Sherlock

K193335 · Open Implants, LLC · NHA · Mar 24, 2020 · Dental

Device Facts

• Record ID: K193335
• Device Name: Sherlock
• Applicant: Open Implants, LLC
• Product Code: NHA · Dental
• Decision Date: Mar 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:

Device Story

Sherlock system consists of dental implant abutments (titanium blank and multi-unit configurations) designed for compatibility with NobelActive implant systems. Abutments are pre-manufactured from Ti-6Al-4V ELI titanium. Titanium blank abutments are customized via CAD/CAM technology at validated milling centers to support prosthetic restorations. Multi-unit abutments and temporary cylinders support multi-unit bridge restorations. Used in dental clinics by clinicians to provide support for prosthetic devices; output is a customized or stock abutment interface. Benefits include restoration of patient esthetics and chewing function. Device is provided non-sterile and requires steam sterilization by the user.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing: sterilization validation (ISO 17665-1, ISO 14937), biocompatibility (ISO 10993-5, ANSI/AAMI ST72), reverse engineering for compatibility, and fatigue testing (ISO 14801).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Interface: Internal conical hex. Configurations: Titanium blank, multi-unit straight/angled (17°, 24°, 30°). Dimensions: 3.5mm (NP) and 3.9mm (RP) restorative platforms. Sterilization: Steam sterilization (provided non-sterile). Connectivity: Compatible with NobelActive implant systems.

Indications for Use

Indicated for patients requiring single-unit or multi-unit prosthetic restorations supported by endosseous dental implants in the maxillary or mandibular arch. Compatible with specific NobelActive implant systems.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Preat Abutments (K183518)

Reference Devices

• Avinent Implant System (K121873)
• NobelActive Internal Connection Implant (K071370)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary - K193335 Open Implants, LLC Sherlock 3/24/2020

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Open Implants, LLC<br>800 West Cummings Ave, Suite 4900<br>Woburn, MA 01801 |
|----------------------------|-----------------------------------------------------------------------------|
| | Telephone: [phone]<br>Fax: n/a |
| Official Contact<br>Email: | Tamara Nazzal, Chief Growth Officer<br>[e-mail] |

#### 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)<br>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.

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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 Device<br>Sherlock<br>Open 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.<br><br>All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.<br><br>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 Device<br>Preat Abutments (K183518)<br>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.<br><br>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®/Tapered<br>Screw-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.

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# Technological Characteristics Comparison Table

| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | Sherlock | Preat Abutments<br>Preat Corporation<br>K183518 | Avinent Implant<br>System<br>Avinent Implant<br>System, S.L.U.<br>K121873 | NobelActive Internal<br>Connection Implant<br>Nobel Biocare<br>K071370 | | |
| Indications<br>for Use | Sherlock abutments are intended to be used<br>in conjunction with endosseous dental<br>implants in the maxillary or mandibular<br>arch to provide support for single-unit or<br>multi-unit prosthetic restorations.<br>All digitally designed CAD/CAM<br>customizations for Sherlock abutments are<br>to be sent to an Open Implants-validated<br>milling center for manufacture.<br>Sherlock abutments are compatible with<br>the implant systems listed in the<br>Compatibility Table: | Preat Abutments are intended to be used in<br>conjunction with endosseous dental implants in<br>the maxillary or mandibular arch to provide<br>support for single-unit or multi-unit prosthetic<br>restorations. The Titanium Base abutments<br>consists of two major parts. Specifically, the<br>titanium base and mesostructured components<br>make up a two-piece abutment.<br>All digitally designed custom abutments,<br>superstructures, and/or hybrid crowns for use<br>with Titanium Base or Titanium Blank are to be<br>sent to a Preat validated milling center for<br>manufacture. | The AVINENT dental<br>implant system is for<br>oral endosseous<br>implantation in the<br>upper and lower jaw<br>and for the functional<br>and esthetic oral<br>rehabilitation of<br>edentulous and<br>partially dentate<br>patients.<br>AVINENT implants are<br>for single-stage or two-<br>stage surgical<br>procedures and cement<br>or screw retained<br>restorations. Implants<br>are intended for<br>immediate loading on<br>single-tooth and/or<br>multiple tooth | Nobel Biocare's<br>NobelActive implants<br>are endosseous implant<br>intended to be surgically<br>placed in the bone of<br>the upper or lower jaw<br>arches to provide<br>support for prosthetic<br>devices, such as an<br>artificial tooth, in order<br>to restore patient<br>esthetics and chewing<br>function. Nobel<br>Biocare's NobelActive<br>implants are indicated<br>for single or multiple<br>unit restorations in<br>splinted on non-splinted<br>applications. Nobel<br>Biocare's NobelActive<br>implants may be placed<br>immediately and put<br>into immediate function<br>provided that initial<br>stability requirements<br>detailed in the manual<br>are satisfied. | Substantially Equivalent<br>Differences in wording of Indications for Use<br>statements do not change the intended use<br>of the Subject, Predicate and Reference<br>devices to provide support for single or multi-<br>unit prosthetic restorations. Differences in<br>restorative systems or platform diameters do<br>not change the intended use of the Subject,<br>Predicate and Reference devices to provide<br>support for single or multi-unit prosthetic<br>restorations. The fact that single abutment<br>Subject and Predicate devices can be<br>customized and Reference devices are not<br>intended to be customized does not change<br>the intended use of the Subject, Predicate and<br>Reference devices to provide support for<br>single or multi-unit prosthetic restorations.<br>The Subject device is offered in titanium blank<br>and multi-unit abutment configurations while<br>the primary Predicate is offered in two-piece<br>Ti-Base and titanium blank configurations.<br>Language related to a Ti-base abutment is<br>not included in the Indications for use of the<br>Subject device. While the abutment<br>configurations are different between the<br>Subject and Predicate devices, this does not<br>change the intended use of the devices to<br>provide support for single-unit or multi-unit<br>prosthetic restorations. Additionally, the<br>Avinent (K121873) Reference includes multi-<br>unit abutments which supports a finding of<br>substantial equivalence. | |
| | Compatibility Table | Compatible Implant Systems | | | | |
| | Compatible<br>Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Restorative<br>Platform<br>Diameter<br>(mm) | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Platform<br>Diameter<br>(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 Tech<br>OsseoSpeed TM | 3.0 | 3.0 |
| | | | | | 3.5, 4.0 | 3.5, 4.0 |
| | | | | | 4.5, 5.0 | 4.5, 5.0 |
| | | | | BioHorizons<br>Tapered<br>Internal | 3.0 | 3.0 |
| | | | | | 3.5 | 3.5 |
| | | | | | 4.0 | 4.5 |
| |…