Implants: Includes one or two step dental implant devices which are designed as conical and cylindrical shapes. They consist of various diameters with a range of 3.6mm-6.0mm and lengths with a range of 8mm-21mm. The internal and external hexagonal shapes are important to maintain the implant stability. One group of the products is HA coated. This surface has been modified to enhance the osseointegration. The dental implants are composed of medical grade 4 pure titanium.

Cover screw and healing cap: The cover screw and healing caps are supplied together with the implants. They cover the internal body of implant to allow gum free space for connection between the implants and restoration abutments.

Abutment: Abutments and accessories are the support part to prosthetic restoration. Screw retained abutments are included in the Reliadent Dental Implant System. The abutments are composed of medical grade 2 titanium.

Surgical Instrument Kit: The surgical instruments include the implants installation set, abutment connections, and drill set. There are hand tools, drill bits of different sizes, and handles in these sets. The instrument kit is designed to be used with a wide range of commercially available implant devices.

AI/ML Overview

This document is a 510(k) summary for the Reliadent Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not present in the provided text.

Here's an analysis of what can be extracted and what is missing:

The provided text does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or technical performance study would for a novel device. Instead, it demonstrates substantial equivalence to an already cleared predicate device (MIS Dental Implant System, K040807). This is a common pathway for device clearance, where the new device is shown to have the same intended use, similar technological characteristics, and equivalent performance to a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, reported device performance metrics (like sensitivity, specificity, accuracy, etc.), sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone performance is not applicable in the context of this 510(k) submission, as these types of studies were not presented or required for this type of submission.

Here's a breakdown based on your request, highlighting what's available and what's explicitly missing/not applicable:

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

Acceptance Criteria (Explicitly Stated)	Device Performance (Reported)
Substantial Equivalence to Predicate Device (MIS Dental Implant System, K040807) concerning:	The Reliadent Dental Implant System:
- Intended Use	- Has the same intended use.
- Material	- Composed of medical grade 4 pure titanium (implants) and medical grade 2 titanium (abutments), similar to predicate.
- Design	- Similar design (conical and cylindrical shapes, various diameters and lengths, internal and external hexagonal shapes). Note: The new device has a "modified surface" (HA coated) to "enhance osseointegration," but this is presented as an improvement without specific quantified performance metrics against the predicate for this aspect.
- Performance Characteristics	- Stated to have "equivalent performance capabilities." (No specific quantitative performance metrics comparing to predicate are provided.)
- Safety and Effectiveness	- "Does not raise any additional concerns regarding safety and effectivity."

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. No specific test set or clinical study data proving performance for the Reliadent Dental Implant System were presented in this 510(k) summary. The submission relies on demonstrating similarity to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. No test set requiring expert-established ground truth was detailed in this substantial equivalence submission.

4. Adjudication method for the test set

Not applicable / Not provided. No test set requiring adjudication was detailed.

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

Not applicable / Not done. This device is a dental implant system, not an AI-powered diagnostic tool. MRMC studies are irrelevant to this product.

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

Not applicable / Not done. This device is a physical medical device (dental implant), not an algorithm or software. Standalone performance studies in this context typically refer to AI algorithms, which is not relevant here.

7. The type of ground truth used

Not applicable / Not provided. As no performance study with a test set was detailed, no ground truth was established within this submission. The "truth" here is the prior clearance and presumed safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable / Not provided. No training set was used. This is not an AI/machine learning device.

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

Not applicable / Not provided. No training set or associated ground truth was established.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence to a predicate device (MIS Dental Implant System, K040807). The argument for meeting the "acceptance criteria" (which is primarily substantial equivalence) is made by:

Comparing Intended Use: The Reliadent system has the "same intended use" as the MIS Dental Implant System.
Comparing Materials: Both devices use medical grade titanium. The Reliadent system specifies medical grade 4 pure titanium for implants and medical grade 2 titanium for abutments.
Comparing Design: The Reliadent system includes "similar" surgical implants, healing caps, restoration abutments, and surgical instruments, with conical and cylindrical shapes, various diameters and lengths, and internal/external hexagonal shapes. A key difference mentioned is the "modified surface" (HA coated) on one group of products in the Reliadent system, intended to "enhance osseointegration." However, this is presented as an enhancement rather than a deviation requiring explicit comparative performance data with the predicate.
Concluding Equivalence in Performance and Safety: The submission states, "All other technological characteristics are similar and both devices show equivalent performance capabilities," and that the Reliadent system "does not raise any additional concerns regarding safety and effectivity."

The FDA's letter (K061323) confirms their review of the submission and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The "Indications for Use" section further clarifies the specific use recognized by the FDA for the RDI Dental Implant System.

Summary

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K06/B23

A 510(k) Summary Pertaining to the Safety and Effectiveness of the Reliadent Dental Implant System

MAY 2 3 2007

Submitter Information:

Chan Q. Wang President Bioinfera, Inc. 23230 Chagrin Blvd #950 Beachwood, Oh 44122 Phone: (216) 360-8103 E-mail:jxh27(@yahoo.com Date Summary Prepared: April 10, 2006

Device Name:

Proprietary name - Reliadent Dental Implant System Common/Usual name - Implant, Endosseous, Root Form Trade name - Reliadent Dental Implant System

This device has been classified Class II Special Controls. Classification number: DZE. Regulation Number: 21 CFR 872.3640. Classification Advisory Committee: Dental

Predicate Device:

MIS Dental Implant System 510(k) - K040807 Cleared - June 6, 2004

Description of the Device:

The Reliadent Dental Implant System includes surgical implants, healing cap, restoration abutments, and surgical instruments.

Implants:

Includes one or two step dental implant devices which are designed as conical and cylindrical shapes. They consist of various diameters with a range of 3.6mm-6.0mm and lengths with a range of 8mm-21mm. The internal and external hexagonal shapes are important to maintain the implant stability. One group of the products is HA coated. This surface has been modified to enhance the osseointegration. The dental implants are composed of medical grade 4 pure titanium.

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Cover screw and healing cap:

The cover screw and healing caps are supplied together with the implants. They cover the internal body of implant to allow gum free space for connection between the implants and restoration abutments.

Abutment:

Abutments and accessories are the support part to prosthetic restoration. Screw retained abutments are included in the Reliadent Dental Implant System. The abutments are composed of medical grade 2 titanium.

Surgical Instrument Kit:

The surgical instruments include the implants installation set, abutment connections, and drill set. There are hand tools, drill bits of different sizes, and handles in these sets. The instrument kit is designed to be used with a wide range of commercially available implant devices.

Indications for Use:

The Reliadent Dental Implant System is indicated for immediate or delayed surgical and restorative application for placement in maxillary and /or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures for the patient.

Substantial Equivalence:

The Reliadent Dental Implant System has the same intended use as the MIS Dental Implant System from MIS Technologies, Inc. Elmwood Park, NJ 07407, cleared under 510(k) Number: K040807. The MIS Dental Implant System has equivalent performance characteristics in its intended use, material and design. The MIS Dental Implant System contain implants, cover screw and healing caps, abutments and the applicable surgical instruments. The Reliadent Dental Implant System is substantially the same as the currently marketed MIS dental implant with a modified surface. This surface promotes osseointegration. All other technological characteristics are similar and both devices show equivalent performance capabilities.

Conclusion:

The evaluation of the Reliadent Dental Implant System does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chan Q Wang President Bioinfera, Incorporated 23230 Chagrin Boulevard Beachwood, Ohio 44122

MAY 2 3 2007

Re: K061323

Trade/Device Name: RDI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 9, 2007 Received: May 14, 2007

Dear Mr. Wang:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Wang

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Suite Y. Michailonis

Chiu Lin, Ph.D. 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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($\frac{v}{s}$

K061323

OINFERA

Indications for Use

510(k) Number: K061323

...

Device Name: RDI Dental implant System

Indications for Use: For immediate or delayed surgical placement of a Dental implant in the anterior region and to allow immediate restoration (for cosmetic purposes).

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

	for MSR
	Sign-Off
	Division of Anesthesiology, General Hospital,
	Infection Control, Dental Devices
(k) Number	K061323
	Toll free: 1-877-RDI-8338 * Fax: 216-839-1752 * http://www.bioinfera.com
	23230 Chagrin Blvd. Suite #950, Beachwood, OH 44122

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.