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.

AI/ML Overview

The provided 510(k) summary for the Inclusive® Mini Implant does not contain specific acceptance criteria with quantifiable metrics or detailed study results that prove the device meets such criteria.

Instead, it relies on demonstrating substantial equivalence to predicate devices and states that the device was subjected to verification and validation studies in accordance with FDA guidance.

Here's an analysis of the information provided, specifically addressing your numbered points:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria with specific numerical targets (e.g., "fatigue strength must exceed X Newtons") or corresponding reported device performance values are provided in this document. The document states: "The Inclusive® Mini Implants were subjected to verification and validation studies... The results of the testing demonstrate the Inclusive® Mini Implants are safe and effective for use." However, it does not present a table outlining these results against predefined criteria.

The types of testing mentioned are:

Static and fatigue strength
Sterilization validation
Bioburden
Shelf life validation
Packaging integrity
Cytotoxicity
Independent clinician evaluations

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The summary only broadly mentions "verification and validation studies" and "independent clinician evaluations" without detailing sample sizes, study designs (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document mentions "independent clinician evaluations," but does not specify the number or qualifications of these clinicians, nor how their evaluations established a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC comparative effectiveness study, and this device is a physical dental implant, not an AI-assisted diagnostic tool. Therefore, the concept of "improving human readers with AI" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical implant, not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (a dental implant), the "ground truth" for its performance would typically be established through biomechanical testing (static and fatigue strength), biological assessments (cytotoxicity, osseointegration inferred from material properties and surface treatment), and clinical outcomes (though outcomes data is not detailed here for this specific submission). The document mentions "independent clinician evaluations," which would relate to clinical performance or usability, but the specific metrics or "ground truth" derived from these are not detailed.

8. The sample size for the training set

This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as this is a physical medical device.

Summary of what is present:

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by comparing their materials, physical dimensions (diameters, lengths), prosthetic head designs, and intended indications for use. It lists various tests performed (static/fatigue strength, sterilization, bioburden, shelf life, packaging, cytotoxicity, clinician evaluations) in accordance with FDA guidance for root-form endosseous dental implants. However, it does not provide the quantitative results of these tests or explicit acceptance criteria. The claim of safety and effectiveness relies on these tests confirming the device's performance is comparable to legally marketed predicates.

Summary

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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 BoulevardNewport Beach, CA 92660
Company Phone:Company FAX:	(949) 440-2683(949) 440-2787
Contact Person:	Keith D. ÀllredKathleen 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

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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 Implantsare self-tapping threadedtitanium screws indicatedfor long-term applications.Inclusive® Mini Implantsmay also be used forprovisional applications.These devices will allowimmediate loading andlong-term stabilization ofdentures and provisionalstabilization of dentureswhile standard implantsheal. To be used forimmediate loading only inthe presence of primarystability and appropriateocclusal loading.	The MDI and MDI PLUS areself-tapping titaniumthreaded screws indicatedfor long-term intra-bonyapplications. Additionally,the MDI may also be used forinter-radicular transitionalapplications. These deviceswill permit immediatesplinting stability and long-term fixation of new orexisting crown and bridgeinstallations, for full orpartial endentulism, andemploying minimally invasivesurgical intervention.	The MII implant is intendedto support single or multi-unit restorations in bothlong-term and temporaryapplications throughoutthe maxillary andmandibular arches. TheMII implant is indicated forimmediate loading whengood primary stability isachieved. Additionally, thisdevice will permit stabilityand long term fixation ofupper and lower denturesin edentulous cases.
Sterility	STERILE	STERILE	STERILE

G. PERFORMANCE DATA

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.

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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.

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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.

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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

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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

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.