(382 days)
No
The summary describes a standard dental implant made of titanium with specific design features and connections. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on mechanical testing of the implant itself.
No
The device is a dental implant used for anchoring prostheses, not for treating a disease or condition.
No.
The device is a dental implant used for anchoring prostheses, not for diagnosing medical conditions.
No
The device description clearly states it is an endosseous dental implant made of Commercially Pure Titanium, indicating it is a physical hardware device.
Based on the provided text, 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 either jaw and used for anchoring or supporting single- and multiple-unit prostheses." This describes a surgical implant used directly in the body for structural support.
- Device Description: The description details a "endosseous dental implant made of Commercially Pure Titanium" with specific physical characteristics and a connection for restorative components. This is a physical device implanted into bone.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The description of this device and its intended use do not align with the definition of an IVD. It is a surgically implanted device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Full OSSEOTITE® Certain® II Dental Implant is a dental implant made of Commercially Pure Titanium. It comes in various lengths (8.5mm to 20.0mm) and body diameters (Ø3.25mm, 4.0mm, 5.0mm, 6.0mm), with corresponding seating platform diameters. The implant has a straight-walled design with a Full OSSEOTITE® surface. It features an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components and an Incremental Cutting Edge (I.C.E.) with apical taper for self-tapping. The device is packaged in a sterile tray with a cover screw and is sterilized by Gamma Irradiation, with a shelf life of 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
either 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)
Design Verification Testing was performed, including cyclic fatigue and static angle bend testing, as well as additional design verification tests to ensure proper device functioning. The FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004) was used as the basis for design verification testing. The results of the performance testing demonstrate that the BIOMET 3i Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to their predicate designs.
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.
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.
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
. APR - 1 20i1
510(k) Summary – K100724
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
| Establishment Reg. | 1038806 |
|---|---|
| Number: | |
| Contact: | Jose E. Cabrera, Sr. Manager, Regulatory Affairs |
| BIOMET 3i | |
| 4555 Riverside Drive | |
| Palm Beach Gardens, FL 33410 | |
| Tel. 561-776-6923 | |
| Fax. 561-514 6316 | |
| Email jose.cabrera@BIOMET.com | |
| Date Prepared: | May 19th, 2010 |
| Trade/Proprietary | |
| Name: | Full OSSEOTITE® Certain® II Dental Implant |
| Common/Usual | |
| Name: | Dental Implant |
| Classification | |
| Name: | Endosseous Dental Implant |
| Device | |
| Classification/Code: | Class II - 21 CFR §872.3640 / DZE |
| Predicate Devices: | K063341 BIOMET 3i OSSEOTITE® Dental Implant System |
| K062636 BIOMET 3i Dental Implants | |
| Indications for Use: | BIOMET 3i Dental Implants are intended for surgical placement in |
| either jaw and used for anchoring or supporting single- and multiple-unit | |
| prostheses. BIOMET 3i Dental Implants can be immediately loaded | |
| when primary stability and proper occlusion have been established. | |
| Statement of | |
| Equivalence: | Full OSSEOTITE® Certain® II Dental Implants are substantially |
| equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have | |
| been previously cleared in K063286 and K063341 |
1
Technological
Characteristics:
| Criteria | Predicate BIOMET 3i
Dental Implant(s) | Proposed BIOMET 3i
Full OSSEOTITE® Certain® II
Dental Implants |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Lengths | Ø3.25: 8.5, 10.0, 11.5,
13.0, 15.0, 18.0mm
Ø4.0: 8.5, 10.0, 11.5,
13.0, 15.0, 18.0, 20.0mm
Ø5.0: 8.5, 10.0, 11.5,
13.0, 15.0mm
Ø6.0: 8.5, 10.0, 11.5,
13.0, 15.0mm | Ø3.25: 8.5, 10.0, 11.5, 13.0, 15.0,
18.0mm
Ø4.0: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0,
20.0mm
Ø5.0: 8.5, 10.0, 11.5, 13.0, 15.0mm
Ø6.0: 8.5, 10.0, 11.5, 13.0, 15.0mm |
| Implant Body
Diameters | Ø3.25, 4.0, 5.0, 6.0mm | Ø3.25, 4.0, 5.0, 6.0mm |
| Seating Platform
Diameter | Ø3.4, 4.0, 5.0, 6.0mm | Ø3.4, 4.0, 5.0, 6.0mm |
| Material | • Commercially Pure
Titanium
• Titanium Alloy | Commercially Pure Titanium |
| Biocompatible | Yes | Yes |
| Thread Design | • 60° thread & 0.6mm
pitch (Straight-Wall)
• 60° thread & 0.9mm
pitch (Straight-Wall)
• 35° thread & 0.8mm
pitch (Tapered) | • 60° thread & 0.6mm pitch (Straight-
Wall)
• 35° thread & 0.8mm pitch (Straight-
Wall) |
| Implant Design | Straight-walled implant
body | Straight-walled implant body |
| Self Tapping
Feature | Incremental Cutting Edge
(I.C.E.) with apical taper | Incremental Cutting Edge (I.C.E.) with
apical taper |
| Implant Surface | • OSSEOTITE®
• Full OSSEOTITE® | Full OSSEOTITE® |
| Color-Coding | • Anodized Seating
Surface
• Color-Coded Labeling | • Anodized Seating Surface
• Color-Coded Labeling |
| Packaging | Packaged in sterile tray
with cover screw | Packaged in sterile tray with cover
screw |
| Sterilization | Sterile (Gamma
Irradiation) | Sterile (Gamma Irradiation) |
| Shelf Life | 5 Years | 5 Years |
| Implant
Placement
Protocol | Per BIOMET 3i Surgical
Catalog CATSM | Per BIOMET 3i Surgical Catalog
CATSM |
| Implant/Abutment
Mating
Connection | Internal Hexagon
Connection | Internal Hexagon Connection |
| Mating
Components | All BIOMET 3i Certain®
Restorative Components | All BIOMET 3i Certain® Restorative
Components |
·
2
BIOMET 31 has established Design Verification Testing to be performed as well as acceptance criteria. These tests include cyclic fatigue and static angle bend testing as well as additional design verification tests to ensure proper device functioning. FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004) is used as the basis for design verification testing.
Proposed Design(s) Vs. Predicate BIOMET 3i Endosseous Implant Design(s):
• Full OSSEOTITE® Certain® II Dental Implants are manufactured from the same Commercially Pure Titanium material as BIOMET 3i External Hex implants and have the same indications and usage as predicated BIOMET 3i implants.
·03.25 & 04.0mm diameter implants utilize the same thread design (pitch, thread angle, minor/major diameters) as predicate BIOMET 3i Straight-Walled implant devices.
·05.0 & Ø6.0mm diameter implants utilize the same thread design (pitch & thread angle) as predicate BIOMET 3i Tapered Implants and the same thread dimensions (minor/major diameters) as predicate BIOMET 31 Straight-Walled implant devices.
· Full OSSEOTITE® Certain® II dental implants have less apical taper shorter apical cutting flute heights.
·Since all BIOMET 3i Endosseous Dental Implants are tested according to FDA Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, the comparison of performance criteria between the proposed design and the predicates is evident.
Conclusion:
The BIOMET 3i Full OSSEOTITE® Certain® II Dental Implants and predicate designs have the same intended use, indications, similar technological characteristics and principles of operation.
The differences noted above do not present new issues of safety or effectiveness for the Full OSSEOTITE® Certain® II Dental Implants. Design verification and performance testing to verify and/or validate the changes has been conducted when risk analysis indicated mitigation with testing necessary. The results of the performance testing demonstrate that the BIOMET 3i Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to their predicate designs.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jose E. Cabrera Senior Manager - Regulatory Affairs BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410
APR - 1 201
Re: K100724
Trade/Device Name: Full OSSEOTITE® Certain® II Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 23, 2011 Received: March 24, 2011
Dear Mr. Cabrera:
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
Page 2 - Mr. Cabrera
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for?
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number:
Device Name:
Full OSSEOTITE® Certain® II Dental Implant
Indications for Use:
BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.
Prescription Use __
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Dovices
510(k) Number:
4 of 91