(30 days)
The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be used in restoration of removable dentures.
Device consists of a series of nylon male attachments in six variable sizes to provide six levels of retention. The six levels of retention are color coded - white, orange, blue, gray, yellow, and red (in order of increasing degrees of retention). Variations in the degree of retention are incorporated to facilitate requirements of individual patients. It also includes a black processing (also referred to as fabricating) male that is not used in the mouth for retention of the finished denture, but only used as a tool to incorporate the final snap-in male into the finished dental appliance. A resin female is also incorporated in this system, along with stainless steel and titanium alloy instruments.
The provided document is a 510(k) summary for the Stern Micro ERA Attachment System, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Instead, this document is a regulatory submission for premarket notification, demonstrating substantial equivalence to a predicate device. It explicitly states: "This submission is a Special 510(k): 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 FDA's guidance document entitled Premarket Notification 510(k): Regulatory Requirements for Medical Devices."
The conclusion further clarifies: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Micro ERA System has been shown to be safe and effective for its intended use."
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a previously approved device (Stern ERA System – 510(k) No. K 913348) rather than presenting a performance study against specific acceptance criteria.
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Special 510(k) Premarket Notification: Abbreviated 510(k)
Kω039q\
Micro ERA 1/31/02
8 2002 MAR 510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to r ursualit to 312(1)(2)(2) of the ification either an "...adequate summary of any submit with the respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Stern Micro ERA Attachment |
|---|---|
| Sponsor: | Sterngold |
| 23 Frank Mossberg Drive | |
| P.O. Box 2967 | |
| Attleboro, MA 02703-0967 | |
| Registration #2921595 | |
| Contact Person: | Maria Rao |
| Device Generic Name: | Micro ERA Precision Attachment |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class III |
| Predicate Devices: | Stern ERA System – 510(k) No. K 913348 |
Manufactured by: Sterngold
Product Description: Device consists of a series of nylon male attachments in six. variable sizes to provide six levels of retention. The six levels of retention are color coded - white, orange, blue, gray, yellow, and red (in order of increasing degrees of retention). Variations in the degree of retention are incorporated to facilitate requirements of individual patients.
It also includes a black processing (also referred to as fabricating) male that is not used in the mouth for retention of the finished denture, but only used as a tool to incorporate the final snap-in male into the finished dental appliance.
A resin female is also incorporated in this system, along with stainless steel and titanium alloy instruments.
Indications for Use: Device is a resilient retention device for dental prosthesis that can be used in restorations of removable dentures.
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Special 510(k) Premarket Notification: Abbreviated 510(k)
Micro ERA 1/31/02
Safety and Performance:
This submission is a Special 510(k): 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 FDA's guidance document entitled Premarket Notification 510(k): Regulatory Requirements for Medical Devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Micro ERA System has been shown to be safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, with three wavy lines representing the branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Sterngold Ms. Maria Rao Quality/Regulatory Manager 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
Re: K020391
Trade/Device Name: Stern Micro Era Attachment System Regulation Number: 872.3640 and 872.3165 Regulation Name: Endosseous Implant, Precision Attachment Regulatory Class: III Product Code: DZE and EGG Dated: January 31, 2002 Received: February 6, 2002
Dear Ms. Rao:
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 (1 m 1), its an 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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sterngold
Special 510(k) Premarket Notification: Abbreviated 510(k)
Micro ERA 1/31/02
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Stern Micro ERA Attachment System Device Name: __
Indications for Use:
The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be The Stern Micro ERA System is a resilient receition as not by 20% to alow additional space used in restoration of removable dentures. Neducal in alle same functionality and ease of use as well as esthetic improvements.
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
Supad Kumar
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Numbe
§ 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.