(346 days)
No
The summary describes a traditional CAD/CAM workflow for designing and manufacturing dental abutments, with design verification based on predefined parameters. There is no mention of AI or ML being used in the design, verification, or manufacturing process.
No.
The device, Straumann CARES Golden Ti/TiN Abutments, is an accessory to dental implants that provides support for prosthetic restorations. It is a structural component for dental reconstruction, not a device intended for treating or alleviating a disease or condition.
No
This device, Straumann CARES Golden Ti/TiN Abutments, is a prosthetic component designed to support dental restorations, not to diagnose medical conditions.
No
The device is a physical dental abutment made of titanium with a titanium nitride coating. While CAD software is used in the design process, the device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Straumann CARES Golden Ti/TiN Abutments are physical components placed into dental implants to support prosthetic restorations. They are a structural part of a dental restoration system.
- Intended Use: The intended use is to provide support for prosthetic restorations in the mouth. This is a mechanical and structural function, not a diagnostic one based on analyzing biological samples.
- Device Description: The description focuses on the material, manufacturing process, design parameters, and coating of the abutment. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical and mechanical properties of the abutment (sterilization, biocompatibility, fatigue, adhesion, abrasion). These are relevant to the device's function as a dental implant component, not as a diagnostic tool.
Therefore, the Straumann CARES Golden Ti/TiN Abutments are a medical device, specifically a dental prosthetic component, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.
The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The previously cleared Straumann CARES Titanium Abutments are placed onto dental implants to support prosthetic reconstructions such as crowns and bridges. The abutment allows for individual customization regarding function and esthetics. The design step is typically performed by the dental laboratory to the specifications from a clinician. The abutments are produced by a Straumann Manufacturing milling center. The patient-specific abutment is designed by a traditional waxup and subsequent scanning or by scanning of the intraoral setting and designing the element via CAD software. The design information is sent via an Internet portal to Straumann. Straumann verifies the design against the validated design parameters. These design limits include a maximum angulation of 30° and a minimum surface area as follows:
| Tooth Position | Minimum surface area mm² |
|---|---|
| 7,10, 24,25 | 37 |
| 4,5,12,13,20,21,28,29 | 47 |
| 26,11,2,27,8,9 | 43 |
| 1-3, 14-16, 17-19,30-32 | 56 |
The abutments are manufactured from solid grade 4 titanium at the Straumann milling center. The abutment is delivered to the dental laboratory for final processing before delivery to the clinician. The abutments are attached to the implant with a titanium alloy basal screw. The occlusal restoration is affixed to the titanium abutment using dental cement.
The proposed devices are a modification of the previously licensed devices. The titanium abutments that serve as the base of the CARES Golden Ti/TiN Abutments (the uncoated abutments) are identical in every respect to the reference devices. The modification consists of the addition of a titanium nitride (TiN) coating on the emergence profile and coronal aspect of the abutment. The apical portion of the abutment consisting of the implant-to-abutment interface is masked during the coating process to assure that the interface remains uncoated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, dental laboratory
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)
Test data to support the evaluation of the subject Straumann CARES Golden Ti/TiN abutments is as follows:
Sterilization validation in accordance with ISO 17665-1 and ISO/TS 17665-2 Biocompatibility assessment per ISO 10993-1 Cytotoxicity testing per ISO 10993-5 Chemical characterization per ISO 10993-18 Dynamic fatigue testing per ISO 14801 by reference to K052272, K072151, K081005 and K082764 Coating characterization including chemical composition, thickness, porosity, mean volume percent voids, SEM images at 100X Adhesion testing by static shear bonding strength per ASTM F1044 employing minimum shear stress acceptance criteria per ASTM F2068 Adhesion testing by dynamic shear bonding strength per ASTM F1160 Abrasion testing consistent with the method described by Tamura, et al, entitled Mechanical Properties of Surface Nitrided Titanium for Abrasion Resistant Implant Materials . No animal or human clinical studies were conducted.
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.
K052272, K072151, K081005, K082764, K992334
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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K162848
Trade/Device Name: Straumann® CARES® Golden Ti/TiN Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 25, 2017 Received: August 28, 2017
Dear Jennifer Jackson:
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.
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
1
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,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K162848
Device Name
Straumann® CARES® Golden Ti/TiN Abutments
Indications for Use (Describe)
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.
The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
| 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 | K162848 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | ||
| Andover, MA 01810 | ||
| Contact Person: | Jennifer M. Jackson, MS | |
| Director, Regulatory Affairs and Quality | ||
| +1 (978) 747-2509 | ||
| Prepared By & | ||
| Secondary Contact: | Christopher Klaczyk | |
| Head of Regulatory Affairs & Compliance | ||
| Institut Straumann AG | ||
| +41 61 965 1260 | ||
| Date Prepared: | September 22, 2017 | |
| 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) | |
| Proprietary Name: | Straumann® CARES® Golden Ti/TiN Abutment | |
| Primary Predicate | ||
| Device: | K082764, Straumann CARES WN Ti Abutments (Institut Straumann) | |
| Reference Device(s): | K052272, Straumann CARES RN Ti Abutments (Institut Straumann) | |
| K072151, Straumann CARES RC Ti Abutments (Institut Straumann) | ||
| K081005, Straumann CARES NC Ti Abutments (Institut Straumann) | ||
| K992334, 3i TiN Coated Implants and Abutments (Implants Innovations, Incorporated (3i)) | ||
| Device Description: | The previously cleared Straumann CARES Titanium | |
| Abutments are placed onto dental implants to support prosthetic | ||
| reconstructions such as crowns and bridges. The abutment | ||
| allows for individual customization regarding function and | ||
| esthetics. The design step is typically performed by the dental | ||
| laboratory to the specifications from a clinician. The abutments | ||
| are produced by a Straumann Manufacturing milling center. |
4
The patient-specific abutment is designed by a traditional waxup and subsequent scanning or by scanning of the intraoral setting and designing the element via CAD software. The design information is sent via an Internet portal to Straumann. Straumann verifies the design against the validated design parameters. These design limits include a maximum angulation of 30° and a minimum surface area as follows:
| Tooth Position | Minimum surface area mm² |
|---|---|
| 7,10, 24,25 | 37 |
| 4,5,12,13,20,21,28,29 | 47 |
| 26,11,2,27,8,9 | 43 |
| 1-3, 14-16, 17-19,30-32 | 56 |
The abutments are manufactured from solid grade 4 titanium at the Straumann milling center. The abutment is delivered to the dental laboratory for final processing before delivery to the clinician. The abutments are attached to the implant with a titanium alloy basal screw. The occlusal restoration is affixed to the titanium abutment using dental cement.
The proposed devices are a modification of the previously licensed devices. The titanium abutments that serve as the base of the CARES Golden Ti/TiN Abutments (the uncoated abutments) are identical in every respect to the reference devices. The modification consists of the addition of a titanium nitride (TiN) coating on the emergence profile and coronal aspect of the abutment. The apical portion of the abutment consisting of the implant-to-abutment interface is masked during the coating process to assure that the interface remains uncoated.
Indications For Use: Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.
The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
- Materials: The substrate material for all Straumann CARES Golden Ti/TiN Abutments is commercially pure Titanium (grade 4) conforming to ISO 5832-2. The surface of the emergence profile and coronal aspect of the abutments are coated with titanium nitride (TiN). The implant-to-abutment interface is masked and remains uncoated.
5
| Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. |
|---|---|
| Performance Data: | Test data to support the evaluation of the subject Straumann CARES Golden Ti/TiN abutments is as follows: |
| Sterilization validation in accordance with ISO 17665-1 and ISO/TS 17665-2 Biocompatibility assessment per ISO 10993-1 Cytotoxicity testing per ISO 10993-5 Chemical characterization per ISO 10993-18 Dynamic fatigue testing per ISO 14801 by reference to K052272, K072151, K081005 and K082764 Coating characterization including chemical composition, thickness, porosity, mean volume percent voids, SEM images at 100X Adhesion testing by static shear bonding strength per ASTM F1044 employing minimum shear stress acceptance criteria per ASTM F2068 Adhesion testing by dynamic shear bonding strength per ASTM F1160 Abrasion testing consistent with the method described by Tamura, et al, entitled Mechanical Properties of Surface Nitrided Titanium for Abrasion Resistant Implant Materials . No animal or human clinical studies were conducted. | |
| Conclusions: | Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices. |
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| Feature | Primary Predicate Devices
CARES Titanium Abutments
(K082764) | Subject Devices
CARES Titanium Gold Abutments | Equivalence
Discussion |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Abutments are placed into the dental
implants to provide support for prosthetic
restoration such as crowns, bridges and
overdentures.
The Straumann Titanium Abutment is
indicated for single tooth replacements
and multiple tooth restorations. The
prosthetic restoration is cement-retained. | Abutments are placed into the dental
implants to provide support for prosthetic
restoration such as crowns, bridges or
overdentures.
The Straumann CARES Golden Ti/TiN
Abutment is indicated for single tooth
replacements and multiple tooth
restorations. The prosthetic restoration is
cement-retained. | Identical |
| Compatible Implants | Straumann Bone Level implants having
the NC and RC implant-to-abutment
interface geometries.
Straumann Tissue Level implants having
the NN, RN and WN implant-to-
abutment interface geometries. | Straumann Bone Level implants having
the NC and RC implant-to-abutment
interface geometries.
Straumann Tissue Level implants having
the NN, RN and WN implant-to-
abutment interface geometries. | Identical |
| Material | Commercially pure grade 4 Titanium
per ISO 5832-2 | Commercially pure grade 4 Titanium
per ISO 5832-2 | Identical |
| Surface Finish | Uncoated (raw titanium) | Titanium nitride (TiN) coating on
emergence profile and coronal surfaces | Equivalent
The TiN coating is being added to impart
gold color to the emergence profile and
coronal surfaces of the abutment in order
to improve the esthetics of the finished
restoration. The presence of the coating
does not change the intended uses or
indications of the devices. This use of
TiN coating was originally cleared to
market per K992334. |
| Construction | One-piece solid devices. | One-piece solid devices. | Identical |
| Feature | Primary Predicate Devices
CARES Titanium Abutments
(K082764) | Subject Devices
CARES Titanium Gold Abutments | Equivalence
Discussion |
| Design Limits: | Maximum Angulation: 30°
Minimum Surface Area:
Pos, 7,10, 24,25 37 mm²
Pos, 4,5,12,1320,21,28,29 47 mm²
Pos, 26,11,2,27,8,9 43 mm²
Pos, 1-3, 14-16, 17-19,30-32 56 mm² | Maximum Angulation: 30°
Minimum Surface Area:
Pos, 7,10, 24,25 37 mm²
Pos, 4,5,12,1320,21,28,29 47 mm²
Pos, 26,11,2,27,8,9 43 mm²
Pos, 1-3, 14-16, 17-19,30-32 56 mm² | Identical |
| Packaging | The abutment and basal screw in
reclosable poly bags, co-packaged in a
kraft board box. | The abutment and basal screw inkraft board box. | Identical |
| Sterility | Provided non-sterile.
Terminally sterilized via moist heat
(autoclave) to a Sterility Assurance Level
of 10-6. Validated per ISO 17665-1. | Provided non-sterile.
Terminally sterilized via moist heat
(autoclave) to a Sterility Assurance Level
of 10-6. Validated per ISO 17665-1. | Identical |
7