(183 days)
No
The document describes a dental implant and its physical characteristics and performance testing. There is no mention of AI or ML technology.
Yes
The device is described as "Dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment," indicating it is used to treat or replace missing teeth, which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the BIOMET 3/ Dental implants are for surgical placement and prosthetic attachment, not for diagnosing any condition.
No
The device description clearly states the device is manufactured from titanium and describes physical features and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the jaw to provide prosthetic attachment. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the physical characteristics and materials of a dental implant. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other bodily fluids, which are characteristic of IVD devices. The performance studies focus on mechanical properties and clinical survival rates of the implant itself.
Therefore, the BIOMET 3/ Dental implants are a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3/T3 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.
BIOMET 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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Product codes
DZE
Device Description
The 3i T3 Dental Implants are manufactured from Commercially Pure Grade 4 titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. The dental implants will consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection/anti-rotation feature; 3.25 and 4/3mm has a 12pt dual hex; 4, 5, 6, 5/4 & 6/5mm has a six-point hex at the top and lower 12-point dual hex. The 3i T3 Dental Implants are available with either the Prevail platform switching feature or standard collar. In addition, the implants are offered with and without the nano-scale discrete crystalline deposition (DCD) calcium phosphate (CaP) surface treatment.
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
- 3/T3 & 3/T3 with DCD Implants - Cyclic Fatigue Testing: ISO 14801:2007, Cyclic Fatigue testing met indications.
- 3/T3 & 3/T3 with DCD Implants - Print Verification: Biomet 3i procedure, Comparison of the original and design verification test models confirms the prints convey the design intent.
Comparative Performance Information Summary
- 31 T3 vs. 31T3 with DCD Implants - Cyclic Fatigue Testing: Requirement: Meet or exceed parameters. New Device: Meet. Predicate Device: K100724.
- 3/T3 with DCD Nano-Scale Calcium Phosphate Adhesion Strength: Requirement: Meet or exceed parameters. New Device: Exceed. Predicate Device: K051461.
- Tolerance Analysis 3iT3 & 3/T3 with DCD Implants - Tolerance Analysis: Requirement: Meet or exceed parameters. New Device: Meet. Predicate Device: K100724.
- 3/T3 and 3/T3 with DCD Implants - Torque Testing: Requirement: Meet or exceed parameters. New Device: Meet. Predicate Device: K100724.
- 3iT3 & 3iT3 with DCD Implants - Fit Check/ Mating Analysis: Requirement: Meet or exceed parameters. New Device: Meet. Predicate Device: K100724.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Data was provided from postmarket clinical studies of the prodicato implants cronented or cunnorted by Biomet 22. Data on over 6,829 implants placed in the posterior from 1996 -2011 were available to demonstrate the difference in clinical survival rates for the various diameters of implants. None of the implant cases included fracture as an etiology for implant failure.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No additional clinical testing was necessary for a determination of substantial equivalence. The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100724, K063341, K051461, K00321
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
Image /page/0/Picture/0 description: The image contains the text "BIOMET 3i" in a stylized, bold font. The letters are outlined, giving them a three-dimensional appearance. The "3i" portion of the text is smaller and has a trademark symbol next to it.
K 1.22300
JAN 3 0 2013
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | BIOMET 3i |
| Address | 4555 Riverside Drive |
| Palm Beach Gardens, Florida 33410 | |
| Phone number | (561) 776-6840 |
| Fax number | (561) 514-6316 |
| Establishment | |
| Registration Number | 1038806 |
| Name of contact | |
| person | Jacquelyn Hughes |
| Date prepared | January 17, 2012 |
| Name of device | |
| Trade or proprietary | |
| name | 3i T3 Dental Implant |
| Common or usual | |
| name | Endosseous Dental Implants |
| Classification name | Implant, Endosseous, Root-Form |
| Classification panel | Dental |
| Regulation | 21CFR §872.3640 |
| Product Code(s) | DZE |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K100724 OSSEOTITE® 2 Certain Implants |
| K063341 Certain® Implants | |
| K051461 NanoTite® Implants | |
| K00321 ITI Dental Implant System | |
| Reason for 510(k) | |
| submission | Addition to BIOMET 3i dental implant product line to include |
| an implant with a multi-level surface topography by adding a | |
| Calcium Phosphate (CaP) media-blasted roughened surface | |
| on the apical aspect of existing BIOMET 3i Certain internal | |
| connection OSSEOTITE 2 (K100724) and internal | |
| connection Tapered (K063341) product lines. | |
| Device description | The 3i T3 Dental Implants are manufactured from |
| Commercially Pure Grade 4 titanium and feature a | |
| roughened apex and traditional OSSEOTITE® coronal | |
| surface. The dental implants will consist of a straight wall | |
| or tapered body type with a basic screw-type design in | |
| various platform options and feature an internal | |
| connection/anti-rotation feature; 3.25 and 4/3mm has a | |
| 12pt dual hex; 4, 5, 6, 5/4 & 6/5mm has a six-point hex at | |
| the top and lower 12-point dual hex. The 3i T3 Dental | |
| Implants are available with either the Prevail platform | |
| Intended use of the device | switching feature or standard collar. In addition, the implants are offered with and without the nano-scale discrete crystalline deposition (DCD) calcium phosphate (CaP) surface treatment. |
| The 3/T3 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. | |
| Indications for use | BIOMET 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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. |
4555 Riverside Drive
Palm Beach Gardens, FL 33410 Office: 561.776.6700 Fax: 561.776.6762
www.3i -online.com
1
Image /page/1/Picture/0 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a stylized font. The "i" in "3i" has a small box above it with the letters "TM" inside.
Summary of the technological characteristics of the device compared to the predicate
| Characteristic | New Device | K100724 | K063341 | K051461 | K003271 |
|---|---|---|---|---|---|
| Description | 3i T3 Dental | Osseotite 2 | Certain | Nanotite | Dental |
| Implants | Dental | Implants | Implants | Implant | |
| Implants | System | ||||
| Material | CP4 Titanium | CP4 Titanium | CP Titanium | CP Titanium | CP4 |
| (ASTM F67) | (ASTM F67) | (ASTM F) | (ASTM F67) | Titanium | |
| Ti -6AL-4V | Ti -6AL-4V | (ASTM F67) | |||
| (ASTM F136) | (ASTM F136) | ||||
| Surface | Grit Blast | Acid-etch | Acid-etch | Acid-etch | Grit Blast |
| Finish | Acid-etch | DCD | Acid-etch | ||
| DCD | |||||
| Implant | Straight-Wall | Straight-wall | Straight-Wall | Straight-Wall | Solid self- |
| Design | Tapered | Tapered | Tapered | tapping | |
| Collar Design | Standard | Standard | Standard | Standard | Unknown |
| Prevail | Prevail | Prevail | |||
| Diameter | Standard: | Standard: | Standard: | Standard: | various |
| 3.25- 6mm | 3.25- 6mm | 3.25- 6mm | 3.25- 6mm | ||
| Prevail: | Prevail: | Prevail: | |||
| 4/3-6/5mm | 4/3-6/5mm | 4/3-6/5mm | |||
| Length | 8.5-18mm | 8.5-18mm | 7-20mm | 8.5-20mm | various |
| Connection | Internal | Internal | Internal | Internal | External |
| Labeling | Sterile | Sterile | Sterile | Sterile | Sterile |
| PERFORMANCE DATA |
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Office: 561.7776.6700
Fax: 561.7776.6762
www.3i -online.com
2
Image /page/2/Picture/0 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 and to the right of the word "BIOMET".
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||||||
|---|---|---|---|---|---|---|
| SUBSTANTIAL EQUIVALENCE | ||||||
| Performance Test Summary-New Device | ||||||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | ||||
| 3/T3 & 3/T3 with DCD | ISO 14801:2007 | Cyclic Fatigue testing met | ||||
| Implants - Cyclic Fatigue | indications | |||||
| Testing | ||||||
| 3/T3 & 3/T3 with DCD | Biomet 3i procedure | Comparison of the original | ||||
| Implants - Print Verification | and design verification test | |||||
| models confirms the prints | ||||||
| convey the design intent. | ||||||
| Comparative Performance Information Summary | ||||||
| Characteristic | Requirement | New Device | Predicate Device | |||
| 31 T3 vs. 31T3 with DCD | Meet or exceed | Meet | K100724 | |||
| Implants - Cyclic Fatigue | parameters | |||||
| Testing | ||||||
| 3/T3 with DCD Nano-Scale | Meet or exceed | Exceed | K051461 | |||
| Calcium Phosphate | parameters | |||||
| Adhesion Strength | ||||||
| Tolerance Analysis 3iT3 & | Meet or exceed | Meet | K100724 | |||
| 3/T3 with DCD Implants - | parameters | |||||
| Tolerance Analysis | ||||||
| 3/T3 and 3/T3 with DCD | Meet or exceed | Meet | K100724 | |||
| Implants - Torque Testing | parameters | |||||
| 3iT3 & 3iT3 with DCD | Meet or exceed | Meet | K100724 | |||
| Implants - Fit Check/ | parameters | |||||
| Mating Analysis | ||||||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||||||
| SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||||||
| Clinical Performance Data/Information: Data was provided from postmarket clinical studies | ||||||
| of the prodicato implants cronented or cunnorted by Biomet 22. Data on over 6. 200 |
sponsored or supported by Biomet 31. Data on over 6,829 implants placed in the posterior from 1996 -2011 were available to demonstrate the difference in clinical survival rates for the various diameters of implants. None of the implant cases included fracture as an etiology for implant failure.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No additional clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2013
Ms. Jacquelyn A. Hughes, RAC Director, Regulatory Affairs & Clinical Research Biomet 31 4555 Riverside Drive PALM BEACH GARDENS FL 33410
Re: K122300
i
Trade/Device Name: 3i T3TM Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 9, 2013
Received: January 14, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K122300 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 3i T3™ Dental Implants
Indications For Use:
BIOMET 3/ 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, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
| Susan Runner DDS, MA | 2013.01.24 |
|---|---|
| 15:26:11 -05'00' |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: