(11 days)
Not Found
Not Found
No
The summary describes a dental implant system made of traditional materials and surgical instruments, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device is described as a dental implant system, which is used for oral rehabilitation rather than for treating or curing a disease or condition. While it improves quality of life, its primary function is prosthetic replacement, not therapy.
No
Explanation: The device description clearly states its intended use is for "dental implant applications for oral rehabilitation of edentulous and partially dentate patients," and it consists of "titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surqical instruments." This indicates it is a therapeutic or restorative device, not one designed to diagnose a condition.
No
The device description explicitly lists hardware components such as titanium screws, prosthetics, restorative components, and surgical instruments.
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 of edentulous and partially dentate patients in the maxilla and mandible." This describes a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device consists of physical components like screws, prosthetics, and surgical instruments. These are used in vivo (within the living body).
- 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.
IVDs are devices used in vitro (outside the living body) to analyze samples from a patient. This device is used in vivo for surgical and restorative purposes.
N/A
Intended Use / Indications for Use
The Sterngold ImplaMed 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 (comma separated list FDA assigned to the subject device)
DZE
Device Description
Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surqical 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
maxillae and mandible
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
SECTION 12.0 510(k) Summary
| Company Name: | Sterngold ImplaMed |
|---|---|
| Address: | 23 Frank Mossberg Drive |
| Attleboro, MA 02703 | |
| Registration #: | 2921595 |
| Contact Person: | Gordon Nelson |
| Date Prepared: | Thursday, April 22, 1999 |
| Classification Name: | Endosseous Implant (DZE) |
Common Name: Narrow Platform Screw Implant, Implant Fixture Sterngold ImplaMed Hex Screw Implant, Trade Name: Narrow 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 surqical 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 narrow diameter titanium screws and related prosthetics and instrumentation. Materials are identical to those currently used in our predicate devices. The Narrow 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. Narrow Platform and diameter screw implants are currently marketed by several companies. Sterngold ImplaMed Narrow Platform implants prosthetics and instruments are substantially equivalent to these marketed devices in design, materials, performance and intended use.
Page 12.01
1
Image /page/1/Picture/2 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 MAY
Mr. Gordon Nelson Director of Operations Sterngold ImplaMed 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
Re: K991436 Sterngold ImplaMed Narrow Platform Dental Trade Name: Implants and Related Prosthetic and Instrumentation Regulatory Class: III Product Code: DZE April 22, 1999 Dated: April 26, 1999 Received:
Dear Mr. Nelson:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Nelson
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamfin.html".
Sincerely yours,
Timothy A. Ulatowski
Director
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
Page 1 of of 1
510(k) Number (if known): K991436
Device Name:
Indications for Use:
The Sterngold ImplaMed 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kunner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K991436 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | OR | Over-the-Counter Use | _ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Page 10.01