(201 days)
No
The summary describes a dental implant system and its expanded indications for use, focusing on mechanical testing and clinical study outcomes. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No.
The device is an implant, not a therapeutic device. It provides a means for prosthetic attachment, but does not diagnose, treat, or prevent a disease or condition.
No
Explanation: This device is a dental implant intended for surgical placement to provide prosthetic attachment, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly mentions "surgical placement," "prosthetic attachment," "abutments and screws," and "new components," all of which are physical hardware components. The 510(k) is for an expansion of indications for use of existing dental implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure involving the placement of implants in the jaw to support prosthetic attachments. This is a surgical device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of the dental implants and their use in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant, not an IVD.
N/A
Intended Use / 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 mandible and splinted in the anterior region, immediate loading is indicated.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, mandible
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)
Nonclinical Performance Testing: "3i implants have been mechanically tested consistent with the FDA guidance document Information Necessary for Premarket Notifications Submissions for Screw-Type Endosseous Implants (December 9, 1996). Static Load compression testing was used to simulate biting forces placed upon the implants and Cyclic Fatigue testing simulated the chewing forces placed upon the implants. The new single piece abutment was tested for insertion torque and passed at more than five times the recommended insertion torque of 20 Ncm. The single piece abutment was also tested and passed Cyclic Fatigue criteria. Animal studies which proved early loading to be successful for 3i's OSSEOTITE implant systems were submitted in K983347 (cleared September 23, 1998). Subsequent data continues to provide evidence of substantial clinical success with early loading. Current practice in the field includes use in a manner described within this 510(k) with clinicians and laboratories working to achieve immediate occlusal loading in edentulous and partially edentulous patients with Types I, II and III bone."
Clinical Performance Testing: "A current review of the literature suggests clinical success using immediate loading 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 of the submission."
- Tarnow et al: "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 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 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 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."
- Clinical 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.
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.
K860653, K874590, K935544, K950204, K955428, K972444, K983347, K014235, K022009
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.
K871863, K871954, K891613, K895462, K895463, K904228, K934126, K933969, K933462, K932123, K951553, K022113, K992937, K022562, K994376, K984104, K980620
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
K030614
SEP 1 5 2003
510(k) Summary
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Implant Innovations, Inc. (3i) |
| Contact
Person | Mrs. Jacquelyn A. Hughes, RAC
Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410
(561) 776-6819
jhughes@3implant.com |
| Date Prepared | June 19, 2003 |
| Device Name | 3i Dental Implants |
| Classification
Names | Endosseous dental implant |
| Device
Classification | Classification: III
Classification Panels: Dental
Regulation Number: 872.3640 |
| Predicate
Device(s) | 3i Dental Implants
(K860653, K874590, K935544,K950204, K955428, K972444, K983347,
K014235, K022009)
3i Abutments/Accessories
K871863, K871954, K891613, K895462, K895463, K904228, K934126,
K933969, K933462, K932123, K951553, K022113
Nobel Biocare Branemark System Implants (K992937, K022562)
FRIADENT FRIALIT-2 Implant (K994376)
Straussman ITI Implant (K984104)
Dentatus MTI Modular Transitional Implants (K980620) |
| Performance
Standards | Performance standards have not been established by the FDA under section
514 of the Federal, Food, Drug and Cosmetic Act. |
:
1
| Device
Description | 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. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 mandible and splinted in the anterior region, immediate loading is
indicated. |
| Technological
Characteristics | The proposed 3i implants and accessories are identical to the currently
marketed 3i dental implants and accessories and similar in design, materials,
and intended use to other legally marketed dental implant systems that are
indicated for immediate loading. In addition to the standard 3i abutments, 3i
proposes to add a single piece abutment which combines the abutment and
screw into a single piece for ease of use. |
| Nonclinical
Performance
Testing | 3i implants have been mechanically tested consistent with the FDA guidance
document Information Necessary for Premarket Notifications Submissions for
Screw-Type Endosseous Implants (December 9, 1996). Static Load
compression testing was used to simulate biting forces placed upon the
implants and Cyclic Fatigue testing simulated the chewing forces placed upon
the implants. The new single piece abutment was tested for insertion torque
and passed at more than five times the recommended insertion torque of 20
Ncm. The single piece abutment was also tested and passed Cyclic Fatigue
criteria. Animal studies which proved early loading to be successful for 3i's
OSSEOTITE implant systems were submitted in K983347 (cleared September
23, 1998). Subsequent data continues to provide evidence of substantial
clinical success with early loading. Current practice in the field includes use
in a manner described within this 510(k) with clinicians and laboratories
working to achieve immediate occlusal loading in edentulous and partially
edentulous patients with Types I, II and III bone. |
| Clinical
Performance
Testing | A current review of the literature suggests clinical success using immediate
loading 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 |
:
:
. "
2
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.
3
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.
4
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.
5
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
6
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)