(95 days)
Sterngold ERA Dental Implant System, Sterngold Narrow Platform Hex Screw Implants
Not Found
No
The 510(k) summary describes a physical dental implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a dental implant used to restore chewing function by providing a base for artificial teeth, which is a restorative rather than therapeutic function.
No
The provided text describes a dental implant system used for restoring chewing function by surgically implanting artificial teeth. It focuses on the physical characteristics and surgical application of the implant, not on diagnosing medical conditions or diseases.
No
The device description clearly details a physical implant made of titanium alloy, which is a hardware component. The 510(k) summary focuses on the physical characteristics and intended use of this implant, not software.
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 implant used directly in the patient's body for a functional purpose.
- 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 treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Sterngold 2.2mm Angled ERA dental implants are intended for long term 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 2.2mm Angled Micro ERA Dental Implant System consists of a threaded, external-hex, selftapping, root-form endosseous implant with integral female insert (abutment). The thread major diameter is 2.2 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in angle-correction (0°, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. (Draft FDA Guidance; distributed for comment May 12, 2004).
Conclusion: Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 2.2mm Angled Micro ERA Dental Implant System has been shown to be safe and effective for the product's intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Sterngold Abbreviated 510(k) Premarket Notification
August 4, 2009 2.2mm Angled ERA Dental Implant System
510(k) Summary
| Trade Name: | Sterngold 2.2mm Angled Micro ERA Dental Implant System | |
|---|---|---|
| Sponsor: | Sterngold | |
| 23 Frank Mossberg Drive | ||
| Attleboro, MA 02703 | ||
| Device Generic Name: | Dental endosseous implant system | NOV 10 2009 |
| 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 2.2mm Angled Micro 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 2.2mm Angled Micro ERA Dental Implant System consists of a threaded, external-hex, selftapping, root-form endosseous implant with integral female insert (abutment). The thread major diameter is 2.2 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in anglecorrection (0°, 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 2.2mm Angled ERA dental implants are intended for long term 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.
1
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:
- . Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. (Draft FDA Guidance; distributed for comment May 12, 2004)
Conclusion:
Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 2.2mm Angled Micro ERA Dental Implant System has been shown to be safe and effective for the product's intended use.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Lee Clermont Director of Regulatory Affairs Sterngold Dental LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
NOV 1 0 2009
Re: K092434
Trade/Device Name: 2.2 mm Angled Micro ERA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 4, 2009 Received: August 31, 2009
Dear Mr. Clermont:
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 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 - Mr. Clermont
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
far
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1097434 510(k) Number (if known):
2.2mm Angled Micro ERA Dental Implant System Device Name:
Indications for Use:
The Sterngold 2.2mm Angled ERA dental implants are intended for long term 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR Prescription (Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Ni
Over-the -Counter Use (21 CFR 807 Subpart D)