(112 days)
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No
The summary describes a physical dental abutment and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a dental abutment, which is a component used in dental implants to support prosthetics, thus serving a therapeutic purpose to restore function and aesthetics.
No
The provided text describes a ceramic abutment for dental implants, which serves as a prosthetic attachment. Its intended use is to extend the implant's coronal aspect through tissues for prosthetic attachment, not to diagnose a condition or disease.
No
The device description clearly states it is comprised of physical components (zirconium ceramic, titanium alloy core, apatite glass-ceramic seal) and undergoes manufacturing processes like machining, molding, bonding, cleaning, inspection, packaging, and sterilization. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for supporting dental prosthetics. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implant component made of ceramic and titanium, designed to be surgically placed. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on mechanical properties like cyclical fatigue, static load, and torsional strength, which are relevant to the structural integrity of an implant component, not the analytical performance of an IVD.
Therefore, this device is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant's coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 3i ceramic abutment is comprised of three basic components: An outer cylinder or sleeve constructed from zirconium ceramic bonded to an inner machined titanium alloy core with a biocompatible, water-insoluble, apatite glass-ceranic seall. Titanium alloy cores or inserts are machined. The ceranic sleeve is molded. The two components are bonded using proprietary process. After bonding, parts are cleaned, inspected, packaged and sterilized. Sterilization is accomplished by gamma irradiation to a SAL of 10°. The 31 ceramic abutment is equivalent in physical strength characteristics as other devices.
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
oral cavity; alveolar ridges
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)
Type: Cyclical Fatigue at 30° Angle
Average result (3i): 5000000 cycles @ 300 N
Average result (Other device): 5000000 cycles @ 250 N
Type: Static load at 30° Angle
Average result (3i): 695 N
Average result (Other device): 517 N
Type: Torsional Strength
Average result (3i): 166 Ncm (Implant hex failed)
Average result (Other device): 79.5 Ncm (Abutment hex failed)
Key Results: In all physical testing undertaken, the 3i ceramic abutment performed as well or better than equivalent other devices.
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.
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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.
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510(k) SUMMARY 3i Ceramic Abutments
To 510(k) Summary Requestor:
Information contained in this summary is from an original Pre-Market Notification [510(k)] submission, provided the United States Food and Drug Administration. No pertinent or known releasable information regarding device safety or efficacy has been intentionally or otherwise knowingly deleted from that submission, for this summary.
William G. Conety
Regulatory Affairs
CLASSIFICATION NAME: Endosseous Dental Implant
COMMON/USUAL NAMES: Abutments; transmucosal abutments/elements
PROPRIETARY NAME: No established marketing name at time of submission.
CLASSIFICATION: Class III
PERFORMANCE STANDARDS: No established performance standards for abutments
FORM and CONSTRUCTION: The 3i ceramic abutment is comprised of three basic components: An outer cylinder or sleeve constructed from zirconium ceramic bonded to an inner machined titanium alloy core with a biocompatible, water-insoluble, apatite glass-ceranic seall.
Titanium alloy cores or inserts are machined. The ceranic sleeve is molded. The two components are bonded using proprietary process. After bonding, parts are cleaned, inspected, packaged and sterilized. Sterilization is accomplished by gamma irradiation to a SAL of 10 ° The 31 ceramic abutment is equivalent in physical strength characteristics as other devices.
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Cyclical Fatigue at 30° Angle (Average result)
| Other device | 3i |
|---|---|
| 5000000 cycles @ 250 N | 5000000 cycles @ 300 N |
| Static load at 30° Angle (Average result) | |
| Other device | 3i |
| 517 N | 695 N |
| 03 Torsional Strength (Average result) | |
| Other device | 3i |
| 79.5 Ncm (¹) | 166 Ncm (²) |
| ¹ Abutment hex failed | ² Implant hex failed |
In all physical testing undertaken, the 3i ceramic abutment performed as well or better than equivalent other devices.
SUBSTANTIAL EQUIVALENCE: The 3i ceramic abutment is substantially equivalent to Nobel Biocare "CerAdapt" abutment in that they are similar in outward appearance, basic design configuration and indications for use do not differ between the two.
The Nobel Biocare device is a one-piece aluminum oxide ceramic device. The 3i ceramic abutment is a three component device: Inner titanium sleeve and outer ceramic body, bonded by a compatible ceramic.
INDICATIONS: Ceramic abutments are indicated for use with endosseous dental implants, to extend implant's coronal aspect through mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.
CONTRAINDICATIONS: No known (reported) or anticipated contraindications in use of ceramic abutments when used with implants that have achieved integration in alveolar bone. 3i abutments are not indicated for use in locations other than alveolar ridges.
Implants/abutments should not be used in cases where remaining jawbone is too diminished to provide adequate width/height to surround implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is insufficient available bone or poor bone quality, poor oral hygiene, heavy smoking or tobacco use or medical conditions such as blood disorders, infection(s), vascular impairment at surgical site, uncontrolled diabetes, heavy
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smoking or tobacco abuse, drug or alcohol abuse, chronic high dose steroid therapy, medical conditions such as blood clotting disorders, current or ongoing anticoagulant therapy, metabolic bone disease or other metabolic or systemic disorders which may adversely affect bone or wound healing or cases in which the available bone is too diminished to provide adequate width or height to adequately hold implants and restorative appliances.
WARNINGS: For safe and effective use of 3i implants and abutments, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized, complex procedures. Improper patient selection and technique can cause implant and/or abutment failure with possible loss of supporting bone. 3i implants are not indicated for use in sites other than alveolar ridges.
PRECAUTIONS: Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT scans and tomogram may also be beneficial.
ADVERSE EFFECTS: Ceramic abutments: No known (reported) or anticipated adverse effects.
Loss of implant anchorage (failure to integrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage.
SURGICAL COMPLICATIONS: Ceramic abutments: No known (reported) or anticipated surgical complications. The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases, the numbness has been permanent. Gingival/mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.
Summary _ End Summary _ _ _ _ _ _ _ _
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Public Hcalth Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Mr. William G. Conety Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re : K991947 Trade Name: 3I Ceramic Abutment System Regulatory Class: III Product Code: DZE September 7, 1999 Dated: Received: September 8, 1999
Dear Mr. Conety:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listi prohibitions against misbranding practice, fabering, and
If your device is classified (see above) into either class II (Special Controls) or class II (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Conety
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaj.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K
Page 1 of 1
Device Name: Ceramic Abutment System
INDICATIONS FOR USE:
Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant's coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.
DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number