(52 days)
Not Found
No
The provided text describes a dental implant system and its intended use, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is an implant system designed to provide support for dental prostheses and restore chewing function, which are therapeutic actions.
No
The device is a dental implant system designed to support dental prostheses, not to diagnose medical conditions.
No
The device description explicitly states it is an "Implant System" intended to be "implanted in the upper or lower jaw arches," which are physical components, 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: The provided text clearly describes a dental implant system that is surgically implanted into the jawbone to support dental prostheses. This is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use is to provide structural support for dental prostheses and restore chewing function, which is a mechanical and functional purpose, not a diagnostic one.
Therefore, based on the provided information, the NSI Implant System is a medical device, specifically a dental implant, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NSI Implant System is intended to 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, NHA
Device Description
The NSI Implant System is intended to 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003620, K020617, K033171, K052490, K053478, K061169, K964220, K023113, K061319
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
510(K) PREMARKET NOTIFICATION SUMMARY
(K070905)
Name/Address of Submitter: Southern Implants, Inc. 10355 B Democracy Lane Fairfax, VA 22030
Establishment Registration Number: 3003845138
MAY 2 4 2007
Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954
Date Summary Prepared: March 16, 2007
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 Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions.
Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Implant System meet applicable voluntary standards. Southern 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 K033171 NSI Hexed and Non-Hexed Implant System K052490 NSI Hexed and Non-Hexed Implant System K053478 NSI Hexed and Non-Hexed Implant System K061169 NSI Hexed and Non-Hexed Implant System K964220 Steri-Oss Replace Titanium Implant System K023113 Nobel BioCare Replace TiUnite Endosseous Implant K061319 Implant Direct Spectra System (RePlant)
Device Description and Intended Use: The NSI Implant System is intended to 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Greta M. Hols Southern Implants. Incorporated 10355 B Democracy Lane Fairfax, Virginia 22030
MAY 2 4 2007
Re: 070905
Trade/Device Name: Endosseous Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 26, 2007 Received: April 02, 2007
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 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 (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 yours,
Sofita y. Michau Qud.
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
510(k) Number:
Device Name: Endosseous Dental Implant System
Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower inuted.com for Ober 21xed 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)
Kei Mulay for MSR
ion of Anesthesiology, General Hospital,
cuon Control, Dental Devices
*K) Number: K070905
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