(17 days)
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No
The summary describes a dental implant system consisting of physical components (screws, prosthetics, instruments) and makes no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device, a dental implant, is used for oral rehabilitation (replacement of missing teeth), which is restorative rather than therapeutic.
No
Explanation: The device description states its use is for dental implant applications for oral rehabilitation, which is a treatment, not a diagnosis. It consists of screws, prosthetics, and instruments, which are physical components used in surgery and restoration, not for determining a medical condition.
No
The device description explicitly lists physical components made of titanium, brass, and stainless steel, indicating it is a hardware device, not software-only.
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 "dental implant applications for oral rehabilitation." This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device consists of physical components like screws, prosthetics, and instruments used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and restoration.
N/A
Intended Use / Indications for Use
The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
Product codes
DZE
Device Description
Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxilla and mandible
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
SECTION 12.0 510(k) Summary
| Company Name: | Sterngold ImplaMed |
|---|---|
| Address: | 23 Frank Mossberg Drive |
| Attleboro, MA 02703 | |
| Registration #: | 2921595 |
| Contact Person: | Chad Patterson |
| Date Prepared: | Friday, October 23, 1998 |
| Classification Name: | Endosseous Implant (DZE) |
Wide Platform Screw Implant. Wide Diameter, Common Name: Implant Fixture Sterngold ImplaMed Hex Screw Implant, Trade Name: Wide Platform Screw Implant
Device Description
Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.
Intended Use
Device can be used in dental implant applications for oral rehabilitation of endentulous and partially dentate patients in the maxillae and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
Technological Characteristics
The modified devices utilize wide diameter titanium screws and related prosthetics and instrumentation. Materials are identical to those currently used in our predicate devices. The wide platform screw products are compatible with current Sterngold ImplaMed installation instrumentation and prosthetic procedures.
Comparative Products
Sterngold ImplaMed currently has permission to market Titanium Screw Implants. Titanium and Titanium alloy prosthetics, and stainless steel instrumentation. Wide platform and diameter screw implants are currently marketed by several companies. Sterngold ImplaMed Wide Platform implants prosthetics and instruments are substantially equivalent to these marketed devices in design, materials, performance and intended use.
1
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Mr. Chad Patterson Director of Product Development Sterngold ImplaMed 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
K983786 Re: Sterngold ImplaMed Wide Platform Dental Trade Name: Implants and Related Prosthetics and Instrumentation Regulatory Class: III Product Code: DZE October 23, 1998 Dated: Received: October 27, 1998
Dear Mr. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Patterson
This letter will allow you to begin marketing your device as described in your 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 markets problems, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ens or on on compressions by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcarned from one unber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 10.0 Indications for Use
Indications:
The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
Prescription Use (Per 21 CFR 801.109)
Susan Runon
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K983781
Page 10.01