(405 days)
Not Found
Not Found
No
The 510(k) summary describes a dental abutment and coping, which are mechanical components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device, ceramic hextop abutments and ceramic copings, are components used in dental implant systems to form the substructure of a prosthesis. They do not directly treat or prevent a disease or condition; rather, they serve as a structural part of a restorative dental procedure.
No
The device description indicates that the ceramic hextop abutments and ceramic coping are components of a dental implant system used for prosthetic reconstruction, not for diagnosing medical conditions.
No
The device description clearly indicates physical components (ceramic hextop abutments, ITI® ceramic coping) used in dental procedures, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a component of a dental prosthesis, designed to be seated on a dental implant within the patient's mouth. This is a direct interaction with the human body for a restorative purpose.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Being used in a laboratory setting
IVDs are devices used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) as a structural component of a dental restoration.
N/A
Intended Use / Indications for Use
Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Not Found
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.
Not Found
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
§ 872.3640 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized eagle. The eagle is depicted with three horizontal lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SFP 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara J. Lewandowski Vident 3150 East Birch Street Brea, California 92821
Re: K012473
Trade/Device Name: Ceramic Hextop Abutment and SynOcta® In-Ceram Coping Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 18, 2002 Received: June 21, 2002
Dear Mr. Lewandowski:
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.
1
Page 2 -- Ms. Lewandowski
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski
Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if known):
Device Name: Ceramic Hextop Abutment
Indications For Use:
Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Prager
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices
510(k) Number K012473
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)
3
510 (k) Number (if known):
Device Name: ITI® Dental Implant System - Ceramic Coping
Indications For Use:
The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Remmo
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices
510(k) Number K012473
Prescription Use / (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)