Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and biological properties of a dental implant, with no mention of AI or ML technology.

Therapeutic

No.
The device is a dental implant used to replace missing teeth and support dental restorations, not for treating a disease or condition.

Diagnostic

No

The device description clearly states its purpose is to replace missing teeth, support restorations, and facilitate osseointegration, which are all therapeutic functions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical implant made of titanium alloy, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device being used in vivo (within the body) to support dental restorations in patients. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
Device Description: The description details a physical implant made of titanium alloy designed to be surgically placed in the jawbone. This is consistent with an implantable medical device, not an IVD.
Performance Studies: The performance studies focus on mechanical properties (fatigue testing), biocompatibility (irritation, cytotoxicity, sensitization), and sterilization. These are typical tests for implantable medical devices, not IVDs which would involve analytical and clinical performance studies related to the examination of specimens.
Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the Inclusive® Tapered Implants are a medical device, specifically a dental implant, and not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DZE

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and mandibular

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)

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).
1. 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
1. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100932, K011028, K953235

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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).
1. 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
1. 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: