(161 days)
No
The document describes dental implants and their surface treatments, focusing on clinical study data to support performance claims. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
This device is a dental implant used for prosthetic attachment, not for treating a disease or condition.
No
Explanation: The device description and intended use clearly state that BIOMET 3i dental implants are for surgical placement and prosthetic attachment, restoring chewing function, rather than for diagnosing medical conditions.
No
The device description clearly states it is a dental implant, which is a physical hardware device intended for surgical placement. The submission is for modifications to performance claims based on clinical studies, not for a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the surgical placement of dental implants in the jaw to support prosthetic attachments for restoring chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is a dental implant, a physical object implanted into bone.
- 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 treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and prosthetic attachment.
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 31 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
DZE
Device Description
BIOMET 3i NanoTite Dental Implants cleared by K051461, K063341 & K063286 have both the proprietary OSSEOTITE acid-etched surface and NanoTite CaP Discrete Crystalline Deposition (DCD) surface treatment.
The devices themselves have not been modified since their original clearance. Specific performance claims for NanoTite Dental Implants are being modified. Two independent prospective randomized controlled studies provide clinical data to support the requested claims.
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)
Two independent prospective randomized controlled studies provide clinical data to support the requested claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MET31
| Summary of Safety and Effectiveness | ||
|---|---|---|
| This summary of 510(k) safety and effectiveness information is being submitted in | ||
| accordance with the requirements of 21 CFR § 807.92 | ||
| Submitter | Biomet 3i, Inc. | |
| 4555 Riverside Drive | ||
| Palm Beach Gardens, FL 33410 | ||
| Contact | Diana Taylor | |
| Manager, Regulatory Affairs | ||
| Biomet 3i, Inc. | ||
| 4555 Riverside Drive | ||
| Palm Beach Gardens, FL 33410 | ||
| Tel. 561-776-6857 | ||
| Fax. 561-776-6852 | JAN 31 2008 | |
| Date Prepared | August 21, 2007 | |
| Device Name | BIOMET 3i NanoTite™ Dental Implants | |
| Classification Name | Endosseous dental implant | |
| Classification | Class II, 21 CFR § 872.3640 | |
| Product Code | DZE | |
| Predicate Device(s) | K051461 - 3i Osseotite (Nano CaP) Dental Implant | |
| Device Description | BIOMET 3i NanoTite Dental Implants cleared by K051461, | |
| K063341 & K063286 have both the proprietary OSSEOTITE | ||
| acid-etched surface and NanoTite CaP Discrete Crystalline | ||
| Deposition (DCD) surface treatment. | ||
| The devices themselves have not been modified since their original | ||
| clearance. Specific performance claims for NanoTite Dental | ||
| Implants are being modified. Two independent prospective | ||
| randomized controlled studies provide clinical data to support the | ||
| requested claims. | ||
| 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 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. | ||
| Conclusion | The clinical data submitted for the NanoTite dental implant | |
| compared to the control implant supports the modifications to | ||
| specific performance claims requested within this premarket | ||
| notification. |
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08/21/07
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 31 2008
Ms. Diana Taylor Manager, Regulatory Affairs Biomet 31, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Rc: K072363
Trade/Device Name: BIOMET 3i NanoTite Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 11, 2008 Received: January 17, 2008
Dear Ms. Taylor:
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. Taylor
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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,
Syute y. Michaudmp
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
4
Indications for Use
510(k) Number (if known): Unknown
Device Name: BIOMET 3i NanoTite 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 31 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)
Susan Perry
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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