Who is the manufacturer of INCLUSIVE TAPERED IMPLANT SYSTEM?

Prismatik Dentalcraft, Inc. filed the 510(k) submission for INCLUSIVE TAPERED IMPLANT SYSTEM (K121406).

What is the FDA product code for INCLUSIVE TAPERED IMPLANT SYSTEM?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for INCLUSIVE TAPERED IMPLANT SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like INCLUSIVE TAPERED IMPLANT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INCLUSIVE TAPERED IMPLANT SYSTEM

Q: What are the predicate devices for INCLUSIVE TAPERED IMPLANT SYSTEM?

Inclusive® Mini Implant (K100932); Sulzer's Screw-Vent Dental Implant System (K011028); KIS-Krauser Implant System (K953235).

K121406 · Prismatik Dentalcraft, Inc. · DZE · Feb 22, 2013 · Dental

Device Facts

Record ID	K121406
Device Name	INCLUSIVE TAPERED IMPLANT SYSTEM
Applicant	Prismatik Dentalcraft, Inc.
Product Code	DZE · Dental
Decision Date	Feb 22, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

Device Story

Inclusive® Tapered Implant System consists of titanium alloy root-form dental implants designed to replace missing teeth. Implants feature internal hex connection, tapered body, and surface treated with Hydroxyl Apatite blasting and acid etching to promote osseointegration. Available in diameters 3.7mm, 4.7mm, 5.2mm and lengths 8mm-16mm. Used by dental clinicians in clinical settings to support prosthetic restorations. Implants are provided sterile via gamma radiation. Clinicians surgically place implants into the jawbone; primary stability is required for immediate loading. The device provides a foundation for dental restorations, potentially improving patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only. Fatigue testing conducted on 30° Multi-Unit Abutments per ISO 14801:2007. Biocompatibility testing performed per ISO 10993-5 (MEM Elution/Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). All testing met acceptance criteria.

Technological Characteristics

Material: Titanium alloy. Design: Threaded root-form, internal hex connection. Surface: Hydroxyl Apatite blasted and acid etched. Dimensions: Diameters 3.7, 4.7, 5.2mm; Lengths 8, 10, 11.5, 13, 16mm. Sterilization: Gamma radiation per ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Mechanical testing: ISO 14801:2007.

Indications for Use

Indicated for maxillary and mandibular partially or fully edentulous patients requiring single, multiple-unit, or overdenture restorations. Contraindicated without primary stability or appropriate occlusal loading for immediate loading applications.

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

Inclusive® Mini Implant (K100932)
Sulzer's Screw-Vent Dental Implant System (K011028)
KIS-Krauser Implant System (K953235)

Related Devices

K153099 — INCLUSIVE TAPERED IMPLANT SYSTEM · Prismatik Dentalcraft, Inc. · May 23, 2016
K143353 — Hahn Tapered Implant System · Prismatik Dentalcraft, Inc. · Apr 2, 2015
K162299 — Spiral Shape Dental Implant System · Gp Implants · Jun 22, 2017
K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant System · Kj Meditech Co., Ltd. · Mar 1, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ PRISMATIK DENTALCRAFT, INC. # FEB 2 2 2013 ### 005-510 (k) Summary-807.92(c) This 510 (K) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. 121406 #### SUBMITTER INFORMATION A. | Company Name: | Prismatik Dentalcraft, Inc. | |-------------------------|-----------------------------------------------------------------------| | Company Address: | 2212 Dupont Dr., Suite IJK Irvine, CA 92612 | | Company Phone: | 949-225-1269 | | Company FAX: | 949-553-0924 | | Primary Contact: | Armin Zehtabchi, Senior RA/QA., /Project Manager (949) 225-1234 | | Secondary Contact: | Marilyn Pourazar Senior Director, RA/QA (949) 225-1269 | | Date Summary Prepared: | 2/20/13 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | Inclusive® Tapered Implant System | | 21 CFR Reference: | 21 CFR 872.3640 | | 21 CFR Common Name: | Implant, endosseous, root-form | | Classification: | Class II | ## B. Product Code: Panel: Dental DZE {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a black triangle on the left and the company name on the right. The triangle is divided into three smaller triangles, with the top triangle being the darkest and the bottom triangle being the lightest. The company name is written in a bold, sans-serif font. #### C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Inclusive® Mini Implant (K100932), Sulzer's Screw-Vent Dental Implant System (K011028) and KIS-Krauser Implant System (K953235-Transffered to Glidewell Laboratories/Prismatik Dentalcraft, Inc., 2/2011) #### D. DEVICE DESCRIPTION The Inclusive® Tapered Implants are manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection and a tapered body to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched to facilitate osseointegration. The Implants are available in the following diameters: 3.7mm. 4.7mm. and 5.2mm, and each diameter is available in the following lengths: 8mm, 10mm, 11.5mm, 13mm, and 16mm. The dental implants are provided sterile (gamma). #### E. INDICATIONS FOR USE Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases. to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading. #### F. SUBSTANTIAL EQUIVALENCE The Inclusive® Tapered Implant System is substantially equivalent to Prismatik's Inclusive® Mini Implant (K100932), Sulzer's Screw-Vent Dental Implant System (K011028) and the KIS-Krauser Implant System (K953235-Transferred to Glidewell Laboratories/Prismatik Dentalcraft, Inc., 2/2011). These implants are substantially equivalent in intended use, indications for use, material, design and performance. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo features a black triangle on the left side of the image. The text "PRISMATIK DENTALCRAFT, INC." is located to the right of the triangle. The text is in black and is in a sans-serif font. # Comparison of Predicate Devices | Elements of Comparison | Prismatik's Inclusive® Tapered Implant System | Sulzer's Screw-Vent Dental Implant System (K011028) | KIS-Krauser Implant System (K953235- Transferred to Glidewell Laboratories/Prismatik Dentalcraft, Inc., 2/2011 | Prismatik's Inclusive Mini Implant (K100932) | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | | Indications | Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading. | Sulzer Dental's implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 4.7mm and 6.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. | The KIS-Krauser Implant System implants are indicated for single tooth replacements, as intermediate abutments on bridgework, as distal abutments for areas to be restored with fixed bridgework, to support overdentures in the totally edentulous mandible, and as abutments supporting a full arch fixed prosthesis. | Inclusive® Mini Implants are self- tapping threaded titanium screws indicated for long- term application. Inclusive® Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal. | | Design | Threaded root-form implant | Threaded root-form implant | Threaded root-form implant | Threaded root-form implant | | Implant Body Geometry | Screw type | Screw type | Screw type | Screw type | | Diameters (mm) | 3.7, 4.7 and 5.2 | 3.7, 4.7 and 6.0 | 4, 5 and 6 | 2.2, 2.5, 3.0 | | Lengths (mm) | 8, 10, 11.5, 13, and 16 | 8, 10, 13 and 16 | 8, 10, 13, 15, 18 | 10, 13, 15 | | Driver Connection | Hex | Hex | Hex | Square | | Prosthetic Head | Internal | Internal | External | N/A | | Sterility | Packaged Sterile | Packaged Sterile | Packaged Sterile | Packaged Sterile | . : - {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font. #### ్ర PERFORMANCE DATA The following FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments was used for the purpose of Implant to Abutment Compatibility. The Tapered Implant was used for the fatigue testing on the 30° Multi-Unit Abutments and by following the ISO 14801: 2007-Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. All testing conducted met the acceptance criteria and evaluated the worst case scenario. In addition, performance testing data indicated the compatibility, and the safety and the effectiveness of the proposed device which meets the mechanical properties. In addition, to assure the biocompatibility, the following tests were performed, and the reports for the results indicated satisfactory and meeting the acceptance criteria: - 1) Irritation (applying ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization). - 2) Media (MEM) Elution test to determine the Cytotoxicity (applying ISO 10993-5: 2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cvtotoxicity - 3) Sensitization Tests for Irritation and Skin Sensitization (applying ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization). The implant packages are sterilized by a gamma sterilization process that conforms to ISO 11137-1: Sterilization of health care products -Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, and ANSI/AAMI/ISO 11137-2: Sterilized of Health Care Products-Radiation-Establishing the sterilized dose. #### COMPARISON OF TECHNOLOGICAL DIFFERENCES H. There are no known technological differences between the Inclusive® Tapered Implant and those of the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a simple, vectorized design. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### February 22, 2013 Mr. Armin Zehtabchi Senior Regulatory Affairs / Quality Assurance, Project Manager Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite IJK IRVINE CA 92612 Re: K121406 Trade/Device Name: Inclusive Tapered Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 11, 2013 Received: February 12, 2013 Dear Mr. Zehtabchi: 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. {5}------------------------------------------------ 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Kwame O. Ulmer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT 510(K) Number: K121406 Device Name: Inclusive Tapered Implant System Indications for Use: Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE) S. Runner 02.22 01 29:36 -05:00, (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 次121406 510(k) Number: