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510(k) Data Aggregation
(186 days)
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.
The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.
The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.
Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:
Description of the Device
The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Description of Test | Reported Device Performance (Results) |
|---|---|---|
| Biological Evaluation | ||
| ISO 10993-1:2018; FDA Guidance on the Use of ISO 10993-1, 2023 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | PASS – All biological endpoint testing performed on the device, along with the analysis on the physical and chemical information, returned passing results. All biological endpoint testing suggests that the Omnibut is biocompatible and does not present a foreseen biological risk to those patient populations it is intended for. |
| ISO 10993-5 (2009) | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | PASS – The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was grade 0 (no reactivity). |
| Sterilization Validation | ||
| AAMI TIR12:2020; ANSI/AAMI/ISO 17665-1:2026/(R)2013; ANSI/AAMI ST79:2017 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers, Overkill method according to Section 5.7 | PASS – Results from testing have demonstrated that the Omnibut was able to achieve a 10-6 SAL when using the recommended parameters in the Instructions for Use (IFU). |
| Mechanical Performance | ||
| ISO 14801:2016; FDA Guidance Document, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) Section 8 | Dentistry — Implants — Dynamic loading test for endosseous dental implants | PASS – The results conclude that when evaluated in a manner consistent with ISO 14801:2016, the Omnibut met all predetermined acceptance criteria. |
| No specific standard (Compatibility) | Reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws were performed to demonstrate that the Omnibut abutments are compatible with the noted implant systems. Compatibility must be demonstrated to ensure proper device functionality. | PASS – The engineering and dimensional analysis concluded that each Omnibut design is compatible with the applicable implant connection. PASS - Omnibut prosthetic side components were demonstrated to be compatible. |
| No specific standard (Retention Force Testing) | The Omnibut has a retention attachment. Retention Force testing was performed via tensile push-out to ensure that the attachment will not detach during clinical use. | PASS – The Omnibut retention attachment did not detach at a predetermined acceptable force. |
| No specific standard (Simulated-Use Testing) | Simulated Use of four Omnibuts with components connected to a Titanium Bar under a clinically relevant cyclic load. | PASS – The Omnibut and components did not yield, deform, or fracture after fatigue testing. |
| No specific standard (Simulated Cleaning Testing) | Simulated cleaning of Omnibuts in a fixture with a clinically worst case cleansibility construction. | PASS – All parts of the Omnibuts were clean of soil indicators after six soilage and cleaning cycles. |
| MR Safety | ||
| FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795). | The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. The document does not explicitly state the results (e.g., "MR Safe" or "MR Compatible"), but implies that the analysis was sufficient to support safety in the MR environment based on the scientific rationale and literature used. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.
- Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance evaluations relies on:
- Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
- Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
- Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.
8. The Sample Size for the Training Set
This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
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(79 days)
NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved. MUA Xeal: The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. On1 Base Xeal: The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.
Onl Universal Abutment (previously cleared by K181869) The Onl 11M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutunent consist of three major parts. Specifically, the Onl Base, the Onl Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material , milling machine and associated tooling and accessories.
TREFOIL System (previously cleared per K172352) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil Implants are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm implant and 14.5 mm for 13.0implant and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants
Healing Cap Multi-Unit Titanium (previously cleared per K171142) The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.
TREFOIL System (previously cleared per K170135) The Trefoil system is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil system are placed between the mental foramina in fully edentitious mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. The following prerequisities must be fulfilled: - Adequate quantity of bone (minimum width of 7 mm; and minimum heights of 13 mm implant and 14.5 mm for 13.0 mm implant) -Adequate mouth opening (minimum 40 mm) to accomodate the guided surgery intruments. -Implant-supported prosthetics seated directly on dedicated implants
Onl Concept (previously cleared per K161655) The On 17M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
NobelZygoma 0° (previously cleared per K 161598) Nobel Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Temporary Snap Abutment (previously cleared per K161435) The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that and in creating an esthetic emergence through the gingiva during period and prior to final restoration. The Temporary SnapAbutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutiment is not to exceed one hundred and eighty(180) days.
Multi-Unit Abutment Plus (previously cleared per K161416) The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
NobelProcera HT ML FCZ Implant Bridge and Framework (previously cleared per K160158) The NobelProcera HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
NobelSpeedy Groovy (previously cleared per K160119) NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bicortical anchorage in cases of reduced bone density. NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.
TREFOIL System (previously cleared per K152836) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is acheved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants
NobelZygoma 45° (previously cleared per K152093) Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthelies and chewing finction. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.
NobelActive Wide Platform (WP) ( previously cleared per K133731) Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient estherics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
NobelProcera Overdenture Bar (previously cleared per K132749) The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants in the treatment of partially or totally edentulous jaws for the purpose of restoring function.
NobelProcera Angulated Screw Channel Abuttment Conical Connection (previously cleared per K 132746) The NobelProcera Angulated Screw Channel Conical Connection are premanufactured prostheire components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare PEEK Abutments (previously cleared per K120954) The Nobel Biocare PEEK Abuments are premanufactured prosthetic components directly connected to the endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
NobelActive 3.0 (previously cleared per K111581) The Nobel Active 3.0 implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate finction provided that stability requirements detailed in the manual are satisfied.
NobelActive 3.0mm (previously cleared per K102436) The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
NobelProcera Implant Bridge Zirconia (previously cleared per K091907) The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
NobelProcera Zi Abutments (previously cleared per K091904) The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
NobelProcera Ti Abutment (previously cleared per K091756) The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
NobelActive 8.5 mm & 18.0 mm (previously cleared per K083205) Nobel Biocare's Nobel Active implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's Nobel ective implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
NobelReplace Hexagonal Implants (previously cleared per K073142) Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediate function provided that initial stability requirements detailed in the manual are satisfied.
NobelActive Multi Unit Abutment (previously cleared per K072570) NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
NobelActive Internal Connection Implant (previously cleared per K071370) Nobel Biocare's Nobel Active implant are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive mplants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Adapter PS (previously cleared per K063592) Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Zygoma Angled Abutments (previously cleared per K052885) The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly connected to the implant and is intended for use as an aid in prosthetic rehabilitation.
Zygoma TiUnite (previously cleared per K050641) Nobel Biocare's zygoma TiUnite is a tianium, endosseous implant with components intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function, Nobel Biocare's Zygoma TiUnite inclueds endosseous implants, a cover screw, healing abutments, and multi unit abutments.
Nobelspeedy Implants (previously cleared per K050406) NOBELSPEEDY TM Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELS PEEDY TM Implants are indicated for single or multiple unt restorations in splinted or non-splications. Nobel Biocare NOBELSPEEDY TM Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. NOBELSPEEDY TM Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY TM Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY TM Implants are preferred in these soft bone indications because bone formation on the Til nore rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates. NOBELSPEEDY TM Implants may be tilted up to 450. When used with angulations between 300 and 450 a minimum of four implants must be used and splinted.
Groovy Implants (previously cleared per K050258) Nobel Biocare's Groovy Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Groovy Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Groovy Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. Groovy implants are indicated for use in soft bone in posterior regions or whenever immediate or early loading is applied. The Groovy implants incorporate a groove on the implant thread and are preferred over models without the grove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants.
Procera Implant Bridge, models 15-1001, 15-1002, 15-1052 (previouly cleared per K041236) The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems: Nobel Biocare Branemark System Nobel Biocare Replace SelectThe Procera Implant Bridge can be used at the implant level of the following implant systems: Nobel Biocare Replace Nobel Biocare Steri-Oss HL Nobel Biocare Novum Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6.5 The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept.
Various Branemark System Implants-Immediate Function Indication previously cleared per K022562 The Branemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on -single tooth and/or multiple tooth applications recognizing stability (type I or n bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
BRANEMARK NOVUM previously cleared per K000018 The "Immediate Loading Treatment Protocol" is intended for use with selected Brânemark System Implants, I hese implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.
Amorphous Diamond Coated Screw (previously cleared per K992538) The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other proshetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.
Procera® Preparable Abutment System (previously cleared per K974150) Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.
AurAdapt Abutment System (previously cleared per K972475) Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutnents which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.
Branemark System - Zygomaticus Fixture System (previously cleared per K970499) The Nobel Biocare Brallemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.
Bio-Esthetic Indirect Abutment (previously cleared per K970073) The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.
Steri-Oss' Tiodized' screws (previously cleared per K964739) The intended use for Steri-Oss' Tiodized screws is the screw retained attachment of prosthetic components to one another and to dental implants.
Replace Titanium Implant System (previously per K964220) The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
STERI-OSS GOLD ATTACHMENT SYSTEM (previously cleared per K963945) Steri-Oss Gold Attachment System, the intended use of this device is for the screw retained attachment of prosthesis to abutments is for the screw and/or abutments to retained implants.
17° Angulated Abutment (previously cleared per K961736) The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis
MirusCone Abutment System (previously cleared per K961728) The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.
Branemark System- Healing Abutment (previously cleared per K925779) The Nobelpharma Branemark System- Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Branemark System Estheticone Abutment complete (previously cleared per K925777) The Nobelpharma Branemark System - EsthetiCone Abutment Complete is intended to be used as a component to an endosseous implant.
Branemark Systems - Titanium CoverScrew (previously cleared per K925771) The Nobelpharma Branemark Systems - Titanium CoverScrew is intended to an endosseous implantprior to the first healing period to protect the innerthread of the fixture and prevent bone overgrowth.
Branemark System Abutment Complete (previously cleared per K925769) The Nobelpharma Branemark System Abutment Complete is intended to be used as a component to an endosseous implant to support a prosthetic device.
Branemark System Temporary Solutions (previously cleared per K925766) The Nobelpharma Branemark System Temporary Solutions are intended to be used in the same manner asthe permanent counterpart except that the former are usedto support transitional reconstructions.
Branemark System Standard 3.75 mm Fixture (previously cleared per K925765) All Nobelpharma fixtures for implant are indicated for use in the anterior and posterior regions of the maxilla and mandible. The fixtures are designed to support full arch reconstructions (fixed bridges and overdentures), partial arch reconstructions (fixed bridges) and single tooth replacement.
Brânemark System Self-Tapping Fixture (previously cleared per K925762) The "Immediate Loading Treatment Protocol" is intended for use with selected Branemark System Implants. These implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.
Titanium Plasma Spray Cylindrical Implant (previously cleared per K911592) The Steri-Oss Titanium plasma sprayed cylindrical dental implant device are indicated for use in the mandible and maxilla for denture retention in the edentulous and partially edentulous patient.
Angulated Abutment, Complete, Titanium SCDA102 (previously cleared per K905434) Devices are used as connection with osseointegration fixtures.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.
In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.
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(270 days)
NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.
NobelActive® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.
NobelActive® 3.0 implants are indicated for single unit restorations only.
Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.
Here's an analysis of the acceptance criteria and supporting studies for the NobelActive® dental implant, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with clear thresholds for success (e.g., "must achieve X% success rate"). Instead, it describes performance benchmarks relative to existing devices and clinical expectations for dental implants.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Validation of recommended drilling protocols | Implant (4.3x13 mm) fully seated in Type 3 bone surrogate at 55 N cm using 2.8/3.2 last drill. Implant fully seated in Type 4 bone surrogate at 45 N cm using 2.4/2.8 last drill. |
| Primary stability and micro-motion performance | Exhibited significantly less micro-motion than comparator devices in both 30 pcf (Type II to III) and 20 pcf (Type III to IV) bone surrogates (p ≤ 0.05). Showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario. |
| Clinical Performance: | |
| Achievable insertion torque for immediate loading | Mean insertion torque: 51.1 (SD 19.5) N cm in all bone qualities (healed sites). Mean insertion torque: 46.15 (SD 17.5) N cm in predominantly cancellous bone (Type 3 and 4) (healed sites). Mean insertion torque: 47.21 (SD 11.4) N cm in all bone qualities (extraction sites). Mean insertion torque: 48.00 (SD 11.45) N cm in predominantly cancellous bone (Type 3 and 4) (extraction sites). Clinicians could reach high insertion torques, often in the 30-40 N cm range (for immediate loading in soft bone). |
| Success/Survival Rate (especially in challenging bone qualities) | In healed and extraction sites (predominantly cancellous bone, Type III and IV): 97% successful after 3 years (out of 164 implants, 5 failed). In healed sites: 96.8% successful. In extraction sites: 97.2% successful. In a separate prospective study (Irinakis and Wiebe, 2009): 2.1% failure rate (140 implants, 24 in soft bone) during observation period. In another study (Demanet et al, 2011): 99.1% total survival rate (466 implants), 98.3% in posterior maxilla (soft bone). |
| Performance in soft bone (Type IV/posterior maxilla) | Irinakis and Wiebe (2009): Mean insertion torque of 47.9 N cm in soft bone (similar to medium bone). Demanet et al (2011): 98.3% survival rate in posterior maxilla. |
2. Sample Size Used for the Test Set and Data Provenance
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Bench Studies:
- Drilling protocols: 1 implant (4.3x13 mm) tested in each of two bone surrogate types.
- Primary stability and micro-motion: Not explicitly stated, but "different implant geometries and simulated bone densities" were used with "comparator devices." The number of implants per geometry/density is not provided.
- Provenance: Not explicitly stated, but these are non-clinical (laboratory) studies.
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Clinical Studies:
- Study 1 (Healed Sites): 199 NobelActive® implants.
- Study 2 (Extraction Sites): 137 NobelActive® implants.
- Study 3 (Implant Handling): 88 implants.
- Study 4 (Irinakis and Wiebe, 2009): 140 implants.
- Study 5 (Demanet et al, 2011): 466 implants.
- Data Provenance: The document does not explicitly state the country of origin. Clinical studies are inherently prospective to some extent, but the reporting here is retrospective (summarizing past studies). The "Irinakis and Wiebe (2009) conducted a prospective study" explicitly states it was prospective. The other clinical data descriptions imply retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Studies: Ground truth is based on physical measurements and engineering principles. Experts (engineers, researchers) are involved in conducting and interpreting these tests, but their specific number or dental qualifications are not specified as they relate to the "ground truth" of implant performance in a lab setting.
- Clinical Studies:
- Bone quality classification (Lekholm and Zarb) was done "by the treating surgeon" according to standard methods, including imaging, pre-surgical investigation, and tactile sensation.
- "Four (4) clinicians" placed implants in the implant handling study.
- The studies mentioned clinical investigators/treating surgeons for implant placement and follow-up. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. However, a "treating surgeon" or "clinician" implies medical/dental professionals experienced in implantology.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or data interpretation. Clinical results are typically derived from direct observation and measurement on patients, with success/failure criteria defined within each study's protocol.
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
This document is for a dental implant (a physical device), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
As noted above, this submission is for a physical medical device (dental implant). It does not involve an algorithm or AI, so the concept of standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- Bench Studies: Physical measurements (torque, micro-motion, seating depth) in simulated environments (bone surrogates).
- Clinical Studies:
- Clinical outcomes: Implant success/failure rates, survival rates, insertion torque values, bone quality classification by the treating surgeon. This is essentially direct clinical observation and measurement of "real-world" performance in patients.
8. The Sample Size for the Training Set
This submission pertains to a physical dental implant, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/algorithms is not applicable. The clinical data described contributes to the overall evidence base for the device's performance, rather than serving as a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since this is not an AI/ML device, there is no "training set" and thus no ground truth established for one. The clinical studies mentioned contribute to demonstrating the device's safety and effectiveness for its intended use.
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