(401 days)
No
The summary describes a standard dental implant system made of titanium, with no mention of AI or ML in its intended use, device description, or performance studies.
Yes
The device is a dental implant system intended to restore aesthetics and mastication function in patients, which is a therapeutic purpose.
No
The device description clearly states that the dental implant system is for surgical insertion into the jawbone to support and retain dental prostheses, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical components made of titanium (implants and abutments) that are surgically inserted into the jawbone. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically inserted into the jawbone to support dental prostheses. This is a direct surgical intervention on the patient's body.
- Device Description: The description details the physical components of the implant system (implants, abutments, screws) which are designed for surgical implantation and mechanical support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Jawbone
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)
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.
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
Image /page/0/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 stylized human profiles facing to the right.
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.
1
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
2
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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3
K151757 510 (K)SUMMARY
SUBMITTER/510(K) HOLDER:
| Company Name: | IMMEDIATELOAD S.A. |
|---|---|
| Company Address: | Via Lugano 11 |
| 6982 Agno - Switzerland | |
| Company Phone: | 041- 916001310 |
| Company Fax: | 041- 916001310 |
| Company e-mail: | qualityassurance@immediateload.com |
| Contact person: | Mr. Giovanni Canino |
| Managing 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
4
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.
5
| COMPARISON CHART UNIVERSE DENTAL IMPLANTS | |||
|---|---|---|---|
| ATTRIBUTE / | |||
| CHARACTERISTICS | IMMEDIATELOAD | ||
| DENTAL IMPLANT | |||
| SYSTEM | |||
| (Submitted Device) | LEGALLY MARKETED | ||
| PREDICATE DEVICES | |||
| OF | |||
| Dentsply Intl., Inc. | LEGALLY MARKETED | ||
| PREDICATE DEVICES | |||
| OF | |||
| Nobel Biocare USA LLC | |||
| 510(k) number | K151757 | K083805 | K071370 |
| Device Name | UNIVERSE | ANKYLOS C/X IMPLANT | |
| SYSTEM (Primary) | NobelActive Internal Connection | ||
| Implant (Reference) | |||
| Endosseous Dental | |||
| Implants | 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 / Indications | |||
| For Use | 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 ANKYLOS C/X Implant | ||
| System is for single-stage or two- | |||
| stage surgical procedures and | |||
| cemented or screw retained | |||
| restorations. The ANKYLOS | |||
| C/X Implant System is intended | |||
| for immediate placement and | |||
| function on single tooth and/or | |||
| multiple tooth applications when | |||
| good primary stability is | |||
| achieved, with appropriate | |||
| occlusal loading, in order to | |||
| restore chewing function. | |||
| Multiple tooth applications may | |||
| be splinted with a bar. | Intended for use in partially or | ||
| fully edentulous mandibles and | |||
| maxillae, in support of single or | |||
| multiple-unit restorations | |||
| including: cement-retained, | |||
| screw-retained, or overdenture | |||
| restorations and terminal or | |||
| intermediate abutment support | |||
| for fixed bridgework | |||
| Design-(Implants) | • Implant Type: bone Level | ||
| implant | |||
| • Connection Type: internal | |||
| conometric connection | |||
| • Neck Design: Straight | |||
| walled neck with | |||
| circumferential thread | |||
| provides crestal seal | |||
| • Body Design: Tapered | |||
| design enables placement | |||
| near impinging anatomical | |||
| structures while | |||
| maximizing prosthetic | |||
| table diameter for natural | |||
| emergence profile | • Implant Type: bone Level | ||
| implant | |||
| • Connection Type: internal | |||
| conometric connection | |||
| • Neck Design: Straight walled | |||
| neck with circumferential | |||
| thread provides crestal seal | |||
| • Body Design: Tapered design | |||
| enables placement near | |||
| impinging anatomical | |||
| structures while maximizing | |||
| prosthetic table diameter for | |||
| natural emergence profile | • Implant Type: bone Level | ||
| implant | |||
| • Connection Type: internal | |||
| conometric connection | |||
| • Neck Design: Straight walled | |||
| neck with circumferential | |||
| thread provides crestal seal | |||
| • Body Design: Tapered design | |||
| enables placement near | |||
| impinging anatomical | |||
| structures while maximizing | |||
| prosthetic table diameter for | |||
| natural 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 fixed | |||
| posts; anchorage posts for | |||
| removable prostheses with | |||
| bars or ball attachments. | |||
| All components are | |||
| dedicated specifically to | |||
| UNIVERSE implants and fit | |||
| to their internal connection | |||
| and vertical drill hole in a | |||
| secure and anti-rotational | |||
| way. | EQUIVALENT Healing | ||
| Abutments, screws, cemented and | |||
| screwed fixed posts; anchorage | |||
| posts for removable prostheses | |||
| with bars or ball attachments. | EQUIVALENT Healing | ||
| Abutments, screws, cemented and | |||
| screwed fixed posts; anchorage | |||
| posts for removable prostheses | |||
| with 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 (inclined | |||
| Abutments) | 15° | 7.5°, 15°, 22.5°, 30°, 37.5° | 15° , 17°, 30° |
| Fixture Sterile - | |||
| (Abutments) | NO, these parts of the | ||
| system can be sterilized by | |||
| the user. Labeling contains | |||
| instructions for | |||
| sterilization. | NO. These parts of the system | ||
| can be sterilized by the user. | NO. These parts of the system | ||
| can be sterilized by the user. |
6
| ATTRIBUTE/
CHARACTERISTICS | IMMEDIATELOAD DENTAL
IMPLANT SYSTEM (Submitted
Device) | LEGALLY MARKETED
PREDICATEDEVICES OF ALPHA-
BIO TEC LTD (Reference) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K151757 | K063364 |
| Device Name | SOLUTION and POWER | Alpha Bio Dental Implant System |
| Endosseous Dental
Implants | 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 / Indications
For Use | 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 POWER and SOLUTION implants can
be used for surgery in single stage. | The Alpha-Bio Dental Implant System is indicated
for use in surgical and restorative applications for
placement in the bone of the upper or lower jaw to
provide support for prosthetic devices, such as
artificial teeth, in order to restore the patient's
chewing function. The Alpha-Bio Dental Implant
System is indicated also for immediate loading
when good primary stability is achieved and
with appropriate occlusal loading. |
| Design-(Implants) | • Implant Type: bone Level implant
• Connection Type: Not Applicable
• Neck Design: Straight walled neck with
circumferential thread provides crestal seal
• Body Design: Cylindrical and Tapered
design enables placement near impinging
anatomical structures while maximizing
prosthetic table diameter for natural
emergence profile | • Implant Type: bone Level implant
• Connection Type: Not Applicable
• Neck Design: Straight walled neck with
circumferential thread provides crestal seal
• Body Design: Tapered design enables
placement near impinging anatomical
structures while maximizing prosthetic table
diameter for natural emergence profile |
7
| POWER diameter and
| length combinations | ||
|---|---|---|
| 3,4 mm x 8, 10, 11.5, 13, 15 | ||
| 4,0 mm x 8, 10, 11.5, 13, 15 | ||
| 5,0 mm x 8, 10, 11.5, 13, 15 | ||
| SOLUTION Diameter | ||
| and length combination | 3,0mm diameter x 11, 13, and 15mm | |
| Predicate Implant | ||
| Diameter | N/A | 3,0 mm 3,3 mm 3,6 mm 4,2 mm 5,0 mm |
| Predicate Implant | ||
| lengths | N/A | from 8 to 15 mm (not all lengths available for all |
| diameters) | ||
| 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.
8
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.