(10 days)
Not Found
No
The summary describes a mechanical dental abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is an abutment for dental implants, providing support for prosthetic reconstructions. While it aids in restoring function, it does not directly treat or cure a disease or condition in a therapeutic manner. Its primary function is structural support.
No
Explanation: The device described is an abutment for dental implants, which is a prosthetic component used to support crowns or bridges. Its function is structural and restorative, not diagnostic.
No
The device description clearly states it is an abutment, which is a physical component of a dental implant system, and describes its physical characteristics and function.
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 abutments are placed into dental bridges to support prosthetic reconstructions. This is a direct medical intervention within the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical implant system designed to be surgically placed in patients. It describes mechanical components for supporting prosthetics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This dental abutment does not fit that definition.
N/A
Intended Use / Indications for Use
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge.
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
Product codes
NHA
Device Description
The ITI 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. The device covered by this submission is an abutment.
The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw restorations.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 4 2004
KUJINGS
ATTACHMENT 7 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-0791 Fax Number: John King Contact Person: Regulatory Affairs
Name of the Device 2.
Trade Name: Common Name: Classification Name: Straumann RN synOcta UCLA Gold Abutment Dental implant abutment Endosseous dental implants 21 CFR 872.3640
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
Straumann 1.5mm synOcta Abutment with Gold Coping (K022859)
Description of the Device 4.
The ITI 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. The device covered by this submission is an abutment.
The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw restorations.
5. Intended Use of the Device
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge.
1
6. Basis for Substantial Equivalence
The Straumann RN synOcta UCLA gold abutment is substantially equivalent in intended use, material, and design to the 1.5 mm synOcta abutments and gold copings cleared under K022859. The intended use of the subject abutiment is identical to the predicate abutment.
5 l0(k) RN synOcta UCLA Gold Abutment
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized graphic of three wavy lines, which are meant to represent the flow of people.
Public Health Service
MAY 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Mr. John King Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K041295
Trade/Device Name: RN SynOcta UCLA Gold Abutment For the Straumann Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 13, 2004 Received: May 14, 2004
Dear Mr. King:
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.
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Page 2 - Mr. King
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 Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
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): K041295
Device Name: RN synOcta UCLA Gold Abutment
Indications for Use:
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
AND/OR Prescription Use _ x (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
Page 1 of _
510(k) Number. K041105