(306 days)
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.
Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.
Implant Direct Custom Bars are computer-aided design/computer-aided manufacturing, individually designed prosthetic devices for partially or fully edentulous restorations. The bars and fixation screws are made from Wrought Titanium Alloy conforming to an FDA recognized consensus standard ASTM F136. The Custom Bars consist of two device types: fixed-detachable frameworks and overdenture bars. The bar systems consists of the bars as well as fixation screws to facilitate the attachment to the dental implants.
Implant Direct Custom Bars are attached directly to an implant to provide support for the fabricated denture. The implant specific interfaces on the Custom Bars are designed and manufactured with precise mating features in order to the mating surfaces of the implants or abutments.
The Implant Direct Custom Bars are designed and produced at Implant Direct under the direction of clinical professionals. The patient requirements and implant locations are obtained conventionally or digitally and a bar is designed, using CAD software, according to established customization parameters. Once the design is finished, the bar design is sent to the clinician for approval before manufacture. After bar design approval is received, the bar design is milled using a precise CAM system, inspected, cleaned, packaged non-sterile, and shipped to the customer where it is finished into the final restoration.
This document describes the premarket notification for "Custom Bars" (K162633), which are patient-specific dental devices. The device is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.
However, I can extract information related to the performance data and the study conducted for this non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| - Fatigue Testing (ISO 14801) | Bar interface successfully completes endurance testing and is equivalent to the predicate device. | Results indicated that the bar interface successfully completed endurance testing and was equivalent to the predicate device. |
| - Bending Strength (modified ASTM F382) | Device is equivalent to the predicate device. | Results indicated that the subject device is equivalent to the predicate device. |
| Biocompatibility Testing | Device meets all biocompatibility requirements for its intended use (ISO 10993-1 and ISO 10993-5). | Cytotoxicity testing and comprehensive biocompatibility evaluation was conducted. Results indicate that the device met all biocompatibility requirements for its intended use. The material conforms to FDA recognized consensus standard ASTM F136 and is equivalent to the reference predicate. |
| Steam Sterilization Validation | Acceptance criteria are met, and devices can be sterilized per Gravity Displacement and Pre-vacuum cycle parameters (ISO 17665-1 and ISO 17665-2). | Results indicated the acceptance criteria was met and the devices can be sterilized per Gravity Displacement and Pre-vacuum cycle parameters. (Performed on worst-case sample) |
Regarding the other requested information, since this is not an AI/ML medical device, the following points are not applicable or not provided in the document:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of mechanical and biocompatibility testing. The testing was performed on "worst-case configurations" and "worst-case sample" as described.
- 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. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic/screening devices, not for physical dental prosthetics.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device performance testing against laboratory standards.
- 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: Not applicable, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (ISO 14801, ASTM F382, ISO 10993-1, ISO 10993-5, ISO 17665-1, ISO 17665-2) and equivalence to predicate devices, as demonstrated through non-clinical laboratory testing.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Additional Information from the document:
- Study Type: Non-clinical testing (mechanical, biocompatibility, and cleaning/sterilization validation). Clinical performance testing was not performed and was deemed not required to support substantial equivalence.
- Predicate Device for Comparison: Dentsply International ISUS Implant Suprastructures (K122424) was the primary predicate. Nobel Biocare NobelProcera Overdenture Bar (K132749) and Biomet 3i CAM StructSURE Overdenture Bars (K101582) were used as references.
- Conclusion: The studies concluded that the Custom Bars are substantially equivalent to the legally marketed predicate devices based on the non-clinical testing performed.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2017
Implant Direct Sybron Manufacturing, LLC Reina Choi Senior Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K162633
Trade/Device Name: Custom Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 26, 2017 Received: June 27, 2017
Dear Reina Choi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162633
Device Name
Custom Bars
Indications for Use (Describe)
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.
| Manufacturer | Implant Line | Body Diameter | Implant Platform |
|---|---|---|---|
| Implant Direct | Inter Active | 4.3mm, 5.0mm | 3.4mm |
| Implant Direct | SwishActive | 4.8mm | 3.4mm |
Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.
| Manufacturer | Implant Line | Implant Platform |
|---|---|---|
| Implant Direct | InterActive | 3.4mm |
| Implant Direct | SwishActive | 3.4mm |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5. 510(k) SUMMARY
1. SUBMITTER
Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
| Contact Person: | Reina Choi |
|---|---|
| Telephone Number: | 818-444-3306 |
| Email Address: | reina.choi@implantdirect.com |
| Alternate Contact: | Kwame Ulmer |
| Telephone Number: | 818-444-3394 |
| Email Address: | kwame.ulmer@implantdirect.com |
| Date Prepared: | July 21, 2017 |
2. DEVICE
| • Proprietary Name: | Custom Bars |
|---|---|
| • Classification Name: | Endosseous Dental Implant Abutment |
| • CFR: | 21 CFR 872.3630 |
| • Regulatory Class: | II |
| • Product Code: | NHA |
3. PREDICATE DEVICES
- Dentsply International ISUS Implant Suprastructures (K122424) Primary . Predicate
- Nobel Biocare NobelProcera Overdenture Bar (K132749) Reference .
- Biomet 3i CAM StructSURE Overdenture Bars (K101582) - Reference
4. DEVICE DESCRIPTION
Implant Direct Custom Bars are computer-aided design/computer-aided manufacturing, individually designed prosthetic devices for partially or fully edentulous restorations. The bars and fixation screws are made from Wrought Titanium Alloy conforming to an FDA recognized consensus standard ASTM F136. The Custom Bars consist of two
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device types: fixed-detachable frameworks and overdenture bars. The bar systems consists of the bars as well as fixation screws to facilitate the attachment to the dental implants.
Implant Direct Custom Bars are attached directly to an implant to provide support for the fabricated denture. The implant specific interfaces on the Custom Bars are designed and manufactured with precise mating features in order to the mating surfaces of the implants or abutments.
The Implant Direct Custom Bars are designed and produced at Implant Direct under the direction of clinical professionals. The patient requirements and implant locations are obtained conventionally or digitally and a bar is designed, using CAD software, according to established customization parameters. Once the design is finished, the bar design is sent to the clinician for approval before manufacture. After bar design approval is received, the bar design is milled using a precise CAM system, inspected, cleaned, packaged non-sterile, and shipped to the customer where it is finished into the final restoration.
| Parameter | Minimum | Maximum |
|---|---|---|
| Number of Cylinders | 4 Note 1 | 10 |
| Bar Span | 0mm | 17mm |
| Distal cantilever extensionNote 2 | 0mm | 10mm |
| Superstructure Cylinderdivergence | 0° | 40° divergence betweentwo implants with nomore than 20°angulation for any oneimplant. |
| Cylinder height | 0mm | 7mm |
| Wall Section | 1mm | None |
Customization Parameters
Note 1: Minimum of two (2) implants allowed in mandible without distal extensions and having soft tissue support.
Note 2: No distal cantilevers allowed for bars with 2 or 3 implants. When using an attachment on the extension, a 2mm radius is required under the bar.
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5. INDICATIONS FOR USE
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4mm Platform) System implants.
| Manufacturer | Implant Line | Body Diameter | Implant Platform |
|---|---|---|---|
| Implant Direct | InterActive | 4.3mm, 5.0mm | 3.4mm |
| Implant Direct | SwishActive | 4.8mm | 3.4mm |
Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4mm Platform) system straight multi-unit abutments.
| Manufacturer | Implant Line | Implant Platform |
|---|---|---|
| Implant Direct | InterActive | 3.4mm |
| Implant Direct | SwishActive | 3.4mm |
6. COMPARISON OF INDICATIONS FOR USE BETWEEN PROPOSED DEVICE AND PRIMARY PREDICATE
| Characteristics | Proposed DeviceCustom Bars(K162633) | Primary PredicateISUS Implant Suprastructure –Bars and Hybrids (K122424) |
|---|---|---|
| Indications for Use | Implant Direct Custom Barsare patient specific devicesindicated for attachment todental implants in thetreatment of partially or fullyedentulous jaws for thepurpose of restoring chewingfunction. | The ISUS Implant Suprastructure areindicated for attachment to dentalimplants or abutments in the treatmentof partially or totally edentulous jawsfor the purpose of restoring chewingfunction. The ISUS ImplantSuprastructures are intended forattachment to a minimum of two(2)implants. |
| Custom bars are compatible atimplant level with InterActive(3.4mm Platform) (D4.3, D5.0)& Swish Active (3.4mmPlatform) (D4.8) systemimplants. | ISUS Implant Suprastructures areindicated for compatibility with thefollowing implant and abutmentsystems:Implants: |
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| Custom bars are compatible atabutment level withInterActive (3.4mm Platform)& Swish Active (3.4mmPlatform) system | * Nobel Biocare Replace Select: NP(3.5mm), RP (4.3mm), WP (5.0mm),and Replace Select 6.0mm * NobelBiocare Active Internal: NP (3.5mm),RP (4.3mm, 5.0mm) *Zimmer ScrewVent: D3.5, D4.5, D5.7 *Straumann:NN (3.5mm), RN (4.8mm), WN(6.0mm)*Straumann Bone Level: NC (3.3mm),RC (4.1 mm, 4.8mm)*3I Internal Connection: D3.4, D4.1,D5, D6 *Friadent XiVE S: D3, D3.4,D3.8, D4.5, D5.5Abutments:*ASTRA TECH- 20° and 45°UniAbutment *ASTRA TECHUniAbutmnent EV: 3.6 *ANKYLOSBalance Base Abutment D5.5 andNarrow Abutment D4.2*Nobel Biocare Multi -Unit AbutmentRP: 4.0 mm*Zimmer Tapered Abutment: 4.5mm*Straumann RN(4.8mm), WN (6.5mm) *Straumann Bone Level:Multi-Base Abutment D3.5, D4.5*Straumann Bone Level AngledAbutment:4.0 mm*3I Low Profile Abutment*Friadent XiVE MP D3.8, D4.5, D5.5*Friadent XiVE TG D3.8, D4.5, D5.5 |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The intended use of the proposed Custom Bar is same as the primary predicate except for the interface compatibilities and customization parameters. The devices have differences in compatibility information and are specified within the Indications for Use. The proposed and predicate devices have differences in the customization parameters and are specified in the Instructions for Use. The device compatibility and customization parameters are supported by performance testing and do not affect substantial equivalence to the predicate.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Characteri | Proposed | Primary | Reference Device | Reference |
|---|---|---|---|---|
| stics | Device | Predicate | Device | |
| Custom Bars | ||||
| (K162633) | ISUS ImplantSuprastructure -Bars and Hybrids(K122424) | NobelProceraOverdenture Bar(K132749) | Biomet 3iCAMStructureOverdentureBars(K101582) | |
| IntendedUse | Attachment todental implantsin the treatmentof partially orfully edentulousjaws for thepurpose ofrestoringchewingfunction. | Attachment todental implants orabutments in thetreatment ofpartially or totallyedentulous jawsfor the purpose ofrestoring chewingfunction. | Attachment toimplants orabutments in thetreatment ofpartially or totallyedentulous jaws forthe purpose ofrestoring chewingfunction. | Accessory toendosseousdental implantsto support aprostheticdevice in apartially oredentulouspatient. |
| AnatomicalSite | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| GeneralDesign | One piecemilled bar withfixation screwsdesigned tointerface withmulti-unitabutments orimplants. | One piece milledbar with fixationscrews designed tointerface withmulti-unitabutments orimplants | One piece milled barwith fixation screwsdesigned to interfacewith multi-unitabutments orimplants. | One piecemilled bar withfixation screwsdesigned tointerface withmulti-unitabutments orimplants. |
| BarMaterial | Titanium alloy | Titanium,Cobalt-ChromiumAlloy | Titanium alloy | Titanium alloy |
| DesignMethod BarOrder | Individuallydesigned foreach patient byorder ofprescription | Individuallydesigned for eachpatient by order ofprescription | Individuallydesigned for eachpatient by order ofprescription | Individuallydesigned foreach patient byorder ofprescription |
| RestorationType | Screw RetainedBar with Patient | Screw RetainedBar with Patient | Screw Retained Barwith Patient | ScrewRetained Bar |
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| RemovableOverdenture orFixedDetachableFramework | RemovableOverdenture orFixed DetachableFramework | RemovableOverdenture orFixed DetachableFramework | with PatientRemovableOverdenture orFixedDetachableFramework | |
|---|---|---|---|---|
| Bar ElementProfiles | Metal Lingual,TraditionalHybrid, Y Bar, IBar, Pawn Bar,Hader,Locator/GPS/Ball Bar | Round, Hader,Dolder (U) “nonresilient”, Dolder(Y) “resilient”,Bredent, BredentVSP f BredentVSP fs, ISUSCustom | Dolder (Micro,Macro, Micro -Resilient, Macro -Resilient), Hader,Round, Free FormMilled, Paris Bar,Wrap-around Bar,Montreal Bar,Montreal withMetallic Lingual,Hybrid, ImplantBridge titanium,Implant BridgeZirconia | Hybrid Bar,WraparoundBar, FreeformBar, CanadaBar, DolderEgg ShapeBar, DolderUshape Bar,Hader,Primary Bar,CombinationPrimary/Hader/Dolder,CopymilledBar/Framework |
| ScrewMaterial | Titanium Alloy | Titanium Alloy | Titanium Alloy | TitaniumAlloy |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
The proposed device and predicates have the same general design, similar production methods, same size cylinder wall, allow for the same final restoration types, and have the same sterilization methods.
The differences between the proposed devices and the predicate devices have also been evaluated. The proposed bars have smaller allowable span, equivalent or smaller distal extension, smaller cylinder height, different bar profiles, and larger fixation screws. Performance testing has shown to support substantial equivalence to the reference predicate. Though the material used in subject device is different from the primary predicate, it is equivalent to that of the reference predicate. The differences in Custom Bar parameters and materials, used to construct the proposed device, do not affect substantial equivalence.
8. PERFORMANCE DATA
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Non-clinical testing was performed on the proposed device. Testing include mechanical strength, biocompatibility, and cleaning and steam sterilization validation. Results indicated that the subject device is equivalent to the predicate device.
- Mechanical testing
- o Fatigue testing was performed on worst-case configuration per ISO 14801. Results indicated that the bar interface successfully completed endurance testing and was equivalent to the predicate device.
- Bending strength testing was performed on worst-case bar according to a o modified version of ASTM F382. Results indicated that the subject device is equivalent to the predicate device.
- Biocompatibility testing was performed per ISO 10993-1 and ISO 10993-5. ● Cytotoxicity testing and comprehensive biocompatibility evaluation was conducted. Results indicate that the device met all biocompatibility requirements for its intended use. The material of subject device conforms to FDA recognized consensus standard ASTM F136 and is equivalent to the reference predicate.
- . The subject devices are provided non-sterile and to be end user sterilized. Steam sterilization validation was performed on the worst case sample per ISO 17665-1 and ISO 17665-2. Results indicated the acceptance criteria was met and the devices can be sterilized per Gravity Displacement and Pre-vacuum cycle parameters.
9. CLINICAL PERFORMANCE DATA
Clinical Performance testing was not performed. Clinical data is not required to support substantial equivalence.
10. CONCLUSION
Implant Direct Custom Bars are substantially equivalent to the legally marketed device(s) from Dentsply International ISUS Implant Suprastructures (K122424). The intended use, design features, and materials of the subject devices are equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicates devices. The application is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification. The subject device is substantially equivalent to the declared predicates.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)