T.A.G. Dental Implant System

K143326 · T.A.G. Medical Products Corporation, Ltd. · DZE · May 14, 2015 · Dental

Device Facts

• Record ID: K143326
• Device Name: T.A.G. Dental Implant System
• Applicant: T.A.G. Medical Products Corporation, Ltd.
• Product Code: DZE · Dental
• Decision Date: May 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

T.A.G. Dental Implant System comprises three sub-families of endosseous dental implants: Massif (self-tapping cylindrical screw), Axis (self-tapping conical), and Crestone (one-piece). Implants are manufactured from titanium alloy (Ti-6Al-4V-ELI) with sand-blasted/acid-etched surfaces. System includes superstructures (healing caps, abutments) made of titanium alloy, stainless steel, or PEEK. Implants are provided sterile (gamma) for single-patient use; superstructures are provided non-sterile. Used by dental professionals in clinical settings for surgical placement into the alveolar process to support prosthetic devices (crowns, bridges, overdentures). Clinical benefit includes restoration of chewing function and tooth replacement. Performance verified via static and cyclic loading tests per ISO 14801.

Clinical Evidence

No clinical data submitted. Bench testing only. Performance testing conducted at an independent laboratory per FDA Class II Special Controls Guidance and ISO 14801 (static and cyclic loading) demonstrated compliance with requirements.

Technological Characteristics

Materials: Titanium alloy grade 23 (Ti-6Al-4V-ELI), stainless steel, PEEK. Surface: Sand-blasted/acid-etched. Design: Cylindrical screw, conical screw, and one-piece configurations. Sterilization: Gamma (implants). Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for patients with fully or partially edentulous mandibular or maxillary alveolar processes requiring replacement of single or multiple teeth. Appropriate for immediate loading given sufficient primary stability and occlusal loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AB Dental Implants and Accessories (K112440)
• MIS Dental Implant System (K040807)
• MIS UNO Narrow Implant System (K092555)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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## 510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

- 1. (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.: [phone] 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).

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| 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 of<br>Technological<br>Characteristics: | 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.

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| Feature | T.A.G.<br>"Massif" | AB Dental "I2" Screw<br>Type Implant | T.A.G.<br>"Axis" | MIS Dental<br>Implants<br>"SEVEN" | T.A.G.<br>"Crestone" | MIS UNO Dental Implants |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The T.A.G.<br>Dental<br>Implant<br>System is<br>intended to<br>replace single<br>or multiple<br>teeth in the<br>fully or<br>partially<br>edentulous<br>mandibular or<br>maxillary<br>alveolar<br>process. The<br>implants are<br>appropriate<br>for immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading. | AB Dental Implants are<br>intended for surgical<br>placement in the<br>maxillary and/or the<br>mandibular arch to<br>support crowns,<br>bridges, or overdentures<br>in edentulous or partially<br>edentulous patients.<br>17 Integral Implant, 15<br>Conical Implant, P15<br>Temporary Abutment,<br>P12-T, L Temporary<br>Flat Connection<br>Abutment and P 16<br>Straight Adapter are<br>appropriate for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | The T.A.G.<br>Dental Implant<br>System is<br>intended to<br>replace single<br>or multiple<br>teeth in the<br>fully or<br>partially<br>edentulous<br>mandibularor<br>maxillary<br>alveolar<br>process. The<br>implants are<br>appropriate for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading. | MIS dental<br>implants are<br>intended to be<br>surgically<br>placed inthe<br>bone of the<br>upper or lower<br>jaw arches to<br>provide support<br>for prosthetic<br>devices, such<br>as artificial<br>teeth, in order<br>to restore a<br>patient's<br>chewing<br>function. | The T.A.G.<br>Dental Implant<br>System is<br>intendedto<br>replace single<br>or multiple<br>teeth in the<br>fully or partially<br>edentulous<br>mandibularor<br>maxillary<br>alveolar<br>process. The<br>implants are<br>appropriate for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading | The UNO Narrow Implant is<br>indicated for use in surgical and<br>restorative applications for<br>placement in the mandibular<br>central, lateral incisor and<br>maxillary lateral incisor regions<br>of partially edentulous jaws<br>where the horizontal space is<br>limited by adjacent teeth and<br>roots, to provide support for<br>prosthetic devices such as<br>artificial teeth, in order to restore<br>the patient chewing function.<br>Mandibular central and lateral<br>incisors must be splinted if using<br>two or more 3.0 mm implants<br>adjacent to one another. The<br>UNO Narrow Implant is<br>indicated for immediate<br>implantation in extraction sites<br>or implantation in partially<br>healed or completely healed<br>alveolar ridge situations. When a<br>one stage surgical procedure is<br>applied, the implant may be<br>immediately loaded when good<br>primary stability is achieved and<br>the functional load is<br>appropriate. |
| Implant Material | Ti6AL4V ELI | same | same | same | same | same |
| Implant<br>Dimensions | Dia. 3.75-6mm<br>L=8-16mm | Dia. 3.3-6mm<br>L=6-16mm | Dia. 3.3-6mm<br>L=8-16mm | Dia. 3.3-6mm<br>L=6-16mm | Dia. 3.0-3.5mm<br>L=10-16mm | Dia. 3.0-3.5mm<br>L=10-16 mm |
| Implant Surface | Sand<br>blasting/<br>acid etching | Sand blasting/<br>acid etching | Sand blasting/<br>acid etching | Sand blasting/<br>acid etching | Sand blasting/<br>acid etching | Sand blasting/<br>acid etching |
| Implant Design<br>Shape | Cylinder<br>screw | Cylinder screw | Conical screw | Conical screw | One-piece | One Piece |

| Feature | T.A.G.<br>"Massif" | AB Dental "I2" Screw<br>Type Implant | T.A.G.<br>"Axis" | MIS Dental<br>Implants<br>" SEVEN" | T.A.G.<br>"Crestone" | MIS UNO Dental Implants |
|-------------------------|--------------------|--------------------------------------|------------------|------------------------------------|----------------------|-------------------------|
| Sterility of<br>Implant | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma |

| Feature | T.A.G.<br>"Massif" | AB Dental "I2" Screw<br>Type Implant | T.A.G.<br>"Axis" | MIS Dental<br>Implants<br>"SEVEN" | T.A.G.<br>"Crestone" | MIS UNO Dental Implants |
|--------------------------|-------------------------------------------------|--------------------------------------|------------------|-----------------------------------|----------------------|-------------------------|
| Abutment<br>Design | Straight and<br>up to 25<br>degrees | Straight and up to 25<br>degrees | same | Straight and up<br>to 20 degrees | NA | NA |
| Abutment<br>Material | Stainless<br>Steel,<br>Titanium,<br>and/or PEEK | Titanium and/or Plastic | same | Titanium and/or<br>Plastic | NA | NA |
| Abutment<br>Length | 4-8 mm | 1-9 mm | same | 1-9 mm | NA | NA |
| Sterility of<br>Abutment | Non sterile | Non sterile | Non sterile | Non sterile | NA | NA |
| 510(k) # | pending | K112440 | pending | K040807 | pending | K092555 |

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- 7. 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.