(255 days)
No
The document describes a mechanical dental implant system and its components. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making. The performance studies focus on mechanical and biological properties.
Yes.
The device is described as "Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws". This indicates it is used for treatment, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a dental implant system used for prosthetic attachment, not for diagnosing medical conditions.
No
The device is a dental implant system, which includes physical components made of titanium, stainless steel, and polymers. The description details the materials, dimensions, and mechanical properties of the implants and accessories, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the maxilla and/or mandible to provide a means for prosthetic attachment. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium that is surgically placed and expanded within the bone. It also describes various prosthetic and surgical components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is implanted inside the body for structural support and prosthetic attachment.
N/A
Intended Use / Indications for Use
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
Product codes
DZE, NHA
Device Description
DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.
The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone.
The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.
All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.
DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.
DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing: 3.3 mm Height
Plastic Cup: 2.7 mm Height
Straight Multi-Unit Sleeve: 11 mm Height
Straight Multi-Unit Screw: 2.3 mm Diameter
Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm
Angled Abutments 15° Large: Total Length: 9 mm – 12 mm
Ball Attachments: 2, 3 and 4 mm Height
Direct Screw Platform: Not Found
Straight Abutments 2, 3, 8.5 mm Length: Not Found
Straight Multi-Unit Abutments 2, 3 and 4 mm Length: Not Found
Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length: Not Found
Healing Caps 3, 4, 5 and 6 mm: Not Found
Cover Screw
The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).
Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and/or in the mandible
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)
A series of safety and performance tests and evaluations were performed to demonstrate that DenTack's PYRAMIDION Dental Implant System does not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations include:
a) Fatigue Test: Conducted according to ISO 14801 standard for Dentistry -Implants - Dynamic fatigue test for endosseous dental implants and with accordance to FDA Guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated: May 12, 2004. Worst case configuration was selected.
b) Surface analysis: Implant surface after surface treatment tested using SEM (Scanning Electron Microscope).
c) Implant Removal after Expansion: Comparative test conducted per DenTack protocol using artificial bone and a reference legally marketed device. Evaluation post implant removal showed both implants performed equally in terms of interaction with the bone.
d) Evaluation of Minimal Rotation Torque after Placement and Expansion: Test conducted per DenTack protocol to evaluate minimal rotation torque after OUAD placement and expansion in artificial bone in comparison to predicate device. Test results were very similar, and OUAD met acceptance criteria.
e) Partially expanded Implant Reciprocating Effect Test: Test conducted per DenTack protocol to demonstrate that counterclockwise and clockwise rotation when the QUAD is partially expanded does not cause additional damage to the surrounding bone or implant. Conducted in comparison to a legally marketed device. Study demonstrated no negative effect on bone or implant, performing similarly to the reference device.
f) Biocompatibility: Evaluated with accordance to ISO 10993-1, ISO 10993-5, and ISO 10993-12. Tests conducted using final and sterilized products considering exhaustive extractions and potential biological (cytotoxic) reaction. Chemical and biological tests revealed no incompatibility potential or adverse effect. Endotoxin testing (LAL test method) per USP showed endotoxins within acceptable criteria.
g) Gamma Sterilization Validation: Sterilization conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 and AAMI TIR 33 (now ISO/TS 13004).
h) Steam Sterilization Validation: Performed to validate instructions for steam sterilization of non-sterile prosthetic parts by the user at the clinic. Conducted with accordance to ISO 17665-1:2006, ANSI AAMI ST79:2010 and ANSI AAMI ST77:2013. Validation results supported SAL 10-6.
i) Cleaning Validation: Conducted to evaluate cleaning effectiveness before each reuse of reusable tools per AAMI TIR 30 standard with successful results.
j) Shelf life validation: Performed with accordance to ISO 11607-1. Confirmed sterility of sterile products remained for device shelf life.
k) Comparative Pull-out Test: Performed according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device.
l) Comparative Bone to Implant Contact Surface Area Analysis: Contact surface area analyzed in comparison to legally marketed device at worst case implant variation.
m) Implant Surface Area Analysis: Implant actual surface area before surface treatment compared to legally marketed device at worst case implant variation.
All results support DenTack's labeling claims for substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DenTack's OUAD Dental Implants and Prostheses, cleared under 510(k) number K152188
Reference Device(s)
Biomet's Biomet 3i T3 Dental Abutments, cleared under 510(k) K072642, Bicon's Bicon Implants with A 2.5mm Internal Connection cleared under 510(k) K092035, Biomet's Biomet 3i T3 Short implant, cleared under 510(k) K150571, Quantum BioEngineering Ltd's Quantum™ Dental Implant System, cleared under 510(k) K112279
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.
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December 13, 2018
DenTack Implants Ltd % Tali Hazan Regulatory Consultant Talmed Ltd. M.P Upper Galillee Ramot Naftali, 13830 ISRAEL
Re: K180859
Trade/Device Name: PYRAMIDION Dental Implants and Prostheses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2018 Received: November 13, 2018
Dear Tali Hazan:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180859
Device Name
PYRAMIDION Dental Implants and Prostheses
Indications for Use (Describe)
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
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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Image /page/3/Picture/0 description: The image shows the logo for Paramidion Implant Solutions. The word "PARAMIDION" is written in blue, with a stylized "lambda" symbol replacing the "A". Below the main word, in a smaller, gray font, are the words "Implant Solutions."
510(K) SUMMARY FOR DENTACK'S PYRAMIDION - DENTAL IMPLANTS AND PROSTHESES -
DATE PREPARED: DECEMBER 13, 2018
1. 510(K) OWNER NAME
DenTack Implants Ltd 24 HaTa'as St. POB 2405 Kfar-Saba 4464102 Israel Phone: +972-9-7660379, Fax: +972-9-7738280, Email: info@dentack.com.
Contact person name:
Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il
2. DEVICE NAME AND CLASSIFICATION
Common/Usual Name: Dental Implants and Prostheses Proprietary/Trade name: PYRAMIDION Dental Implants and Prostheses Classification: DenTack's PYRAMIDION device has been classified as Class II device under the following classification names:
Classification Name | Product Code | 21 CFR Ref. | Panel |
---|---|---|---|
Endosseous dental implant | Primary: DZE | ||
Secondary: NHA | 872.3640 | Dental |
4
3. PREDICATE DEVICES
DenTack's PYRAMIDION Dental Implants and Prostheses are substantially equivalent to the following Predicate Devices:
- 3.1 Primary Predicate Device: DenTack's OUAD Dental Implants and Prostheses, cleared under 510(k) number K152188 on January 28, 2016.
- 3.2 Reference Device: Biomet's Biomet 3i T3 Dental Abutments, cleared under 510(k) K072642 on December 20, 2007.
- 3.3 Reference Device: Bicon's Bicon Implants with A 2.5mm Internal Connection cleared under 510(k) K092035 on October 15, 2009.
- 3.4 Reference Device: Biomet's Biomet 3i T3 Short implant, cleared under 510(k) K150571 on November 20, 2015.
- 3.5 Reference Device: Quantum BioEngineering Ltd's Quantum™ Dental Implant System, cleared under 510(k) K112279 on May 01, 2012.
DEVICE DESCRIPTION 4.
DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.
The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone.
The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.
5
All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.
DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.
DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing | 3.3 mm Height |
---|---|
Plastic Cup | 2.7 mm Height |
Straight Multi-Unit Sleeve | 11 mm Height |
Straight Multi-Unit Screw | 2.3 mm Diameter |
Angled Abutments 15° And 22.5° | Length: 7 mm – 9 mm |
Angled Abutments 15° Large | Total Length: 9 mm – 12 mm |
Ball Attachments | 2, 3 and 4 mm Height |
Direct Screw Platform | |
Straight Abutments 2, 3, 8.5 mm | |
Length | |
Straight Multi-Unit Abutments 2, 3 | |
and 4 mm Length | |
Angled Multi Unit Abutments 17° | |
and 1.5 and 3 mm Length | |
Healing Caps 3, 4, 5 and 6 mm |
Cover Screw
The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).
Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
6
5. INTENDED USE
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
PERFORMANCE DATA 6.
A series of safety and performance tests and evaluations were performed to demonstrate that DenTack's PYRAMIDION Dental Implant System does not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations include are:
- a) Fatigue Test This test was conducted according to ISO 14801 standard for Dentistry -Implants - Dynamic fatigue test for endosseous dental implants and with accordance to FDA Guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated: May 12, 2004. Worst case configuration was selected to reflect the most challenging situation for the implant and abutment.
- b) Surface analysis The implant surface after surface treatment was tested using the SEM (Scanning Electron Microscope) which is a valid, conventional and known method.
- c) Implant Removal after Expansion This comparative test was conducted per DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue.
7
For the purpose of this test artificial bone was used and a reference legally marketed device for comparison. Both implants were "implanted" in the artificial bone and removed per instructions for use.
The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone.
- d) Evaluation of Minimal Rotation Torque after Placement and Expansion -The test was conducted per DenTack protocol, in order to evaluate the minimal rotation torque after OUAD placement and expansion in the artificial bone. This evaluation was conducted in comparison to predicate device, simulating the product use per their instructions for use. The tests results found to be very similar and thus equivalent. The OUAD met the acceptance criteria and performed at least as good as or better than the predicate device.
e) Partially expanded Implant Reciprocating Effect Test -
The test was conducted per DenTack protocol, in order to demonstrate that the instructions to counterclockwise and clockwise rotation, when the QUAD only partially expanded, do not cause to an additional damage to the surrounding bone or to the implant. The test was conducted in comparison to a legally marketed device with similar instructions for use (counterclockwise rotation when insufficient insertion occurs). The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device.
- f) Biocompatibility Biocompatibility was evaluated with accordance to ISO 10993-1 standard for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering exhaustive extractions and potential biological (cytotoxic) reaction.
The tests were conducted using final and sterilized products with accordance to above mentioned ISO 10993-1 as well as; ISO 10993-5 for Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and; ISO 10993-12 for Biological evaluation of medical devices - Part 12: Sample preparation and
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
December 13, 2018
8
reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect.
Endotoxin testing (LAL test method) conducted per USP to show endotoxins are within acceptable criteria (i.e., not more than 20EU/Device or 0.5EU/mL).
- g) Gamma Sterilization Validation Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 for Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently replaced by ISO/TS 13004).
- h) Steam Sterilization Validation Was performed to validate the instructions for steam sterilization provided by DenTack for prosthetic parts that are provided non-sterile and are to be steam sterilized by the user at the clinic. The validation was conducted with accordance to ISO 17665-1:2006, ANSI AAMI ST79:2010 and ANSI AAMI ST77:2013. The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results.
- i) Cleaning Validation This test was conducted in order to evaluate the cleaning effectiveness before each reuse of reusable tools. The validation was conducted per AAMI TIR 30 standard with successful results.
- j) Shelf life validation Was performed with accordance to ISO 11607-1 for Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems. This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life.
- k) Comparative Pull-out Test The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device.
9
- I) Comparative Bone to Implant Contact Surface Area Analysis - Contact surface area was analyzed in comparison to legally marketed device at worst case implant variation.
- m) Implant Surface Area Analysis Implant actual surface area before surface treatment was compared to legally marketed device at worst case implant variation.
All results support DenTack's labeling claims in order to establish substantial equivalency with the selected predicate devices.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
DenTack Implants are manufactured from biocompatible Titanium 6Al-4V-ELI and Pure Titanium. Implant surface is treated by an established Titanium blasting method. Restorative components are manufactured with common titanium alloy, stainless-steel and polymers.
The proposed DenTack's Dental Implant System has similar indications for use, technological characteristics, mode of operation and, performance specification as the above identified predicate devices. The proposed device utilizes same intended use as the predicate devices and shares same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.
With the exception of the lengths and connection platform DenTack's previously cleared OUAD (K152188) and PYRAMIDION implants are identical. These differences were bridged by reference devices and performance testing. Therefore, it was concluded that they are substantially equivalent.
The comparison of the similarities and differences between PYRAMIDION implant and predicate devices are hereby presented in the tables as follows:
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PARAMIDION Implant Solutions
| Implant
Feature | - Primary Predicate
Device -
DenTack's QUAD
Implant cleared under
510(k) K152188 | - Reference Device -
Bicon Implants
cleared under
510(k) K092035 | - Reference Device -
Biomet's
3i T3 short implant
cleared under 510(k)
K150571 | - Reference Device -
Quantum's dental
implant system
Cleared under 510(k)
K112279 | - New Device -
DenTack's
PYRAMIDION |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended | DenTack Dental | The Bicon implant is | The 3i T3® Short
Implants are intended | Quantum™, Dental
Implant System implants | DenTack |
| Use | Implants and Prostheses
are intended for
surgical placement in
the maxilla and/or in
the mandible to provide
a means for prosthetic
attachment in single
tooth restorations and in
partially or fully
edentulous jaws
utilizing conventional,
delayed or immediate
loading; when good
primary stability is
achieved. | designed for use in
edentulous sites in
the mandible or
maxilla for support
of a complete
denture prosthesis, a
final or intermediate
abutment for fixed
bridgework or for
partial dentures, or
as a single tooth
replacement. | for surgical placement
in the upper or lower
jaw to provide a
means for prosthetic
attachment in single
tooth restorations and
in partially or fully
edentulous spans with
multiple single teeth
utilizing delayed
loading, or with a
terminal or
intermediary abutment
for fixed or removable
bridgework, and to
retain overdentures. | are intended for immediate
or delayed placement in
the bone of the maxillary
or mandibular arch.
Quantum Dental Implant
System abutments are
intended for use as support
for crowns, bridges or
overdentures. When a one-
stage surgical approach is
applied, threaded implant
may be immediately
loaded when good primary
stability is achieved and
the functional load is
appropriate. Delayed
loading is required when
using the push-in
technique for fin-type or
threaded implants, or when
using any 5mm or 6mm
length implant. | PYRAMIDION Dental
Implants and Prostheses
are intended for surgical
placement in the maxilla
and/or in the mandible
to provide a means for
prosthetic attachment in
single tooth restorations
and in partially or fully
edentulous jaws
utilizing conventional,
delayed or immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading. Implants in
5-6mm length are
indicated for delayed
loading only. |
| Implant
Feature | - Primary Predicate
Device -
DenTack's QUAD
Implant cleared under
510(k) K152188 | - Reference Device -
Bicon Implants
cleared under
510(k) K092035 | - Reference Device -
Biomet's
3i T3 short implant
cleared under 510(k)
K150571 | - Reference Device -
Quantum's dental
implant system
Cleared under 510(k)
K112279 | - New Device -
DenTack's
PYRAMIDION |
| Patient
Population | Edentulous or partially
Edentulous individuals | Edentulous or
partially Edentulous
individuals | Edentulous or
partially Edentulous
individuals | Edentulous or partially
Edentulous individuals | Edentulous or partially
Edentulous individuals |
| Material | Implant body: Titanium
alloy ELI,
Implant foils: Pure
Titanium, unalloyed. | Titanium alloy ELI | Pure titanium | Titanium alloy | Implant body: Titanium
alloy ELI,
Implant foils: Pure
Titanium, unalloyed. |
| Implant
Model | DenTack
PYRAMIDION
expandable dental
implants for
conventional, delayed
or immediate load
(7-11mm length
implants). | Non-expandable
short implants (5mm
length), not for
immediate loading. | Non-expandable, short
implants (5-6mm
length) not for
immediate loading. | Non-expandable, short
implants (5-6mm length)
not for immediate loading. | Expandable dental
implants in 5-6mm
length implants, not for
immediate loading but
for delayed load only. |
| Implant
Dimensions | Length (mm): 7, 8, 9,
10 and 11
Diameter (mm): 3.75,
4.1 | Length (mm): 5
Diameter (mm): 4 | Length (mm): 5, 6
Diameter (mm): 5, 6 | Length (mm): 5, 6
Diameter (mm): 4 | Length (mm): 5, 6
Diameter (mm): 4.1 |
| Surface | Titanium Oxide
Blasting and acid
etching | Hydroxylapatite
(HA) | The implants are
offered with or
without a nano-scale
discrete crystalline
deposition (DCD®)
calcium phosphate | RBM,
Acid etch,
HA coated | Titanium Oxide
Blasting and acid
etching |
| Implant
Feature | - Primary Predicate
Device -
DenTack's QUAD
Implant cleared under
510(k) K152188 | - Reference Device -
Bicon Implants
cleared under
510(k) K092035 | - Reference Device -
Biomet's
3i T3 short implant
cleared under 510(k)
K150571 | - Reference Device -
Quantum's dental
implant system
Cleared under 510(k)
K112279 | - New Device -
DenTack's
PYRAMIDION |
| | | | (CaP) surface
treatment. | | |
| Implants
Design | Apically expandable
root form dental
implant. | Cylindrical implant | The dental implants
are basic screw-type
designs available in
parallel walled body
geometries with an
external hex
connection | Threaded and a grooved
design | Apically expandable
root form dental
implant. |
| Expansion
Mechanism | Expansion tool is
inserted in the implant
upper platform and
implant is expanded
using the ratchet torque. | No expansion
mechanism | No expansion
mechanism | No expansion mechanism | Expansion tool is
inserted in the implant
upper platform and
implant is expanded
using the ratchet torque. |
| Sterility | Sterile by Gamma
Irradiation | Sterile | Sterile | Sterile | Sterile by Gamma
Irradiation |
| Placement
method | Placing the implant
immediately after
drilling | Placing the implant
immediately after
drilling by tapping it | Placing the implant
immediately after
drilling | Placing the implant
immediately after drilling | Placing the implant
immediately after
drilling |
| Self-
Tapping | Yes | No | Yes | Yes | Yes |
| Connection
type | Internal hex | Internal Hex | External Hex | Internal and External Hex | External hex |
| Implant
Feature | - Primary Predicate
Device -
DenTack's QUAD
Implant cleared under
510(k) K152188 | - Reference Device -
Bicon Implants
cleared under
510(k) K092035 | - Reference Device -
Biomet's
3i T3 short implant
cleared under 510(k)
K150571 | - Reference Device -
Quantum's dental
implant system
Cleared under 510(k)
K112279 | - New Device -
DenTack's
PYRAMIDION |
| Maximum
abutment
angle | 25° | 0° (straight) | 30° | Up to 25° | 22.5° |
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11
PARAMIDION
Implant Solutions
12
PARAMIDION
Implant Solutions
13
PARAMIDION
Implant Solutions
14
The comparison of the similarities and differences between PYRAMIDION Prostheses and predicate device are hereby presented in the tables below:
| Abutment
Feature | - Reference Device -
Biomet's 3i T3 Dental Abutments
cleared under 510(k) K072642 | - New Device -
DenTack's PYRAMIDION |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | BIOMET 3i Dental Abutments are
intended
for use as accessories to endosseous
dental implant to support a prosthetic
device in a partially or completely
edentulous patient. A dental abutment
is intended for use to support single and
multiple tooth prosthesis, in the
mandible or maxilla. The prosthesis
can be screw retained or cement
retained.
Restorative Components:
• Temporary Healing Abutments are
intended for use to shape and
maintain the soft tissue opening
during healing.
• Castable restorative components
are intended for use as accessories
to endosseous dental implants to
aid in the fabrication of dental
prosthetics.
• Screw components are intended for
use as accessories to endosseous
dental implants for retention of
screw retained abutments to the
dental implant. | Same intended use and clinical
purpose. |
| Abutment
Feature | - Reference Device -
Biomet's 3i T3 Dental Abutments
cleared under 510(k) K072642 | - New Device -
DenTack's PYRAMIDION |
| Items
Identification
and
Description | PAP452G, Angled abutment total
length 9 mm 15° angle | Angled Abutment total length 9 mm
15° angle |
| | PAP452G, Angled abutment total
length 9 mm 15° angle | Angled Abutment total length 12 mm
15° angle |
| | IPAP462G, Angled Abutment (AA) 8
mm length 15° angle. | Angled Abutment 7.0 mm length
22.5° angle |
| | PAP452G, Angled Abutment total
length 9 mm 15° angle. | Angled Abutment total length 9 mm
22.5° angle |
| | LOA002, Titanium alloy removable
overdentures 2 mm height | Ball attachment abutment 2 mm
height |
| | LOA003, Titanium alloy removable
overdentures 3 mm height | Ball attachment abutment 3 mm
height |
| | LOA004, Titanium alloy removable
overdentures 4 mm height | Ball attachment abutment 4 mm
height |
| | LAIC1, Overdenture metal housing | Metal housing 3.3 mm height.
*Made of SS |
| | LAERM, Extended range males | Plastic cup 2.7 mm height.
*Made of Plastic (Nylon) |
| | UNAB2C, Direct Screw Platform 11.0
mm height. | Direct Screw Platform
*to be used with burn-out plastic sleeve
ensuring a minimum post-height of 4mm
(with no angular correction) |
| | APP452G, Straight Abutment vary
according to gingival height | Straight abutment 2, 3, 8.5 mm
length - Similar to Biomet part
presented for DenTack's SA-xxxEX,
dimensions |
| | APP452G straight abutment 2 mm
length (One representative model
among others that vary in gingival
height) | Straight abutment 2, 3 and 8.5 mm
length |
| | Straight Multi-unit abutments 2 mm
length LPC442U (One representative | Straight Multi-unit abutments 2, 3
and 4 mm length |
| Abutment
Feature | - Reference Device -
Biomet's 3i T3 Dental Abutments
cleared under 510(k) K072642 | - New Device -
DenTack's PYRAMIDION |
| | model among others that vary in
gingival height) | |
| | LPAC4217, 2 mm length, 17º angle | Angled Multi Unit Abutment, 17º angle correction, 1.5 mm length |
| | LPAC4330, 3 mm length, 17º angle | Angled Multi Unit Abutment, 17º angle correction, 3.0 mm length |
| | LPCTC2
Retaining screw | Straight Multi-unit Sleeve 11 mm height + Straight Multi-unit Screw 2.3 mm |
| | THA53
EP® Healing Abutment 3 mm length | Healing caps 3 mm length |
| | THA54
EP® Healing Abutment 4 mm length | Healing caps 4 mm length |
| | THA56
EP® Healing Abutment 6 mm length | Healing caps 5 and 6mm length |
| Materials | Titanium, Titanium alloy, gold, gold
alloy, zirconium, vanadium, stainless
steel, polyetheretherketone (PEEK),
cobalt chromium alloy, and
polyoxymethylene (Delrin) | Titanium alloy, stainless-steel and
polymers (nylon) not in body contact |
| Sterility | Some are provided sterile and some
provided non-sterile and to be sterilized
by the user | Non-sterile provided (except for the
cover screw). Non-sterile parts are to
be sterilized by the user |
| Single Use | Single use | Single use |
| Abutment
Max Angle | 15º | 22.5º |
| Connection | Internal and External hex connections | External hex connection |
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16
17
8. DISCUSSION AND CONCLUSIONS
The DenTack's PYRAMIDION dental implants and prostheses, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. Differences in the length dimensions were bridged using BICON'S reference device (K092035) which is available in the same dimensions. External hex platform of the subject device was bridged by Biomet's reference device cleared under K150571 and was validated through fatigue test. The external hex abutments were supported by Biomet's reference device cleared under K072642.
The difference in using 22.5° angled abutment for 4.1mm diameter PYRAMIDION implants was bridged by Quantum BioEngineering's reference device (Quantum™ Dental Implant System K112279). This device clearance includes angled abutments of 25.5° for implant diameter of 4.0mm. Therefore, is suitable to support DenTack's PYRAMIDION's 25.5° angled abutments for implant diameter of 4.1mm.
The subject device met all its requirements and labeling claims per its intended use. The device does not introduce new risks and does not present any new adverse health effects or safety potential risks to patients when used as intended.
Therefore, it was concluded that the overall evaluation of our device performances demonstrates that it is substantial equivalent to the selected predicate devices.
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