K Number

Device Name

INCLUSIVE MINI IMPLANT

Manufacturer

PRISMATIK DENTALCRAFT, INC.

Date Cleared

2010-12-27

(266 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

Inclusive® Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. 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 loading.

Device Description

Prismatik Dentalcraft, Inc.'s Inclusive® Mini Implant is a one-piece, root-form, screw-type, endosseous dental implant. These self-tapping, threaded implants are manufactured from Ti6Al-4V ELI, titanium alloy for surgical implant applications (ASTM F136). The Mini Implant will be available in 9 sizes: 2.2mm, 2.5mm, and 3.0mm diameters in 10mm, 13mm, and 15mm thread lengths. The implant body has a thread design for bone compression and the surface is blasted and etched to facilitate osseointegration. The 3.0mm implant has microthreads at the intra-osseous collar to preserve crestal bone. The Mini Implants have a transgingival collar 2mm in height and an O-Ball design prosthetic head.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031106, K08165

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant and its mechanical properties and testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes

The device is a dental implant used for long-term stabilization of dentures, which serves a therapeutic purpose by improving the patient's oral function and quality of life.

Diagnostic

No
The device, Inclusive® Mini Implants, is described as a medical implant (threaded titanium screws) used for long-term and provisional stabilization of dentures. Its purpose is therapeutic and structural (to support dentures and facilitate osseointegration), not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device description clearly describes a physical, metallic implant made of titanium alloy, which is a hardware component. The performance studies also focus on physical properties like strength and sterilization, not software validation.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The provided text clearly describes a dental implant, which is a medical device surgically placed into the jawbone. Its purpose is to provide support for dentures, not to analyze biological samples for diagnostic purposes.

The information provided focuses on the physical characteristics, materials, intended surgical use, and performance testing related to the mechanical and biological compatibility of the implant within the body. This is consistent with a medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

DZE

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 Inclusive® Mini Implants were subjected to verification and validation studies. This testing was conducted in accordance with the FDA Guidance for Industry and FDA Staff, Class II Special Controls Guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments issued May 12, 2004. The results of the testing demonstrate the Inclusive® Mini Implants are safe and effective for use.

Testing included Static and fatigue strength, sterilization validation, bioburden, and shelf life validation, packaging integrity, cytotoxicity, and independent clinician evaluations.

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.

K031106, K08165

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

K100932

510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

A. SUBMITTER INFORMATION

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	4141 Mac Arthur Boulevard
Newport Beach, CA 92660
Company Phone:
Company FAX:	(949) 440-2683
(949) 440-2787
Contact Person:	Keith D. Àllred
Kathleen Dragovich, (949) 399-1940
Date Summary Prepared:	December 13, 2010

B. DEVICE IDENTIFICATION

Trade/Proprietary Name:	Inclusive® Mini Implant
21 CFR Reference:	872.3640
21 CFR Common Name:	Endosseous Dental Implant
Classification:	Class II
Panel:	Dental DZE

C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: IMTEC Sendax MDI and MDI Plus, K031106 (8/12/2003) Trade/Proprietary Name: IMTEC MDI MII One-Piece Implant, 2.9mm, K08165 (9/19/2008)

D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

F. SUBSTANTIAL EQUIVALENCE

The Inclusive® Mini Implants are substantially equivalent to the IMTEC Sendax MDI and MDI Plus and the IMTEC MDI Mil One-Piece Implant, 2.9mm. These devices are all one piece endosseous dental implants that are a combination of implant and abutment sections. All are made of titanium alloy commonly used for surgical implant applications. Also, the retention feature on the Inclusive® Mini Implant which retains the denture is identical to the predicate devices. The implants are intended for use in long-term and provisional applications. They all allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. All are provided STERILE.

Element of	Prismatik's	IMTEC Sendax MDI	IMTEC MDI MII One-
Comparison	Inclusive® Mini Implant	and MDI Plus	Piece Implant, 2.9mm
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
Diameters (mm)	2.2, 2.5, 3.0	1.8, 2.1, 2.4	2.9
Lengths (mm)	10, 13, 15	10, 13, 15, 18	10, 13, 15, 18
Prosthetic Head	O-Ball	O-Ball, Square	O-Ball, Square
Driver	Square	Square	Square
Connection
Housing/O-Ring	Titanium Alloy/EPDM	Titanium Alloy/EPDM	Titanium Alloy/EPDM
Indications	Inclusive® Mini Implants
are self-tapping threaded
titanium screws indicated
for long-term applications.
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 loading.	The MDI and MDI PLUS are
self-tapping titanium
threaded screws indicated
for long-term intra-bony
applications. Additionally,
the MDI may also be used for
inter-radicular transitional
applications. These devices
will permit immediate
splinting stability and long-
term fixation of new or
existing crown and bridge
installations, for full or
partial endentulism, and
employing minimally invasive
surgical intervention.	The MII implant is intended
to support single or multi-
unit restorations in both
long-term and temporary
applications throughout
the maxillary and
mandibular arches. The
MII implant is indicated for
immediate loading when
good primary stability is
achieved. Additionally, this
device will permit stability
and long term fixation of
upper and lower dentures
in edentulous cases.
Sterility	STERILE	STERILE	STERILE

G. PERFORMANCE DATA

Testing included Static and fatigue strength, sterilization validation, bioburden, and shelf life validation, packaging integrity, cytotoxicity, and independent clinician evaluations.

H. COMPARISON OF TECHNOLOGICAL DIFFERENCES

There are no known technological differences between the Inclusive® Mini Implants and those of the predicate devices.

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Keith Allred Director, Professional Services Prismatik Dentalcraft, Incorporated 4141 Mac Arthur Boulevard Newport Beach, California 92660

DEC 2 7 2010

Re: K100932

Trade/Device Name: Inclusive Mini Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 13, 2010 Received: December 14, 2010

Dear Mr. Allred:

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.

Page 2 - Mr. Allred

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 yours

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

PRISMATIK DENTALCRAFT. INC Prismatik Dentalcraft, Inc. 4141 Mac Arthur Boulevard Newport Beach, CA 92660

INDICATIONS FOR USE STATEMENT

510(K) Number:

K100932

DEC 2 7 2010 -

Inclusive Mini Implant Device Name:

Indications for Use:

Inclusive Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. 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 loading.

Prescription Use _ × (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)

Rebekah L. Dr. S. Rumer

Hospita