(411 days)
CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
CeraRoot is an endosseous zirconia implant that incorporates both the implant and abutment into a one-piece design, and is intended for use in prosthetic dentistry to support single or multiple tooth restorations. The main characteristics of the CeraRoot implant are its extreme hardness, and ability to be fabricated into final net shapes with very tight tolerances via state-of-the-art CNC processing. The implants are single use devices and are delivered in sterile condition having been sterilized using ethylene oxide (EtO). Depending on the particular tooth to be replaced, CeraRoot implants are made available in five different implant shapes: Wide Upper Central Incisor & Cuspid, Upper Central Incisor & Cuspid, Upper Lateral & Lower Incisor, Bicuspid, Molar; four different implant lengths: 8, 10, 12 & 14 mm; and five different implant diameters: 3.5, 4.1, 4.8, 6, & 6.5 mm. The CeraRoot implants have similar indications to the predicate devices produced by Z-Systems and Nobel Biocare, are made of virtually identical materials (i.e., zirconia that is at least 95% by weight Z.O.) and are available in similar lengths and diameters. The primary difference in the CeraRoot implants and the predicate devices lies in their overall shapes, surface finish and threaded areas. The CeraRoot implants are made available in five different unique shapes that have been designed for specific areas of the mouth, and use a color coding method that matches the correct implant shape to the location in the mouth where it is to be placed. The CeraRoot implants are also subjected to an acid etching process called ICE -surface that is used to impart the unique surface finish to the device that helps to enhance the osseointegration process. This compares to the more conventional mechanical processes that are imparted to the surfaces of the predicate devices. Additionally, the CeraRoot 14 Bicuspid implant is designed to be press-fit into place, as only the coronal half of the endosseous implant contains threads. The surgical method by which this implant is placed requires that it be tapped into place, with no rotational aspect to the insertion as compared to all the remaining implant shapes, which are surgically inserted by conventional means (i.e., screwed into place). This design is unique to the CeraRoot 14 Bicuspid implant only, and is not found on any of the other predicate implants.
The provided text does not contain typical "acceptance criteria" as would be defined for the performance of a diagnostic or AI-powered medical device (e.g., sensitivity, specificity thresholds). Instead, the document describes the substantial equivalence criteria for a dental implant, focusing on material, design, and intended use as compared to predicate devices, and reports on non-clinical (bench) and clinical data supporting that equivalence.
Therefore, the response below will describe the criteria and studies based on the information provided for this specific type of device submission.
Acceptance Criteria and Study Details for CeraRoot Implant System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on substantial equivalence requirements) | Reported Device Performance/Evidence |
|---|---|
| Intended Use: Similar to predicate devices: surgical implantation in maxilla and mandible for retention of fixed prosthetic devices, restoring aesthetics and chewing function, single/multiple unit restorations, immediate/delayed extractions, not for immediate loading, indicated for metal allergies/chronic illness.Technological Characteristics - Material: Made of zirconia (at least 95% by weight Z.O.), similar to predicate devices.Technological Characteristics - Design & Performance: - Similar lengths and diameters to predicate devices. - Manufacturing process results in clean, textured, pure zirconia surface (acid etching and post-etching validated for repeatability). - Mechanical strength to withstand physiological loading (demonstrated via dynamic fatigue testing in wet and dry environments, worst-case scenario). - Biocompatibility suitable for long-term dental implant devices. - Clinical safety and effectiveness (osseointegration, long-term success rate). | Intended Use: The device states the identical intended use as explicitly described in the acceptance criteria. It explicitly states indications for metal allergies. Technological Characteristics - Material: Confirmed as zirconia (at least 95% Z.O.), explicitly stating "made of virtually identical materials (i.e., zirconia that is at least 95% by weight Z.O.)".Technological Characteristics - Design & Performance: - Available in similar lengths and diameters (8, 10, 12, 14 mm; 3.5, 4.1, 4.8, 6, 6.5 mm). - SEM surface analysis and surface topography studies proved clean, textured, pure zirconia surface; acid etching and surface cleaning processes validated for repeatability. - Fatigue testing performed on CeraRoot Model 14 Bicuspid implant (worst-case) in dry (air) and wet (saline) environments, adhering to ISO 14801. - Biocompatibility testing performed in accordance with applicable parts of ISO 10993-1 for long-term dental implant devices. - Clinical study demonstrated a "Five-Year Success Rate of 831 Consecutively Placed Zirconia Dental Implants" and a case report on full-mouth rehabilitation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data):
- Sample Size: The primary clinical study reported a "Five-Year Success Rate of 831 Consecutively Placed Zirconia Dental Implants."
- Data Provenance: The study was part of a "European clinical study," indicating European origin. It is explicitly described as a "five-year follow-up study for their implants," suggesting a prospective nature, although "consecutively placed" also implies data collected over time rather than a single point in time retrospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish a "ground truth" in the manner of diagnostic performance evaluations. For a dental implant study focused on success rates, the "ground truth" would generally be established via clinical outcomes (e.g., implant survival, absence of complications, osseointegration assessed radiographically), potentially adjudicated by the treating clinicians or independent assessors.
The authors of the referenced publications are:
- Xavi Oliva, DDS, MSc
- Josep Oliva, DDS, MSc
- Josep D. Oliva, DDM
These individuals, with DDS, DDM, and MSc qualifications, would be considered qualified dental professionals. The text does not detail the specific adjudication method or independent expert review for the clinical outcomes.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1) for the clinical outcomes presented in the study summary. Clinical success and failure in implantology are typically ascertained through defined criteria observed by the treating clinicians or documented in patient records and radiographs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance evaluation was not done. This type of evaluation is relevant for AI/ML-driven diagnostic devices. The CeraRoot Implant System is a physical dental implant.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on clinical outcomes data, including implant survival/success rate over a five-year period, likely assessed through clinical examination and radiographic images as the document mentions "radiographic images that were part of its European clinical study." The outcomes were published in peer-reviewed dental journals.
8. The Sample Size for the Training Set
The document does not specify a "training set" as it would for an AI/ML device. This submission is not for an AI/ML device, but for a medical device (dental implant). The "training" for such a device effectively involves its design, material selection, and manufacturing process development, validated by extensive non-clinical testing and clinical studies.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML device, this question is not applicable. For the CeraRoot Implant System, the "ground truth" of its design and manufacturing would be established through engineering specifications, material science testing, and adherence to quality standards. The bench testing (fatigue, surface analysis, biocompatibility) serves as validation that the device meets its design requirements.
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SECTION 5 - 510(k) SUMMARY
Submission Correspondent
Emergo Group, Inc.
www.emergogroup.com/
Address
611 West Fifth Street Third Floor Austin, Texas 78701
Phone
(512) 327-9997
Fax
(512) 327-9998
Contact
Stuart R. Goldman
Submission Sponsor
Oral Iceberg S.L. Josep Umbert, 128 08402 Granollers Barcelona, Spain Tel: +34 93 861 48 41 Fax: +34 93 879 23 73
Date Prepared
January 4, 2011
Trade Name
CeraRoot Implant System
JAN - 4 2011
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Regulation Name
Endosseous Dental Implant
Regulation Number
872.3640
Classification Name
Implant, Endosseous, Root-Form
Product Code(s)
DZE
Classification Panel
Dental Devices
Regulatory Class
Class II
Predicate Device(s)
- Nobel Biocare AB - Zirconia Implant - (K061971) 2. Z-Systems AG - Z-Look3 Dental Implant System - (K062542)
Intended Use
CeraRoot dental implants are especially designed for the surqical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
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Device Description
CeraRoot is an endosseous zirconia implant that incorporates both the implant and abutment into a one-piece design, and is intended for use in prosthetic dentistry to support single or multiple tooth restorations.
The main characteristics of the CeraRoot implant are its extreme hardness, and ability to be fabricated into final net shapes with very tight tolerances via state-ofthe-art CNC processing. The implants are single use devices and are delivered in sterile condition having been sterilized using ethylene oxide (EtO).
Depending on the particular tooth to be replaced, CeraRoot implants are made available in five different implant shapes:
- . Wide Upper Central Incisor & Cuspid,
- Upper Central Incisor & Cuspid,
- . Upper Lateral & Lower Incisor,
- . Bicuspid,
- Molar; .
four different implant lengths:
-
. 8, 10, 12 & 14 mm;
and five different implant diameters: -
3.5, 4.1, 4.8, 6, & 6.5 mm. .
The CeraRoot implants have similar indications to the predicate devices produced by Z-Systems and Nobel Biocare, are made of virtually identical materials (i.e., zirconia that is at least 95% by weight Z.O.) and are available in similar lengths and diameters. The primary difference in the CeraRoot implants and the predicate devices lies in their overall shapes, surface finish and threaded areas.
The CeraRoot implants are made available in five different unique shapes that have been designed for specific areas of the mouth, and use a color coding method that matches the correct implant shape to the location in the mouth where it is to be placed. The CeraRoot implants are also subjected to an acid etching process called ICE -surface that is used to impart the unique surface finish to the device that helps to enhance the osseointegration process. This compares to the more conventional mechanical processes that are imparted to the surfaces of the predicate devices.
Additionally, the CeraRoot 14 Bicuspid implant is designed to be press-fit into place, as only the coronal half of the endosseous implant contains threads. The
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surgical method by which this implant is placed requires that it be tapped into place, with no rotational aspect to the insertion as compared to all the remaining implant shapes, which are surgically inserted by conventional means (i.e., screwed into place). This design is unique to the CeraRoot 14 Bicuspid implant only, and is not found on any of the other predicate implants.
Non-Clinical Data - Bench Testing
As part of demonstrating safety and effectiveness of CeraRoot dental implants and in showing substantial equivalence to the predicate devices that are the subject of this 510(k) submission, Oral Iceberg submitted a selected number of its dental implants for fatigue testing in accordance with ISO 14801, Dentistry -Implants - Dynamic Fatigue Test for Endosseous Dental Implants, where their implants were tested in both dry (i.e., air) and wet (i.e., saline solution) environments. Testing was performed on the CeraRoot Model 14 Bicuspid implant to simulate worst-case loading conditions.
Further, CeraRoot dental implants also underwent extensive SEM surface analysis and surface topography studies to prove that both the acid etching and post-etching surface cleaning process used during the manufacture of these devices produced implants that resulted in a clean, textured, pure zirconia surface. Both the acid etching and surface cleaning processes were subjected to extensive validation studies to prove their repeatability.
CeraRoot dental implants also underwent biocompatibility testing in accordance with the applicable parts of ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing as required for long-term dental implant devices.
Clinical Data - CeraRoot 14 Bicuspid Implant
As part of demonstrating the safety and effectiveness of CeraRoot dental implants, particularly for the CeraRoot 14 Bicuspid implant, Oral Iceberg submitted a summary report and radiographic images that were part of its European clinical study, and represent the five-year follow-up study for their implants, which have been published in the International Journal of Oral & Maxillofacial Implants [2010; 25:336-344] by Xavi Oliva, DDS, MSc, Josep Oliva, DDS, MSc & Josep D. Oliva, DDM: Five-Tear Success Rate of 831 Consecutively Placed Zirconia Dental Implants in Humans – A Comparison of Three Different Rough Surfaces, and in the European Journal of Esthetic Dentistry [Volume 5, Number 2 (2010) pp. 190-2041 by Xavi Oliva, DDS, MSc & Josep Oliva, DDS, MSc. Full-Mouth Oral Rehabilitation in a Titanium Allergy Patient Using Zirconium Oxide Dental Implants and Zirconium Oxide Restorations. A Case Report from an Ongoing Clinical Study.
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Safety and Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the CeraRoot Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The CeraRoot Implant System, as designed and manufactured, therefore is determined to be substantially equivalent to the referenced predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oral Iceberg S.L. C/O Mr. Stuart R. Goldman Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin. Texas 78746
14 - 4 2011
Re: K093595
Trade/Device Name: CeraRoot Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 14, 2010 Received: December 15, 2010
Dear Mr. Goldman:
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. Goldman
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 (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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
h for
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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SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): K093595
Device Name
CeraRoot Implant System
JAN - 4 2011
Indications for Use
CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K093595 |
|---|---|
| ---------------- | --------- |
§ 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.