(107 days)
K150899 Straumann® CARES® Titanium Alloy (TAN) Abutments
No
The description focuses on the material (CoCr), design process (conventional wax-up or scanning and software design), and fabrication (central milling center). There is no mention of AI or ML being used in the design or manufacturing process.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an abutment for a dental implant, which is a restoration rather than a treatment for a disease.
No
The device description indicates that Straumann® CARES® Abutments CoCr are prosthetic restorations used for single tooth replacement and multiple tooth restorations, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical abutment made of CoCr, which is a hardware component. While software is used in the design process, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Straumann® CARES® Abutments CoCr are physical components (dental abutments) used for the restoration of dental implants. They are designed and fabricated based on scans of the patient's mouth or a model, and then physically placed in the patient's mouth.
- Intended Use: The intended use is for single tooth replacement and multiple tooth restorations, which is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description focuses on the material, design process, and fabrication of the abutments, not on analyzing biological samples.
- Performance Studies: The performance studies described are bench tests evaluating mechanical properties, biocompatibility, and manufacturing processes, not diagnostic accuracy or performance on biological samples.
The device is a medical device used in dentistry for prosthetic restoration, but it does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.
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)
The material used in the manufacture of Straumann® CARES® Abutments CoCr is a cobalt-chromium alloy which meets the requirements of ISO 22674 type 4. Bench testing was performed to evaluate the performance of the proposed Straumann® CARES® Abutments CoCr. Dynamic fatigue tests were conducted according to the ISO 14801 "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The biocompatibility of the subject device is demonstrated by "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", ISO 10993-5:2009 "Tests for in vitro cytotoxicity", and ISO 10993-18 "Chemical characterization of materials". Veneering performance testing of the Straumann CoCr alloy (coron) has been performed per ISO 9693-1, Dentistry – Compatibility testing – Part 1: Metal ceramic systems; A final workflow validation according to internal procedures has also been conducted. Corrosion resistance was demonstrated according to ISO 10271:2011 – "Corrosion test methods for metallic materials". Sterilization validation was carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10-6 in accordance to the ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. 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.
K150899 Straumann® CARES® Titanium Alloy (TAN) Abutments
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.
K132844 Straumann® CARES® SRBB, K101465 Straumann® CARES® Bridge, Straumann® CARES® Bar, K083550 Modified S/SP/BL 3.3 Implants, K150203 Medentika CAD/CAM Abutments, K162890 Small Diameter Implant (SDI), K062129 Straumann Dental Implant System: P.004 Implants
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2018
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K172798
Trade/Device Name: Straumann® CARES® Abutments CoCr Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 4, 2017 Received: December 5, 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.
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for 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) K172798p here to enter text
Device Name
Straumann® CARES® Abutments CoCr
Indications for Use (Describe)
The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary
-
| 510(k) Number: [K172798](https://510k.innolitics.com/search/K172798) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
+1 (978) 747-2509 |
| Prepared By & Secondary
Contact: | Shokoufeh Khodabandeh
Regulatory Affairs and Compliance Manager
Institut Straumann AG
+41 61 965 1260 |
| Date Prepared: | January 3, 2018 |
| Product Code(s): | NHA |
| Device Class: | II |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name:
Predicate Device(s): | Straumann® CARES® Abutments CoCr
K150899 Straumann® CARES® Titanium Alloy (TAN) Abutments;
Manufacturer Straumann |
| Reference Device(s): | K132844Straumann® CARES® SRBB; Manufacturer Straumann
K101465 Straumann® CARES® Bridge, Straumann® CARES®
Bar ; Manufacturer Straumann
K083550 Modified S/SP/BL 3.3 Implants;Manufacturer Straumann
K150203 Medentika CAD/CAM Abutments; Manufacturer Medentika
Gmbh
K162890 Small Diameter Implant (SDI); Manufacturer Straumann
K062129 Straumann Dental Implant System: P.004 Implants;
Manufacturer Straumann |
| Device Description: | Straumann® CARES® Abutments CoCr are used for the restoration
of Straumann dental implant platforms RN (Regular Neck), WN
(Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The
Straumann® CARES® Abutments CoCr allow for individual
customization regarding function and esthetics. Straumann®
CARES® Abutments CoCr are designed by the dental laboratory
technician either by means of a conventional wax-up model that is
subsequently scanned or by scanning the intraoral situation and
designing the shape by using a Straumann-approved software (such
as Straumann® CARES® Visual). The design data is then
transferred to a Straumann central milling center where the
fabrication of the customized abutment is carried out.
The Straumann® CARES® Abutments CoCr can be directly
veneered. |
4
| Indications For Use: | The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.. |
|---|---|
| Materials: | Straumann CARES Abutments CoCr: cobalt-chromium based dental alloy, trade named coron. This material is identical to the coron material used in Straumann® CARES® SRBB (K132844 and K101465). Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw component of the Straumann® CARES® Abutments CoCr are identical to the basal screw components of the Straumann predicates (K150899, K041295, K071357, and K062129 ). |
| Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and the primary predicate is provided in the table that follows. |
| Feature | Subject Device
Straumann® CARES® Abutments
CoCr | Primary Predicate Devices
Straumann® CARES® Titanium
Alloy (TAN) Abutments
(K150899) | Equivalence
Discussion |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indication for
use | The Straumann® CARES®
Abutments CoCr are indicated for
single tooth replacement and
multiple tooth restorations. The
prosthetic restoration can be
cemented or directly
veneered/screw-retained. | The Straumann® CARES®
Abutments TAN are indicated for
single tooth replacement and
multiple tooth restorations. The
prosthetic restoration can be
cemented or directly
veneered/screw-retained. | Identical |
| Compatible
Implants | Straumann Bone Level implants
having the NC and RC implant-to-
abutment interface geometries.
Straumann Tissue Level implants
having the 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, WN implant-to-
abutment interface geometries. | Identical |
| Material | CARES abutment: Cobalt-chromium
Alloy (coron)
Basal screw: Titanium alloy
(Ti6Al7Nb), TAN | CARES abutment: Titanium alloy
(Ti6Al7Nb), TAN
Basal screw: Titanium alloy
(Ti6Al7Nb), TAN | Equivalent |
5
| Feature | Subject Device
Straumann® CARES® Abutments
CoCr | Primary Predicate Devices
Straumann® CARES® Titanium
Alloy (TAN) Abutments
(K150899) | Equivalence
Discussion | | | | | | | | | | | | | | | | | | | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|-----------|
| Design
Limits: | Max. Angulation 30°
Minimum thickness 0.33 mm Tooth Position Minimum
surface
area mm² 7,10, 24,25 37 4,5,12,1320,21,28,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-
19,30-32 56 | | | | | | | | | | | Max. Angulation 30°
Minimum thickness 0.33mm Tooth Position Minimum
surface
area mm² 7,10, 24,25 37 4,5,12,1320,21,2
8,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-
19,30-32 56 | | | | | | | | | | | Identical |
| Construction | One-piece solid Abutment supplied
with the compatible basal screw | One-piece solid abutment supplied
with the compatible basal screw | Identical | | | | | | | | | | | | | | | | | | | | |
| Packaging | The abutment in reclosable poly bag
and the corresponding basal screw is
individually packed in a blister,
co-packaged in a craft board box | The abutment in reclosable poly
bag and the corresponding basal
screw is individually packed in a
blister, co-packaged in a craft
board box. | Identical | | | | | | | | | | | | | | | | | | | | |
| Sterility | Provided non-sterile.
To be sterilized by the user in a
steam autoclave process. | Provided non-sterile.
To be sterilized by the user in a
steam autoclave process. | Identical | | | | | | | | | | | | | | | | | | | | |
| Fatigue
performance | Tested according to ISO 14801 | Tested according to ISO 14801 | Equivalent | | | | | | | | | | | | | | | | | | | | |
Performance Data: The material used in the manufacture of Straumann® CARES® Abutments CoCr is a cobalt-chromium alloy which meets the requirements of ISO 22674 type 4. Bench testing was performed to evaluate the performance of the proposed Straumann® CARES® Abutments CoCr. Dynamic fatigue tests were conducted according to the ISO 14801 "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The biocompatibility of the subject device is demonstrated by "Biological evaluation of
6
medical devices - Part 1: Evaluation and testing within a risk management process", ISO 10993-5:2009 "Tests for in vitro cytotoxicity", and ISO 10993-18 "Chemical characterization of materials". Veneering performance testing of the Straumann CoCr alloy (coron) has been performed per ISO 9693-1, Dentistry – Compatibility testing – Part 1: Metal ceramic systems; A final workflow validation according to internal procedures has also been conducted. Corrosion resistance was demonstrated according to ISO 10271:2011 – "Corrosion test methods for metallic materials". Sterilization validation was carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10-6 in accordance to the ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2.
No animal or human clinical studies were conducted.
Conclusions: Based upon our assessment of the design and applicable performance data, the subiect devices have been determined to be substantially equivalent to the identified predicate devices.