(210 days)
Not Found
No
The summary describes a dental implant system and does not mention any AI or ML components or functionalities.
No.
The device is a dental implant system intended to provide support for dental prostheses and restore chewing function, which is a restorative rather than therapeutic function.
No
The device is described as an implant system for dental prostheses, focused on providing support and restoring chewing function, rather than diagnosing conditions.
No
The device description clearly states it is an "Implant System" intended for implantation in the jaw, indicating it is a physical medical device, not software.
No, 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 and Intended Use: The description clearly states the NSI Implant System is intended to be implanted in the jaw to support dental prostheses. This is a surgical implant, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from testing.
The NSI Implant System is a dental implant, which is a type of medical device used for surgical implantation.
N/A
Intended Use / Indications for Use
The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The NSI Implant System is intended for implantation in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches, mandible
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)
Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
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.
K003620, K020617, K874590, K970499, K894593, K022562, K024111, K012965, K030007, K024004
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
APR 2 7 2004
510(k) Summary
Name/Address of Submitter: Northern Implants, LLC. 10565 Lee Highway, Suite 100 Fairfax, VA 22030
Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954
Date Summary Prepared: September 23, 2003
Device Name: Endosseous Implant and Accessories
Trade Name: NSI Hexed and Non-Hexed Implant System
- Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System (K003620) and K020617 that did not fall within the size range and design shapes identified in our original 510(k) submissions for our system. Additionally, it is to expand upon the intended usage to include the option for immediate loading.
Predicate Devices:
K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K874590 Innovative Implants and Cover Screws K970499 Branemark System Zygomaticus Fixture System K894593 Straumann USA Hollow Cylinder implant, 15° angled K022562 Nobel Biocare Various Branemark System Dental Implant Products K024111 and K012965 Astra Dental Implants K030007 ITI Straumann Dental Implant System K024004 Friadent XiVE Transgingival Dental Implant System
- Device Description and Intended Use: The NSI Implant System is intended for implantation in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
- Brief Discussion of Clinical Studies: Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Ms. Greta M. Hols Director of Operations Northern Implant, LLC 10565 Lee Highway Suite 100 Fairfax, Virginia, 22030
Re: K033171
Trade/Device Name: Endosseous Dental Implant System and Immediate Loading Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 5, 2004 Received: February 10, 2004
Dear Ms. Hols:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
2
Page 2 - Ms. Hols
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 (301) 594-4613. 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,
Chih 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
3
Indication for Use
510(k) Number: K033171
Device Name: Endosseous Dental Implant System
Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Concurrence of CDRH Office of Device Evaluation
Prescription Use
(Per 21 CFR801.109)
OR
Over-the-counter Use
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510(k) Number: K033171