(377 days)
No
The 510(k) summary describes a standard dental implant system with mechanical components and surgical instruments. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a dental implant system designed for surgical placement and restoration, which is a therapeutic intervention for replacing missing teeth.
No
The device description indicates that the Reliadent Dental Implant System is comprised of surgical implants, healing caps, restoration abutments, and surgical instruments, all designed for the immediate or delayed surgical placement of a dental implant and immediate restoration. These components are used for treatment and reconstruction, not for diagnosing a condition or disease.
No
The device description explicitly lists physical components such as surgical implants, healing caps, restoration abutments, and surgical instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Reliadent Dental Implant System is a physical device designed for surgical implantation into the jawbone to support dental prosthetics. It consists of implants, abutments, and surgical instruments.
- Intended Use: The intended use is for surgical placement and restoration of dental implants, which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgically implanted medical device, not a diagnostic tool used outside the body on biological samples.
N/A
Intended Use / 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.
For immediate or delayed surgical placement of a Dental implant in the anterior region and to allow immediate restoration (for cosmetic purposes).
Product codes
DZE
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and /or mandibular arches, anterior region
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K06/B23
2
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.
1
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.
2
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.
3
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
4
($\frac{v}{s}$
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 |