(112 days)
Not Found
No
The provided text describes a dental implant system and its intended use, with no mention of AI or ML technology.
No
The device is described as an implant system to support dental prostheses and restore chewing function, which addresses a physical deficit or dysfunction rather than treating a disease or disorder.
No
The device description indicates its purpose is to provide support for dental prostheses, restore chewing function, and offer immediate loading options, rather than to diagnose medical conditions or diseases.
No
The device description clearly states it is an "Implant System" intended to be "implanted in the upper or lower jaw arches," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is intended to be implanted in the jaw to support dental prostheses. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reiterates the implantable nature of the device for supporting dental prostheses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health condition.
IVD devices are used in vitro (outside the body) to perform tests on biological samples to diagnose diseases, monitor health, or determine treatment options. This device is used in vivo (inside the body) as a structural support.
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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Product codes
DZE
Device Description
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 loading on single and splinted multiple unit restorations 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
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)
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.
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5 2006 APR
510(k) Premarket Notification Summary
Name/Address of Submitter: Northern Implants, LLC 10355 B Democracy Lane Fairfax, VA 22030
Establishment Registration Number: 3003845138
Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954
Date Summary Prepared: December 1, 2005
Device Classification Name: Endosseous Implant and Accessories
Device Classification Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630
Device Regulatory Status: Class II Special Controls
Trade Name: Endosseous Dental Implant
- Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions for our system.
- Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Hexed Implant System meet applicable voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
- Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K954347 Implant Innovations 3.25mm microminiplant
- Device Description and Intended 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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Sterilization Methods Used: Sterilization of these implants will be achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 104. Validation of sterilization will be done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). Standards utilized include:
| ISO 11137 | Sterilization of Health Care Products – Requirements for validation and routine control –
Radiation sterilization |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11737-2 | Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterility
performed in the validation of a sterilization process |
| ISO 13409 | Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGy
as a sterilization dose for small or infrequent production batches. |
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Packaging Validation:
Validation protocols followed the following standards:
| ASTM D 4169-04 | Standard Practice for Performance Testing of Shipping Containers and Systems |
|---|---|
| ASTM F 88-00 | Standard Test Method for Seal strength of Flexible Barrier Materials |
| ASTM F 1929-98 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by |
| Dye Penetration | |
| ISO 11607 | Packaging for terminally sterilized medical devices |
- Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were company 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.
- Conclusions Drawn: The NSI Hexed and Non-Hexed Implant System has the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers.
5 2006 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Greta M. Hols Northern Implants, Limited Liability Company 10355 B Democracy Lane Fairfax, Virginia 22030
Re: K053478
Trade/Device Name: Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endossesous dental implant Regulatory Class: II Product Code: DZE Dated: March 23, 2006 Received: March 31, 2006
Dear Ms. Hols:
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 (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 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 Ms. Greta M. 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Curec
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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Indication for Use
510(k) Number: K053478
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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Concurrence of CDRH Office of Device Evaluation
Prescription Use OR Over-the-counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR801.109) v General F 3 of 56