Search Results

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:

1. 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.
2. 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.

Ask a specific question about this device

The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.

This is a 510(k) summary for the DSP Implant System, a dental implant device. It establishes substantial equivalence to various predicate devices rather than providing performance data against specific acceptance criteria for the new device. Therefore, it does not present a typical study design with acceptance criteria and results in the way a clinical trial or device performance study would.

However, based on the provided text, we can infer the approach taken by the manufacturer to demonstrate substantial equivalence, which serves as their "proof" that the device meets regulatory requirements.

Here's an interpretation of the requested information based on the 510(k) summary:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focusing on substantial equivalence, there isn't a table of discrete acceptance criteria and reported device performance in terms of clinical outcomes or specific quantitative measures as one might find in a standalone performance study. Instead, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate devices, and the "reported device performance" is the demonstration that the subject device shares these characteristics or has equivalent performance as validated through non-clinical testing.

The acceptance is based on demonstrating that the DSP Implant System is substantially equivalent to the predicate devices in terms of:

• Intended Use: The indications for use statement of the subject device is equivalent to the primary predicate device K101207, and within the scope of reference devices.
• Technological Characteristics: The subject device's design features, materials (CPTi Gr4, CoCr, POM, Ti6Al4V-ELI), sterilization methods (irradiation), and surface treatments (grit-blasted and acid-etched, machined collar) are compared to the predicate and reference devices. Minor differences are justified as not raising new questions of safety or effectiveness.
• Performance: Non-clinical testing demonstrates that the device performs comparably to the predicate devices in relevant areas for dental implants.

Implicit Acceptance Criteria and Reported Device Performance (based on substantial equivalence justification):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable for a typical clinical or performance study as presented in this 510(k). The "testing" referred to is non-clinical bench testing (sterilization, biocompatibility, pyrogenicity, material analysis). These tests typically use a representative sample size specified by the relevant standard (e.g., a certain number of devices for sterility testing). The document does not specify these individual sample sizes.
• Data Provenance: The data is non-clinical (bench testing) and generated by the manufacturer to support device characteristics. The 510(k) is submitted by a Brazilian manufacturer (D.S.P. Industrial Eireli) and prepared by a Brazilian regulatory affairs specialist (PR Servicos Regulatorios Administrarivos Ltda). The location of the actual testing labs is not specified. The studies are not clinical, so concepts like "retrospective" or "prospective" do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a non-clinical submission. Ground truth, in the sense of expert opinion on clinical data, is not established. The "ground truth" for the non-clinical tests is established by the specifications of the referenced international and national standards (ISO, ASTM, USP, AAMI/ANSI).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically for evaluation of conflicting expert opinions or clinical outcomes, which is not the nature of this non-clinical submission.

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

• No. This is a submission for a dental implant system (hardware), not an AI/software device. An MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is a physical medical device. Not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical performance data, the "ground truth" is defined by the requirements and test methodologies of the referenced industry standards (e.g., ISO 11137 for sterilization, ISO 10993-5 for biocompatibility, AAMI/ANSI ST72 and USP <85> for pyrogenicity, SEM/EDS for material analysis). The demonstration is that the device conforms to these standards and shares equivalent characteristics with legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for 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.

The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for 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.

This document is a 510(k) Pre-market Notification for the Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System. It is an older document from 1997, and the information provided is typical for devices seeking substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable or present in this document.

The core of this submission is a comparison of technological characteristics to predicate devices to establish substantial equivalence.

Here's an attempt to fill in the table and address the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance Study Summary (K970499)

This 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices. Performance acceptance criteria for a "new" device, as would be expected for an AI/ML device, are not explicitly defined or tested in the way typically required today. Instead, the "acceptance criteria" here implicitly revolve around demonstrating that the new device's components are technologically identical to the predicate components and serve the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device. The "test" here is the comparison of technological characteristics to predicate devices.
• Data Provenance: Not applicable. No clinical or dataset-based performance data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No "ground truth" was established for a test set as would be done for an AI/ML device. The "ground truth" for this submission is essentially the understanding of the design and materials of the predicate devices.
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

• MRMC Study: No. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for this 510(k) is the established technological characteristics and intended uses of the predicate devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable.

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