(9 days)
Not Found
No
The summary describes a dental abutment, a mechanical component, and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an abutment for dental implants, used to support prosthetic restorations. It is a structural component for a medical device rather than a standalone therapeutic device that treats a condition or disease.
No
Explanation: The document describes a dental implant system, specifically abutments, which are therapeutic devices used to support prosthetic restorations. It does not mention any function related to diagnosing a disease, condition, or state.
No
The device description clearly states it is a system of dental implants, abutments, and surgical/prosthetic parts and instruments, indicating it includes hardware components.
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 Description: The description clearly states that the Straumann WN CARES Titanium Abutment is a component of a dental implant system. It is a physical device placed into the body to support prosthetic restorations.
- Intended Use: The intended use is to provide support for dental prosthetics, which is a structural and mechanical function, not a diagnostic one performed on a sample.
Therefore, this device falls under the category of a medical device, specifically a dental implant component, rather than 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 WN CARES Titanium Abutment is 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 Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
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)
Not Found
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.
Not Found
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
Kosa764
Section I 510(k) Summary
Applicant's Name and Address 1.
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: September 19, 2008
2. Name of the Device
| Trade Name: | Straumann WN CARES Titanium Abutment |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | $§872.3630$ |
Legally Marketed Device to which Equivalence is Claimed (Predicate 3. Device)
RN CARES Titanium Abutment, K052272
4. Description of the Device
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
5. Intended Use of the Device
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cementretained.
6. Technological Characteristics
The proposed abutment is substantially equivalent to the currently cleared device. The intended use is identical to the predicate device. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently cleared device.
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 01 2008
Institut Straumann AG C/o Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K082764
Trade/Device Name: Straumann WN CARES Titanium Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 19, 2008 Received: September 22, 2008
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 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.
2
Pagc 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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
JHKmuele-Lindmy forell
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Device Name: Straumann WN CARES Titanium Abutment
Indications for Use:
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.
The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susa Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD82764
510(k) Submission: WN CARES Titanium September 19, 2008
Straumann US Page 5 of 58