(266 days)
No
The device description focuses on materials, mechanical properties, and traditional manufacturing techniques (casting, soldering). There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as "Prosthetic components" intended for "prosthetic rehabilitations" and functions as an "Abutment Base" for dental implants, which serves a mechanical and restorative purpose, not a therapeutic one.
No
The device is described as an assembly of an abutment base and a modeling aid, intended for use in prosthetic rehabilitations directly or indirectly connected to dental implants. Its purpose is to aid in the fabrication of dental prosthetics, not to diagnose medical conditions or diseases.
No
The device description explicitly states the device is an assembly of a noble metal alloy Abutment Base and a polymer Modeling Aid, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitations," specifically for components connected to dental implants. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details the physical components (abutment base, modeling aid, screw) and their function in creating a dental prosthesis. There is no mention of analyzing biological samples or providing diagnostic information.
- Anatomical Site: The anatomical site is the "endosseous dental implant," which is a part of the patient's body, not a sample taken from the body for analysis.
- Intended User / Care Setting: The intended user is a "Dental laboratory," which is involved in fabricating dental devices, not performing diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosing a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices.
The subject devices interface with Straumann Tissue Level ( TL ) implants having the Regular Neck ( RN ) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.
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)
Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.
New biocompatibility and sterilization studies were not required for the subject devices. The materials of construction and methods of manufacture are the same for the subject device as for the identified Straumann primary predicate device.
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.
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.
K063789, K133421, K141871, K150814
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
§ 872.3630 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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810
Re: K151590
Trade/Device Name: Straumann® synOcta Gold Abutments for Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 2, 2016 Received: February 3, 2016
Dear Mr. Klaczyk:
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.
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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 devicerelated 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 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
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Indications for Use
510(k) Number (if known) K151590
Device Name
Straumann® synOcta Gold Abutments for Bridge
Indications for Use (Describe)
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K151590 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | ||
| Andover, MA 01810 | ||
| Registration No.: 1222315 Owner/Operator No.: 9005052 | ||
| Contact Person: | Christopher Klaczyk | |
| Director of Regulatory Affairs and Clinical Research | ||
| (978) 747-2575 | ||
| Date Prepared: | February 23, 2016 | |
| Product Code(s): | NHA (21 CFR 872.3630) | |
| Device Class: | II | |
| (21 CFR 872.3630) | ||
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | |
| Common Name: | Endosseous dental implant abutment | |
| Proprietary Name: | Straumann® synOcta Gold Abutments for Bridge | |
| Primary Predicate Device: | K041295, RN synOcta UCLA Gold Abutment (Straumann) | |
| Reference Device(s) | K063789, WN synOcta UCLA Gold Abutment (Straumann) | |
| K133421, Magellan Screw Retained Abutments (Straumann) | ||
| K141871, Straumann Screw-Retained Abutments (Straumann) | ||
| K150814, Straumann Screw-Retained Abutments (Straumann) | ||
| Device Description: | The subject devices represent a line extension of the Straumann | |
| Dental Implant System (SDIS). The subject devices are an | ||
| assembly of a noble metal alloy (Ceramicor®) Abutment Base | ||
| and a polymer (POM) Modeling Aid. The Modeling Aid is | ||
| attached to the abutment base by means of a friction fit. The | ||
| subject devices employ the same Modeling Aid (catalog no. | ||
| 049.217) as the identified predicate devices. The subject | ||
| devices use the same Basal Screw for fixing the finished | ||
| restoration to the implant (catalog no. 049.128) as the identified | ||
| predicate devices. | ||
| The subject devices interface with Straumann Tissue Level | ||
| ( TL ) implants having the Regular Neck ( RN ) or Wide Neck | ||
| (WN) implant-to-abutment interface. The subject devices do | ||
| not engage the anti-rotation features within the TL implants. | ||
| The non-engaging design makes these devices suitable for the | ||
| fabrication of bar and bridge superstructures by the dental | ||
| laboratory using either casting or soldering techniques. | ||
| Indications For Use: | Prosthetic components directly or indirectly connected to the | |
| endosseous dental implant are intended for use as an aid in | ||
| prosthetic rehabilitations. | ||
| Materials: | The subject devices are an assembly of a noble metal alloy | |
| (Ceramicor®) Abutment Base and a polymer (POM) Modeling | ||
| Aid. The Modeling Aid is sacrificed during the casting | ||
| procedure and is no longer present in the final restoration. | ||
| The Abutment Base of the subject devices consists of the | ||
| Ceramicor precious metal alloy provided by Cendres + Metaux | ||
| (Biel-Bienne, Switzerland). Ceramicor is a non-oxidizing alloy | ||
| for casting-on with precious metal alloys or for soldering with | ||
| precious metal or non-precious metal alloys. The Melting | ||
| Range is 1400 – 1490°C (2552 – 2714°F). The 0.2% Proof | ||
| Strength is 780 N/mm² as delivered and 635 N/mm² after | ||
| processing, which satisfies the requirements of a Type 5 | ||
| material per ISO 22674, Dentistry -- Metallic materials for | ||
| fixed and removable restorations and appliances. The material | ||
| is self-hardening. | ||
| Technological | ||
| Characteristics: | The Abutment Base component of the proposed Straumann® | |
| synOcta Gold Abutments for Bridge are manufactured using | ||
| precision machining systems from solid material (i.e. one-piece | ||
| construction). The Modeling Aid and Basal Screw components | ||
| are the same components used for the identified predicate | ||
| devices. A comparison of the technological characteristics of | ||
| the subject devices and the predicate devices is provided in the | ||
| table below. | ||
| The Indications for Use language for the subject and primary | ||
| predicate devices have slightly different. However, this | ||
| difference in language does not materially change the intended | ||
| uses of these devices or the determination of substantial | ||
| equivalence. |
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5
| Feature | Subject Devices
Straumann® synOcta Gold
Abutments for Bridge | Primary Predicate Devices
Straumann RN synOcta UCLA
Gold Abutment
(K041295) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Prosthetic components directly or
indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations. | Abutments are intended to be placed
into dental implants to provide
support for prosthetic
reconstructions such as crowns or
bridges. |
| Implant-to-Abutment
Connection | Tissue Level Regular Neck (RN)
Tissue Level Wide Neck (WN) | Tissue Level Regular Neck (RN)
Tissue Level Wide Neck (WN) |
| Implant-to-Abutment
Platform(s) | Regular Neck (RN)
Wide Neck (WN) | Regular Neck (RN)
Wide Neck (WN) |
| Abutment Angulation(s) | Straight, Angled to 30° | Straight |
| Engagement | Non-engaging; suitable for multi-
unit (bridge) restorations | Engaging; suitable for single-unit
(crown) restorations |
| Material(s) | Ceramicor noble metal alloy
POM polymer
Ti-6Al-7Nb alloy | Ceramicor noble metal alloy
POM polymer
Ti-6Al-7Nb alloy |
| Primary Package | Medical grade polyethylene blister
with a sealing lid | Medical grade polyethylene blister
with a sealing lid |
| Sterilization | Non-sterile; intended for terminal
sterilization via moist heat
(autoclave) | Non-sterile; intended for terminal
sterilization via moist heat
(autoclave) |
Performance Data: Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed.
Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.
New biocompatibility and sterilization studies were not required for the subject devices. The materials of construction and methods of manufacture are the same for the subject device as for the identified Straumann primary predicate device.