(86 days)
L123022, K133592
No
The document describes a dental implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a dental implant system used to support prosthetic devices, which aids in restoring chewing function. While it restores a bodily function, its primary purpose isn't to diagnose, cure, mitigate, treat, or prevent disease.
No
This device is a dental implant system intended for surgical placement in the bone to support prosthetic devices, not to diagnose a condition.
No
The device description clearly details physical components (threaded, self-tapping, root form, endosseous dental implants) made of specific materials and with specific dimensions and surface finishes. The performance studies also focus on bench testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "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." This describes a surgical implant used for structural support, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical implant made of specific materials and with certain dimensions and features. This aligns with a medical device intended for implantation, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, controls, or instruments used for testing
The device described is a dental implant, which falls under the category of a medical device used for structural support and restoration of function.
N/A
Intended Use / 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.
Product codes
DZE, NHA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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: Bench studies (Dynamic fatigue test, risk analysis via FMEA)
Sample Size: Not specified
Key Results: Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. The load-bearing features of the implant-abutment connection were tested in conjunction with angled prosthetic abutments representative of the worst-case scenario. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices. A risk analysis in the form of a Failure Modes and Effect Analysis was conducted to assess substantial equivalence of the submission device with respect to the changes to the device and labeling. FMEA demonstrated sterility, packaging, and biocompatibility assessments for the predicate and reference devices are also applicable to the subject devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
2
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)
3
K150182
510(k) Summary
| Submitter: | Instradent USA, Inc. (on behalf of JJGC Indústria e Comércio
de Materiais Dentários SA)
60 Minuteman Road
Andover, MA 01810
Registration No.: 3010593814
Owner/Operator No.: 10045493 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk
Acting Director of Regulatory Affairs
Tel.: (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 |
4
| | 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. |
| Intended 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. |
| Materials: | The subject devices are produced from commercially pure
titanium conforming to ASTM F67. This is the same material
as for the predicate devices cleared to market per premarket
notification submission K123022. |
| Technological
Characteristics: | The proposed Neodent Implant System – CM Drive Implants
are manufactured using precision machining systems from solid
material (i.e. one-piece construction). All technological
characteristics of the subject devices are the same as for the
predicate devices. |
5
| Feature | Subject Devices
CM Drive Implants
K150182 | Predicate Devices
CM Drive Implants
K123022 & K133592 | Comparison
Summary |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Implant-to-Abutment
Connection | 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 device
K101945 |
| Material | Commercially pure titanium,
Grade 4 | Commercially pure titanium,
Grade 4 | Same |
| Primary Package | Styrene-butadiene copolymer
vial with a polystyrene and
thermoplastic elastomer cap
contained within a PET tray
and sealed with a Tyvek lid | Styrene-butadiene copolymer
vial with a polystyrene and
thermoplastic elastomer cap
contained within a PET tray
and sealed with a Tyvek lid | Same |
| Sterilization | Gamma irradiation, 25 kGy
min. | Gamma irradiation, 25 kGy
min. | Same |
| Dynamic Fatigue
Test Configuration | 30° Universal CM Exact
Abutment | No test data submitted -
limited to straight abutments | Similar to reference device
K101945 |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special
Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments dated May 12,
2004, the substantial equivalence of the subject device(s) are
satisfactorily addressed via bench studies. Dynamic fatigue test
data consistent with FDA guidance and ISO 14801 have been
referenced in support of this submission. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | The load-bearing features of the implant-abutment connection
were tested in conjunction with angled prosthetic abutments
representative of the worst-case scenario. The results of the
fatigue load testing demonstrate that the subject devices are
substantially equivalent to the predicate devices. |
| | |
| | A risk analysis in the form of a Failure Modes and Effect
Analysis was conducted to assess substantial equivalence of the
submission device with respect to the changes to the device and
labeling. FMEA demonstrated sterility, packaging, and
biocompatibility assessments for the predicate and reference
devices are also applicable to the subject devices. |
| Summary: | The primary modification of the subject device is addition of
an 18mm length for the device system CM Drive implants,
cleared in K123022 (primary predicate) and K133592. While
the subject CM Drive implants having 18 mm length exceed
the 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 same
intended use, have similar technological characteristics,
identical material composition and encompass a very similar
or the exact same range of physical dimensions, including
diameter and length of the implants and Implant to Abutment
connection and sterilization.Based upon our assessment of the
design and applicable performance data, the subject devices
have been determined to be substantially equivalent to the
identified predicate devices. |