(269 days)
Not Found
No
The summary describes a dental implant device with specific surface treatments and designs. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on laboratory testing and risk analysis, not AI/ML model performance.
Yes.
The device, dental implants, is intended for surgical placement in the jaw to provide prosthetic attachment and restore chewing function, which are therapeutic actions.
No
Explanation: The device is a dental implant intended for surgical placement and prosthetic attachment. Its purpose is to restore chewing function and support dental prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical dental implant made of materials with specific surface treatments and designs, not software.
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 for surgical placement in the jaw to support dental prosthetics. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description details the physical characteristics of dental implants, such as surface treatments, designs, diameters, and lengths. These are components for implantation, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, whereas this device is a medical implant placed within the body.
N/A
Intended Use / Indications for Use
BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface, both with and without the additional proprietary NanoTite treatment. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Implants are also offered in various diameters and length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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)
Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA'S Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Results from all of these tests were included in the premarket notification submissions for the predicate device.
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.
K014235, K972444, K935554, K980549, K983347, K022009, K955428, K031475, K031632, K030614, K041402, K051189, K051461, K062432
Reference Device(s):
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 logo for BIOMET 3i. The logo is in black and white and features a stylized font. The '3i' portion of the logo is smaller than the 'BIOMET' portion.
JUN - 1 2007
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | BIOMET 3i, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410 | Device Description | BIOMET 3i Dental Implants are provided with the
proprietary OSSEOTITE acid-etched surface, both with
and without the additional proprietary NanoTite
treatment. Implants are offered in both tapered and
parallel-walled/straight designs, and each design provides
offerings for either external hex or internal connections.
Implants are also offered in various diameters and length. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jacquelyn A. Hughes, RAC
Director, RA/QA
BIOMET 3i, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6819
Fax. 561-514-6316
Email jhughes@3implant.com | Indications for Use | BIOMET 3i dental implants are intended for surgical
placement in the upper or lower jaw to provide a means
for prosthetic attachment in single tooth restorations and
in partially or fully edentulous spans with multiple single
teeth utilizing delayed or immediate loading, or as a
terminal or intermediary abutment for fixed or removable
bridgework, and to retain overdentures. |
| Date Prepared | May 30, 2007 | | BIOMET 3i Osseotite and NanoTite dental implants are
intended for immediate function on single tooth and/or
multiple tooth applications when good primary stability
is achieved, with appropriate occlusal loading, in order to
restore chewing function. |
| Device Name | BIOMET 3i Dental Implants | Technological
Characteristics | The design features and functions are identical to the
currently available OSSEOTITE, OSSEOTITE NT,
OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail,
NanoTite and BIOMET 3i implants and cover screws. |
| Classification Name | Endosseous Dental Implants | Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act |
| Device
Classification | Class II
Dental Devices Panel
21 CFR § 872.3640 | Performance Testing | Laboratory testing was conducted to determine device
functionality and conformance to design input
requirements, as well as FDA'S Class II special controls
guidance document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments. Risk
analysis was conducted in accordance with ISO 14971.
Results from all of these tests were included in the
premarket notification submissions for the predicate
device. |
| Predicate
Devices | OSSEOTITE NT Dental Implants - K014235
3i Innovation Implants and Cover Screws - K972444
Threaded/Self-Tapping Threaded Implants - K935544
OSSEOTITE Dental implants - K980549
OSSEOTITE Dental Implants - K983347
3i Dental Implants - K022009
HA- Coated Endosseous Dental Implants - K955428
3i OSSEOTITE NT Certain Implants - K031475
3i IOL Implants - K031632
3i Implants - K030614
OSSEOTITE NT Certain Implants - K041402
Prevail Implants – K051189
3i OSSEOTITE Dental Implants - K051461
NanoTite Dental Implants - K062432 | Conclusion | BIOMET 3i Dental Implants are substantially equivalent
to the dental implants described in the premarket
notification submissions for the predicate devices. |
1
.
.
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2007
Ms. Jacquelyn A. Hughes, RAC Director, Regulatory Affairs/Quality Assurance BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K062636
Trade/Device Name: BIOMET 3i Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 3, 2007 Received: May 4, 2007
Dear Ms. Hughes:
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.
3
Page 2 - Ms. Hughes
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sophie Y. M. ichleee DmD.
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
4
Image /page/4/Picture/0 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a bold, sans-serif font. The "3i" portion of the logo is smaller than the "BIOMET" portion and is located to the right of it. The logo has a textured appearance.
Indications for Use Statement
510(k) Number (if known): K062636
Device Name: BIOMET 3i Dental Implants
Indications for Use:
BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K062636 |
|---|---|
| ---------------- | --------- |