(314 days)
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
The provided text describes a 510(k) submission for the "Chaorum Implant System," which is an endosseous dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested categories about acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document. This submission pertains to a physical medical device (dental implants), not a software or AI/ML-driven device.
However, I can extract information regarding the non-clinical testing performed to validate the safety and substantial equivalence of the physical device.
Here's the relevant information that can be extracted, acknowledging that it does not fit the typical format for AI/ML algorithm evaluation:
1. A table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it report specific performance values against those criteria. Instead, it lists the types of non-clinical tests conducted to validate the device's safety and substantial equivalence. The conclusion states that "Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device." This implies that the device met the unstated acceptance criteria for each test to support the substantial equivalence claim.
Therefore, for AI/ML-specific criteria, this section is N/A as this is not an AI/ML device.
For the physical device, a table summarizing the types of non-clinical tests performed is provided in the document:
| No | Test Title | Test Standard | Implied Acceptance |
|---|---|---|---|
| 1 | Physical tests (visual, packaging, packaging seal efficacy, dimension, sterility - direct transfer method) | Not explicitly listed for each, but general quality control and sterility standards apply. | The device's physical attributes, packaging integrity, and sterility were confirmed to meet established standards. For sterility, the direct transfer method was used, implying successful sterilization according to protocol. Dimensions and visual inspection would have ensured conformance to design specifications. |
| 2 | RBM/SLA Surface treatment tests (roughness average, developed surface area ratio, surface characteristics (SEM), surface composition analysis (EDX)) | Not explicitly listed for each, but general material and surface characterization standards apply. | The RBM and SLA surface treatments were characterized and confirmed to be consistent with the intended design and expected properties for dental implants, ensuring appropriate surface characteristics for osseointegration. |
| 3 | TiN coating tests (surface roughness and abrasion testing) | Not explicitly listed, but material and coating standards apply. | The TiN coating was evaluated for its roughness and abrasion resistance, confirming its suitability for the device's function and durability. |
| 4 | Mechanical properties test (adaptation accuracy (Implant to abutment compatibility), 35° compressive loads, torsional breaking force, removal torque force, fatigue test) | Not explicitly listed, but industry standards for dental implant mechanical testing apply. | The mechanical integrity and performance of the implant system (fixtures, abutments, screws) were confirmed through various tests, demonstrating appropriate strength, compatibility, and durability under simulated physiological loads to ensure device functionality and patient safety. This would include ensuring the device can withstand chewing forces without failure and maintain a stable connection between components. |
| 5 | Sterilization validation and shelf-life tests | Not explicitly listed, but ISO 11137 series and ISO 11607 series are common standards. | Sterilization processes (gamma irradiation) were validated to ensure the device is sterile at the point of use, and shelf-life testing confirmed that the sterility and integrity of the device are maintained over its intended storage period. |
| 6 | Biocompatibility tests (Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity, Pyrogen Test, Local Lymph Node Assay (LLNA), Bone Implantation Test) | ISO10993 series (specific parts listed in the document) | The device materials and design were proven to be biocompatible, meaning they do not cause adverse biological reactions (e.g., cell toxicity, irritation, sensitization, systemic toxicity, fever, or undesirable tissue reactions) when in contact with human tissue or implanted in bone. The bone implantation test would demonstrate appropriate osteointegration or tissue response in a living model. |
2. Sample size used for the test set and the data provenance:
N/A. This does not refer to an AI/ML algorithm's test set. The non-clinical tests described involve physical devices and material samples. The document does not specify the number of units or samples used for each physical or biocompatibility test, nor the provenance in the context of "data" (e.g., country of origin, retrospective/prospective). These are laboratory tests on manufactured articles.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. This is not an AI/ML device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would be the accepted standards and specifications for material science, mechanical engineering, and biocompatibility, as evaluated by engineers and scientists in accredited labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or interpretive task (often in AI/ML performance evaluation). This is not relevant to the non-clinical physical and biological testing of a dental implant.
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:
N/A. MRMC studies are used to evaluate diagnostic systems, often with AI components assisting human readers. This document describes a physical medical device, not a diagnostic system with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
N/A. This is not an AI/ML algorithm; it is a physical dental implant system.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by:
- Engineering specifications and design requirements: For dimensional accuracy, mechanical properties, and compatibility.
- Material standards: ASTM F136, ASTM F67 for titanium alloys.
- International standards: ISO10993 series for biocompatibility.
- Sterilization validation protocols: For sterility and shelf-life.
There is no "expert consensus" or "pathology" in the sense of clinical diagnostic ground truth for these types of tests, other than expert evaluation within the relevant engineering and scientific fields to ensure compliance with standards.
8. The sample size for the training set:
N/A. This is not an AI/ML algorithm. There is no concept of a "training set" for the physical device.
9. How the ground truth for the training set was established:
N/A. As above, no training set is involved.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Medimecca Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92606
Re: K160536
Trade/Device Name: Chaorum Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 6, 2016 Received: December 8, 2016
Dear Priscilla Chung:
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.
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
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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,
Michael J. Ryan -S
for 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Chaorum Implant System
Indications for Use (Describe)
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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See PRA Statement below.
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510(k) Summary
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 12/06/2016
1. Applicant / Submitter
| Submitter | |
|---|---|
| Name | Medimecca Co., Ltd. |
| Address | Daeryung Techno town 3-cha 104, 105, 109, 110 Gasan-dong,115, GasanDigital 2-ro, Geumcheon-gu,Seoul, Republic of Korea 153-772 |
| Phone | +82-2-856-8282 |
| Fax | +82-2-856-0238 |
| Contact | Park Young Wan, QMR |
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92606 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Chaorum Implant System
- Common Name: Dental Implant System .
- . Classification Name: Endosseous Dental Implant System
- Product Code: DZE, NHA
- . Classification regulation: 21CFR872.3640
4. Predicate Device:
- Primary Predicate Device: . UD Implant System by MEDIMECCA Co., Ltd. (K131682)
- . Reference Predicate Device: Hahn Tapered Implant System by PRISMATIK DENTALCRAFT, INC (K143353) JDentalCare Implant System by J DENTAL CARE S.r.l.. (K143142)
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IDI Implant Systems by IDI BIOMEDICAL LLC (K081806) NobelActive® by NOBEL BIOCARE USA, LLC (K142260) 31 OSSEOTITE CERTAIN DENTAL IMPLANTS by IMPLANT INNOVATIONS, INC. (K063341)
5. Description:
Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
5.1. Fixtures -RBM (Titanium 6AL4V, ASTM F136)
| Shape | Size |
|---|---|
| Image: SFB Model Series | NP (Narrow Platform) Connection Type Fixture3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L)/14.0mm(L) / 15.0mm(L)3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)RP (Regular Platform) Connection Type Fixture3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) |
| Image: ASFS Model Series | NP (Narrow Platform) Connection Type Fixture3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L)/14.0mm(L)3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)RP (Regular Platform) Connection Type Fixture3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.28mm Dia. x 8.0mm(L) / 10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) |
| Image: MSF Model | NP (Narrow Platform) Connection Type Fixture3.25mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L)3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) /15.0mm(L)RP (Regular Platform) Connection Type Fixture4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L) / 15.0mm(L)4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L) / 15.0mm(L) |
510(k) Submission.
510(k) summary , 2 / 10 page
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Series
5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L)
5.2. Fixtures --SLA(Titanium Gr 4, ASTM F67)
| Shape | Size |
|---|---|
| Image: ASF Model Series | NP (Narrow Platform) Connection Type Fixture3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / 12.0mm(L) /14.0mm(L) / 15.0mm(L)/15.5mm(L)3.89mm Dia. x 8.0mm(L)/10.0mm(L) / 12.0mm(L) / 14.0mm(L)RP (Regular Platform) Connection Type Fixture3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) |
| Image: ATF Model Series | NP (Narrow Platform) Connection Type Fixture3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)RP (Regular Platform) Connection Type Fixture3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L)6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) |
| Image: PSF Model Series | NP (Narrow Platform) Connection Type Fixture3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) /15.0mm(L)RP (Regular Platform) Connection Type Fixture4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L) / 15.0mm(L)4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L)/15.0mm(L)5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L) / 15.0mm(L)6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/13.0mm(L) / 15.0mm(L) |
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5.3. Abutments
- · NP (Narrow Platform) Connection Type Two Piece Abutments
| Abutments | Material | Dia(mm) |
|---|---|---|
| Dual Abutment | 3.5/4.0/4.5 | |
| Combi Abutment | 3.5/4.0/4.5 | |
| AngledAbutment(15°,17°, 25°) | MSAA--CSAA--Titanium Gr 4 ASTM F67 / TiN Coating | 3.5/4.0/4.5 |
| Billow Abutment | 3.5/4.0/4.5 | |
| Temporary Abutment | 3.5/4.0/4.5 | |
| Ball Abutment | 3.5/4.0 | |
| Healing Abutment | Ti6AL4V ELI, ASTM F136 | 3.5/4.0/4.5 |
- · RP (Regular Platform) Connection Type Two Piece Abutments
| Abutments | Material | Dia(mm) |
|---|---|---|
| Dual Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| Combi Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| AngledAbutment(15°,17°, 25°) | MSAA-- | 4.5/5.0/5.5/6.0 |
| CSAA-- | ||
| Billow Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| Temporary Abutment | 4.5/5.0/5.5 | |
| Ball Abutment | 3.5/4.0 | |
| Healing Abutment | Ti6AL4V ELI, ASTM F136 | 4.0/4.5/5.0/5.5/6.0/6.5/7.5/8.5 |
- 5.4. Cover Screws (Ti6AL4V ELI, ASTM F 136)
1.95mm Dia. x 5.8mm (L) / 6.5mm(L)
6. Indication for use:
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
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7. Basis for Substantial Equivalence
The Chaorum Dental Implant System has the identified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with RBM or SLA roughened surfaces. The subject and predicate devices are both bone-level implants that shape design such as straight walled neck and tapered body design.
The subject and predicate devices are similar in size, materials, surface treatment, and are sterlized via gamma irradiation for fixtures.
| Item | SubjectDevice | PrimaryPredicateDevice | Reference Predicate Devices | |||||
|---|---|---|---|---|---|---|---|---|
| 510(K) Number | - | K131682 | K143353 | K143142 | K081806 | K142260 | K063341 | |
| Device Name | ChaorumImplantSystem | UD ImplantSystem | Hahn TaperedImplant System | JDentalCareImplantSystem | IDI ImplantSystems | NobelActive® | 3I OSSEOTITECERTAINDENTALIMPLANTS | |
| Manufacturer | MEDIMECCACo., Ltd. | MEDIMECCACo., Ltd. | PRISMATIKDENTALCRAFT,INC | J DENTALCARE S.r.l. | IDIBIOMEDICALLLC | NOBELBIOCAREUSA, LLC | IMPLANTINNOVATIONS,INC | |
| Indications for Use | ChaorumImplantSystem isintended foruse in partiallyor fullyedentulousmandibles andmaxilla, insupport ofsingle ofmultiple-unitrestorationsincluding;cemented | UD ImplantSystem isintended foruse in partiallyor fullyedentulousmandibles andmaxilla, insupport ofsingle ofmultiple-unitrestorationsincluding; | Hahn Implantsare indicated foruse in maxillaryand mandibularpartially or fullyedentulous cases,to support single,multiple-unit, andoverdenturerestorations. Theimplants are to beused forimmediateloading only inthe presence of | JDentalCare®implantsystem isintended forsurgicalplacement inthe upper orlower jaw.JDentalCare®implantsystem iscomprised ofdental implantfixtures andprosthetic | IDI ImplantSystems (IDIFixtures and IDIAbutments withscrews) areendosseousimplantsintended to besurgicallyplaced in thebone of theupper or lowerjaw arches toprovide supportfor prosthetic | NobelActive®implants areendosseousimplantsintended to besurgicallyplaced in theupper or lowerjaw bone foranchoring orsupportingtoothreplacementsto restorepatient | 3i dentalimplants areintended forsurgicalplacement in theupper or lowerjaw toprovide a meansfor prostheticattachment insingle toothrestorations andin partially orfully edentulousspans with |
510(k) Submission.
510(k) summary , 5 / 10 page
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| retained, screwretained, oroverdenturerestorations,and terminal orintermediateabutmentsupport forfixedbridgework.ChaorumImplantSystemis for singlestage and twostage surgicalprocedures.This system isintended fordelayedloading. | cementedretained, screwretained, oroverdenturerestorations,and terminal orintermediateabutmentsupport forfixedbridgework.UD ImplantSystem is forsingle stageand two stagesurgicalprocedures.This system isintended fordelayedloading. | primary stabilityand appropriateocclusal loading | devices.JDentalCare®implantsystemprovides ameansfor prostheticattachment insingle toothrestorationsand partiallyor fullyedentulousspans withmultiple singleteeth utilizingdelayedor immediateloading, or asa terminal orintermediaryabutment forfixed orremovablebridgework orto retainoverdentures.Prostheticdevicesprovidesupport andretention forscrewretainedor cementedrestorations inmandibleand maxilla.JDentalCare® | devices, such asan artificialtooth, in order torestore patientesthetics andchewingfunction.Straightabutmentsindicated forboth screwretained andcementedrestorations areincluded. Theimplants areindicated forsingle ormultiple unitrestorations andcan be used insplinted andnon-splintedapplications.The device isintended forimmediateloading whengood primarystability hasbeen achievedand withappropriateocclusalloading. | esthetics andchewingfunction.NobelActive®implants areindicated forsingle ormultiple unitrestorations insplinted ornon-splintedapplications.This can beachieved by a2-stage or 1-stage surgicaltechnique incombinationwithimmediate,early ordelayedloadingprotocols,recognizingsufficientprimarystability andappropriateocclusalloading for theselectedtechnique.NobelActive®3.0 implantsare intended toreplace alateral incisor | multiple singleteeth, or as aterminal orintermediaryabutment forfixed orremovablebridgework, andto retainoverdentures.In addition,when aminimum of 4implants,>IOmni inlength, areplaced in themandible andsplinted in theanterior region,immediateloading isindicated. | |
|---|---|---|---|---|---|---|---|
| implantsystem isintended forimmediatefunction onsingle toothand/ormultiple toothapplicationswhen goodprimarystability isachieved, withappropriateocclusalloading, inorder torestorechewingfunction. | in the maxillaand/or acentral orlateral incisorin themandible.NobelActive®3.0 implantsare indicatedfor single unitrestorationsonly. | ||||||
| Design/Principle ofOperation | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant- EndomaximInternalConnection- Implantthreads allowself drilling | Image: dental implant- InternalHexagonconnection- Self-tapingcutting edgethreads | Image: dental implant- InternalHexagonconnection- Self-tapingcutting edgethreads | |
| - InternalHexagonconnection- Self-tapingcutting edgethreads | - InternalHexagonconnection- Self-tapingcutting edgethreads | - InternalHexagonconnection- Self-tapingcutting edgethreads | - Internal Hexagon connection- Self-tapingcutting edgethreads | ||||
| EndosseousImplant Material | Titanium(ASTM F136,ASTM F67) | Titanium(ASTM F136,ASTM F67) | Titanium(ASTM F136,ASTM F67) | Titanium(ASTM F136,ASTM F67)Ti Gr. 5 for Ø3,25mm | Titanium | CP Titanium | Titanium(ASTM F136,ASTM F67) |
| Surface Treatment | RBM,SLA | RBM | RBM | SLA | RBM | TiUnite | SLA |
| Implant SterilizationMethod | RadiationSterile | RadiationSterile | Radiation Sterile | Radiation Sterile | - | RadiationSterile | - |
| Implant Diameters | 3.25-6.0mm | 3.5-6.0mm | 3.0-7.0mm | 3.25-6.0mm | 3.5-6.0mm | 3.0-5.5mm | 3.25-6.0mm |
| Implant Lengths | 7.3-15.0mm | 7.3-15.0mm | 8.0-16.0mm | 8.0-15.0mm | 8.8-16.0mm | 7.0-18.0mm | 7.0-20.0mm |
| Angulations ofAngledabutments | 15°, 17°, 25° | 15°, 25° | 15° ~ 30° | 0° ~ 30° | 15° | 0°~30° | 0-25° |
| AbutmentsDiameters | 3.5-6.0mm | 4.0-6.0mm | 3.0-7.0mm | 3.2-6.0mm | - | 3.6-6.0mm | 3.4-7.5 |
| AbutmentsMaterials | - Ti-6Al-4VELI- Titanium Gr | -Ti-6Al-4VELI- Titanium Gr 4 | Ti-6Al-4V ELI | Ti-6Al-4VELI | Ti-6Al-4VELI | Ti-6Al-4VELI | Ti-6Al-4V ELI |
510(k) Submission.
510(k) summary , 6 / 10 page
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510(k) Submission.
510(k) summary , 7 / 10 page
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510(k) Submission.
510(k) summary , 8 / 10 page
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| 4 ASTM F 67 | ASTM F 67 | ||||||
|---|---|---|---|---|---|---|---|
| -- | ------------- | ----------- | -- | -- | -- | -- | -- |
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8. Non-Clinical Testing
The following non-clinical testing was conducted to validate its safety.
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Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
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RBM/SLA Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
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TiN coating tests including surface roughness and abrasion testing
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Mechanical properties test including adaptation accuracy test (Implant to abutment compatibility), 35° compressive loads test, torsional breaking force test, removal torque force test, and fatigue test
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Sterilization validation and shelf life tests
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The following biocompatibility tests have been performed in accordance with ISO10993 series.
| No | Test Title | Test Standard |
|---|---|---|
| 1 | Cytotoxicity Test | ISO10993-5:2009 |
| 2 | Acute Systemic Toxicity Test | ISO10993-11:2006 |
| 3 | Intracutaneous Reactivity Test | ISO10993-10:2010 |
| 4 | Pyrogen Test | ISO10993-11:2006 |
| 5 | Local Lymph Node Assay, LLNA Test | ISO10993-10:2010 |
| 6 | Bone Implantation Test | ISO10993-6:2007 |
9. Conclusion
Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device.
§ 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.