(198 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower iaw 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. Multiple tooth applications may be rigidly splinted.
The Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple abutments are provided for each diameter implant for both cement-retained and screwretained prostheses.
Here's an analysis of the provided text regarding the Neodent Implant System's acceptance criteria and studies:
Based on the provided K101945 510(k) summary for the Neodent Implant System, the information is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device. Therefore, many of the requested categories (2-6, 8-9) that pertain to traditional clinical studies or AI model development are not explicitly addressed in this type of submission.
The "testing" mentioned is a bench performance test, not a clinical study involving human subjects or AI algorithms.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from ISO 14801) | Reported Device Performance (From Summary) |
|---|---|---|
| Mechanical Strength (Fatigue) | Implants and abutments must withstand dynamic fatigue forces appropriate for intended use in the oral cavity. (Referencing ISO 14801: Dentistry - Implants - Dynamic fatigue tests for endosseous dental implants) | "Results confirmed the strength of the system." (Specifically for Titamax CM Implants with CM Abutments) |
Study Details (Applicable to Bench Testing)
-
1. Table of Acceptance Criteria and Reported Device Performance: (Addressed above)
-
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the summary, but ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to establish a statistically significant fatigue limit or to demonstrate survival at specific load levels.
- Data Provenance: The study was a bench test, not a clinical study with patient data. Its provenance is the manufacturer's testing facility (JJGC Indústria e Comércio de Materiais Dentários SA).
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3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This was a physical bench test to measure mechanical properties, not an assessment requiring expert interpretation of images or clinical outcomes.
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4. Adjudication Method for the Test Set:
- Not applicable. This was a physical bench test, not an assessment requiring consensus among observers. The "ground truth" was the physical behavior of the materials under stress according to the ISO standard.
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5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This was a bench test for mechanical strength. MRMC studies are typically for evaluating diagnostic imaging devices or AI tools that assist human readers.
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6. Standalone Performance Study (Algorithm Only):
- No. This device is a physical dental implant system, not a software algorithm.
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7. Type of Ground Truth Used:
- For the dynamic fatigue test, the "ground truth" is defined by the physical and mechanical properties of the materials and the assembly, as measured and interpreted according to the ISO 14801 standard. This standard specifies how to conduct the tests and determine failure or endurance limits.
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8. Sample Size for the Training Set:
- Not applicable. This was not a machine learning model, so there is no training set.
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9. How Ground Truth for Training Set was Established:
- Not applicable. As above, no training set for an AI model.
Overall Conclusion from Document
The 510(k) summary for the Neodent Implant System focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. The primary "study" mentioned is a bench performance test that confirmed the mechanical strength of the implants and abutments according to the ISO 14801 standard. This type of submission relies heavily on proving that the new device shares the same intended use, technological characteristics, materials, and operating principles as established predicate devices, and that any differences do not raise new questions of safety or effectiveness. It is not an AI/software device submission and thus does not include details regarding clinical trials, expert adjudication, or AI model development specific to those types of products.
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Summary
K10/945
Neodent Implant System
JAN 2 6 2011
510(k) Summary
JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System
January 25, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Oliveira, 3291 – CICCuritiba - PR - CEP, 81270-200, BrazilTelephone: +55 41 2169 4071Fax: +55 41 2169 4046 | |
|---|---|---|
| Official Contact: | Daniel Lecuona | |
| Representative/Consultant: | Linda K. Schulz, BSDH, RDHKevin A. Thomas, PhDPaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | ||
| San Diego, CA 92130, USA | ||
| Telephone: | +1 (858) 792-1235 | |
| Fax: | +1 (858) 792-1236 | |
| email: | lschulz@paxmed.comkthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Neodent Implant System |
|---|---|
| Common Name: | Endosseous dental implantEndosseous dental implant abutment |
| Classification Regulations: | 21 CFR 872.3640 |
| Product Code: | DZENHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
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INTENDED USE
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower iaw 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. Multiple tooth applications may be rigidly splinted.
DEVICE DESCRIPTION
The Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple abutments are provided for each diameter implant for both cement-retained and screwretained prostheses.
TESTING
Testing was performed in conformance to ISO 14801 Dentistry - Implants - Dynamic fatigue tests for endosseous dental implants to ensure that the strength of the Titamax CM Implants in conjunction with CM Abutments is appropriate for the intended use. Results confirmed the strength of the system.
EQUIVALENCE TO MARKETED DEVICE
The Neodent Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Lifecore Biomedical Stage-1 Single Stage RBM Dental Implant System cleared under K003226.
Lifecore Biomedical Stage-1Angled Abutment System cleared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental Implant System cleared under K083805.
Nobel Biocare NOBELSPEEDY™ Implants cleared under K050406,
Nobel Biocare Esthetic Zirconia Abutment cleared uinder K031719.
Straumann ITI® Dental Implant System cleared under K033922,
Straumann synOcta® Prosthetics cleared under K041295,
Straumann UCLA Gold Abutment cleared under K022859, and
Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053384,
JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System cleared under K101207.
The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium conforming to ASTM F67 and have similar surface treatments. The subject and
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Summary
predicate abutments are also made of the same materials (titanium alloy, gold alloy, zirconia). The subject and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height, and gingival height of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
Overall, Neodent Implant System has the following similarities to the predicate devices:
- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JJGC Industria Commercio e Comercio de Materiais Dentarios SA C/O Linda K. Schulz Paxmed International, LLC 11234 El Camino Real. Suite 200 San Diego. California 92130
Re: K101945
JAN 2 6 2011
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: January 13, 2011 Received: January 14, 2011
Dear Ms. Schulz:
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- Ms. Schulz
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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): 14/12/945
Device Name: Neodent Implant System
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. Multiple tooth applications may be rigidly splinted.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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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Jivision of Anesthesiology, General Hospital
Jivision of Anest Devices Infection Control, Dental Devices
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§ 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.