(211 days)
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.
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.
The provided text is a 510(k) summary for the Reliadent Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, materials, and design. This type of document generally does not include detailed acceptance criteria or extensive study data comparing performance against specific metrics. Instead, it relies on inferring equivalent performance based on similarities to a device already on the market.
Therefore, for the specific questions regarding acceptance criteria and studies proving the device meets them, much of the requested information is not present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document.
The 510(k) summary asserts "equivalent performance characteristics" to the predicate device, but it doesn't define specific acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates) or present a table of results directly from tests on the Reliadent device against such criteria. The "performance" is primarily inferred from the similarities in design, materials, and intended use as compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided.
The document does not describe a "test set" in the context of a performance study with specific data points. The assessment is qualitative, comparing the Reliadent Dental Implant System to the MIS Dental Implant System. There is no mention of a prospective or retrospective study, nor any country of origin for specific data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided.
No ground truth establishment process for a test set is described. The equivalency claim is based on the submitter's assertion and FDA's review of the submission.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
Since no specific test set or multi-reader evaluation is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
There is no mention of an MRMC study or any study involving human readers. This device is a dental implant system, not an imaging or diagnostic device that would typically involve human reader studies.
6. Standalone (Algorithm Only) Performance Study
No.
This device is a physical medical device (dental implant system), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
Not applicable/Not provided in the context of performance data.
The "truth" in this submission relies on the established safety and effectiveness of the predicate device (MIS Dental Implant System) and the argument that the Reliadent system is substantially equivalent. There's no mention of using pathology, outcomes data, or expert consensus to establish a "ground truth" for a performance study of the Reliadent device itself.
8. Sample Size for the Training Set
Not applicable/Not provided.
As this is a physical medical device and not an AI/ML algorithm requiring training data, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
Since there's no training set, there's no ground truth establishment process for it.
Summary of what the document does provide regarding "proof":
The "proof" for the Reliadent Dental Implant System's safety and effectiveness in this 510(k) summary is based on substantial equivalence to an already legally marketed predicate device (MIS Dental Implant System, K040807).
The key arguments for substantial equivalence are:
- Same Intended 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." This is identical to the predicate's intended use.
- Similar Performance Characteristics: The document states the predicate has "equivalent performance characteristics in its intended use, material and design." For the Reliadent system, it asserts "All other technological characteristics are similar and both devices show equivalent performance capabilities."
- Similar Design and Materials: Both systems include implants (conical/cylindrical shapes, various diameters/lengths, internal/external hexagonal shapes), cover screws/healing caps, abutments, and surgical instruments. Both use medical grade pure titanium, with the Reliadent system specifying grade 4 for implants and grade 2 for abutments.
- One Differentiating Feature: The Reliadent system "is substantially the same as the currently marketed MIS dental implant with a modified surface. This surface promotes osseointegration." The implication is that this modification enhances a desirable characteristic (osseointegration) without introducing new safety or effectiveness concerns, and thus does not alter the substantial equivalence.
In conclusion, the provided document is a regulatory submission for substantial equivalence, not a detailed scientific study report with specific acceptance criteria and performance data from clinical trials or bench testing for the Reliadent device itself. The evidence for meeting criteria is indirect, rooted in its similarity to a predicate device.
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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.
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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:
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.
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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.
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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 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
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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
Page 1 of
§ 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.)