(160 days)
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing related to AI or ML.
Yes
The device is intended to be surgically placed to provide prosthetic support for dental restorations, which is a therapeutic intervention.
No
The device is described as an implant system for prosthetic support, not for diagnosing medical conditions. Its intended use is surgical placement for dental restorations.
No
The device description explicitly states it is an "integrated system of endosseous dental implants" and includes "implants," "abutment systems," and "instruments," which are all 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 clearly states the device is for surgical placement in the mouth to support dental restorations. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system of endosseous dental implants, abutments, and instruments. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used for structural support.
N/A
Intended Use / 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, 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, NHA
Device Description
The 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.
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)
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
§ 872.3640 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
510(K) PREMARKET NOTIFICATION SUMMARY
APR - 2 2007
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
2. US Agent/Contact:
Kenny Lim 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone: 562-404-8466, Fax: 562-404-2757
3. Date Prepared:
March 28, 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 Dental Implant System.
1
7. Device Description and Intended Use:
The 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.
KCk3216
8. Performance Standards:
FDA has not established a performance standard applicable to endosseous The materials in the Rescue Internal Implant System meet applicable implants. 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. Packing / 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 Rescue External Implant System (K053353). The noted difference in the design and material does not effectively change the performance of the device.
| Subject Device | Precedent Device | |
|---|---|---|
| 510(K) Number | Not available yet | K053353 |
| Characteristic | Rescue Dental Internal Implant Systems | Rescue Dental External Implant Systems |
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla Endosseous Dental | |
| Implant & Accessories | Mandible and Maxilla Endosseous Dental | |
| Implant & Accessories | ||
| Design: | Internal Hex and | External Hex and |
2
KC63216
. 3073
| Morse Taper | Morse Taper | |
|---|---|---|
| Endosseous Implant | ||
| Material | CP4 Titanium and It's Alloy | CP3 Titanium and It's Alloy |
| Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | 6.0, 6.5, 7.0, 8.0 | 6.0, 6.5, 7.0, 8.0 |
| Implant Lengths | 7.0 - 12.5 mm | 7.0 - 10.0 mm |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |
:
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the branches of government and a staff entwined with a serpent, representing healing and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MegaGen Company Limited C/O Mr. Sun Hahm Consultant KoDent, Incorporated 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670
APR - 2 2007
Re: K063216
Trade/Device Name: Rescue Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 28, 2007 Received: March 30, 2007
Dear Mr. Hahm:
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 vour 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. Hahm
· 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 vours.
Sujata Y. Michaud MD
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):
Device Name: Rescue Internal Implant System
Indications For Use:
Subpart C)
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, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Use (Part 21 CFR 801 Subpart D)
(21 CFR 807
Over ? The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert H. Betz DDS for Dr. Susan Sumner
510(k) Number: K063216