(134 days)
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No
The document describes a custom-designed dental abutment and its intended use, with no mention of AI or ML technology in its design, manufacturing, or function.
Yes
The device is a dental abutment, which is a component used in dental implants to support prosthetic reconstructions, directly contributing to the restoration of oral function and esthetics for the patient.
No
The device description clearly states its purpose is to "provide support for prosthetic reconstructions such as crowns or bridges" and is "inserted into the implant with a basal screw" to support a prosthetic reconstruction. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a physical titanium abutment, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutment is placed into dental implants to support prosthetic reconstructions. This is a surgical/dental procedure, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a physical component of a dental implant system used for structural support. It does not describe a test or assay for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Straumann C.A.R.E.S. Titanium Abutment is a medical device used in dental procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann C.A.R.E.S. Titanium Abutment is a device that provides support for cement-retained prosthetic reconstruction, such as a crown. The Straumann C.A.R.E.S. Titanium Abutment is of particular interest in the anterior, canine, and premolar regions where there are high esthetic demands, will be uniquely customized for an individual then placed into the dental implant.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations {crowns, bridges, overdentures}. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Titanium Abutment, is designed to be custom modified for a particular patient, then inserted into the implant with a basal screw. The titanium abutment provides support for a prosthetic reconstruction, such as a crown.
The Straumann C.A.R.E.S. Titanium abutment is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Titanium Abutment are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/0 description: The image shows the text "JAN 3 2006" on the top line and "K052272" on the second line. The second line is underlined. The text appears to be handwritten.
510 (k) Summary
1 . Applicant's Name and Address
Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810 Telephone Number: 800-448-8168 Fax Number: 978-747-003 1 Contact Person: Elaine Alan Regulatory and Clinical Affairs
2. Name of the Device
| Trade Name: | Straumann Computer Aided Restoration Service
(C.A.R.E.S.) Titanium Abutment |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Abutment for endosseous implant |
| Classification Name: | Accessory to dental implant,
21 CFR 872.3640 |
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
Straumann's synOcta Meso Abutment (K033243)
Description of the Device এ.
The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations {crowns, bridges, overdentures}. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Titanium Abutment, is designed to be custom modified for a particular patient, then inserted into the implant with a basal screw. The titanium abutment provides support for a prosthetic reconstruction, such as a crown.
The Straumann C.A.R.E.S. Titanium abutment is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Titanium Abutment are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.
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5. Intended Use of the Device
The Straumann C.A.R.E.S. Titanium Abutment is a device that provides support for cement-retained prosthetic reconstruction, such as a crown. The Straumann C.A.R.E.S. Titanium Abutment is of particular interest in the anterior, canine, and premolar regions where there are high esthetic demands, will be uniquely customized for an individual then placed into the dental implant.
ర. Basis for Substantial Eguivalence
The Straumann C.A.R.E.S. Titanium Abutment is substantially equivalent to previously cleared meso titanium abutments intended to be used with endosseous dental implants. The design of the subject abutment is very similar to the previously cleared Straumann synOcta Meso Abutment (K033243). Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elaine Alan Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K052272
Trade/Device Name: Straumann C.A.R.E.S. Titanium Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 20, 2005 Received: December 21, 2005
Dear Ms. Alan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affectung 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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Page 2 - Ms. Alan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clive
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K
Straumann C.A.R.E.S. Titanium Abutment Device Name:
Indications for Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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