(86 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The subject Neodent Implant System implants are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. The proposed CM Drive implants come in three diameters (3.5, 4.3 and 5.0 mm) and a length of 18.0 mm. They are made of commercially pure and acid etched surface finish or the Acqua grit blasted, acid etched and hydrophilic, chemically active surface finish.
The CM Drive implants (K123022) have been shown to be compatible with the previously cleared angled abutments (K101945) having the CM implant-to-abutment interface.
The addition of the 18mm lengths to the previously cleared CM Drive Implants has no detrimental impact on device indications or performance. All other attributes are identical. No modifications were made to the coronal features of the implant that would impact dynamic fatigue performance.
A groove has been added to the conic portion of six (6) CM Mini Conical Abutments to ensure that the abutments do not release from the transfer tool during transfer from the package until secured in the implant. This feature also assures secure retention of the abutment in the package during storage and shipment.
The pilot hole depth of the CM Abutments was reduced in order to increase the minimum wall thickness of the abutment. The length of the internally threaded portion of the abutment was not changed, so engagement between the occlusal screw and the abutment is also unchanged.
This document is a 510(k) Pre-market Notification for the Neodent Implant System. It primarily addresses the substantial equivalence of the new device to previously cleared predicate devices, rather than detailing a study with specific acceptance criteria for a novel AI/software device. As such, most of your requested information (related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.
However, I can extract information related to the performance data presented and the comparison to predicate devices, which serves a similar function to acceptance criteria in the context of a 510(k) submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k) for a dental implant system, "acceptance criteria" are implicitly defined by the demonstration of substantial equivalence to predicate devices. The primary performance criterion mentioned is dynamic fatigue testing, consistent with FDA guidance and ISO 14801. The "reported device performance" is that the device demonstrated substantial equivalence through these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K123022 & K133592) in terms of safety and effectiveness. | The subject devices (Neodent Implant System - CM Drive Implants with 18mm length) were shown to be substantially equivalent to predicate devices. |
| Compliance with dynamic fatigue test data requirements per FDA guidance and ISO 14801. | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Load-bearing features of the implant-abutment connection demonstrate acceptable performance with angled prosthetic abutments (worst-case scenario). | Load-bearing features were tested, and results demonstrated substantial equivalence. |
| Risk analysis (FMEA) demonstrates that changes have no adverse impact on sterility, packaging, and biocompatibility. | FMEA was conducted and demonstrated applicability of predicate/reference device assessments to the subject devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of implants or tests performed for the dynamic fatigue testing. It generally states that "Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced." ISO 14801 typically involves mechanical testing of multiple samples, but the exact count is not given here.
- Data Provenance: The data is presented as "bench studies" performed by the manufacturer (JJGC Industria e Comercio de Materiais Dentarios SA or Instradent USA, Inc.). The country of origin of the data is not explicitly stated in terms of where the tests were physically conducted. The submission is from New Hampshire, USA on behalf of a Brazilian company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this medical device submission is based on engineering and material science standards (e.g., ISO 14801) and the performance of predicate devices, not on expert consensus or clinical outcomes from a test "set" in the way an AI algorithm test set would be adjudicated.
4. Adjudication method for the test set
This information is not applicable for a physical device's substantial equivalence review. Testing is based on pre-defined engineering standards.
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
This information is not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/software device.
7. The type of ground truth used
The "ground truth" in this context is the mechanical performance standards (specifically dynamic fatigue strength as per ISO 14801) and the established safety and effectiveness profile of the legally marketed predicate devices. The new device's performance is compared against these engineering standards and the characteristics of the predicate devices.
8. The sample size for the training set
This information is not applicable. This is not an AI/software device. No training set is mentioned or implied.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/software device. No training set or ground truth establishment method for a training set is mentioned.
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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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
JJGC Industria e Comercio de Materiais Dentarios SA c/o Mr. Christopher Klaczyk Instradent USA 60 Minuteman Road Andover, MA 01810
Re: K150182
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 23, 2015 Received: March 24, 2015
Dear Mr. Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Christopher Klaczyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang-S
for Erin I. Keith, M.S. 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): K150182
Neodent Implant System Device Name:
Indications for Use:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use____________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K150182
510(k) Summary
| Submitter: | Instradent USA, Inc. (on behalf of JJGC Indústria e Comérciode Materiais Dentários SA)60 Minuteman RoadAndover, MA 01810Registration No.: 3010593814Owner/Operator No.: 10045493 |
|---|---|
| Contact Person: | Christopher KlaczykActing Director of Regulatory AffairsTel.: (978) 747-2575 |
| Date Prepared: | April 23, 2015 |
| Product Code(s): | DZE, NHA |
| Device Class: | II |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Proprietary Name: | Neodent Implant System |
| Predicate Device(s): | • Neodent Implant System (K123022) CM Drive Implants; Primary predicate• Neodent Implant System (K133592) Acqua Surface |
| Reference Device(s): | • Neodent Implant System (K101945) Titamax CM EX Implants• Straumann Screw Retained Abutments (K141871) |
| Device Description: | The subject Neodent Implant System implants are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. The proposed CM Drive implants come in three diameters (3.5, 4.3 and 5.0 mm) and a length of 18.0 mm. They are made of commercially pure |
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| and acid etched surface finish or the Acqua grit blasted,acid etched and hydrophilic, chemically active surfacefinish. | |
|---|---|
| The CM Drive implants (K123022) have been shown to becompatible with the previously cleared angled abutments(K101945) having the CM implant-to-abutment interface. | |
| The addition of the 18mm lengths to the previously clearedCM Drive Implants has no detrimental impact on deviceindications or performance. All other attributes areidentical. No modifications were made to the coronalfeatures of the implant that would impact dynamic fatigueperformance. | |
| A groove has been added to the conic portion of six (6) CMMini Conical Abutments to ensure that the abutments do notrelease from the transfer tool during transfer from the packageuntil secured in the implant. This feature also assures secureretention of the abutment in the package during storage andshipment. | |
| The pilot hole depth of the CM Abutments was reduced in orderto increase the minimum wall thickness of the abutment. Thelength of the internally threaded portion of the abutment wasnot changed, so engagement between the occlusal screw and theabutment is also unchanged. | |
| Intended Use: | The Neodent Implant System is intended to be surgically placedin the bone of the upper or lower jaw to provide support forprosthetic devices such as artificial teeth, to restore chewingfunction. It may be used with single-stage or two-stageprocedures, for single or multiple unit restorations, and may beloaded immediately when good primary stability is achievedand with appropriate occlusal loading. |
| Materials: | The subject devices are produced from commercially puretitanium conforming to ASTM F67. This is the same materialas for the predicate devices cleared to market per premarketnotification submission K123022. |
| TechnologicalCharacteristics: | The proposed Neodent Implant System – CM Drive Implantsare manufactured using precision machining systems from solidmaterial (i.e. one-piece construction). All technologicalcharacteristics of the subject devices are the same as for thepredicate devices. |
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| Feature | Subject DevicesCM Drive ImplantsK150182 | Predicate DevicesCM Drive ImplantsK123022 & K133592 | ComparisonSummary |
|---|---|---|---|
| Implant-to-AbutmentConnection | Morse Taper | Morse Taper | Same |
| Diameter(s) | 3.5, 4.3 & 5.0 mm | 3.5, 4.3 & 5.0 mm | Same |
| Length(s) | 18 mm | 8, 10, 11.5, 13 & 16 mm | Similar to reference deviceK101945 |
| Material | Commercially pure titanium,Grade 4 | Commercially pure titanium,Grade 4 | Same |
| Primary Package | Styrene-butadiene copolymervial with a polystyrene andthermoplastic elastomer capcontained within a PET trayand sealed with a Tyvek lid | Styrene-butadiene copolymervial with a polystyrene andthermoplastic elastomer capcontained within a PET trayand sealed with a Tyvek lid | Same |
| Sterilization | Gamma irradiation, 25 kGymin. | Gamma irradiation, 25 kGymin. | Same |
| Dynamic FatigueTest Configuration | 30° Universal CM ExactAbutment | No test data submitted -limited to straight abutments | Similar to reference deviceK101945 |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II SpecialControls Guidance Document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments dated May 12,2004, the substantial equivalence of the subject device(s) aresatisfactorily addressed via bench studies. Dynamic fatigue testdata consistent with FDA guidance and ISO 14801 have beenreferenced in support of this submission. |
|---|---|
| The load-bearing features of the implant-abutment connectionwere tested in conjunction with angled prosthetic abutmentsrepresentative of the worst-case scenario. The results of thefatigue load testing demonstrate that the subject devices aresubstantially equivalent to the predicate devices. | |
| A risk analysis in the form of a Failure Modes and EffectAnalysis was conducted to assess substantial equivalence of thesubmission device with respect to the changes to the device andlabeling. FMEA demonstrated sterility, packaging, andbiocompatibility assessments for the predicate and referencedevices are also applicable to the subject devices. | |
| Summary: | The primary modification of the subject device is addition ofan 18mm length for the device system CM Drive implants,cleared in K123022 (primary predicate) and K133592. Whilethe subject CM Drive implants having 18 mm length exceedthe range of previously cleared lengths for predicate devices,the previously cleared reference predicate Titamax CM EX(K101945) series includes implants with length of 19mm. |
| Conclusions: | The subject device and the predicated devices have the sameintended use, have similar technological characteristics,identical material composition and encompass a very similaror the exact same range of physical dimensions, includingdiameter and length of the implants and Implant to Abutmentconnection and sterilization.Based upon our assessment of thedesign and applicable performance data, the subject deviceshave been determined to be substantially equivalent to theidentified 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.