(128 days)
No
The device description and performance studies focus on mechanical properties and fit, with no mention of AI or ML.
No
The device supports and retains removable dental prostheses to restore chewing function, which is a restorative process rather than a therapeutic one. Therapeutic devices are typically used to treat or cure a disease or condition.
No
This device is an attachment for dental implants used to support and retain removable dental prostheses, restoring chewing function and accommodating angulation of divergent implants. It is a therapeutic device rather than a diagnostic one.
No
The device description clearly indicates it is a physical attachment (SternSnap Angled Attachment) that screws into dental implants and abutments. It describes mechanical properties like pivoting and rotation, and the performance studies involve non-clinical testing of physical components (dimensional verification, fit checks, fatigue testing, cyclic load testing, retention force testing). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The SternSnap Angled Attachment is a mechanical device used to support and retain removable dental prostheses on dental implants. It is a physical component placed within the patient's mouth.
- Intended Use: The intended use is to restore chewing function in partially or totally edentulous patients by providing a stable connection for dentures. This is a functional and structural purpose, not a diagnostic one based on analyzing biological samples.
- Device Description: The description details the mechanical components and how they interact with the SFI Abutment and the denture. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical properties like fatigue, cyclic load, and retention force. These are relevant to the structural integrity and function of the device within the mouth, not to diagnostic accuracy based on biological samples.
In summary, the SternSnap Angled Attachment is a medical device used for prosthetic support and retention within the oral cavity, not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The SternSnap Angled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.
The SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.
Product codes
NHA
Device Description
The SternSnapAngled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. An appropriate height Sterngold SFI Abutment is screwed into an endosseous implant. A SternSnap Angled Attachment is screwed into the SFI Abutment. The SternSnap Angled Attachment can be manually pivoted on the hemispherical occlusal of the SFI Abutment until alignment is achieved. A retaining cap is processed into the denture. The retention cap engages the outside of the modified ball shape and allows retention of the prosthesis to the denture.
The proposed device is intended for angulation of divergent implants.
The SternSnap Angled Attachment can be pivoted from a central, 0 degree, position up to and including 17 degrees. It can also be rotated through 360 degrees. Therefore, two SternSnap Attachments can align two implants that are up to and including 34° out of parallel. The SternSnap Angled Attachment is only to be used with Sterngold SFI Abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Nonclinical test data was used to support the substantial equivalency. Clinical testing was not necessary. Non-clinical testing consisted of analysis of the SFI abutment top portion (head) and SternSnap Angled Attachment screw section, dimensional verification against drawing, and fit checks of angled attachment to SFI abutment to ensure connection was reliable and functional.
Review of fatigue testing data performed on the Angled SFI Bar by Cendres & Metaux showed the device being tested "with an angle of 30° to the implant axes". The SFI abutments support the pivoting ball component of the SFI Bar. This demonstrates that the proposed device is substantial equivalent to its predicates.
Cyclic Load testing was conducted to ensure prosthetic screw would remain tightened to the initial torque after 10,000 cycles and angled attachment would still be in their original orientation after 1,000 cycles. Retention force testing was conducted to ensure level of retention was acceptable.
Evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Testing has shown that the SternSnap Angled Attachment is equivalent in performance characteristics to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Retentive Force: Up to 4.0 lb (17.8 N) (Proposed Device)
Predicate Device(s)
K142407, K130183, K130618, K131526
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
Sterngold Dental, LLC Ms. Maria Rao Director of Quality & Regulatory Affairs 23 Frank Mossberg Drive Attleboro, Massachusetts 02703
Re: K150250
Trade/Device Name: SternSnap Angled Attachment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 4, 2015 Received: May 6, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K150250 510(k) Number (if known):
Device Name: SternSnap Angled Attachment
Indications for Use:
The SternSnap Angled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.
The SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.
(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 Subparts D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
ਨ 2.
3
510(k) Summary
| Sponsor: | Sterngold Dental, LLC
23 Frank Mossberg Drive
Attleboro, MA 02703 |
|----------------------|-------------------------------------------------------------------------|
| Contact: | Maria Rao, QA/RA Director
Ph: 508-226-5660 ext 1206 |
| Date: | June 3, 2015 |
| Trade Name: | SternSnap Angled Attachment |
| Common Name: | Dental Attachment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | 21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Legally Marketed Device to which Equivalence is claimed (Predicate Devices): |
|---|
| Trade Name | 510(k) No. | Manufacturer | Manufacturer |
|---|---|---|---|
| Straight Stud Attachment | K142407 | Sterngold Dental, LLC | Primary Predicate |
| SFI Bar® Implant Abutments | K130183 and K132814 | Sterngold Dental, LLC | Reference Predicate |
| SFI Anchor | K130618 | Cendres & Metaux, SA | Reference Predicate |
| SFI Bar | K131526 | Cendres & Metaux, SA | Reference Predicate |
Description of Device:
The SternSnapAngled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. An appropriate height Sterngold SFI Abutment is screwed into an endosseous implant. A SternSnap Angled Attachment is screwed into the SFI Abutment. The SternSnap Angled Attachment can be manually pivoted on the hemispherical occlusal of the SFI Abutment until alignment is achieved. A retaining cap is processed into the denture. The retention cap engages the outside of the modified ball shape and allows retention of the prosthesis to the denture.
The proposed device is intended for angulation of divergent implants.
The SternSnap Angled Attachment can be pivoted from a central, 0 degree, position up to and including 17 degrees. It can also be rotated through 360 degrees. Therefore, two SternSnap Attachments can align two implants that are up to and including 34° out of parallel. The SternSnap Angled Attachment is only to be used with Sterngold SFI Abutments.
4
The SFI abutments are compatible with several implant systems and have been previously cleared under K130183 and K132184 - SFI Bar® Implant Abutments.
Intended Use of the Device:
The SternSnav Angled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.
The SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.
Summary Technological Characteristics:
The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices - titanium alloy, polyurethane (brown, green, yellow, black) were also used in legally marketed predicate devices.
| Attributes | Proposed Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | Reference Predicate
Device |
|------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| | SternSnap Angled
Attachment
Sterngold Dental, LLC | Straight Stud
Attachment
Sterngold Dental, LLC
K142407 | SFI Implant
Abutments
Sterngold Dental, LLC
K130183, K132814 | SFI Anchor
Cendres & Metaux,
SA
K130618 | SFI Bar
Cendres & Metaux,
SA
K131526 |
| Device Material | Wrought Titanium-6AL-4
Vanadium ELI Alloy | Wrought Titanium-6AL-
4 Vanadium ELI Alloy | Wrought Titanium-
6AL-4 Vanadium
ELI Alloy | Wrought Titanium-
6AL-4 Vanadium ELI
Alloy | Titanium |
| Manufacturing | Machined | Machined | Machined | Machined | Machined |
| Retentive Force | Up to 4.0 lb (17.8 N) | Up to 4.0 lb (17.8 N) | Up to 4.5 lb (20 N) | Up to 3.93 lb (17.5 N) | N/A |
| Operating
Principle | Screw fixation to SFI
Abutment. Connecting
principle to overdenture:
Retentive system | Screw fixation to SFI
Abutment. Connecting
principle to overdenture:
Retentive system | Screw fixation to
Implant.
Connecting principle
to overdenture:
Retentive system | Screw fixation to
Implant.
Connecting principle
to overdenture:
Retentive system | Screw fixation to
Implant.
Connecting principle
to overdenture:
Retentive system |
| Indications for
Use | Intended for the fixation
of dental prostheses to
corresponding dental
implants. | Intended for the fixation
of dental prostheses to
corresponding dental
implants. | Intended for the
fixation of dental
prostheses to
corresponding dental
implants. | Intended for the
fixation of dental
prostheses to
corresponding dental
implants. | Intended to provide
support for the
fixation of dental
prostheses to
corresponding dental
implants. |
Non-Clinical Performance Data:
The specifications for a reliable connection between the SternSnap Angled Attachment and the SFI implant abutments were developed by analyzing the SFI Abutment specifications. Nonclinical test data was used to support the substantial equivalency. Clinical testing was not necessary. Non-clinical testing consisted of analysis of the SFI abutment top portion (head) and SternSnap Angled Attachment screw section, dimensional verification against drawing, and fit checks of angled attachment to SFI abutment to ensure connection was reliable and functional.
5
Review of fatigue testing data performed on the Angled SFI Bar by Cendres & Metaux showed the device being tested "with an angle of 30° to the implant axes". The SFI abutments support the pivoting ball component of the SFI Bar. This demonstrates that the proposed device is substantial equivalent to its predicates.
Cyclic Load testing was conducted to ensure prosthetic screw would remain tightened to the initial torque after 10,000 cycles and angled attachment would still be in their original orientation after 1,000 cycles. Retention force testing was conducted to ensure level of retention was acceptable.
Evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Testing has shown that the SternSnap Angled Attachment is equivalent in performance characteristics to the predicate devices.
Substantial Equivalence: The summary of technological characteristics and performance testing indicate that the device is substantially equivalent to its predicate devices. The intended use and technological characteristics are the Straight Stud Attachment previously cleared under K142407.