(201 days)
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, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.
This 510(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted implants ≥ 10mm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.
The provided 510(k) summary for K030614 describes the acceptance criteria and supporting studies for the 3i Dental Implants, specifically for the expansion of indications to include immediate loading procedures in the mandible.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a clear, tabulated format for the clinical performance. Instead, it relies on substantiating "clinical success" and "osseointegration" based on existing literature and previous clearances.
| Acceptance Criteria (Inferred from submission) | Reported Device Performance (Summary of Clinical Studies) |
|---|---|
| Mechanical Performance: | |
| Static Load Compression Testing | Passed (to simulate biting forces) |
| Cyclic Fatigue Testing | Passed (to simulate chewing forces) |
| Insertion Torque (for new single piece abutment) | Passed (at more than five times the recommended 20 Ncm) |
| Cyclic Fatigue (for new single piece abutment) | Passed |
| Clinical Performance (Immediate Loading): | |
| Maintenance of Osseointegration | Tarnow et al: 104 out of 107 implants osseointegrated (for various implants, including 3i and others). Implants failed due to infection or provisional restoration issues, not immediate loading itself. Testori et al: Clinical and histologic osseointegration confirmed for immediately loaded implants (78%-85% bone-to-implant contact after 4 months). Ibanez and Jalbout: 100% success after 2-3 years follow-up for 87 Osseotite implants in immediate loading. |
| Absence of Implant Mobility | Ibanez and Jalbout: No implant mobility found. |
| Absence of Periimplant Radiolucency | Ibanez and Jalbout: No periimplant radiolucency found. |
| Low Implant Loss Rate | Defrancq et al: 2 out of 417 Osseotite implants lost in 68 mandibular procedures (0.48% loss). 9 out of 309 Osseotite implants lost in 34 maxilla procedures (2.9% loss). |
| Overall "Clinical Success" | Tarnow et al, Testori et al, Defrancq et al, Ibanez and Jalbout all report successful use or clinical success. |
2. Sample Size Used for the Test Set and the Data Provenance
The submission primarily relies on a literature review of previously published clinical studies, rather than a single, dedicated prospective clinical trial for this specific 510(k) submission. Therefore, "test set" sample sizes are derived from these referenced studies.
- Tarnow et al.: 107 implants (in 10 edentulous cases).
- Testori et al.: 12 Osseotite implants (in 1 patient).
- Defrancq et al.: 417 Osseotite implants in 68 mandibular procedures; 309 Osseotite implants in 34 maxilla procedures.
- Ibanez and Jalbout: 87 Osseotite implants in 11 patients.
- Data Provenance: The studies are published clinical literature. The country of origin is not explicitly stated for all, but given the names and journals, they are likely international, possibly with an emphasis on European and North American research. All are retrospective analyses of cases or small prospective case reports/series.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The summarized studies are clinical publications, and the ground truth (e.g., osseointegration, implant success/failure) would have been established by the clinicians/researchers involved in those individual studies based on standard dental and surgical assessment methods (clinical examination, radiographs, and for one study, histologic analysis). There is no mention of an independent panel of experts establishing a ground truth for a unified "test set" for this 510(k) specifically.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable in the context of this submission. Since the submission relies on published literature, there's no mention of a formal adjudication method for a specific test set. The outcomes in the referenced studies were assessed by the respective study authors.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This submission is for dental implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (dental implant), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the referenced clinical studies was primarily:
- Outcomes Data: Clinical success/failure, implant survival rates, absence of mobility, absence of periimplant radiolucency.
- Clinical Examination: Assessment of implant stability and health.
- Radiographic Examination: To check for periimplant radiolucency and bone levels.
- Histology/Pathology: Testori et al. specifically mention "histologic analysis after 4 months of occlusal loading" and "histomorphometric evaluation revealed 78%-85% bone-to-implant contact."
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a medical device, not a machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The submission leverages a combination of non-clinical (mechanical) testing and a literature review of clinical studies to demonstrate that the 3i Dental Implants, when used for immediate loading, are "substantially equivalent" to predicate devices and clinically successful.
Non-clinical Testing:
- Mechanical tests (Static Load Compression, Cyclic Fatigue) were performed on 3i implants and the new single-piece abutment. These tests simulated biting and chewing forces and passed established criteria, showing the components' physical integrity. Insertion torque for the new abutment also passed, exceeding recommended levels.
Clinical Performance (Literature Review):
The submission relies on a review of existing clinical literature, specifically highlighting four studies:
- Tarnow et al. (1997): A case series involving various implant types (including 3i) for immediate loading in edentulous arches, reporting high osseointegration rates.
- Testori et al. (2001): A case report on Osseotite implants in the mandible, demonstrating clinical and histologic osseointegration during immediate loading, with good bone-to-implant contact.
- Defrancq et al. (2002): A report on successful immediate loading techniques using Osseotite implants in both maxilla and mandible, with very low implant loss rates (e.g., 0.48% in mandibular procedures).
- Ibanez, JC, Jalbout,ZN (2002): A two-year follow-up study on Osseotite implants for immediate loading, reporting 100% success with no implant mobility or periimplant radiolucency.
The submission argues that these studies, along with prior animal studies (K983347) and general current clinical practice, provide sufficient evidence of "substantial clinical success with early loading" for implants similar in design and materials to the 3i implants, thereby supporting the expanded indication for immediate loading. The overall argument for acceptance is based on the substantial equivalence of the 3i implants to other legally marketed devices indicated for immediate loading, supported by safety and performance data from both non-clinical testing and clinical literature review.
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K030614
SEP 1 5 2003
510(k) Summary
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Implant Innovations, Inc. (3i) |
| ContactPerson | Mrs. Jacquelyn A. Hughes, RACImplant Innovations, Inc.4555 Riverside DrivePalm Beach Gardens, FL 33410(561) 776-6819jhughes@3implant.com |
| Date Prepared | June 19, 2003 |
| Device Name | 3i Dental Implants |
| ClassificationNames | Endosseous dental implant |
| DeviceClassification | Classification: IIIClassification Panels: DentalRegulation Number: 872.3640 |
| PredicateDevice(s) | 3i Dental Implants(K860653, K874590, K935544,K950204, K955428, K972444, K983347,K014235, K022009)3i Abutments/AccessoriesK871863, K871954, K891613, K895462, K895463, K904228, K934126,K933969, K933462, K932123, K951553, K022113Nobel Biocare Branemark System Implants (K992937, K022562)FRIADENT FRIALIT-2 Implant (K994376)Straussman ITI Implant (K984104)Dentatus MTI Modular Transitional Implants (K980620) |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Federal, Food, Drug and Cosmetic Act. |
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| DeviceDescription | This 510(k) requests an expansion of the indications for use of all externallyand internally hexed 3i dental implants to include immediate loadingprocedures in the mandible when using a minimum of four (4) splintedimplants $≥$ 10mm in length. Standard, commercially available 3i abutmentsand screws can be used with 3i dental implants in immediate loadingprocedures. Several new components will complement the standard line forthe clinicians use as necessary in immediate occlusal loading. |
|---|---|
| Indications forUse | 3i dental implants are intended for surgical placement in the upper or lowerjaw to provide a means for prosthetic attachment in single tooth restorationsand in partially or fully edentulous spans with multiple single teeth,freestanding bridges and to retain overdentures. |
| In addition, when a minimum of 4 implants, $≥$ 10 mm in length, are placed inthe mandible and splinted in the anterior region, immediate loading isindicated. | |
| TechnologicalCharacteristics | The proposed 3i implants and accessories are identical to the currentlymarketed 3i dental implants and accessories and similar in design, materials,and intended use to other legally marketed dental implant systems that areindicated for immediate loading. In addition to the standard 3i abutments, 3iproposes to add a single piece abutment which combines the abutment andscrew into a single piece for ease of use. |
| NonclinicalPerformanceTesting | 3i implants have been mechanically tested consistent with the FDA guidancedocument Information Necessary for Premarket Notifications Submissions forScrew-Type Endosseous Implants (December 9, 1996). Static Loadcompression testing was used to simulate biting forces placed upon theimplants and Cyclic Fatigue testing simulated the chewing forces placed uponthe implants. The new single piece abutment was tested for insertion torqueand passed at more than five times the recommended insertion torque of 20Ncm. The single piece abutment was also tested and passed Cyclic Fatiguecriteria. Animal studies which proved early loading to be successful for 3i'sOSSEOTITE implant systems were submitted in K983347 (cleared September23, 1998). Subsequent data continues to provide evidence of substantialclinical success with early loading. Current practice in the field includes usein a manner described within this 510(k) with clinicians and laboratoriesworking to achieve immediate occlusal loading in edentulous and partiallyedentulous patients with Types I, II and III bone. |
| ClinicalPerformanceTesting | A current review of the literature suggests clinical success using immediateloading with fully and partially edentulous patients with OSSEOTITE, TPS,Ha-coated, and grit-blasted surfaces when the occlusal load is well-distributed.A few are summarized here and a bibliography may be found in Appendix 3 |
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of the submission.
Tarnow DP,Emtiaz S, Classi A. Immediate loading of threaded implants at stage 1 surgery in edentulous arches: Ten consecutive case reports with 1 to 5 year data.Int. J. Oral Maxillofac Implants 1997; 12:319-324. Tarnow et al report on ten consecutive, edentulous cases comparing the use of implants manufactured by Nobel Biocare (cases 1-3 and 5-7), ITI Straumann (case 4), Astra Tech (cases 8 and 9)and 3i Implant Innovations (case 10). Of 107 implants placed, 104 osseointegrated. For medicolegal reasons, 38 of the implants were submerged and unloaded. The three failed implants occurred in cases 2 and 3, one submerged due to an infection from an adjacent extraction site and two loaded implants due to the cemented provisional restoration being tapped off at 4 months.
Testori T, Szmukler-Moncler s,Francetti L,Del Fabbro M, Scarano A, Piattelli A, Weinstein R Immediate loading of Osseotite implants: A case report and histologic analysis after 4 months of occlusal loading. Int. J. Periodontics Restorative Dent. 2001;21,5:451-459. Testori et al studied 12 Osseotite implants in the mandible of one patient of which 6 were bilaterally splinted and immediately loaded and 6 were left to heal in a submerged manner. Clinical and histologic osseointegration was confirmed for two of the immediately loaded implants by retrieval after 4 months of function. Histomorphometric evaluation revealed 78%-85% bone-to-implant contact, indicating osteogenesis and bone remodeling were not impeded by immediate loading.
Defrancq WD,Luc MDT,Rutten P. Immediate loading: Immediate loading of implants - clinical and technical procedure. Dental Dialogue 2002;2:246-275. Defrancq et al report successful use of an immediate loading technique in 102 procedures for both maxilla and mandible. Of 417 Osseotite implants in 68 mandible procedures only 2 were lost and only 9 of 309 Osseotite implants were lost in 34 maxilla procedures. In ten patients, implants were inserted in both the mandible and maxilla in the surgery for immediate loading.
Ibanez, JC, Jalbout,ZN. Immediate loading of Osseotite implants: Two-year results. Implant Dentristry 2002;11,2:128-134. Ibanez and Jalbout report 100% success in the use of 87 Osseotite implants for immediate loading in eleven patients after two-three years follow-up. Follow-up consisted of both clinical and radiographic examination which found no implant mobility or periimplant radiolucency.
Clincal reports are included in Appendix 3 for reference by Chiapasco et al, Jaffin et al, Schnitman et al, Szmukler-Moncler et al, and Balshi and Wolfinger which discuss the use of immediate loading with various competitive implants to which 32 implants are substantially equivalent in design and materials.
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The 3i dental implants and accessories are substantially equivalent to the Conclusion legally marketed 3i dental implant systems, Branemark System (Nobel Biocare), FRIALIT-2, Straumann ITI and Dentatus dental implant systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
SEP 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K030614
Trade/Device Name: 31 Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 19, 2003 Received: June 20, 2003
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.
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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 (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.
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K030614 Device Name: 3i Dental Implants
Indications for Use:
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, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.
Rein Muly for MSR
Division of Anesthesiolo Infection Control, Denta
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 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.