(175 days)
The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The T.A.G.'s Dental Implant System is composed of three sub-families:
(1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm.
(2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2
(3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm.
The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
Provided are accessories which are used in dental implantation procedures. They are: Superstructures which are Healing Caps & Abutments made from Titanium Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are single patient use to be supplied non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the T.A.G. Dental Implant System.
It's important to note that the provided document is a 510(k) summary for a dental implant system, which is a medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "training set," "ground truth experts," "adjudication," and "MRMC studies" are typically not applicable in the context of hardware medical devices like dental implants. The "performance" here refers to mechanical and material performance, not diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic device with metrics like sensitivity, specificity, or AUC. Instead, it refers to compliance with established standards for mechanical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments | Met the requirements of the standards (ISO14801). |
| Compliance with ISO 14801: Static and Cycling Loading Test of Dental Implants | Met the requirements of the standards (ISO14801). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For ISO 14801, standard practice involves testing multiple samples per device configuration (e.g., different lengths, diameters) to establish statistical significance. The document states "testing, which was submitted."
- Data Provenance: The testing was "performed at an accredited independent laboratory." The country of origin of the data is not explicitly stated, but the manufacturer (T.A.G. Medical Products) is located in Kibbutz Gaaton, Israel. The testing would, therefore, likely originate from a lab commissioned by the manufacturer, possibly in Israel or an international lab accredited to perform such tests. The study is prospective in the sense that the implants were manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This concept is not applicable to this type of device and study. "Ground truth" for mechanical testing is established by the physical testing results themselves and their compliance with engineering specifications, not by expert consensus or interpretation of images. An independent accredited laboratory performing the tests serves as the "expert" in terms of confirming the test methodology and results.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device and study. Adjudication typically refers to resolving discrepancies in human interpretation, which is not relevant for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of a device (often AI-assisted) on human performance. Since the T.A.G. Dental Implant System is a physical implant, such a study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable. The device is a physical dental implant, not an algorithm. The performance testing described (mechanical loading) is inherently "standalone" in the sense that it assesses the device's physical properties directly, without human interpretation of results needing to be factored into the device's intrinsic function.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the dental implant system is the physical measurement and observation of the implant's behavior under controlled mechanical stress, as defined by the ISO 14801 standard. This standard specifies how dental implants should be subjected to static and dynamic (cycling) loading to evaluate their fatigue strength and resistance to fracture. The "truth" is whether the implant withstands the specified forces and cycles without failure, thus meeting the criteria of the standard.
8. The Sample Size for the Training Set
This concept is not applicable. Dental implants are hardware devices. There is no "training set" in the machine learning sense. The design and manufacturing process are informed by engineering principles, material science, and previous experience, but not through an iterative learning process with a "training set" of data like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for a hardware medical device. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material specifications (e.g., Ti-6Al-4V-ELI), regulatory requirements (e.g., FDA guidance, ISO standards), and clinical experience with similar devices.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2015
T.A.G Medical Products Corporation, Ltd. c/o Mr. George J. Hattub MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K143326
Trade/Device Name: T.A.G. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant and Abutments Regulatory Class: II Product Code: DZE, NHA Dated: January 28, 2015 Received: February 4, 2015
Dear Mr. Hattub:
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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
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}------------------------------------------------
Indications for Use
510(k) Number (if known): K143326
Device Name: T.A.G. Dental Implant System
Indications For Use: The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
{3}------------------------------------------------
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
-
- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer T.A.G. Medical Products Address: D. N. Ashrat Kibbutz Gaaton 25130, Israel Mfq. Phone: Tel.: 972-3-647-4840 Contact Person: Erez Adiv Date: May 6, 2015 2. Device & Endosseous Dental Implant & Abutments- class II device (product codes: Classification DZE & NHA). 21 CFR 872.3640 T.A.G. Dental Implant System Name: MIS Dental Implant System (K040807), AB Dental Implants and Accessories 3. Predicate Devices: (K112440) & MIS UNO Narrow Implant System (K092555) 4. The T.A.G.'s Dental Implant System is composed of three sub-families: Description: (1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm. (2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2 (3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm. The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
{4}------------------------------------------------
| Provided are accessories which are used in dental implantation procedures. | |
|---|---|
| They are: | |
| Superstructures which are Healing Caps & Abutments made from Titanium | |
| Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are | |
| single patient use to be supplied non-sterile. | |
| 5. Intended Use: | The T.A.G. Dental Implant System is intended to replace single or multiple |
| teeth in the fully or partially edentulous mandibular or maxillary alveolar | |
| process. The implants are appropriate for immediate loading when good | |
| primary stability is achieved and with appropriate occlusal loading. | |
| 6. Comparison ofTechnologicalCharacteristics: | With respect to its indication for use, the T.A.G. Dental Implant System is |
| substantially equivalent to its predicate devices in that it intended for the | |
| same clinical purpose. With respect to technology, the design is similar as | |
| confirmed by comparison, and the performance is the same as verified by | |
| validation. Based upon this, T.A.G. Medical Products believes that its device | |
| is substantially equivalent to its predicate devices. |
Please see comparison table on next page.
{5}------------------------------------------------
| Feature | T.A.G."Massif" | AB Dental "I2" ScrewType Implant | T.A.G."Axis" | MIS DentalImplants"SEVEN" | T.A.G."Crestone" | MIS UNO Dental Implants |
|---|---|---|---|---|---|---|
| Intended Use | The T.A.G.DentalImplantSystem isintended toreplace singleor multipleteeth in thefully orpartiallyedentulousmandibular ormaxillaryalveolarprocess. Theimplants areappropriatefor immediateloading whengood primarystability isachieved andwithappropriateocclusalloading. | AB Dental Implants areintended for surgicalplacement in themaxillary and/or themandibular arch tosupport crowns,bridges, or overdenturesin edentulous or partiallyedentulous patients.17 Integral Implant, 15Conical Implant, P15Temporary Abutment,P12-T, L TemporaryFlat ConnectionAbutment and P 16Straight Adapter areappropriate forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. | The T.A.G.Dental ImplantSystem isintended toreplace singleor multipleteeth in thefully orpartiallyedentulousmandibularormaxillaryalveolarprocess. Theimplants areappropriate forimmediateloading whengood primarystability isachieved andwithappropriateocclusalloading. | MIS dentalimplants areintended to besurgicallyplaced inthebone of theupper or lowerjaw arches toprovide supportfor prostheticdevices, suchas artificialteeth, in orderto restore apatient'schewingfunction. | The T.A.G.Dental ImplantSystem isintendedtoreplace singleor multipleteeth in thefully or partiallyedentulousmandibularormaxillaryalveolarprocess. Theimplants areappropriate forimmediateloading whengood primarystability isachieved andwithappropriateocclusalloading | The UNO Narrow Implant isindicated for use in surgical andrestorative applications forplacement in the mandibularcentral, lateral incisor andmaxillary lateral incisor regionsof partially edentulous jawswhere the horizontal space islimited by adjacent teeth androots, to provide support forprosthetic devices such asartificial teeth, in order to restorethe patient chewing function.Mandibular central and lateralincisors must be splinted if usingtwo or more 3.0 mm implantsadjacent to one another. TheUNO Narrow Implant isindicated for immediateimplantation in extraction sitesor implantation in partiallyhealed or completely healedalveolar ridge situations. When aone stage surgical procedure isapplied, the implant may beimmediately loaded when goodprimary stability is achieved andthe functional load isappropriate. |
| Implant Material | Ti6AL4V ELI | same | same | same | same | same |
| ImplantDimensions | Dia. 3.75-6mmL=8-16mm | Dia. 3.3-6mmL=6-16mm | Dia. 3.3-6mmL=8-16mm | Dia. 3.3-6mmL=6-16mm | Dia. 3.0-3.5mmL=10-16mm | Dia. 3.0-3.5mmL=10-16 mm |
| Implant Surface | Sandblasting/acid etching | Sand blasting/acid etching | Sand blasting/acid etching | Sand blasting/acid etching | Sand blasting/acid etching | Sand blasting/acid etching |
| Implant DesignShape | Cylinderscrew | Cylinder screw | Conical screw | Conical screw | One-piece | One Piece |
| Feature | T.A.G."Massif" | AB Dental "I2" ScrewType Implant | T.A.G."Axis" | MIS DentalImplants" SEVEN" | T.A.G."Crestone" | MIS UNO Dental Implants |
|---|---|---|---|---|---|---|
| Sterility ofImplant | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma |
| Feature | T.A.G."Massif" | AB Dental "I2" ScrewType Implant | T.A.G."Axis" | MIS DentalImplants"SEVEN" | T.A.G."Crestone" | MIS UNO Dental Implants |
|---|---|---|---|---|---|---|
| AbutmentDesign | Straight andup to 25degrees | Straight and up to 25degrees | same | Straight and upto 20 degrees | NA | NA |
| AbutmentMaterial | StainlessSteel,Titanium,and/or PEEK | Titanium and/or Plastic | same | Titanium and/orPlastic | NA | NA |
| AbutmentLength | 4-8 mm | 1-9 mm | same | 1-9 mm | NA | NA |
| Sterility ofAbutment | Non sterile | Non sterile | Non sterile | Non sterile | NA | NA |
| 510(k) # | pending | K112440 | pending | K040807 | pending | K092555 |
{6}------------------------------------------------
-
- Discussion of No clinical testing was submitted for this 510(k) notification. Performance Testing Submitted: testing, which was submitted, was performed at an accredited independent laboratory in accordance with FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff and ISO14801 Static and Cycling Loading Test of Dental Implants. This results of this testing demonstrated that T.A.G. Dental Implant System meets the requirements of the standards.
8. Conclusions Based upon the descriptive information provided in this 510(k) notification as Drawn: well as the test results of the performance testing submitted, the T.A.G. Dental Implant System function in a substantially equivalent manner and do not raise additional safety issues. As such, the T.A.G. Dental Implant System is substantially equivalent to its predicate devices.
§ 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.