(163 days)
The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.
For specific product descriptions, please refer to individual product labels.
The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.
The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet 3i LLC Mariela Cabarcas Sr. Regulatory Affairs Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K220978
Trade/Device Name: TSXTM Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 11, 2022 Received: August 12, 2022
Dear Mariela Cabarcas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
TSXTM Implants
Indications for Use (Describe)
The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
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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TSX™ Implants 510(k) Summary 09/12/2022
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
I. Submitter Information:
| Name: | Biomet 3i LLC | |
|---|---|---|
| Address: | 4555 Riverside DrivePalm Beach Gardens, Florida 33410 | |
| Phone: | (561) 776-6923 | |
| Fax: | (561) 514-6316 | |
| Contact Person: | Mariela Cabarcas | |
| Job Title: | Sr. Regulatory Affairs Specialist | |
| Email: | mariela.cabarcassanclemente@ZimVie.com | |
| II. | Proprietary Trade Name: | TSXTM Implants |
| III. | Device Classification Name: | Implant, Endosseous, Root-Form (21 CFR 872.3640) |
| IV. | Regulatory Class: | Class II |
| V. | Product Code: | DZE |
| VI. | Reviewing Branch: | Dental Devices Branch |
| VII. | Predicate Devices: | |
| Primary predicate device: | ||
| Trade Name: | Tapered Screw-Vent Implant, 4.1mmD | |
| 510(k): | K072589 |
- 21 CFR 872.3640 Regulation Number: ●
- Product Code: DZE
- . SE Date: 10/04/2007
Reference Device:
| Trade Name: | Zimmer 3.1mmD Dental Implant System |
|---|---|
| 510(K): | K142082 |
| Regulation Number: | 21 CFR 872.3640 |
- Prooduct Code: DZE, NHA
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- . SE: 10/28/2014
Reference Device:
- . Trade Name: ScrewVent Implant; Tapered ScrewVent Implant
- . 510(K): K013227
- Regulation Number: 21 CFR 872.3640 .
- Product Code: DZE
- 11/19/2001 ● SE:
Reference Device:
| • Trade Name: | 3i T3 Dental Implants |
|---|---|
| • 510(K): | K122300 |
| • Regulation Number: | 21 CFR 872.3640 |
| • Product Code: | DZE |
| • SE: | 01/30/2013 |
Reference Device:
| • Trade Name: | 3i T3 Short Implants |
|---|---|
| • 510(K): | K150571 |
| • Regulation Number: | 21 CFR 872.3640 |
| • Product Code: | DZE |
| • SE: | 11/20/2015 |
VIII. Product Description:
TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.
For specific product descriptions, please refer to individual product labels.
| ImplantConnection | Implant Diameter(mm) | Implant Platform(mm) | Implant Length (mm) |
|---|---|---|---|
| Conical +Internal Hex | 3.1 | 2.9 | 8, 10, 11.5, 13, 16 |
| Internal Hex | 3.7 | 3.5 | 8, 10, 11.5, 13, 16 |
| 4.1 | 3.5 | 8, 10, 11.5, 13, 16 | |
| 4.7 | 3.5 | 8, 10, 11.5, 13, 16 | |
| 5.4 | 4.5 | 8, 10, 11.5, 13, 16 | |
| 6.0 | 4.5 | 8, 10, 11.5, 13, 16 |
TSXTM Implants:
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NOTE: The Zimmer Dental and Biomet 3i Zirconia-based abutments have not been tested for compatibility with the TSX Implant and therefore should not be used.
IX. Indications for Use:
The TSX Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the premolar region and should not be used in the molar region.
X. Summary of the Technological Characteristics:
The TSX Implants are similar to that of the predicate devices and reference devices listed below in terms of intended use, indications for use, operating principle, fundamental scientific technology, implant connection, and material. The technological characteristics such as implant diameters, length, connection and platform geometry, as well as mating abutments are similar to that of the predicate devices and reference devices, except for Zimmer Dental Zirconia-based abutments which have not been tested for compatibility with the subject devices and therefore should not be used. The subject device features a tapered design with a similar screw-type design as the predicate and reference devices. Like the Predicate Device (K072589) and Reference Devices (K013227, K142082), TSX Implants are manufactured from titanium alloy (Ti 6Al-4V ELI) per ASTM F136. The primary change from the predicate devices is the external tapered thread geometry, the hybrid surface (Dual acid-etched + MTX Surface), the new 5.4mm(D) size in 8.0, 10.0, 11.5. 13.0. and 16.0mm lengths, and the one style packaging Inner Vial for all diameters and lengths, with a Titanium sleeve based on implant size, as well as an anodized alignment pin.
The subject devices have indications for use that are similar to the predicate devices. The differences include additional information around immediate placement in extractions and natural loss of teeth. This additional language is in the indications for use for the reference devices in K142082. The intended use of the subject devices is not changed by the addition of this additional language.
A substantial equivalence comparison between the Subject Device and the Predicate and Reference Devices is provided in Table 5a below.
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| Table 5a: General Device Comparison | |||||
|---|---|---|---|---|---|
| Comparison | Primary Predicate DeviceDevice (K072589) | Reference Device #1(K142082) | Reference Device #2(K122300) | Reference Device #3(K013227) | Subject Device |
| Tapered Screw-VentImplantZimmer Dental | Zimmer Eztetic, 3.1mmDDental Implant SystemZimmer Dental | 3i T3 Dental ImplantsBiomet 3i | ScrewVent® and TaperedScrewVent®Sulzer Dental, Incorporated(Became Zimmer Dental) | TSX ImplantsBiomet 3i | |
| Indications forUse | The Tapered Screw-VentImplants are designed foruse in the maxilla ormandible for immediateloading or for loading aftera conventional healingperiod. Implants may beused to replace one ormore missing teeth.Immediate loading isindicated when there isgood primary stability andan appropriate occlusalload. | Zimmer 3.1mmD DentalImplants are designed foruse in the anterior maxillaor mandible for immediateloading or for loading aftera conventional healingperiod. Implants may beused to replace one ormore missing teeth.Immediate loading isindicated when there isgood primarystability and an appropriateocclusal load.Zimmer 3.1mmD DentalImplants may be placedimmediately following anextraction or loss of naturalteeth provided there issufficient volume ofalveolar bone to minimallysupport the implant(minimum 1mmcircumferential and 2mm | 3i T3 Dental Implants areintended for surgicalplacement in the upper orlower jaw to provide ameans for prostheticattachment in single toothrestorations and in partiallyor fully edentulous spanswith multiple single teethutilizing delayed orimmediate loading, or as aterminal or intermediaryabutment for fixed orremovable bridgework,and to retain overdentures.3i T3 Dental Implants areintended for immediatefunction on single toothand/or multiple toothapplications when goodprimary stability isachieved, with appropriateocclusal loading, in orderto restore chewingfunction. | The ScrewVent andTapered Screw VentImplants are intended forsurgical implantation inedentulous or partiallyedentulous mandibles ormaxillae for attachment ofcomplete dentureprostheses, or as a terminalor intermediary abutmentfor fixed or removablebridgework, or as afreestanding single toothreplacement.In patients with anedentulous mandible,ScrewVent and TaperedScrewVent Implants maybe loaded immediatelywhen at least four implantsare placed between themetal foramina and rigidlysplinted with a bar.ScrewVent® and TaperedScrewVent® implants are | The TSX Implants aredesigned for use in themaxilla or mandible forimmediate loading or forloading after aconventional healingperiod. Implants may beused to replace one or moremissing teeth. Immediateloading is indicated whenthere is good primarystability and an appropriateocclusal load. Implantsmay be placed immediatelyfollowing an extraction orloss of natural teethprovided there is sufficientvolume of alveolar bone tominimally support theimplant (minimum 1mmcircumferential and 2mmapical) and provide goodprimary stability.The 3.1mmD TSXImplants should be splinted |
| Table 5a: General Device Comparison | |||||
| Comparison | Primary Predicate DeviceDevice (K072589) | Reference Device #1(K142082) | Reference Device #2(K122300) | Reference Device #3(K013227) | Subject Device |
| Tapered Screw-VentImplantZimmer Dental | Zimmer Eztetic, 3.1mmDDental Implant SystemZimmer Dental | 3i T3 Dental ImplantsBiomet 3i | ScrewVent® and TaperedScrewVent®Sulzer Dental, Incorporated(Became Zimmer Dental) | TSX ImplantsBiomet 3i | |
| apical).The Zimmer 3.1mmDDental Implants should besplinted to additionalimplants when used in thepre-molar region andshould not be used in themolar region. | placed into a preparedosteotomy and oncestability is achieved, theimplant is restored with acompatible restorativedevice. | to additional implantswhen used in the pre-molarregion and should not beused in the molar region. | |||
| OperatingPrinciple | The Tapered Screw-VentImplant Dental Implantsare placed into a preparedosteotomy and oncestability is achieved, theimplant is restored with acompatible restorativedevice. | The Tapered Screw-VentImplant Dental Implants areplaced into a preparedosteotomy and once stabilityis achieved, the implant isrestored with a compatiblerestorative device. | The 3i T3 Dental Implantsachieve their intendedpurpose based upon theirmacro design features,which maximize primarystability at time ofplacement. | The Tapered Screw-VentImplant Dental Implantsare placed into a preparedosteotomy and oncestability is achieved, theimplant is restored with acompatible restorativedevice. | The TSX Dental Implantsachieve their intendedpurpose based upon theirmacro design features,which maximize primarystability at time ofplacement. |
| FundamentalScientificTechnology | Endosseous DentalImplants;Screw-type designs | Endosseous DentalImplants;Screw-type designs | Endosseous DentalImplants;Screw-type designs | Endosseous DentalImplants;Screw-type designs | Endosseous DentalImplants;Screw-type designs |
| Material | Titanium Alloy (Ti-6Al-4VELI) Per ASTM 136 | Titanium Alloy (Ti-6Al-4VELI) Per ASTM 136 | Commercially PureTitanium (CP4)Per ASTM F67 | Titanium Alloy (Ti-6Al-4VELI) Per ASTM 136 | Titanium Alloy (Ti-6Al-4VELI) Per ASTM 136 |
| Table 5a: General Device Comparison | |||||
| Comparison | Primary Predicate DeviceDevice (K072589) | Reference Device #1(K14082) | Reference Device #2(K122300) | Reference Device #3(K013227) | Subject Device |
| Tapered Screw-VentImplantZimmer Dental | Zimmer Eztetic, 3.1mmDDental Implant SystemZimmer Dental | 3i T3 Dental ImplantsBiomet 3i | ScrewVent® and TaperedScrewVent®Sulzer Dental, Incorporated(Became Zimmer Dental) | TSX ImplantsBiomet 3i | |
| SurfaceTopography | Single stage surface:MTXGrit Blast usingHydroxyapatite blastmedia | Single stage surface:MTXGrit Blast usingHydroxyapatite blast media | Contemporary hybridsurface:Grit Blast usingHydroxyapatite blastmedia followed byOsseotite Dual AcidEtching | Single stage surface:MTXGrit Blast usingHydroxyapatite blast media | Contemporary hybridsurface:hybrid surface: OsseotiteDual Acid Etching surfacefrom the coronal surface toapproximately 1.5mmdown the implant collar,followed by MTXGrit Blast usingHydroxyapatite blast media |
| Implant BodyDiameterRange | 4.1mm | 3.1mm | 3.25mm, 4.0mm, 5.0mmand 6.0mm | 3.7mm, 4.7mm, 6.0mm | 3.1mm, 3.7mm, 4.1mm,4.7mm, 5.4mm (new),6.0mm |
| SeatingPlatformDiameter | 3.5mm | 2.9mm | 3.25mm, 4.0mm, 5mm and6mm | 3.5mm, 4.5mm, 5.7mm | 2.9mm, 3.5mm, 4.5mm |
| ImplantLength | 8.0mm, 10.0mm, 11.5mm,13.0mm, 16.0mm | 8.0mm, 10.0mm, 11.5mm,13.0mm, 16.0mm | 8.5mm, 10mm, 11.5mm,13mm and 15.0mm | 8mm, 10.0mm, 13.0mm,16.0mm | 8.0mm, 10.0mm, 11.5mm,13.0mm, 16.0mm |
| PlatformGeometry | Platform switched only | Platform switched only | Platform Switched andNon-Platform SwitchedImplants | Platform switched only | Platform switched only |
| ImplantExternalGeometryDesign | Tapered only | Tapered only | Tapered / andParallel Walled | Tapered only | Tapered only |
| Table 5a: General Device Comparison | |||||
| Comparison | Primary Predicate DeviceDevice (K072589) | Reference Device #1(K142082) | Reference Device #2(K122300) | Reference Device #3(K013227) | Subject Device |
| Tapered Screw-VentImplantZimmer Dental | Zimmer Eztetic, 3.1mmDDental Implant SystemZimmer Dental | 3i T3 Dental ImplantsBiomet 3i | ScrewVent® and TaperedScrewVent®Sulzer Dental, Incorporated(Became Zimmer Dental) | TSX ImplantsBiomet 3i | |
| ImplantConnection | 2.5, 3.0mm Hex withFriction Fit | 2.1mm Hex with Friction Fit | Different implantconnection | 2.5, 3.0mm Hex withFriction Fit | 2.1mm, 2.5mm Hex withFriction Fit |
| Thread Design | 60° Thread Angle; 1.8mmPitchTriple Lead Thread | 60° Thread Angle; 1.2mmPitchTriple Lead Thread | 35° Thread Angle; 0.8mmPitchSingle Lead Thread | 60° Thread Angle; 1.8mmPitchTriple Lead Thread | 30° Thread Angle; 1.6mmPitchDual Lead Thread |
| RestorativeandProstheticsComponents | Zimmer Dental TSVInternal ConnectionRestorative Components | Zimmer Dental 3.1mmEztetic Internal ConnectionRestorative Components | Biomet 3i InternalConnection | Zimmer Dental TSVInternal ConnectionRestorative Components, | Zimmer Dental TSVInternal ConnectionRestorative Components,except for the Zirconia-based abutments |
| SterilizationMethod | Supplied Sterile(Gamma radiation) | Supplied Sterile(Gamma radiation) | Supplied Sterile(Gamma radiation) | Supplied Sterile(Gamma radiation) | Supplied Sterile(Gamma radiation) |
| Shelf Life | 5 years | 5 years | 5 years | 5 years | 1 year |
| Single Use | Yes | Yes | Yes | Yes | Yes |
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XI. Non-Clinical Testing
A full ISO-Curve testing has been conducted to substantiate sufficient fatigue endurance limits for the TSX Implants for placement in the anterior and posterior regions of the mouth with compatible abutments. Testing has been performed in accordance with ISO 14801:2016 and FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants. The worst-case comparison for the subject devices have demonstrated substantially equivalent to K122300 with regard to mechanical performance. MR compatibility testing to support the MR conditional labeling is leveraged from K150571, where testing was conducted on the worst case cleared Biomet 31 device constructs. Hence the subject devices are labeled as MR conditional as the review of the testing is leveraged from K150571. The subject devices do not introduce a new worst-case.
Radiation sterilization validation according to ISO 11137-1 and 11137-2 was provided, demonstrating a sterility assurance level (SAL) of 106 and accelerated aging study demonstrating a shelf life of one (1) year.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device. Testing was leveraged from the reference devices in K142082 as the subject devices do not introduce a new worst-case.
Though, the LAL Bacterial Endotoxin testing determined the device meets pyrogen limit specifications, it will not be sufficient alone to demonstrate "non-pyrogenic", therefore, the subject devices will not be labeled as non-pyrogen-free, nor will any claims be made in regards to non-pyrogenicity.
SEM and Energy Dispersive x-ray Spectroscopy imaging was conducted on the subject and predicate finished devices to assess the presence of residual blast media particles on the device due to the modification of the surface treatment in the subject device. The assessment conducted that the subject TSX devices presented no statistical difference compared to the predicate TSV devices and therefore are considered substantially equivalent.
Biocompatibility assessment of the final finished device per recommendations of current FDA guidance (issued on September 4, 2020) in accordance to "ISO 10993-1, Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process" has been conducted including chemical characterization, cytotoxicity and toxicological risk assessment. It is concluded that the TSX Implants are substantially equivalent to the predicate devices in terms of biocompatibility inclusive of base materials, manufacturing processes inclusive of surface treatments.
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No clinical data were included in this submission.
ХІІ. Conclusion:
The subject device has demonstrated substantial equivalence to the predicate devices in that it has the same intended use, the same operating principle, identical materials and similar fundamental design.
§ 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.