reference devices K150669 and K183024. K150669 is for substantial equivalence of the abutment entirely made of CoCr alloy while K183024 is for the range of dimensions.
The subject Anatomical Abutments are substantially equivalent to the reference device K183024 in designs and range of dimensions.
The subject Titanium Abutments are substantially equivalent are substantially equivalent to the primary predicate device K101207 in technology.
The subject Mini Conical Abutments are substantially equivalent to the primary predicate device K101207, and reference devices K183024 in designs and range of dimensions. The reference devices K183024 is for substantial equivalence of raw material.
The subject O'ring Abutment is substantially equivalent to the primary predicate device K101207 in designs and range of dimensions.
The subject Temporary Coping is substantially equivalent to the reference device K183024 in design and range of dimensions.
22
DSP Implant System
The subject CoCr Base Coping is substantially equivalent to the reference device K183024. The CoCr Base Coping is provided with a prosthetic screw made of titanium alloy as it is the reference device.
The subject One Step Hybrid Coping is substantially equivalent to the reference devices K101945 and K183024. The K101945 is for the design characteristics and technology and K183024 is for the implant to abutment interface.
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. SO 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 testing according to ISO 10993-5. Pyrogenicity monitoring according to AAMI/ANSI ST72, The method selected to determine pyrogen limit specifications is the Bacterial Endotoxin Test (BET) performed according to USP using the photometric technique. Representative samples are selected for testing based upon the raw material, manufacturing processes, and sterilization process. No clinical data were included in this submission.
In order to analyze the blasted and acid etched surface and verify if some residual contaminants substances used during implant surface treatment remains over the implant, a scanning electron microscopy (SEM) coupled with Energy Dispersive Spectroscopy (EDS) was performed. The implant surface (modified surface) was analyzed. The elements were quantified by EDS no presence of contaminating metal particles was observed.
The following FDA guidance's were followed:
-
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 21, 2016.
-
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16. 2016.
-
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015.
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Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
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 predicate devices.