(127 days)
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured byTerrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured byZfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
The provided text is a 510(k) summary for a medical device (Immediate Molar Implants) and does not contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.
The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, non-clinical testing (fatigue, MR compatibility, pull-out tests, surface area analysis, sterilization, biocompatibility, shelf life), and contractual agreements for compatible components.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using clinical or performance data, as this information is not present in the provided text. The document describes a dental implant, not an AI or software-based device that would typically have acceptance criteria presented in the manner requested.
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Image /page/0/Picture/0 description: The image shows 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.
October 23, 2024
Biomet 3i, LLC Krupal Patel Regulatory Affairs Principal 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K241753
Trade/Device Name: Immediate Molar Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 18, 2024 Received: September 19, 2024
Dear Krupal Patel:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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 -S
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 Quality Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K241753
Device Name: Immediate Molar Implants
Indications for Use:
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured byTerrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured byZfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Part 21 CFR 801 Subpart D) and/or
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Product Evaluation and Quality (OPEQ)
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Immediate Molar Implants 510(k) Summary 21 CFR 807.92 23-Oct-2024
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: | Krupal Patel |
|---|---|
| Job Title: | Principal Regulatory Specialist |
| Email: | krupal.patel@zimvie.com |
- II. Proprietary Trade Name: Immediate Molar Implants
- III. Device Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
- IV. Regulatory Class: Class II
- V. Product Code: DZE
VI. Predicate Devices:
Primary Predicate Device:
-
T3 PRO Implants (K213672)
Reference Predicate Devices: -
. TSX Implants (K220978)
-
Tapered Screw Vent Implants (K013227)
-
3i T3 Short Dental Implants (K150571) ●
-
Implanova (K210523)
-
. Southern Implants MAX Implant System (K191054)
VII. Product Description:
The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is
{5}------------------------------------------------
packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.
VIII. Indications for Use:
Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
| Abutment System Name | Models | Platform Diameters |
|---|---|---|
| Abutments manufactured byTerrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured byZfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |
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IX. Summary of the Technological Characteristics:
The Immediate Molar Implant devices are identical to the predicate devices listed below in terms of operating principle and material. The subject device Indications for Use adds language for immediate implant placement to reflect the information that was included for the reference predicate device labeling which includes immediate implant placement. The technological characteristics such as length, connection & platform geometry, and the mating abutments are identical as the predicate devices. The subject device features a tapered design with a similar screw-type design and thread form as the predicate device. Like the primary predicate device, Immediate Molar Implant are manufactured out of commercially pure titanium per ASTM F67. The primary change from the predicate devices is implant diameter and thread form. Also, Immediate Molar Implant are offered in platform switched design only.
A substantial equivalence comparison of subject and predicate device is provided in table below.
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| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IntendedUse/Indicationsfor Use | Immediate MolarDental Implants areintended for surgicalplacement in theupper or lower jawto provide a meansfor prostheticattachment in singletooth restorationsand in partially orfully edentulousspans with multiplesingle teeth utilizingdelayed loading, orwith a terminal orintermediaryabutment for fixed orremovablebridgework, and toretain overdentures.Immediate MolarDental Implants mayalso utilizeimmediate loadingfor these indications.Immediate MolarDental Implants areintended forimmediate function | The T3 Pro DentalImplants are intendedfor surgical placementin the upper or lowerjaw to provide a meansfor prostheticattachment in singletooth restorations andin partially or fullyedentulous spans withmultiple single teethutilizing delayed orimmediate loading, oras a terminal orintermediary abutmentfor fixed or removablebridgework, and toretain overdentures.The T3 Pro Implantsmay also utilizeimmediate loading forthese indications. TheT3 Pro Implants areintended for immediatefunction on single toothand/or multiple toothapplications when goodprimary stability isachieved, with | The TSX Implants aredesigned for use inthe maxilla ormandible forimmediate loading orfor loading after aconventional healingperiod. Implants maybe used to replace oneor more missingteeth. Immediateloading is indicatedwhen there is goodprimary stability andan appropriateocclusal load.Implants may beplaced immediatelyfollowing anextraction or loss ofnatural teeth providedthere is sufficientvolume of alveolarbone to minimallysupport the implant(minimum 1mmcircumferential and2mm apical) andprovide good primarystability. | The Tapered Screw-Vent and Screw-VentImplants are intendedfor surgicalimplantation inedentulous mandiblesor maxillae forattachment ofcomplete dentureprostheses, or as aterminal orintermediaryabutment for fixed orremovablebridgework, or as afreestanding singletooth replacement. | The 3i T3 Short areintended for surgicalplacement in theupper or lower jaw toprovide a means forprosthetic attachmentin single toothrestorations and inpartially or fullyedentulous spanswith multiple singleteeth utilizingdelayed loading, orwith a terminal orintermediaryabutment for fixed orremovablebridgework, and toretain overdentures. | The Implanova®implants are intendedfor endosseousimplantation in themandible and maxillafor use as an artificialroot structure. Theseroot form implantscan be used toreplace single ormultiple teethmissing teeth and/orto support a fixed orremovable prosthesisin partially orcompletelyedentulous upper andlower dental arches.Implanova® All-in-One™ implants areindicated to be usedwhen primarystability of theimplant allowspresence of anabutment at the timeof placement.Implanova® All-in-one™ are | Southern ImplantsMAX implant isintended forimplantation inmaxillary ormandibular molarregion where boneexists and thesurgeon hasdetermined that theplacement of anarrower diameterimplant wouldincrease theprobability of failuredue to poor primarystability, or increasedsurgical proceduresleading tocomplications. ThisMAX implantprovides support forfixed or removabledental prostheses in asingle tooth, partiallyedentulous prosthesesor full archprostheses. It furtheradds the option forimmediate loading on | ||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| on single toothand/or multiple toothapplications whengood primarystability is achieved,with appropriateocclusal loading, inorder to restorechewing function.The ImmediateMolar DentalImplants may beplaced immediatelyfollowing anextraction or loss ofnatural teethprovided there issufficient volume ofalveolar bone toprovide goodprimary stability.The ImmediateMolar DentalImplants areintended forimplantation in themaxillary ormandibular molarregion where boneexists and thesurgeon hasdetermined that the | appropriate occlusalloading, in order torestore chewingfunction. | The 3.1mmD TSXImplants should besplinted to additionalimplants when used inthe pre-molar regionand should not beused in the molarregion. | immediately loadedby the presence of theabutment, but theocclusal forces needto be controlled andrestricted whileosseointegrationtakes place. | single and splintedmultiple unitrestorations whengood primarystability is achievedand with appropriateocclusal loading, torestore chewingfunction. | |||||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| placement of anarrower diameterimplant wouldincrease theprobability offailure due to poorprimary stability, orincreased surgicalprocedures leadingto complications.The ImmediateMolar DentalImplants are alsocompatible withtitanium abutmentsmanufactured byTerrats Medical S.L.and Zfx GmbH | |||||||||||||||||
| OperatingPrinciple | The ImmediateMolar DentalImplants achievetheir intendedpurpose based upontheir macro designfeatures, whichmaximize primarystability at time ofplacement. | The T3 Pro DentalImplants achieve theirintended purpose basedupon their macrodesign features, whichmaximize primarystability at time ofplacement. | The TSX DentalImplants achievetheir intendedpurpose based upontheir macro designfeatures, whichmaximize primarystability at time ofplacement. | The Tapered ScrewVent Dental Implantsare placed into aprepared osteotomyand once stability isachieved; the implantis restored with acompatiblerestorative device. | The 3i T3 ShortDental Implants areplaced into aprepared osteotomyand once stability isachieved, the implantis restored with acompatiblerestorative device. | The ImplanovaDental Implants areplaced into aprepared osteotomyand once stability isachieved, the implantis restored with acompatiblerestorative device. | The Southern MaxDental Implants areplaced into aprepared osteotomyand once stability isachieved, the implantis restored with acompatiblerestorative device. | ||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| Fundamental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | ||||||||||
| Scientific | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | ||||||||||
| Technology | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | ||||||||||
| Material | Commercially PureTitanium (CP4)Per ASTM F67 | Commercially PureTitanium (CP4)Per ASTM F67 | Titanium Alloy (Ti-6Al-4V ELI) perASTM F136 | Titanium Alloy (Ti-6Al-4V ELI) perASTM F136 | Commercially PureTitanium (CP4)Per ASTM F67 | Titanium Alloy(ASTM F136) | Commercially PureTitanium (CP4)Per ASTM F67 | ||||||||||
| ImplantBodyDiameterRange | Ø7.0mm, 8.0mm,and 9.0mm | Ø3.25mm, 4mm,5.0mm and 6.0mm | Ø3.1mm, 3.7mm,4.1mm, 4.7mm,5.4mm and 6.0mm | Ø3.7mm, 4.7mm and6.0mm | Ø5.0mm and 6.0mm | Ø6.5, 7.5 and 8.5mm | Ø6.0mm, 7.0mm,8.0mm and 9.0mm | ||||||||||
| SeatingPlatformDiameter | Subject T3 PROImmediate MolarImplant: Ø6.0mmSubject TSXImmediate MolarImplant: Ø5.7mm | Ø3.4mm, 4.1mm,5.0mmand 6.0mm | Ø2.9mm, 3.5mm and4.5mm | Ø3.5mm, 4.5mm and5.7mm | Ø5.0mm and 6.0mm | Ø6.5mm | Ø4.5mm, 5.5mm,5.7mm, 6.5mm and7.5mm | ||||||||||
| ImplantLength | Subject T3 PROImmediate MolarImplant:8.0mm, 10.0mm and11.5mmSubject TSXImmediate Molar | 8.5mm, 10mm,11.5mm, 13.0mm and15mm | 8.0mm, 10mm,11.5mm, 13.0mm and16mm | 8.0mm, 10.0mm,13.0mm and 16.0mm | 5.0mm and 6.0mm | 6.0mm, 8.0mm and10.0mm | 6.0mm, 7.0mm,9.0mm and 11.0mm | ||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| Implant:6.0mm, 8.0mm,10mm, and 11.5mm(Note: 6.0mm lengthoption is notavailable for the9mmD diameteroption of TSXImmediate MolarImplants) | |||||||||||||||||
| PlatformGeometry | Platform Switchedonly | Platform Switched andNon-Platform SwitchedImplants | Platform Switchedonly | Platform Switchedonly | Non-PlatformSwitched Implants | Platform Switchedonly | Platform Switchedonly | ||||||||||
| InternalExternalGeometryDesign | Tapered only | Tapered only | Tapered only | Tapered only | Parallel Walled only | Tapered only | Tapered only | ||||||||||
| ImplantConnection | Subject T3 PROImmediate MolarImplant:Biomet 3i InternalHex (Certain®Connection)Subject TSXImmediate Molar | Biomet 3i Internal Hex(Certain® Connection) | 2.1mm, 2.5mm Hexwith Friction Fit | 2.5mm, 3.0mm Hexwith Friction Fit | External Hex | InternalHexagon | External HexTri-lobeInternal Hex | ||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| Implant:3.0mm Hex withFriction Fit | |||||||||||||||||
| SurfaceFinish | • Grit Blasted withCalciumPhosphate (CaP)• Dual-acid Etching(OSSEOTITE®) | • Grit Blasted withCalcium Phosphate(CaP)• Dual-acid Etching(OSSEOTITE®) | Contemporary hybridsurface: OsseotiteDual Acid Etchingsurface from thecoronal surface toapproximately 1.5mmdown the implantcollar, followed byMTX Grit Blast usingHydroxyapatite blastmedia. | Single stage surface:MTX Grit Blast usingHydroxyapatite blastmedia | • Grit Blasted withCalciumPhosphate (CaP)• Dual-acid Etching(OSSEOTITE®) | ResorbableBlast TextureMedia (CalciumPhosphate) | Grit-blasted | ||||||||||
| AnodizedPlatformSurfaceColor | Subject T3 PROImmediate MolarImplant: GreenSubject TSXImmediate MolarImplant: None | Purple, Blue, Yellowand Green | None | None | Yellow and Green | None | None | ||||||||||
| MatingComponents | Subject T3 PROImmediate MolarImplant: | Biomet 3i Internal HexConnectionRestorativeComponents | Zimmer Dental TSVInternal ConnectionRestorativeComponents, except | Zimmer Dental TSVInternal ConnectionRestorativeComponents | Biomet 3i ExternalHex ConnectionRestorativeComponents | Straight typeabutments, straighttype abutment screwsand straight type | Southern ImplantsRestorativeComponents withexternal hex, tri-lobe | ||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| Biomet 3i InternalHex ConnectionRestorativeComponents(Compatible with4.1mm, 5.0mm and6.0mm connection);and titaniumabutmentsmanufactured byTerrats Medical SLand Zfx GmbH. | for the Zirconia basedabutments | temporary abutmentsthat are intended tobe on Astra Tech'sOsseoSpeed™ TX3.5S andOsseoSpeed™ TX4.0S implant fixtures. | and internal hexinterface | ||||||||||||||
| Subject TSXImmediate MolarImplant:Zimmer Dental TSVInternal ConnectionRestorativeComponents(Compatible with5.7mm connection);and titaniumabutmentsmanufactured byTerrats Medical SLand Zfx GmbH. | |||||||||||||||||
| Feature | Subject DeviceImmediate MolarDental Implants | Primary PredicateDeviceT3 PRO DentalImplants (K213672) | Reference PredicateDeviceTSX Dental Implants(K220978) | Reference PredicateDeviceTSV Dental Implants(K013227) | Reference PredicateDevice3i T3 Short DentalImplants (K150571) | Reference PredicateDeviceImplanova(K210523) | Reference PredicateDeviceSouthern ImplantsMAX ImplantSystem (K191054) | ||||||||||
| SterilizationMethod | Supplied Sterile(Gamma radiation) | Supplied Sterile(Gamma radiation) | 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 | 5 years | 5 years | 5 years | ||||||||||
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Table 1: Substantial equivalence table
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X. Non-Clinical Testing:
The worst-case comparison for the subject devices have demonstrated substantially equivalent to K213672 and K220978 with regard to fatigue 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 3i device constructs. Pull out tests and surface area analyses of the short implants with implantable thread length less than 7mm) demonstrated that the subject device is substantially equivalent to the reference device T3 Shorts (K150571). The Immediate Molar Implants possess the same multi-level surface topography by reference to K213672, which consist of surface treatments in the form of grit blasting with Calcium Phosphate (CaP) media per ASTM F1185 followed by the well-established dual acid etching process. The subject devices do not introduce a new worst-case.
Non-clinical data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstration a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K213672 demonstrating a shelf life of five years.
There is a contractual agreement with Terrats Medical SL to support compatibility of Immediate Molar Implants for use with their Titanium abutments, without needing reverse engineering analysis testing. Zfx GmbH is a wholly owned subsidiary of ZimVie, which is also the parent company of Biomet 3i LLC. Engineering drawings are shared between Biomet 3i LLC and Zfx GmbH to support compatibility of Immediate Molar Implants for use with their Titanium abutments, without needing reverse engineering analysis testing.
The subject devices will not be labeled as non-pyrogenic or pyrogen-free, nor will any claims be made in regards to non-pyrogenicity.
No clinical data were included in this submission.
XI. Conclusion:
The subject devices have demonstrated substantial equivalence to the predicate devices in that they utilize same materials and fundamental designs and also have the same intended use and principles of operation.
§ 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.