(74 days)
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No
The document describes a mechanical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, an angled abutment for dental implants, is a prosthetic component used to support dental restorations, not to treat or cure a disease or condition. While it aids in optimal restoration, its primary function is mechanical support.
No
The device is an angled abutment used to support prosthetic dental restorations, indicating a therapeutic or reconstructive purpose rather than detecting or diagnosing a disease or condition.
No
The device description clearly states it is a physical component (angled abutment made of titanium) used in dental implants, not a software program.
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 this device is an angled abutment used in dental implants to support prosthetic devices. It is a physical component implanted into the body.
- Intended Use: The intended use is for supporting dental crowns and bridges in patients with dental implants. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
Therefore, this device falls under the category of a medical device (specifically, a dental implant component), but not an IVD.
N/A
Intended Use / Indications for Use
The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Product codes (comma separated list FDA assigned to the subject device)
DZE
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 angled abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the position of the dental implant requires an angled reconstruction for an optimal restoration.
The 15° synOcta angled abutment for the Wide Neck Implant is made from commercially pure Grade 4 titanium (F67). The basal portion of the abutment has an 8° conical taper with 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 restorations.
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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§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
KOI 3891
FEB 0 5 2002
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: Linda Jalbert Contact Person: Director, Regulatory Affairs
2. Name of the Device
Trade Name: Common Name: Classification Name: ITI® synOcta Angled Abutments Dental implant abutment Endosseous dental implants 21 CFR 872.3640
Devices to which Equivalence is Claimed 3. Legally Marketed (Predicate Devices)
ITI synOcta Angled Abutment (K994119)
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 angled abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the position of the dental implant requires an angled reconstruction for an optimal restoration.
The 15° synOcta angled abutment for the Wide Neck Implant is made from commercially pure Grade 4 titanium (F67). The basal portion of the abutment has an 8° conical taper with an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the
1
basal portion of the abutment. The abutment is used for cemented restorations.
5. Intended Use of the Device
The subject devices of this 510(k) are angled abutments which are used for angulation correction in cases where the position of the implant requires an angled abutment for optimal restoration. The subject abutments are designed for use with the ITI Wide Neck Implant with internal octagon. The subject abutments are modifications of the ITI synOcta angled abutments, cleared under K994119.
6. Basis for Substantial Equivalence
The ITI synOcta angled abutments for the Wide Neck Implant are substantially equivalent in intended use, material, and design to the ITI synOcta angled abutments cleared under K994119.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a double helix intertwined around a staff. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Institut Straumann AG C/O Ms. Linda Jalbert Straumann USA 1601 Trapelo Place Waltham, Massachusetts 02451
Re: K013891
Trade/Device Name: SynOcta Angled Abutments for the ITI® Wide Neck Implant Regulation Number: 872.3640 Regulation Name: Dental Implant Abutment Regulatory Class: III Product Code: DZE Dated: January 28, 2002 Received: January 29, 2002
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.
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.
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Page 2 - Ms. Jalbert
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
Timothý A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
K613891 510(k) Number (if known):
Device Name: synOcta Angled Abutments for the ITI® Wide Neck Implant
Indications For Use:
The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for 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)
Sverker
(Division Sign-Off) ാസ്.sion of Dental, Infection Control, and General Hospital Devices (134) F 100k) Number _______________________________________________________________________________________________________________________________________________________________