(169 days)
K/DEN number: Not Found
Not Found
No
The summary describes a physical dental implant and its materials, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to restore the patient's chewing function, which addresses a bodily function and qualifies it as therapeutic.
No
This device is a dental implant used for restoring chewing function by supporting prosthetic systems, not for diagnosing conditions.
No
The device description clearly outlines a physical, implantable dental device made of titanium alloy with specific dimensions and surface treatments. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems... in order to restore the patient's chewing function." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed in bone.
- 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 samples. This device is surgically implanted inside the body.
N/A
Intended Use / Indications for Use
The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.
Product codes
DZE
Device Description
The Sterngold 3.25mm ERA Dental Implant System consists of a threaded, external-hex, self-tapping, rootform endosseous implant with integral female insert (abutment). The thread major diameter is 3.25 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in straight and anglecorrection (5°, 11° & 17°) versions with cuff heights ranging from 0.76-4mm. The implants are manufactured from pure, implant-grade titanium alloy. The external surface of the implants (excluding the neck and the implant head) is lightly acid etched to remove any surface contaminants remaining from the manufacturing operation, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The female insert is titanium nitride coated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the patient's upper or lower arch
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
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:
- Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance)
- Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)
Key Metrics
Not Found
Predicate Device(s)
Sterngold ERA Dental Implant System, Sterngold Narrow Platform Hex Screw Implants
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
Image /page/0/Picture/0 description: The image shows a date, "OCT 28 2004", in a simple, sans-serif font. The text is printed in black ink, and the date is formatted with the month abbreviated, followed by the day and year. The date appears to be part of a document or label, and the overall impression is clear and legible.
SIOCKS
Summary
Koy 127/
| Trade Name: | Sterngold 3.25mm ERA Dental Implant System |
|---|---|
| Sponsor: | Sterngold |
| 23 Frank Mossberg Drive | |
| Attleboro, MA 02703 | |
| Device Generic Name: | Dental endosseous implant system |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II | |
| Product Code: | DZE (21CFR872.3640) |
Predicate Devices:
The Sterngold 3.25mm ERA Dental Implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process, including the Sterngold ERA Dental Implant System and the Sterngold Narrow Platform Hex Screw Implants.
Product Description:
The Sterngold 3.25mm ERA Dental Implant System consists of a threaded, external-hex, self-tapping, rootform endosseous implant with integral female insert (abutment). The thread major diameter is 3.25 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in straight and anglecorrection (5°, 11° & 17°) versions with cuff heights ranging from 0.76-4mm. The implants are manufactured from pure, implant-grade titanium alloy. The external surface of the implants (excluding the neck and the implant head) is lightly acid etched to remove any surface contaminants remaining from the manufacturing operation, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The female insert is titanium nitride coated.
Indications for Use:
The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:
- . Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance)
- . Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)
Conclusion:
Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 3.25mm ERA Dental Implant System has been shown to be safe and effective for the product's intended use.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2004
Sterngold C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K041271
Trade/Device Name: 3.25mm ERA Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 20, 2004 Received: August 23, 2004
Dear Ms. Papineau:
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. Papineau
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I Drimas made a detes and regulations administered by other Federal agencies. of the Act of ally I oderal base survey with and submitted to: registration 1 ou must comply with an are Hooding (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labeling (QS) regulation (21 CFR Part 820); and if requirements as bet form in are qt 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) IThis letter will and n yourse Finding of substantial equivalence of your device to a premarket notification - 12 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), If you desire speed to 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 may obtain 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,
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 (if known): Ko41271
3.25mm ERA Dental Implant System Device Name:
appropriate occlusal design and a soft diet.
Indications for Use:
The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
Susan Rumer
Division of Anesthesiology, General H Infection Control, Dent
510(k) Number: K091271