(382 days)
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.
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. The device is an endosseous dental implant made of Commercially Pure Titanium. It is available in various lengths and diameters with a straight-walled implant body, Incremental Cutting Edge (I.C.E.) with apical taper, and a Full OSSEOTITE® surface. It has an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components. The implants are packaged in a sterile tray with a cover screw and sterilized by Gamma Irradiation with a shelf life of 5 years.
This document describes the 510(k) summary for the Full OSSEOTITE® Certain® II Dental Implant, focusing on its substantial equivalence to predicate devices rather than a study with a traditional AI-specific acceptance criteria framework. Therefore, many of the typical categories for AI/ML performance studies (like sample size for test sets, expert ground truth, MRMC studies, or training set details) are not directly applicable or reported in this type of submission.
Here's an analysis of the provided text based on your request, with a focus on what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on design verification testing, ensuring proper device functioning and substantial equivalence to legally marketed predicate devices. The performance is demonstrated by meeting these engineering and material standards, rather than statistical performance metrics for diagnostic accuracy.
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Commercially Pure Titanium (same as predicate) | Commercially Pure Titanium. |
| Thread Design | Same thread design (pitch, thread angle, minor/major diameters) as various predicate BIOMET 3i Straight-Walled or Tapered implants. | For Ø3.25 & Ø4.0mm: Same as predicate Straight-Walled. For Ø5.0 & Ø6.0mm: Same as predicate Tapered, and same thread dimensions as predicate Straight-Walled. |
| Implant Surface | Full OSSEOTITE® (same as predicate) | Full OSSEOTITE®. |
| Biocompatibility | Yes (same as predicate) | Yes. |
| Mechanical/Structural Integrity | Meet criteria from cyclic fatigue and static angle bend testing. Conform to FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004). | Stated to have successfully conducted design verification and performance testing as indicated by risk analysis. Results "demonstrate that the BIOMET 3i Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to their predicate designs." |
| Sterilization & Shelf Life | Sterile (Gamma Irradiation), 5 Years | Sterile (Gamma Irradiation), 5 Years. |
| Indications for Use | Intended for surgical placement in either jaw for anchoring/supporting single- and multiple-unit prostheses; can be immediately loaded if primary stability and proper occlusion established. | Same as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical or data-driven validation. The testing performed is "design verification testing," likely involving a set number of implants for mechanical and material property assessments, as per engineering and regulatory standards (e.g., ISO, ASTM, or specific FDA guidance for dental implants). However, the exact sample sizes for these engineering tests are not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to engineering test results and manufacturing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the device is not an AI/ML diagnostic or assistive tool requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for device performance is based on established engineering standards and regulatory guidance for dental implants.
4. Adjudication Method for the Test Set
- Not applicable for this type of device submission. Adjudication methods are typically relevant for clinical studies where human reviewers assess diagnostic outputs, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of a dental implant submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study in the context of an algorithm is not applicable. This device is a physical dental implant, not a software algorithm. Its performance is assessed through physical and material property tests.
7. The Type of Ground Truth Used
- The "ground truth" here is based on engineering standards, material specifications, and regulatory guidance documents (specifically, the "FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004)"). This includes established benchmarks for mechanical strength, biocompatibility, and dimensions of dental implants.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a machine learning model.
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. 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 AffairsBIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-514 6316Email jose.cabrera@BIOMET.com |
| Date Prepared: | May 19th, 2010 |
| Trade/ProprietaryName: | Full OSSEOTITE® Certain® II Dental Implant |
| Common/UsualName: | Dental Implant |
| ClassificationName: | Endosseous Dental Implant |
| DeviceClassification/Code: | Class II - 21 CFR §872.3640 / DZE |
| Predicate Devices: | K063341 BIOMET 3i OSSEOTITE® Dental Implant SystemK062636 BIOMET 3i Dental Implants |
| Indications for Use: | BIOMET 3i Dental Implants are intended for surgical placement ineither jaw and used for anchoring or supporting single- and multiple-unitprostheses. BIOMET 3i Dental Implants can be immediately loadedwhen primary stability and proper occlusion have been established. |
| Statement ofEquivalence: | Full OSSEOTITE® Certain® II Dental Implants are substantiallyequivalent to BIOMET 3i's OSSEOTITE® Dental Implants which havebeen previously cleared in K063286 and K063341 |
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Technological
Characteristics:
| Criteria | Predicate BIOMET 3iDental Implant(s) | Proposed BIOMET 3iFull OSSEOTITE® Certain® IIDental Implants |
|---|---|---|
| Implant Lengths | Ø3.25: 8.5, 10.0, 11.5,13.0, 15.0, 18.0mmØ4.0: 8.5, 10.0, 11.5,13.0, 15.0, 18.0, 20.0mmØ5.0: 8.5, 10.0, 11.5,13.0, 15.0mmØ6.0: 8.5, 10.0, 11.5,13.0, 15.0mm | Ø3.25: 8.5, 10.0, 11.5, 13.0, 15.0,18.0mmØ4.0: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0,20.0mmØ5.0: 8.5, 10.0, 11.5, 13.0, 15.0mmØ6.0: 8.5, 10.0, 11.5, 13.0, 15.0mm |
| Implant BodyDiameters | Ø3.25, 4.0, 5.0, 6.0mm | Ø3.25, 4.0, 5.0, 6.0mm |
| Seating PlatformDiameter | Ø3.4, 4.0, 5.0, 6.0mm | Ø3.4, 4.0, 5.0, 6.0mm |
| Material | • Commercially PureTitanium• Titanium Alloy | Commercially Pure Titanium |
| Biocompatible | Yes | Yes |
| Thread Design | • 60° thread & 0.6mmpitch (Straight-Wall)• 60° thread & 0.9mmpitch (Straight-Wall)• 35° thread & 0.8mmpitch (Tapered) | • 60° thread & 0.6mm pitch (Straight-Wall)• 35° thread & 0.8mm pitch (Straight-Wall) |
| Implant Design | Straight-walled implantbody | Straight-walled implant body |
| Self TappingFeature | Incremental Cutting Edge(I.C.E.) with apical taper | Incremental Cutting Edge (I.C.E.) withapical taper |
| Implant Surface | • OSSEOTITE®• Full OSSEOTITE® | Full OSSEOTITE® |
| Color-Coding | • Anodized SeatingSurface• Color-Coded Labeling | • Anodized Seating Surface• Color-Coded Labeling |
| Packaging | Packaged in sterile traywith cover screw | Packaged in sterile tray with coverscrew |
| Sterilization | Sterile (GammaIrradiation) | Sterile (Gamma Irradiation) |
| Shelf Life | 5 Years | 5 Years |
| ImplantPlacementProtocol | Per BIOMET 3i SurgicalCatalog CATSM | Per BIOMET 3i Surgical CatalogCATSM |
| Implant/AbutmentMatingConnection | Internal HexagonConnection | Internal Hexagon Connection |
| MatingComponents | All BIOMET 3i Certain®Restorative Components | All BIOMET 3i Certain® RestorativeComponents |
·
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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.
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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.
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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
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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:
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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.