(113 days)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
Compatibility Table
| Compatible Implant Systems | Implant Body Diameter (mm) | Restorative Platform Diameter (mm) |
|---|---|---|
| NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP)
Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP).
The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user.
Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment.
The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture.
The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.
The provided document describes a 510(k) premarket notification for a dental implant abutment called "Sherlock." It does not contain information about a study with acceptance criteria and device performance in the context of a diagnostic AI device or a comparative effectiveness study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.
Therefore, many of the requested items related to acceptance criteria for a study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of FDA submission.
However, I can extract the information available from the document that relates to the device's characteristics and the non-clinical performance data used to support its substantial equivalence.
Here's a summary based on the provided text, addressing the points where information is available and indicating where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for a study in terms of metrics like sensitivity, specificity, or accuracy, nor does it report device performance against such criteria. Instead, it discusses "performance testing" to validate differences in design parameters for demonstrating substantial equivalence. The specific acceptance criteria for these non-clinical tests (e.g., fatigue testing, biocompatibility) are not explicitly detailed in a table format with corresponding results, beyond stating that they were performed according to specific ISO standards.
| Acceptance Criteria (Not explicitly stated for a "study" as per the prompt's likely intent for diagnostic AI) | Reported Device Performance (Non-Clinical Validation) |
|---|---|
| Sterilization validated according to ISO 17665-1 and ISO 14937 | Performed according to standards. |
| Biocompatibility evaluated according to ISO 10993-5 and ANSI/AAMI ST72 | Performed according to standards. |
| Compatibility confirmed through reverse engineering of OEM implant abutments and screws | Confirmed. |
| Fatigue testing according to ISO 14801 | Performed, validating differences in abutment design parameters, supporting substantial equivalence. |
| Abutment design parameters (e.g., minimum wall thickness, maximum angulation, min/max gingival height) | Differences have been validated through performance testing, supporting substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document focuses on non-clinical performance data, not a clinical test set.
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. The document describes non-clinical performance testing and substantial equivalence, not a study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of an adjudication process as no clinical test set requiring ground truth adjudication is 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
Not applicable. This is a 510(k) submission for a dental implant abutment, not an AI or diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical performance data, the "ground truth" would be the engineering specifications, material properties, and performance limits defined by the relevant ISO standards (e.g., successful sterilization, biocompatible materials, passing fatigue tests).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 24, 2020
Open Implants, LLC % Chris Brown Manager Aclivi, LLC 6455 Farley Road Pinckney, Michigan 48169
Re: K193335
Trade/Device Name: Sherlock Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 18, 2019 Received: December 26, 2019
Dear Chris Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193335
Device Name Sherlock
Indications for Use (Describe)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
Compatibility Table
| Compatible Implant Systems | Implant Body Diameter (mm) | Restorative Platform Diameter (mm) |
|---|---|---|
| NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) |
| 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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{3}------------------------------------------------
510(k) Summary - K193335 Open Implants, LLC Sherlock 3/24/2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Open Implants, LLC800 West Cummings Ave, Suite 4900Woburn, MA 01801 |
|---|---|
| Telephone: +1 781-587-3242Fax: n/a | |
| Official ContactEmail: | Tamara Nazzal, Chief Growth Officertnazzal@openimplants.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Sherlock |
|---|---|
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K183518 | Preat Abutments | Preat Corporation |
| Reference Device Name | ||
|---|---|---|
| K121873 | Avinent Implant System | Avinent Implant System, S.L.U. |
| K071370 | NobelActive Internal Connection Implant | Nobel Biocare |
DEVICE DESCRIPTION
Open Implants' Sherlock abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant connection interface. The implant body diameters are 3.5 mm with a restorative diameter of 3.5 mm (NP), 4.3 and 5.0 mm with a restorative diameter of 3.9 mm (RP).
The Subject device abutments, multi-unit sleeves and corresponding abutment screws are all premanufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided nonsterile to the user.
{4}------------------------------------------------
Subject device abutments are available in two configurations; a customizable titanium blank abutment, and a multi-unit abutment.
The titanium blank abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed customized abutments from titanium blank abutments are to an Open Implant-validated milling center for manufacture.
The Multi-unit abutments are intended to provide support for multiple tooth bridge supported prosthetic restorations. Multi-unit Temporary Cylinders are intended to be used to fabricate temporary multi-unit prosthetic restorations. The temporary cylinder and associated prosthetic restoration have a maximum intended use of six months.
INDICATIONS FOR USE
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implantsvalidated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
Compatibility Table
| Compatible Implant Systems | Implant Body Diameter (mm) | Restorative Platform Diameter (mm) |
|---|---|---|
| NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) |
EQUIVALENCE TO MARKETED DEVICE
The Subject device is substantially equivalent to the predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
| Device | Indications for Use Statement | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject DeviceSherlockOpen Implants, LLC | Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: | ||||||||||||
| Compatible Implant System Implant Body Diameter (mm) Restorative Platform Diameter (mm) NobelActive® 3.5 3.5 (NP) 4.3, 5.0 3.9 (RP) | |||||||||||||
| Predicate DevicePreat Abutments (K183518)Preat Corporation | Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. | ||||||||||||
| Compatible Implant Systems Implant Body Diameter (mm) Implant Platform Diameter (mm) 3i OSSEOTITE® Certain® 3.25 3.4 4.0 4.1 5.0 5.0 |
Comparison of Indications for Use Statements
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| Device | Indications for Use Statement | ||
|---|---|---|---|
| 6.0 | 6.0 | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | |
| 3.5, 4.0 | 3.5, 4.0 | ||
| 4.5, 5.0 | 4.5, 5.0 | ||
| BioHorizons Tapered Internal | 3.0 | 3.0 | |
| 3.5 | 3.5 | ||
| 4.0 | 4.5 | ||
| HIOSSEN ET III | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Implant Direct Legacy | 3.2 | 3.0 | |
| 3.7, 4.2 | 3.5 | ||
| 4.7, 5.2 | 4.5 | ||
| 5.7, 7.0 | 5.7 | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 | |
| NobelActive® | 3.5 | NP | |
| 4.3, 5.0 | RP | ||
| Nobel Replace™ | 3.5 | NP | |
| 4.0, 4.3, 5.0 | RP | ||
| 5.0 | WP | ||
| 6.0 | 6.0 | ||
| Straumann® Bone Level | 3.3 | NC | |
| 4.1, 4.8 | RC | ||
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN | |
| 4.8, 6.5 | WN | ||
| Zimmer Screw-Vent®/TaperedScrew-Vent® | 3.3, 3.7, 4.1 | 3.5 | |
| 4.7 | 4.5 | ||
| 6.0 | 5.7 |
The Subject device is only being offered in a configuration compatible with listed Nobel Active implant system while Predicate device is offered with more compatible platforms, but this does not change the intended use of the device to provide support for single-unit or multi-unit prosthetic restorations.
The Subject device is offered in titanium blank and multi-unit abutment configurations while the primary Predicate is offered in two-piece Ti-Base and one-piece titanium blank configurations. Language related to a Tibase abutment is not included in the Indications for use of the Subject device. While the abutment configurations are different between the Subject and Predicate devices, this does not change the intended use of the devices to provide support for single-unit or multi-unit prosthetic restorations.
Slight differences in wording of the Indications for Use statements do not change the intended use of the Subject and Predicate devices to provide support for single or multi-unit prosthetic restorations.
{6}------------------------------------------------
Technological Characteristics Comparison Table
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
|---|---|---|---|---|---|---|
| Sherlock | Preat AbutmentsPreat CorporationK183518 | Avinent ImplantSystemAvinent ImplantSystem, S.L.U.K121873 | NobelActive InternalConnection ImplantNobel BiocareK071370 | |||
| Indicationsfor Use | Sherlock abutments are intended to be usedin conjunction with endosseous dentalimplants in the maxillary or mandibulararch to provide support for single-unit ormulti-unit prosthetic restorations.All digitally designed CAD/CAMcustomizations for Sherlock abutments areto be sent to an Open Implants-validatedmilling center for manufacture.Sherlock abutments are compatible withthe implant systems listed in theCompatibility Table: | Preat Abutments are intended to be used inconjunction with endosseous dental implants inthe maxillary or mandibular arch to providesupport for single-unit or multi-unit prostheticrestorations. The Titanium Base abutmentsconsists of two major parts. Specifically, thetitanium base and mesostructured componentsmake up a two-piece abutment.All digitally designed custom abutments,superstructures, and/or hybrid crowns for usewith Titanium Base or Titanium Blank are to besent to a Preat validated milling center formanufacture. | The AVINENT dentalimplant system is fororal endosseousimplantation in theupper and lower jawand for the functionaland esthetic oralrehabilitation ofedentulous andpartially dentatepatients.AVINENT implants arefor single-stage or two-stage surgicalprocedures and cementor screw retainedrestorations. Implantsare intended forimmediate loading onsingle-tooth and/ormultiple tooth | Nobel Biocare'sNobelActive implantsare endosseous implantintended to be surgicallyplaced in the bone ofthe upper or lower jawarches to providesupport for prostheticdevices, such as anartificial tooth, in orderto restore patientesthetics and chewingfunction. NobelBiocare's NobelActiveimplants are indicatedfor single or multipleunit restorations insplinted on non-splintedapplications. NobelBiocare's NobelActiveimplants may be placedimmediately and putinto immediate functionprovided that initialstability requirementsdetailed in the manualare satisfied. | Substantially EquivalentDifferences in wording of Indications for Usestatements do not change the intended useof the Subject, Predicate and Referencedevices to provide support for single or multi-unit prosthetic restorations. Differences inrestorative systems or platform diameters donot change the intended use of the Subject,Predicate and Reference devices to providesupport for single or multi-unit prostheticrestorations. The fact that single abutmentSubject and Predicate devices can becustomized and Reference devices are notintended to be customized does not changethe intended use of the Subject, Predicate andReference devices to provide support forsingle or multi-unit prosthetic restorations.The Subject device is offered in titanium blankand multi-unit abutment configurations whilethe primary Predicate is offered in two-pieceTi-Base and titanium blank configurations.Language related to a Ti-base abutment isnot included in the Indications for use of theSubject device. While the abutmentconfigurations are different between theSubject and Predicate devices, this does notchange the intended use of the devices toprovide support for single-unit or multi-unitprosthetic restorations. Additionally, theAvinent (K121873) Reference includes multi-unit abutments which supports a finding ofsubstantial equivalence. | |
| Compatibility Table | Compatible Implant Systems | |||||
| CompatibleImplantSystem | ImplantBodyDiameter(mm) | RestorativePlatformDiameter(mm) | ImplantBodyDiameter(mm) | ImplantPlatformDiameter(mm) | ||
| NobelActive ® | 3.5 | 3.5 (NP) | 3i | 3.25 | 3.4 | |
| 4.3, 5.0 | 3.9 (RP) | OSSEOTITE ® Certain ® | 4.0 | 4.1 | ||
| 5.0 | 5.0 | |||||
| 6.0 | 6.0 | |||||
| Astra TechOsseoSpeed TM | 3.0 | 3.0 | ||||
| 3.5, 4.0 | 3.5, 4.0 | |||||
| 4.5, 5.0 | 4.5, 5.0 | |||||
| BioHorizonsTaperedInternal | 3.0 | 3.0 | ||||
| 3.5 | 3.5 | |||||
| 4.0 | 4.5 | |||||
| HIOSSEN ET/// | 3.5 | Mini | ||||
| 4.0, 4.5,5.0, 6.0,7.0 | Regular | |||||
| ImplantDirectLegacy | 3.2 | 3.0 | ||||
| 3.7, 4.2 | 3.5 | |||||
| 4.7, 5.2 | 4.5 | |||||
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat AbutmentsPreat CorporationK183518 | Avinent ImplantSystemAvinent ImplantSystem, S.L.U.K121873 | NobelActive InternalConnection ImplantNobel BiocareK071370 | |||
| 5.7, 7.0 | 5.7 | |||||
| MegaGenAnyRidge | 3.5, 4.0,4.5, 5.0,5.5 | 3.5 | ||||
| Neoss | 3.5, 4.0,4.5, 5.0,5.5 | 4.1 | ||||
| NobelActive® | 3.5 | NP | ||||
| 4.3, 5.0 | RP | |||||
| NobelReplace™ | 3.5 | NP | ||||
| 4.0, 4.3,5.0 | RP | |||||
| 5.0 | WP | |||||
| 6.0 | 6.0 | |||||
| Straumann®Bone Level | 3.3 | NC | ||||
| 4.1, 4.8 | RC | |||||
| Straumann®Tissue Level | 3.3, 4.1,4.8 | RN | ||||
| 4.8, 6.5 | WN | |||||
| ZimmerScrew-Vent®/Tapered Screw-Vent® | 3.3, 3.7,4.1 | 3.5 | ||||
| 4.7 | 4.5 | |||||
| 6.0 | 5.7 | |||||
| Regulation # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3640 | 21 CFR 872.3640 | Substantially Equivalent with Predicate | |
| ClassificationName | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dentalimplant | Endosseous dentalimplant | Substantially Equivalent with Predicate | |
| ProductCode | NHA | NHA | DZE, NHA | DZE, NHA | Substantially Equivalent with Predicate | |
| Classification | Class II | Class II | Class II | Class II | Substantially Equivalent | |
| Materials | Titanium Ti-6Al-4V ELI (ASTM F136) | Titanium Ti-6Al-4V ELI (ASTM F136) | Abutments - TitaniumTi-6Al-4V ELI (ASTMF136) and PEEK | Abutments - TitaniumTi-6Al-4V ELI (ASTMF136) | Substantially Equivalent with Predicate | |
| SurfaceFinish | Non-coated | Non-coated | Abutments – non-coated | Abutments – non-coated | Substantially Equivalent with Predicate | |
| Abutment/ImplantInterface | Internal connection conical hexMulti-unit and temp abutments include non-engaging | Internal connection conical hex (for NobelActiveConnection) | Internal hex and conicalhex connectionsMulti-unit and tempabutments include non-engaging | Internal conical hexconnection | Substantially EquivalentMulti-unit and temp non-engaging isSubstantially equivalent with ReferenceDevice | |
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat AbutmentsPreat CorporationK183518 | Avinent ImplantSystemAvinent ImplantSystem, S.L.U.K121873 | NobelActive InternalConnection ImplantNobel BiocareK071370 | |||
| Abutmentplatformdiameter | 3.5 mm (NP for the NobelActive Connection)3.9 mm (RP for the NobelActive Connection) | 3.5 mm (NP for the NobelActive Connection)3.9 mm (RP for the NobelActive Connection) | 3.5 to 5.1 mm | 3.5-3.9 (NP and RP) | Substantially EquivalentPredicate and reference device dimensionslisted which are outside of the Nobel ActiveNP and RP connections are for other implantsystems, not part of the Subject devicesubmission and do not change the intendeduse of the devices. Any differences indimensions have been validated throughperformance testing and support substantialequivalence. | |
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement retainedScrew-retained | Cement retainedScrew-retained | Substantially Equivalent | |
| AbutmentDesigns | Ti-Blank | Ti-Blank | Stock, fixed angulation0°, 17° | Stock, fixed angulation0°, 15° | Substantially EquivalentDifferences in available abutment designconfigurations do not change the intendeduse of the devices. Subject and Predicatedevices may be customized. Customizationshave limitations which have been validatedthrough performance testing and supportsubstantial equivalence. | |
| Multi-Unit StraightMulti-Unit Angled 17°, 24°, 30° | Multi-Unit StraightMulti-Unit Angled 17° | Multi-Unit StraightMulti-Unit Angled 17°, 24°, 30° | Multi-Unit StraightMulti-Unit Angled 17°, 30° | Substantially EquivalentSubstantially EquivalentMultiple correction angle options of theSubject device not change the intended use ofthe device. Any differences in correctionangles have been validated throughperformance testing and support substantialequivalence. | ||
| Restoration | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Substantially Equivalent | |
| Mode ofoperation | Used in conjunction with endosseous dentalimplants to provide support for single andmulti-unit prostheses. | Used in conjunction with endosseous dentalimplants to provide support for single and multi-unit prostheses. | Used in conjunctionwith endosseous dentalimplants to providesupport for prostheticreconstructions. | Used in conjunctionwith endosseous dentalimplants to providesupport for single andmulti-unit prostheses. | Substantially Equivalent with PredicateSlight differences in wording does not changethat all devices are used to provide supportfor dental prosthesis. | |
| Sterility | Provided non-sterile | Provided non-sterile | Sterile | Sterile Multi-unitNon-sterile stockabutments. | Substantially Equivalent with Predicate | |
| Sterilizationmethod | Steam Sterilization | Steam sterilization | Gamma radiation | Not specified | Substantially Equivalent with Predicate | |
| AbutmentDesignParameters | Minimum wall thickness: 0.42 mmMaximum angulation: 30°Minimum post height: 4 mmMinimum gingival height: 0.5mmMaximum gingival height: 5 mm | Minimum wall thickness: 0.5 mmMaximum angulation: 30° (Ti-Blank)Minimum post height: 4 mmMaximum gingival height: 1.5 to 2.65mm (variesby implant line) | Minimum wallthickness: notspecifiedMaximum angulation:30°Minimum post height:not specifiedMinimum gingivalheight: 0.5mm | Minimum wallthickness: not specifiedMaximum angulation:30°Minimum post height:not specifiedMinimum gingivalheight: 1.5 mm | Substantially EquivalentSlight differences in abutment designparameters do not change the intended useof the device. Differences in Subject Devicespecified parameters have been validated byfatigue testing a worst-case construct of theSubject device and support substantialequivalence. | |
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat AbutmentsPreat CorporationK183518 | Avinent ImplantSystemAvinent ImplantSystem, S.L.U.K121873 | NobelActive InternalConnection ImplantNobel BiocareK071370 | |||
| Maximum gingivalheight: 5 mm | Maximum gingivalheight: 4.5 mm |
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K193335
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The Subject and Predicate devices include Ti-Blank Abutments which can be customized by CAD/CAM technology. The Subject, Predicate and Reference devices all offer Straight or Angled Multi-Unit abutments. Customized Ti-Blank abutments, Multi-Unit abutments and "stock" or fixed angle abutments are all intended to provide support for the prosthetic devices.
Slight differences in available multi-unit abutment angles, maximum gingival height design parameters and platform diameters for the Subject, Predicate and Reference devices do not change the intended use of the devices to provide support for single and multi-unit prostheses. Offering fewer restorative platform diameters than the Predicate device does not change the intended use of the devices to provide support for single and multi-unit prostheses.
Overall, there may be slight differences in wording of Indications for Use or Mode of Operation statements, but the Subject. Predicate and Reference devices share a common intended use to provide support for prosthetic devices.
Overall, there may be slight differences between the Subject, Predicate and Reference devices in device design parameters, such as restorative implant system, platform diameters, abutment configurations, abutment correction angles, wall thicknesses, gingival heights, etc... Those differences don't change the intended use to provide support for prosthetic devices. Any differences in parameters, have been validated through performance testing and support a finding of Substantial Equivalence.
Overall, the Technological Characteristics of the Subject device are substantially equivalent to that of the Predicate and Reference devices.
NON-CLINICAL PERFORMANCE DATA
Non-clinical performance data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 14937; biocompatibility according to ISO 10993-5 and ANSI/AAMI ST72; reverse engineering of the OEM implant abutments and OEM implant abutment screws to confirm compatibility; and fatigue testing according to ISO 14801. No clinical data is included in this submission.
CONCLUSION
Slight variations in the wording of the Indications for the Subject and Predicate devices do not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations.
Slight differences in the Technological Characteristics of the Subject and Predicate devices do not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations. Differences in Subject device abutment design parameters were validated with respect to intended use through Performance testing, supporting a finding of substantial equivalence.
Overall, the Sherlock Subject device is substantially equivalent to the Predicate device.
§ 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.)