(401 days)
The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function.
The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The UNIVERSE implants can be used for surgery in two stages or in single stage.
The POWER and SOLUTION implants can be used for surgery in single stage.
All IMMEDIATELOAD dental implants have a double external thread that looks flattened from the proximal area to the distal area. There are three types of implants: UNIVERSE (conical biphasic), POWER (conical monophasic), and SOLUTION (cylindrical monophasic), available in different diameters and length combinations. All the implants are made of Titanium Grade 4. They are provided sterile and are ready to be implanted.
For each measure, the connection between the biphasic implant and the relative prosthetic component is secured by a locking taper connection and a preformed hexagon and by a retained screw.
The abutments are prosthetic accessories made of Titanium Grade 5; they are used to engage, form and create dentures. In particular, the abutment is designed to be applied on the biphasic implant during the surgical reopening, after osseointegration. The straight abutment IMMEDIATE has a straight axis compared to implant's axis. It has a transmucosal collar height ranging from 1 mm to 4 mm.
The inclined abutment IMMEDIATE has axis inclined of 15° compared to the implant's axis. It has a transmucosal collar height ranging from 1 mm to 3 mm. These abutments are fixed to the UNIVERSE implant via a connection screw. The OTK abutment is straight and contains an internal connection screw. It has a transmucosal collar height from 1 mm to 3 mm. The abutments are provided non-sterile and the connection screw for abutments are all provided non-sterile and are intended to be sterilized before use.
This document is a 510(k) summary for a medical device called the "IMMEDIATELOAD Dental Implant System." It describes the device, its intended use, and argues for its substantial equivalence to previously approved predicate devices, primarily based on design, materials, and mechanical performance. It does not describe an AI medical device or a study involving human readers or AI in a clinical setting.
Therefore, I cannot extract the requested information in the format provided because the document does not contain details about:
- Acceptance criteria for an AI device.
- Reported device performance of an AI device.
- Sample sizes for test sets (in the context of AI models).
- Data provenance for AI models.
- Number of experts to establish ground truth for an AI task.
- Adjudication methods for AI performance.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI models.
- Sample size for a training set of an AI model.
- How ground truth for a training set was established for an AI model.
The "studies" mentioned in this document are non-clinical laboratory tests for a dental implant (e.g., sterilization, biocompatibility, fatigue testing) to demonstrate its physical performance and safety, not for an AI algorithm's diagnostic or predictive capabilities.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
IMMEDIATELOAD S.A. Mr. Giovanni Canino Managing Director Via Lugano 11 Agno, 6982 SWITZERLAND
Re: K151757
Trade/Device Name: IIMMEDIATELOAD Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 24, 2016 Received: June 27, 2016
Dear Mr. Canino:
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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina Kiang -
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151757
Device Name
IMMEDIATELOAD DENTAL IMPLANT SYSTEM
Indications for Use (Describe)
The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function.
The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The UNIVERSE implants can be used for surgery in two stages or in single stage.
The POWER and SOLUTION implants can be used for surgery in single stage.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K151757 510 (K)SUMMARY
SUBMITTER/510(K) HOLDER:
| Company Name: | IMMEDIATELOAD S.A. |
|---|---|
| Company Address: | Via Lugano 116982 Agno - Switzerland |
| Company Phone: | 041- 916001310 |
| Company Fax: | 041- 916001310 |
| Company e-mail: | qualityassurance@immediateload.com |
| Contact person: | Mr. Giovanni CaninoManaging Director |
| Date Summary Prepared: | August 2, 2016 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | IMMEDIATELOAD Dental Implant System |
|---|---|
| Classification Name: | Endosseous Dental Implant |
| Device Class: | Class II |
| Product Code: | DZE & NHA |
| Classification Panel: | Dental |
| Regulation Number: | 872.3640 |
LEGALLY MARKETED PREDICATE DEVICE
| Predicate device | 510 (k) Holder | 510 (k) No. |
|---|---|---|
| ANKYLOS C/X IMPLANT SYSTEM* | Dentsply Intl., Inc. | K083805 |
| NobelActive Internal Connection Implant** | Nobel Biocare USA LLC | K071370 |
| Alpha Bio Dental Implant System** | ALPHA-BIO TEC LTD | K063364 |
-
- Primary Predicate
** - Reference Predicate
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DEVICE DESCRIPTION
All IMMEDIATELOAD dental implants have a double external thread that looks flattened from the proximal area to the distal area. There are three types of implants: UNIVERSE (conical biphasic), POWER (conical monophasic), and SOLUTION (cylindrical monophasic), available in different diameters and length combinations. All the implants are made of Titanium Grade 4. They are provided sterile and are ready to be implanted.
For each measure, the connection between the biphasic implant and the relative prosthetic component is secured by a locking taper connection and a preformed hexagon and by a retained screw.
The abutments are prosthetic accessories made of Titanium Grade 5; they are used to engage, form and create dentures. In particular, the abutment is designed to be applied on the biphasic implant during the surgical reopening, after osseointegration. The straight abutment IMMEDIATE has a straight axis compared to implant's axis. It has a transmucosal collar height ranging from 1 mm to 4 mm.
The inclined abutment IMMEDIATE has axis inclined of 15° compared to the implant's axis. It has a transmucosal collar height ranging from 1 mm to 3 mm. These abutments are fixed to the UNIVERSE implant via a connection screw. The OTK abutment is straight and contains an internal connection screw. It has a transmucosal collar height from 1 mm to 3 mm. The abutments are provided non-sterile and the connection screw for abutments are all provided non-sterile and are intended to be sterilized before use.
INDICATIONS FOR USE STATEMENT
The IMMEDIATELOAD Dental implant system is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function.
The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The UNIVERSE implants can be used for surgery in two stages or in single stage.
The POWER and SOLUTION implants can be used for surgery in single stage.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
IMMEDIATELOAD S.A. claims the substantial equivalence of the IMMEDIATELOAD Dental Implant System to the predicate devices, based on the equivalent intended use, fundamental technology, and operation characteristics. Side-by-side comparison between IMMEDIATELOAD Dental Implant System and its predicate devices is included below.
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| COMPARISON CHART UNIVERSE DENTAL IMPLANTS | |||
|---|---|---|---|
| ATTRIBUTE /CHARACTERISTICS | IMMEDIATELOADDENTAL IMPLANTSYSTEM(Submitted Device) | LEGALLY MARKETEDPREDICATE DEVICESOFDentsply Intl., Inc. | LEGALLY MARKETEDPREDICATE DEVICESOFNobel Biocare USA LLC |
| 510(k) number | K151757 | K083805 | K071370 |
| Device Name | UNIVERSE | ANKYLOS C/X IMPLANTSYSTEM (Primary) | NobelActive Internal ConnectionImplant (Reference) |
| Endosseous DentalImplants | Root-form tapered | Root-form tapered | Root-form tapered |
| CFR Section | 872.3640 | 872.3640 | 872.3640 |
| Pro-code | DZE & NHA | DZE | DZE & NHA |
| Intended / IndicationsFor Use | The IMMEDIATELOADDental implant system isintended to be surgicallyinserted into the jawbonefor support and retention ofdental prosthesis such asartificial teeth, crowns,bridges and overdenture torestore the aesthetics of thepatient and the masticationfunction.The IMMEDIATELOADdental implant system isindicated also for immediateloading when good primarystability is achieved and withappropriate occlusal loading.The UNIVERSE implantscan be used for surgery intwo stages or in single stage. | The ANKYLOS C/X ImplantSystem is for single-stage or two-stage surgical procedures andcemented or screw retainedrestorations. The ANKYLOSC/X Implant System is intendedfor immediate placement andfunction on single tooth and/ormultiple tooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applications maybe splinted with a bar. | Intended for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding: cement-retained,screw-retained, or overdenturerestorations and terminal orintermediate abutment supportfor fixed bridgework |
| Design-(Implants) | • Implant Type: bone Levelimplant• Connection Type: internalconometric connection• Neck Design: Straightwalled neck withcircumferential threadprovides crestal seal• Body Design: Tapereddesign enables placementnear impinging anatomicalstructures whilemaximizing prosthetictable diameter for naturalemergence profile | • Implant Type: bone Levelimplant• Connection Type: internalconometric connection• Neck Design: Straight walledneck with circumferentialthread provides crestal seal• Body Design: Tapered designenables placement nearimpinging anatomicalstructures while maximizingprosthetic table diameter fornatural emergence profile | • Implant Type: bone Levelimplant• Connection Type: internalconometric connection• Neck Design: Straight walledneck with circumferentialthread provides crestal seal• Body Design: Tapered designenables placement nearimpinging anatomicalstructures while maximizingprosthetic table diameter fornatural emergence profile |
| Diameter (Implants) | 3,4 mm 4,0 mm 5,0 mm | 3,5 mm 4,5 mm 5,5 mm 7,0 mm | 3,0 mm 3,5 mm 4,3 mm 5,0 mm |
| Length (Implants) | from 8 to 15 mm | from 8 to 17 mm | from 8,5 to 18 mm |
| Material (Implants) | Pure titanium, ASTM F67 | Pure titanium, ASTM F67 | Pure titanium, ASTM F67 |
| Fixture Sterile -(Implants) | Yes | Yes | Yes |
| Sterilization method | Beta Ray | Gamma Ray | Gamma Ray |
| Surface Finish(Implants) | double acid etched | Sandblasted and etched | TiUnite Surface treatment |
| Design -(Abutments) | Healing Abutments, screws,cemented and screwed fixedposts; anchorage posts forremovable prostheses withbars or ball attachments.All components arededicated specifically toUNIVERSE implants and fitto their internal connectionand vertical drill hole in asecure and anti-rotationalway. | EQUIVALENT HealingAbutments, screws, cemented andscrewed fixed posts; anchorageposts for removable prostheseswith bars or ball attachments. | EQUIVALENT HealingAbutments, screws, cemented andscrewed fixed posts; anchorageposts for removable prostheseswith bars or ball attachments. |
| Materials-(Abutments) | Titanium Ti 6Al 4V ELI,ASTM F136 | Pure titanium, ASTM F67 | Titanium Ti 6Al 4V ELI,ASTM F136 |
| Inclination (inclinedAbutments) | 15° | 7.5°, 15°, 22.5°, 30°, 37.5° | 15° , 17°, 30° |
| Fixture Sterile -(Abutments) | NO, these parts of thesystem can be sterilized bythe user. Labeling containsinstructions forsterilization. | NO. These parts of the systemcan be sterilized by the user. | NO. These parts of the systemcan be sterilized by the user. |
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| ATTRIBUTE/CHARACTERISTICS | IMMEDIATELOAD DENTALIMPLANT SYSTEM (SubmittedDevice) | LEGALLY MARKETEDPREDICATEDEVICES OF ALPHA-BIO TEC LTD (Reference) |
|---|---|---|
| 510(k) number | K151757 | K063364 |
| Device Name | SOLUTION and POWER | Alpha Bio Dental Implant System |
| Endosseous DentalImplants | Root-form tapered(cylindrical and conical implant) | Root-form straight & tapered(cylindrical and conical implant) |
| CFR Section | 872.3640 | 872.3640 |
| Pro-code | DZE | DZE |
| Intended / IndicationsFor Use | The IMMEDIATELOAD Dental implantsystem is intended to be surgically insertedinto the jawbone for support and retention ofdental prosthesis such as artificial teeth,crowns, bridges and overdenture to restorethe aesthetics of the patient and themastication function.The IMMEDIATELOAD dental implantsystem is indicated also for immediateloading when good primary stability isachieved and with appropriate occlusalloading.The POWER and SOLUTION implants canbe used for surgery in single stage. | The Alpha-Bio Dental Implant System is indicatedfor use in surgical and restorative applications forplacement in the bone of the upper or lower jaw toprovide support for prosthetic devices, such asartificial teeth, in order to restore the patient'schewing function. The Alpha-Bio Dental ImplantSystem is indicated also for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. |
| Design-(Implants) | • Implant Type: bone Level implant• Connection Type: Not Applicable• Neck Design: Straight walled neck withcircumferential thread provides crestal seal• Body Design: Cylindrical and Tapereddesign enables placement near impinginganatomical structures while maximizingprosthetic table diameter for naturalemergence profile | • Implant Type: bone Level implant• Connection Type: Not Applicable• Neck Design: Straight walled neck withcircumferential thread provides crestal seal• Body Design: Tapered design enablesplacement near impinging anatomicalstructures while maximizing prosthetic tablediameter for natural emergence profile |
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| POWER diameter andlength combinations | ||
|---|---|---|
| 3,4 mm x 8, 10, 11.5, 13, 154,0 mm x 8, 10, 11.5, 13, 155,0 mm x 8, 10, 11.5, 13, 15 | ||
| SOLUTION Diameterand length combination | 3,0mm diameter x 11, 13, and 15mm | |
| Predicate ImplantDiameter | N/A | 3,0 mm 3,3 mm 3,6 mm 4,2 mm 5,0 mm |
| Predicate Implantlengths | N/A | from 8 to 15 mm (not all lengths available for alldiameters) |
| Material (Implants) | Pure titanium, ASTM F67 | Titanium alloy Ti 6Al 4V ELI, ASTM F136 |
| Fixture Sterile -(Implants) | Yes | Yes |
| Sterilization method | Beta Ray | Gamma Ray |
| Surface Finish(Implants) | double acid etched | TiUnite Surface treatment |
PERFORMANCE DATA
IMMEDIATELOAD S.A. has conducted laboratory testing and determined device functionality and conformance to design input requirements. The material used for the IMMEDIATELOAD dental Implant System, as well as the manufacturing methods, are similar to legally marketed devices. Surface treatment used for IMMEDIATELOAD dental Implant System is considered equivalent to the surface treatment method used for the predicate devices.
Non-clinical Testing of the subject device included the following:
- End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- · Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
- · Fatigue Testing according to ISO 14801:2007
The results regarding the fatigue testing of IMMEDIATELOAD dental implants and the predicate devices were comparable. Therefore, it concluded that the IMMEDIATELOAD dental implants perform as intended. Cytotoxicity testing has demonstrated the biocompatibility of the devices. Sterility validation testing was performed and demonstrated the equivalence of the devices to their predicates.
Implants are all made of Titanium medical grade 4 (commercially named pure titanium), while the abutments are grade 5 Ti4Al6V ELI Titanium.
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SUBSTANTIAL EQUIVALENCE DISCUSSION
The subject device and the primary predicate device have slight differences in the language of the Indications for Use Statements; however, these slight differences specifying particular models to single or two-stage surgeries do not change the intended use of the device. The subject device and the predicated devices also have similar technological characteristics, and are made of similar, if not identical materials. The subject device and predicate devices encompass a very similar or the exact same range of physical dimensions, including diameter and length of the implants and diameter. height and angle of the abutments and a comparative surface area.
CONCLUSION
IMMEDIATELOAD S.A. has demonstrated that the IMMEDIATELOAD Dental Implants System is substantially equivalent to the predicate devices in terms of intended use, material composition, fundamental scientific technology, principles of operation, and basic design.
Based on the foregoing, the IMMEDIATELOAD Dental Implants System is substantially equivalent to the legally marketed, claimed predicate devices.
§ 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.