(138 days)
K01085, K050712
Not Found
No
The summary describes a dental implant system and its intended use and components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are laboratory tests, not studies involving AI/ML model performance metrics.
No
The device is described as an implant system for prosthetic support in dental restorations, which functions as a structural component rather than providing a therapeutic effect. Its purpose is to support dental prosthetics in edentulous areas.
No
The device is described as an implant system for prosthetic support of dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is an "integrated system of endosseous dental implants" and includes "implant Fixtures" and "abutment systems," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be surgically placed in the mouth to support dental restorations. This is a surgical implant, not a test performed on samples from the body to diagnose or monitor a condition.
- Device Description: The description details a system of dental implants and abutments, which are physical devices implanted into the bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rescue® Implant System does not fit this description.
N/A
Intended Use / Indications for Use
The Rescue® 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, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular molar areas
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)
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
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.
K01085, K050712
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
§ 872.3640 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
K053353
APR 1 9 2006
13. 510(K) SUMMARY
Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432
510(K) Summary
510(K) SUMMARY AND CERTIFICATION This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93
13-9. Device Description
- 13-1. Submitter
- 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone : 82-53-857-5770, Fax : 82-53-857-5432
Mega'Gen Co., Ltd.
- 13-2. US Agent / Dae Kyu Chang Contact Person 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone : 562-404-8466, Fax : 562-404-2757
- 13-3. Date Prepared November 30, 2005
- 13-4. Device Name RESCUE® IMPLANT SYSTEMS
- 13-5. Classification Name Endosseous Dental Implant System Class II 13-6. Device Classification Dental Devices panel 21 CFR & 872.3640 Regulation Number: 872.3640
- 13-7. Predicate Devices BICON Implant Systems (K01085, K050712)
- 13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
1
Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.
13-9. Device Description
Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.
13-10. Packing / Labeling / Product Information
In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. Rescue ™ Implant Systems (Rescue ™ Implant Fixtures, Rescue Protective Cap, and Rescue Implant System Surgery Tray) will be packaged.
13-11. Intended Use
The Rescue® 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, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
13-12. Substantial Equivalence Comparison
2
13-13. Comparative Data
Comparison between the Rescue® Implant System, and BICON Implant
| Characteristic | Rescue Dental Implant Systems | BICON Dental Implant System
K010185, K050712 |
|--------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | MegaGen Co., Ltd. | BICON Dental Implants |
| Indications for Use | Mandible and Maxilla
Endosseous Dental Implant &
Accessories | Mandible and Maxilla
Endosseous Dental Implant &
Accessories |
| Design: | External Hex and
Morse Taper | External Hex and
Morse Taper |
| Endosseous
Implant Material | C.P Titanium and It's Alloy | C.P Titanium and It's Alloy |
| Implant Sterile | Yes | Same |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | 6.0, 6.5, 7.0,8.0 | 4.5, 6.0 |
| Implant Lengths | 7.0 - 10.0 mm | 5.7-6.0mm |
| Attachments | Various abutments and
components | Equivalent |
| Product Code | DZE & NHA | Same |
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2PR 1 0 2006
Mega'Gen Company, Limited C/O Mr. Dae Chang Kodent, Incorporated 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670
Re: K053353
Trade/Device Name: Rescue Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: March 30, 2006 Received: April 3, 2006
Dear Mr. Chang:
We have reviewed your Scction 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.
4
Page 2 - Mr. Dae 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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Quetta y. Michie Davis
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
5
Indication for Use
510(K) Number (if known): K053353
Device Name: Rescue Dental Implant System
Indications for Use:
The Rescue® 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, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
AND/OR Prescription Use X (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)
Shari Ruan
. General Hosp
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