(13 days)
Not Found
No
The document describes a physical dental abutment and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: The device is an abutment for dental implants, providing structural support for prosthetics. It does not actively treat or diagnose a disease or condition.
No
The device, an abutment for dental implants, is designed to support prosthetic reconstructions. Its function is structural and restorative, not to provide diagnostic information about a patient's condition.
No
The device description clearly states that the device is made from commercially pure Grade 4 titanium and is a physical component (abutment) placed into a dental implant. It is part of a system of physical dental implants, abutments, and surgical/prosthetic parts.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is an abutment intended to be placed into dental implants to support prosthetic reconstructions. It is a physical component used in a surgical and restorative procedure within the mouth.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the oral cavity.
The information provided describes a dental prosthetic component, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI synOcta Measo abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
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 devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.
The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
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
Not Found
Key Metrics
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
K033 243
ATTACHMENT 6 - 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 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Contact Person: Linda Jalbert Director, Requlatory Affairs
2. Name of the Device
Trade Name: Common Name: Classification Name: ITI synOcta Meso Abutments Dental implant abutment Endosseous dental implants 21 CFR 872.3640
3. Devices to which Equivalence is Claimed Legally Marketed (Predicate Devices)
ITI Esthetic Abutments (K020096)
4. Description of the Device
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 devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.
The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.
1
Intended Use of the Device 5.
The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Basis for Substantial Equivalence 6.
The ITI esthetic abutments are substantially equivalent in intended use, material, and design to the ITI esthetic ease abutments previously cleared under K020096.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three overlapping profiles of human faces, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2003
Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Walth, Massachusetts 02451
Re: K033243
Trade/Device Name: ITI Synocta Meso Abutments Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: October 7, 2003 Received: October 10, 2003
Dear Ms. Jalbert:
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 -Ms. Jalbert
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 (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.
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- 4618. 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,
Sina Runon
Chiu Lin, Ph.D.
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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Page 1 of 1
510(k) Number (if known):
(033243
Device Name: ITI synOcta Meso Abutments
Indications For Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI synOcta Measo abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Runo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033243
Special 510(k) for synOcta Meso Abulments ITI Dental Impiani System Oclober 6, 2003