(64 days)
Not Found
No
The summary describes a standard dental implant system and its components, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or manages a disease or condition. This device is an implant system used in dental restorations, which is a supportive device rather than a therapeutic one.
No
This device is a dental implant system used for restorative purposes in edentulous areas, not for diagnosing medical conditions.
No
The device description clearly outlines physical components including dental implants, abutments, and surgical/restorative instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The NEOPLANT Internal Hex Implant system is a dental implant system. It is surgically implanted into the jawbone to support dental restorations.
- Intended Use: The intended use is to support dental restorations in the mouth.
- No Mention of Samples or Testing: The description and intended use do not involve analyzing samples from the body or performing diagnostic tests.
Therefore, the NEOPLANT Internal Hex Implant system falls under the category of a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NEOPLANT Internal Hex Implant system is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Product codes
DZE
Device Description
NEOBIOTECH Internal Hex Implant System(NEOPLANT) consists of two-stage, root-form tapered and straight walled threaded dental implant and associated abutment system, which provide the clinical with Screw-Retained(UCLA, Cement-on Crown), and overdenture Snap Abutments. The System also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauge, abutment drivers, ratch-type drivers, open end wrench, and hand-piece adapters. NEOBIOTECH implant system(NEOPLANT) is available with a S.L.A. roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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)
K86063, K874590, K950204, K955428
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV - 2 2004
-
- 510(K) Summary
NEOBIOTECH. Co.Ltd. 510(K) Premarket Notification NEOPLANT Implant System
- 510(K) Summary
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
| 11-1. Submitter | NEOBIOTECH. Co.Ltd.
8th. Floor Jeongkok B/D, 44-25
Yeou-leudong, Youngdeungpo-Gu,
Seoul city, South Korea |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| 11-2. Contact Person | Dae K Chang
9778 Katella Ave. Ste. 215,
Anaheim, CA 92804
Phone: 714-537-0600
Fax: 714-537-0601 |
| 11-3. Date Prepared | August 25, 2004 |
| 11-4. Device Name | NEOPLANT IMPLANT SYSTEM |
| 11-5. Classification Name | Endosseous Dental Implant System |
| 11-6. Device Classification | Class III
Dental Devices panel
21 CFR § 872.3640
Regulation Number: 872.3640 |
| 1-7. Predicate Devices | 3i Dental Implants
(K86063, K874590, K950204, K955428) |
11-8. Performance
1
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
11-9. Device Description
NEOBIOTECH Internal Hex Implant System(NEOPLANT) consists of two-stage, root-form tapered and straight walled threaded dental implant and associated abutment system, which provide the clinical with Screw-Retained(UCLA, Cement-on Crown), and overdenture Snap Abutments. The System also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauge, abutment drivers, ratch-type drivers, open end wrench, and hand-piece adapters. NEOBIOTECH implant system(NEOPLANT) is available with a S.L.A. roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.
11-10. PACKING/LABELING/PRODUCT INFORMATION
NEOBIOTECH Internal Hex Implant System (NEOPLANT) will be packaged.
11-11. Intended Use
NEOBIOTECH Internal Hex Implant System(NEOPLANT) is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
11-12. Substantial Equivalence Comparison
NEOBIOTECH Internal Hex Implant System(NEOPLANT) and the predicate implants share a substantially equivalent intended use. The 3i Dental Implants.(K86063, K874590, K950204, K955428) The screw -Vent and NEOBIOTECH Implant system(NEOPLANT) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices are similar in size and materials. All three system offers abutment systems for cement-retained, screw-retained and overdenture restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Implant system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle faces left and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2004
NEOBIOTECH Company Limited C/O Mr. Dae-Kyu Chang 9778 Katella Avenue Suite 215, Anaheim, California 92804
Re: K042339
Trade/Device Name: NEOPLANT IMPLANT SYSTEM Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 25, 2004 Received: September 7, 2004
Dear Mr. 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.
3
Page 2 - Mr. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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
NEOBIOTECH. Co.Ltd. 510(K) Premarket Notification NEOBIOTECH Implant System
510(K) Summary
INDICATIONS FOR USE STATEMENT
4 23339
510(k) Number (If known):
Device Name : NEOPLANT IMPLANT SYSTEM
Intended use/ Indications for Use:
NEOPLANT Internal Hex Implant system is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
510(k) Number:
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED
Rx ✓
Susan Suarez
Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: ka12334