(164 days)
The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.
This document is a 510(k) Premarket Notification Summary for the Rescue Internal Implant System, which is a dental implant device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a medical device utilizing an algorithm or AI would.
The document primarily focuses on establishing "substantial equivalence" of the new Rescue Internal Implant System components to previously cleared predicate devices (Rescue Internal Implant System K063216 and BIOCON Dental Implants K010185 and K050712). Substantial equivalence in this context means that the device is as safe and effective as a legally marketed device.
Here's why the requested information cannot be extracted from this document:
- Type of Device: This is a physical, endosseous dental implant system, not a software or AI-driven diagnostic or treatment device. The performance of such devices is typically assessed through aspects like material biocompatibility, mechanical strength, and clinical outcomes over time, rather than metrics like sensitivity, specificity, or predictive accuracy.
- Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. It doesn't typically require a clinical study demonstrating performance against specific acceptance criteria for algorithm performance.
- Lack of Performance Data: The document states, "FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Internal Implant System meet applicable standards." This indicates that the regulatory pathway for this physical device does not require a study with performance metrics as would be expected for a device using an algorithm. The "standards" referred to are likely material and manufacturing standards, not performance metrics related to diagnostic accuracy.
Therefore, I cannot provide the requested information because the provided text describes a physical medical device (dental implant) approved through the 510(k) pathway by demonstrating substantial equivalence, and not a device that would typically have acceptance criteria and a study design focused on algorithm performance, such as sensitivity/specificity, sample sizes for test/training sets, expert ground truth, or MRMC studies.
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Rescue Internal Implant Syst
14. 510(K) PREMARKET NOTIFICATION SUMMARY
14.1 Submitter:
Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax : 82-53-857-5432
14.2 US Agent/Contact:
Kodent Inc. (PhD. Steve Chang) 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone: 562-404-8466, Fax: 562-404-2757
14.3 Date Prepared:
Oct 18, 2007
4. Device Name:
Rescue Internal Dental Implant System
5. Device Classification:
Status: Class II Special Controls Name: Endosseous Implant and Accessories Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630
6. Purpose:
The purpose of this 510(k) is to include the components that are to be used with the internal method in joining the fixtures and prosthetics to the prior 510(k) submission for the Rescue Internal Implant System.
7. Device Description and Intended Use:
Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where
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smaller implants have failed.
8. Performance Standards:
FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Internal Implant System meet applicable standards.
9. Device Description:
Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.
10. Facking / Labeling / Product Information:
Rescue Internal Implant System follows the guidance of the 21 CFR 872.3640 and 21 CFR 872.3630.
11. Substantial Equivalence Comparison:
Rescue Internal Implant System is essentially an addition to the predicate device previously cleared for marketing by FDA, Rescue Internal Implant System (K063216). The noted difference in the design and material does not effectively change the performance of the device. Rescue Internal Implant System is substantially equivalent to marketed BIOCON Dental Implants (K010185 and K050712).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 11 2008
MegaGen Company, Limited C/O Dr. Steve Chang U.S. Agent / Consultant KoDent Incorporated 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670
Re: K073058
Trade/Device Name: Rescue Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 11, 2008 Received: March 14, 2008
Dear Dr. Chang:
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 - Dr. Chang
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,
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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Rescue Internal Implant system
Indication for Use
510(K) Number (if known):
Device Name: Rescue Internal Implant System
Indications For Use:
The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. intended to be used where smaller implants have failed.
Robert S. Betz DDS for Dr. Susan Renner
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
Prescription Use_ (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)
AND/OR
§ 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.