(176 days)
No
The summary describes a mechanical dental implant system and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is described as "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," which directly indicates its use for treating a medical condition (tooth loss).
No
Explanation: The device is a dental implant system intended for surgical placement and prosthetic attachment, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of Titanium, stainless-steel, and polymers, including implants, abutments, and tools. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment." This describes a surgical implant used in vivo (within the body) for structural support and prosthetic attachment.
- Device Description: The description details the materials and components of dental implants and prostheses, which are physical devices implanted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used in a laboratory or clinical setting outside the body.
Therefore, the DenTack QUAD Dental Implants and Prostheses are medical devices, specifically dental implants and related components, and not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
DenTack QUAD 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 delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical 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 attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw
The QUAD 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 performance tests and evaluations were performed to demonstrate that DenTack's Dental Implant System is substantially equivalence with the predicate devices. These tests are:
- Fatigue Test: This test was conducted according to ISO 14801:2007 standard a) 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.
- Surface analysis: The implant surface was tested using the SEM (Scanning Electron Microscope).
- QUAD Removal after Expansion: This comparative test was conducted per C) DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue. 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.
- 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 QUAD 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 QUAD met the acceptance criteria and performed at least as good as or better than the predicate device.
- Partially expanded QUAD 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.
- Biocompatibility: Biocompatibility was evaluated with accordance to ISO f) 10993-1 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering 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 reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect.
- Gamma Sterilization Validation: Sterilization was conducted with g) successful results, using Gamma Irradiation according to VDmax method with accordance to ISO 11137-2 for Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently revised to: ISO TS 13004).
- Steam Sterilization Validation: Was performed to validate the instructions for steam sterilization provided by DenTack for prosthetic parts that are provided nonsterile 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°. IFU (instructions for use) are in-line with the validation results.
- Shelf life validation: Was performed with accordance to ISO 11607-1 for i) 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.
All results are supporting DenTack's labeling claims in order to establish substantial equivalency with the selected predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2016
DenTack Implants Ltd c/o Ms. Tali Hazan Regulatory Consultant Talmed Ltd M.P. Upper Galilee Ramot Naftali, 13830 ISRAEL
Re: K152188
Trade/Device Name: QUAD Dental Implants and Prostheses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 14, 2015 Received: December 17, 2015
Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152188
Device Name
QUAD Dental Implants and Prostheses
Indications for Use (Describe)
DenTack QUAD 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 delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image is a logo for Dentack Implants. The logo features a series of blue arcs that get progressively larger, with a green circle behind the largest arc. To the right of the arcs is the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters below it. The "TACK" portion of "DENTACK" is on a green background.
510(K) SUMMARY FOR DENTACK'S QUAD DENTAL IMPLANTS AND PROSTHESES
DATE PREPARED: January 20, 2016
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: QUAD Dental Implants and Prostheses Classification: DenTack's QUAD 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 | 21 CFR 872.3640 | Dental |
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Image /page/4/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green circle, followed by the word "DENTACK" in blue, with a green rectangle behind it. Below "DENTACK" is the word "IMPLANTS" in a smaller font.
3. PREDICATE DEVICES
DenTack's QUAD Dental Implants and Prostheses are substantially equivalent to the following Predicate Devices (primary and secondary):
- 3.1 Primary Predicate Device: Sargon's Immediate Load Implant Model D: cleared under 510(k) number K981141 on June 23, 1999.
- 3.2 Reference Predicate Device: Biomet's Biomet 3i Dental Abutments and Restorative Components; cleared under 510(k) K072642 on December 20, 2002.
- 3.3 Reference Predicate Device: Nobel Biocare, NobelActive Internal Connection Implant; cleared under 510(k) K071370 on August 3, 2007.
- 3.4 Reference Predicate Device: Implant Direct, Legacy3 6mm Length Implants; cleared under 510(k) K131097 on August 22, 2013.
4. DEVICE DESCRIPTION
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical 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 attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/5/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue concentric circles emanating from a green sphere. To the right of the circles, the word "DENTACK" is written in a large, bold, blue font. Below "DENTACK", the word "IMPLANTS" is written in a smaller, thinner font.
DenTack's Prostheses are identified as follows:
| Metal housing |
|---|
| Plastic cup |
| Straight Multi-unit Sleeve |
| Straight Multi-unit Screw |
| Angled abutments 15° and 25° |
| Angled abutments 15° Large |
| Ball Attachments |
| (1, 2 & 3 mm) |
| Direct screw platform |
| Straight abutments |
| Screw retained abutments |
| Straight Multi-unit abutments |
| Healing caps |
| Cover Screw |
The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
5. INTENDED USE
DenTack OUAD 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 delayed loading, or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
6. PERFORMANCE DATA
A series of performance tests and evaluations were performed to demonstrate that DenTack's Dental Implant System is substantially equivalence with the predicate devices. These tests are:
- Fatigue Test This test was conducted according to ISO 14801:2007 standard a) 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.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/6/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green circle, followed by the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters underneath. The logo is clean and professional, suggesting a company that specializes in dental implants.
- b) Surface analysis The implant surface was tested using the SEM (Scanning Electron Microscope).
- QUAD Removal after Expansion This comparative test was conducted per C) DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue.
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 QUAD 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 QUAD met the acceptance criteria and performed at least as good as or better than the predicate device.
Partially expanded QUAD Implant Reciprocating Effect Test e)
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.
- Biocompatibility Biocompatibility was evaluated with accordance to ISO f) 10993-1 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering 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;
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/7/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green sphere on the left side. To the right of the arcs is the word "DENTACK" in blue, with the "ACK" portion set against a green background. Below "DENTACK" is the word "IMPLANTS" in a smaller, sans-serif font.
ISO 10993-12 for Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect.
- Gamma Sterilization Validation Sterilization was conducted with g) successful results, using Gamma Irradiation according to VDmax method with accordance to ISO 11137-2 for Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently revised to: 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 nonsterile 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°. IFU (instructions for use) are in-line with the validation results.
- Shelf life validation Was performed with accordance to ISO 11607-1 for i) 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.
All results are supporting DenTack's labeling claims in order to establish substantial equivalency with the selected predicate devices.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 7.
DenTack Implants are manufactured from biocompatible Titanium. Implant surface is treated by an established sand-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 predicates and is placed using the same methodology as all of the selected predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw. Therefore it was concluded that they are substantially equivalent.
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/8/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of overlapping blue circles on the left, with a green sphere in the center. To the right of the circles is the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters underneath. The word "DENTACK" is partially overlaid on a green rectangle.
Certain differences between subject and predicate devices did not alter the substantial equivalent determination, since they were established by performance testing. The implant expansion was evaluated through tests 'c'-'d' described above. Differences in abutment maximal angulation and connection types were evaluated through fatigue tests under worst case scenario (DenTack's 25° abutment with the narrowest implant OD). Differences between the submission device and the primary predicate with respect to surgical protocol for rotation after partial expansion are supported by the reference predicate K071370 and the comparative partial expansion rotation performance testing. Differences between the submission device and the primary predicate with respect to implant length are supported by the reference predicate K131097.
The comparison of the similarities and differences between QUAD implant and predicated devices are hereby presented in the tables below:
| Feature | - Primary Predicate Device -
Sargon's 510(k) K981141 | - New Device -
DenTack's QUAD |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in either partially or fully edentulous
mandibles and maxillae as a final or
intermediary abutment for fixed detachable
prosthesis and for use in support of free
standing restorations with or without the
involvement of adjacent dentition. | DenTack 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. |
| Patient
Population | Edentulous or partially Edentulous
individuals | Edentulous or partially Edentulous
individuals |
| Material | Titanium alloy ELI | Titanium |
| Implant Model | Sargon Immediate Load Implant
(expandable) | DenTack QUAD Dental Implants
(expandable) for conventional, delayed or
immediate load. |
| Implant
Dimensions | Length (mm): 10, 13,16
Diameter (mm): 3.8 | Length (mm): 7, 8, 9, 10, 11
Diameter (mm): 3.75, 4.1 |
| Surface | Alumina blasting (grit blasting and then acid
etching surface) | Sand Blasting and acid etching |
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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Image /page/9/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of concentric circles on the left, transitioning into a green sphere. To the right of the circles is the word "DENTACK" in a bold, dark blue font, with the word "IMPLANTS" in a smaller font underneath.
| Feature | - Primary Predicate Device -
Sargon's 510(k) K981141 | - New Device -
DenTack's QUAD |
|---------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Implants Design | Apically expandable root form dental implant. | Apically expandable root form dental implant. |
| Expansion
Mechanism | Screw driver manipulates internal parts until
expanded. | Expansion tool is inserted in the implant
upper platform and implant is expanded
using the ratchet torque. |
| Sterility | Sterile by Gamma Irradiation | Sterile by Gamma Irradiation |
| Placement
method | Placing the implant immediately after drilling | Placing the implant immediately after
drilling |
| Self-Tapping | Yes | Yes |
| Connection type | Internal and External hex | Internal hex |
| Abutment
connection | With and without abutment | With abutment |
| Maximum
abutment angle | N/A
(Sargon 510(k) refers only to the implant) | 25° |
| Subject | - Reference Predicate Device - | - New Device - |
|---|---|---|
| Biomet 510(k) K072642 | DenTack Prostheses | |
| Indications for | ||
| 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 indications and clinical purpose | |
| Subject | - Reference Predicate Device - | |
| Biomet 510(k) K072642 | - New Device - | |
| DenTack Prostheses | ||
| Items | ||
| Identification | ||
| and Description | IPAP462G, Angled abutment 8 mm length | |
| 15° angle | Angled Abutment 8.5 mm length 15° | |
| angle | ||
| IPAP474G Angled Abutment 11.5 mm | ||
| length 15° angle | Angled Abutment, large, 11.6 mm | |
| length 15° angle | ||
| IPAP462G Angled Abutment (AA) 8 mm | ||
| length 15° angle. | ||
| Note that except for the angle, DenTack AA | ||
| 25° is the same in all respects to the AA-15° | ||
| and that AA 25° was used as part of the | ||
| worst case scenario in the fatigue test where | ||
| it showed good failure resistance. | Angled Abutment 8.5 mm length 25° | |
| angle | ||
| Ball Attachment (BA) Similar to Biomet part | ||
| presented for DenTack's Ball Attachment | ||
| (BA), dimensions vary according to gingival | ||
| height. | Ball attachment abutment 3 mm height | |
| Ball attachment abutment 2 mm height | ||
| OSO20 | ||
| O-Ring Abutment 2 mm height | Ball attachment abutment 1 mm height | |
| IGUCA2C | ||
| Direct Screw Platform 11.0 mm height. | ||
| *Same as DenTack's | Direct Screw Platform (casting | |
| abutment) 11.7 mm height | ||
| *Made of both Titanium & Plastic. | ||
| Titanium is gingival contact. The Plastic | ||
| has no body contact. | ||
| Straight Abutment - Similar to Biomet part | ||
| presented for DenTack's Straight Abutment | ||
| (SA), dimensions vary according to gingival | ||
| height. | Straight abutment 1 mm length | |
| IAPP454G | ||
| GingiHue© Post 4 mm height | ||
| (One representative model among others that | ||
| vary in gingival height) | Straight abutment 2 mm length | |
| Straight abutment 3 mm length | ||
| Straight abutment 0.5 mm length | ||
| ICAOO2 | ||
| Certain® Conical Abutment 4.1mm(D) X | ||
| 2mm length | Screw retained abutments 1.5 mm length | |
| Screw retained abutments 2.5 mm length | ||
| Subject | - Reference Predicate Device - | |
| Biomet 510(k) K072642 | - New Device - | |
| DenTack Prostheses | ||
| ILPC342U | ||
| (One representative model among others that | ||
| vary in gingival height) | Straight Multi-unit abutments 2 mm | |
| length | ||
| Straight Multi-unit abutments 3 mm | ||
| length | ||
| Straight Multi-unit abutments 4 mm | ||
| length | ||
| THA52 | ||
| EP® Healing Abutment 2 mm length. | Healing caps 2 mm length | |
| THA53 | ||
| EP® Healing Abutment 3 mm length | Healing caps 3 mm length | |
| THA54 | ||
| EP® Healing Abutment 4 mm length | Healing caps 4 mm length | |
| N/A – Part of DenTack's implant | ||
| (designated) | Cover Screw 0.1 mm length | |
| LAIC1 | ||
| Impression coping. | ||
| *Same. | Metal housing 3.3 mm height. | |
| *Made of SS | ||
| LAERM | ||
| Extended range males | ||
| *Same as DenTacks (Plastic). | Plastic cup 2.7 mm height. | |
| *Made of Plastic (Nylon) | ||
| ILPC342U | ||
| (One representative model among others that | ||
| vary in gingival height) | Straight Multi-unit Sleeve 10 mm height |
- Straight Multi-unit Screw 1.8 mm
height |
| 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) |
| Sterility | Some are provided sterile and some provided
non-sterile and to be sterilized by the user | Non-Sterile (except for the cover screw) |
| Single Use | Sterile provided: Single use | Single use |
| Abutment Max.
Angle | 15° | 25° |
| Connection | Internal and External Hex Connections | Internal Hex Connection |
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Image /page/10/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of curved lines emanating from a green sphere, followed by the word "DenTack" in a dark blue, serif font. Below "DenTack" is the word "IMPLANTS" in a smaller, sans-serif font.
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Image /page/11/Picture/0 description: The image is a logo for Dentack Implants. The logo features a series of blue arcs that get progressively larger, with a green sphere in the center. To the right of the arcs is the word "DENTACK" in blue, with the word "IMPLANTS" in a smaller font below it.
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Image /page/12/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of concentric circles in blue, with a green sphere at the center. To the right of the circles, the word "DENTACK" is written in blue, with the word "IMPLANTS" written in a smaller font size below it.
8. CONCLUSIONS
The DenTack's QUAD dental implants and prostheses, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. The device met 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 substantially equivalent to the predicate devices.
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