(211 days)
Not Found
No
The device description focuses on the physical components and materials of a dental implant system, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device description indicates it is a dental implant system used to provide support for prosthetic devices, not to treat or cure a disease or condition. Its purpose is to restore chewing function.
No
This device is intended for surgical and restorative applications to support prosthetic devices, not to diagnose a condition or disease.
No
The device description explicitly lists physical components such as surgical implants, healing caps, restoration abutments, and surgical instruments, all made of physical materials like titanium.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic devices in the bone of the jaw to restore chewing function. This is a surgical and restorative application, not a diagnostic one.
- Device Description: The device components (implants, healing caps, abutments, surgical instruments) are all physical devices used in a surgical procedure. They are not used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health conditions, or determine compatibility (like blood typing). This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
Indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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-17mm. 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
upper or lower jaw
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): 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.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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JUL 12 2005
Page 1
A 510(k) Summary Pertaining to the Safety and Effectiveness of the Reliadent Dental Implant System
Submitter Information:
Chan Q. Wang President Bioinfera. Inc. 21205 Halworth, Rd Beachwood, Oh 44122 Phone: (216) 226-2680 E-mail:jxh27 a`vahoo.com Date Summary Prepared: December 7, 2004
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-17mm. 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:
Indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
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 and Human Services (HHS) in the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the serpent entwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2005
Mr. Chan Q. Wang President Bioinfera, Incorporated 21205 Halworth, Road Beachwood, Ohio 44122
Re: K043428
Trade/Device Name: Reliadent Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: July 1, 2005 Received: July 5, 2005
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 and iloting (21 cert 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), nlease 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cintron vintbon
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
Indications for Use
510(k) Number (if known): K043428
Device Name: Reliadent Dental Implant System
Indications for Use: Indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
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)
Kain Muelly for ASR
(Division Sign-Off (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental D
510(k) Number. K 043428
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