(166 days)
No
The description focuses on traditional CAD/CAM design and fabrication processes based on scanning or wax-ups, with no mention of AI or ML for design, analysis, or fabrication.
No.
The device is an abutment for dental implants, described as a prosthetic restoration used for single or multiple tooth replacements, and its function relates to restoring the form and function of teeth, not treating a disease or condition.
No.
The device described is an abutment for dental implants, which is a restorative component, not a diagnostic tool. Its purpose is to provide a base for prosthetic restorations.
No
The device description clearly states that the device is a physical abutment and basal screw, which are hardware components. 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Straumann CARES® TAN abutments are dental prosthetics used to restore dental implants. They are physical components placed within the mouth to support crowns or other dental restorations.
- 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 details the physical characteristics and use of the abutments in relation to dental implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
The device is clearly a medical device, specifically a dental prosthetic, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann CARES® TAN abutments 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® TAN Abutments are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths. The abutments are available with interface geometry compatible with the bone level NC (3.3 mm) and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and WN (4.8 mm) implants. The proposed CARES® TAN abutments are provided in a set that contains the individualized abutment and a corresponding basal screw. The Straumann CARES TAN Abutments allow for individual customization regarding function and esthetics. Straumann CARES TAN Abutments are designed by the customer either by means of a traditional wax-up abutment that is subsequently scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out. The Straumann CARES TAN Abutments can be directly veneered or a dental restoration like a crown or bridge can be cemented to the 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)
Bench studies:
- Dynamic fatigue test data consistent with FDA guidance and ISO 14801.
- Veneer testing consistent with ISO 9693-1.
- Corrosion resistance testing performed per ISO 10271.
- Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-18 (chemical analysis).
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.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Straumann USA, LLC Mr. Christopher Klaczyk Director, Regulatory and Clinical Affairs 60 Minuteman Road Andover, Massachusetts 01810
Re: K150899
Trade/Device Name: Straumann® CARES® Titanium Alloy (TAN) Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 12, 2015 Received: August 13, 2015
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.
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 (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
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) K150899
Device Name
Straumann® CARES® Titanium Alloy (TAN) Abutments
Indications for Use (Describe)
The Straumann CARES® TAN abutments 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)
X 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
K150899
| 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 |
| Date Prepared: | August 29, 2015 |
| 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® Titanium Alloy (TAN) Abutments |
| Primary Predicate
Device: | K061277 - Straumann RN CARES Ceramic Coping |
| Reference Predicate
Device(s): | K072151 – P.004 RC CARES Titanium and Ceramic Abutment
K081005 – P.004 NC CARES Titanium and Ceramic Abutment |
| Reference Device(s): | K052272 – Straumann RN CARES Titanium Abutment
K082764 – Straumann CARES WN Titanium Coping |
| Device Description: | Straumann® CARES® TAN Abutments are used for the
restoration of Straumann dental implants of different types,
endosteal diameters, lengths. The abutments are available with
interface geometry compatible with the bone level NC (3.3 mm)
and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and
WN (4.8 mm) implants. The proposed CARES® TAN
abutments are provided in a set that contains the individualized
abutment and a corresponding basal screw.
The Straumann CARES TAN Abutments allow for individual
customization regarding function and esthetics. Straumann
CARES TAN Abutments are designed by the customer either
by means of a traditional wax-up abutment that is subsequently |
4
scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out. Design limits are as follows:
| | Predicate
Ceramic | Subject
TAN
RC, RN 4.1, WN | Subject
TAN
NC, RN 3.3 |
|---------------------|----------------------|----------------------------------|------------------------------|
| Parameter | Limit | Limit | Limit |
| Max.
Angulation | 30° | 30° | 0° |
| Emergence
Offset | 0.1 mm | 0.1 mm | 0.1 mm |
| Emergence
Angle | 65° | 65° | 65° |
| Min.
Thickness | 0.5 mm | 0.4 mm | 0.4 mm |
| Smooth
Distance | 0.5 mm | 0.5 mm | 0.5 mm |
The Straumann CARES TAN Abutments can be directly veneered or a dental restoration like a crown or bridge can be cemented to the abutments.
- The Straumann CARES® TAN abutments are indicated for Indications For Use: single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
- Intended Use: Prosthetic components connected to the implant are intended for use as an aid in prosthetic rehabilitation.
- Materials: The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11.
Technological See table below. Characteristics:
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| FEATURE | SUBJECT
Straumann® CARES® TAN
Abutments | PREDICATE
Straumann® CARES®
Ceramic Abutments
(K061277, K072151, K081005) | REFERENCE
Straumann® CARES®
Titanium Abutments
(K052272, K072151, K081005,
K082764) | Equivalence
Discussion |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for | The Straumann CARES® TAN | Abutments are placed into the | Abutments are placed into the | Equivalent |
| Use | abutments are indicated for
single tooth replacement and
multiple tooth restorations. The
prosthetic restoration can be
cemented or directly veneered/
screw-retained. | dental implants to provide
support for prosthetic restoration
such as crowns, bridges and
overdentures.
The P.004 NC CARES Ceramic
Abutment is indicated for single
tooth replacements and multiple
tooth restorations. The
prosthetic restoration can be
cemented or directly
veneered/screw retained. | dental implants to provide
support for prosthetic restoration
such as crowns, bridges and
overdentures.
The P.004 NC CARES Titanium
Abutment is indicated for
cemented restoration. The
abutment can be used in single
tooth replacements and multiple
tooth restorations. | The indicated uses of the subject
and ceramic predicate devices
are equivalent, including the
ability to be directly veneered;
the opening paragraph for the
ceramic abutments does not
materially change the
indications.
The predicate titanium
abutments are not indicated for
direct veneering. |
| Abutment | Titanium-Aluminum-Niobium | Zirconium dioxide ceramic | Commercially pure grade 4 | Equivalent |
| Material | alloy (Ti-6Al-7Nb, TAN) | (ZrO2) | titanium | Different materials, both
meeting accepted standards for
use in dental restorations |
| FEATURE | SUBJECT
Straumann® CARES® TAN
Abutments | PREDICATE
Straumann® CARES®
Ceramic Abutments
(K061277, K072151, K081005) | REFERENCE
Straumann® CARES®
Titanium Abutments
(K052272, K072151, K081005,
K082764) | Equivalence
Discussion |
| Abutment
Apical
Design | Engaging | Engaging | Engaging | Equivalent |
| | BoneLevel | BoneLevel | BoneLevel | The subject TAN abutments
employ the same implant-to-
abutment platforms as the
titanium predicates. The
ceramic predicates do not
include the WN platform. |
| | Narrow CrossFit (NC) | Narrow CrossFit (NC) | Narrow CrossFit (NC) | |
| | Regular CrossFit (RC) | Regular CrossFit (RC) | Regular CrossFit (RC) | |
| | Tissue Level | Tissue Level | Tissue Level | |
| | Regular Neck (RN) | Regular Neck (RN) | Regular Neck (RN) | |
| | Wide Neck (WN) | | Wide Neck (WN) | |
| Abutment
Coronal
Design | CADCAM design process. | CADCAM design process. | CADCAM design process. | Identical |
| | Designs controlled by material- | Designs controlled by material- | Designs controlled by material- | |
| | specific design limits in the | specific design limits in the | specific design limits in the | |
| | CARES Visual CAD software, | CARES Visual CAD software, | CARES Visual CAD software, | |
| | model verification performed by | model verification performed by | model verification performed by | |
| | the CAM software and milling | the CAM software and milling | the CAM software and milling | |
| | blank dimensions used by the
Straumann milling center. | blank dimensions used by the
Straumann milling center. | blank dimensions used by the
Straumann milling center. | |
| FEATURE | SUBJECT
Straumann® CARES® TAN
Abutments | PREDICATE
Straumann® CARES®
Ceramic Abutments
(K061277, K072151, K081005) | REFERENCE
Straumann® CARES®
Titanium Abutments
(K052272, K072151, K081005,
K082764) | Equivalence
Discussion |
| CAD Design
Limits | RC, Ø4.1RN, WN platforms:
Max. Angulation 30°
Emergence Offset 0.1 mm
Emergence Angle 65°
Min. Thickness 0.4 mm
Smooth Distance 0.5 mm
NC, Ø3.3RN platforms:
Max. Angulation 0°
Emergence Offset 0.1 mm
Emergence Angle 65°
Min. Thickness 0.4 mm
Smooth Distance 0.5 mm | All platforms:
Max. Angulation 30°
Emergence Offset 0.1 mm
Emergence Angle 65°
| All platforms:
Max. Angulation 30°
Emergence Offset 0.1 mm
Emergence Angle 65°
Min. Thickness 0.33 mm
Smooth Distance 0.5 mm | Equivalent
The applied limits are identical
with the exception of minimum
wall thickness which is a
function of the material
properties. The minimum wall
thickness for TAN is within the
range defined by the ceramic
and titanium predicates. |
| Directly
Veneerable? | Yes | Yes | No | Equivalent
The veneering technique for the
subject devices requires an
initial firing to form the oxide
layer, otherwise it is identical to
that for the ceramic abutments. |
6
7
8
| 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 via bench studies. Dynamic fatigue test
data consistent with FDA guidance and ISO 14801 have been
provided in support of this submission. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Veneer testing consistent with ISO 9693-1 has been provided in
support of this submission. |
| | Corrosion resistance testing performed per ISO 10271 has been
provided in support of this submission. |
| | Biocompatibility testing per ISO 10993-5 (cytotoxicity) and
ISO 10993-18 (chemical analysis) have been submitted in
support of this submission. |
| 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. |