(113 days)
No
The summary describes a system of dental implant abutments and their manufacturing process using CAD/CAM technology. There is no mention of AI or ML being used in the design, manufacturing, or function of the device. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device specifically states it provides support for prosthetic restorations and is not intended to treat or cure a disease or condition.
No
The device description indicates that Sherlock abutments are dental implant components designed to support prosthetic restorations. Their function is structural and restorative, not diagnostic.
No
The device description explicitly states that the Sherlock abutments are premanufactured from Ti-6Al-4V ELI (Grade 23) titanium and are available as physical components (customizable titanium blank abutment and multi-unit abutment). While CAD/CAM technology is mentioned for customization, the core device is a physical implant abutment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Sherlock abutments are dental implant abutments intended to be used in conjunction with dental implants to support prosthetic restorations in the mouth.
- Intended Use: The intended use is to provide support for dental prosthetics, which is a mechanical function within the body, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Sherlock abutments are a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / 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 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) |
Product codes
NHA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K183518 Preat Abutments
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
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.
1
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
2
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, LLC
800 West Cummings Ave, Suite 4900
Woburn, MA 01801 |
|----------------------------|-----------------------------------------------------------------------------|
| | Telephone: +1 781-587-3242
Fax: n/a |
| Official Contact
Email: | Tamara Nazzal, Chief Growth Officer
tnazzal@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 Device | |||||||||||||
| Sherlock | |||||||||||||
| 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. |
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 Device
Preat 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
5
| 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 | |||
| 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.
6
Technological Characteristics Comparison Table
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
|---|---|---|---|---|---|---|
| Sherlock | Preat Abutments | |||||
| Preat Corporation | ||||||
| K183518 | Avinent Implant | |||||
| System | ||||||
| Avinent Implant | ||||||
| System, S.L.U. | ||||||
| K121873 | NobelActive Internal | |||||
| Connection Implant | ||||||
| Nobel Biocare | ||||||
| K071370 | ||||||
| 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 Implants-validated | ||||||
| milling center for manufacture. | ||||||
| Sherlock abutments are compatible with | ||||||
| the implant systems listed in the | ||||||
| Compatibility Table: | 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. | The AVINENT dental | |||||
| implant system is for | ||||||
| oral endosseous | ||||||
| implantation in the | ||||||
| upper and lower jaw | ||||||
| and for the functional | ||||||
| and esthetic oral | ||||||
| rehabilitation of | ||||||
| edentulous and | ||||||
| partially dentate | ||||||
| patients. | ||||||
| AVINENT implants are | ||||||
| for single-stage or two- | ||||||
| stage surgical | ||||||
| procedures and cement | ||||||
| or screw retained | ||||||
| restorations. Implants | ||||||
| are intended for | ||||||
| immediate loading on | ||||||
| single-tooth and/or | ||||||
| multiple tooth | Nobel Biocare's | |||||
| NobelActive 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 on 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. | Substantially Equivalent | |||||
| Differences in wording of Indications for Use | ||||||
| statements do not change the intended use | ||||||
| of the Subject, Predicate and Reference | ||||||
| devices to provide support for single or multi- | ||||||
| unit prosthetic restorations. Differences in | ||||||
| restorative systems or platform diameters do | ||||||
| not change the intended use of the Subject, | ||||||
| Predicate and Reference devices to provide | ||||||
| support for single or multi-unit prosthetic | ||||||
| restorations. The fact that single abutment | ||||||
| Subject and Predicate devices can be | ||||||
| customized and Reference devices are not | ||||||
| intended to be customized does not change | ||||||
| the intended use of the Subject, Predicate and | ||||||
| Reference devices to provide support for | ||||||
| single 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 titanium blank configurations. | ||||||
| Language related to a Ti-base 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. Additionally, the | ||||||
| Avinent (K121873) Reference includes multi- | ||||||
| unit abutments which supports a finding of | ||||||
| substantial equivalence. | ||||||
| Compatibility Table | Compatible Implant Systems | |||||
| Compatible | ||||||
| Implant | ||||||
| System | Implant | |||||
| Body | ||||||
| Diameter | ||||||
| (mm) | Restorative | |||||
| Platform | ||||||
| Diameter | ||||||
| (mm) | Implant | |||||
| Body | ||||||
| Diameter | ||||||
| (mm) | Implant | |||||
| Platform | ||||||
| Diameter | ||||||
| (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 | ||||||
| OsseoSpeed TM | 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 | ||||||
| /// | 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 | |||||
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat Abutments | |||||
| Preat Corporation | ||||||
| K183518 | Avinent Implant | |||||
| System | ||||||
| Avinent Implant | ||||||
| System, S.L.U. | ||||||
| K121873 | NobelActive Internal | |||||
| Connection Implant | ||||||
| Nobel Biocare | ||||||
| K071370 | ||||||
| 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®/Taper | ||||||
| ed 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 | |
| Classification | ||||||
| Name | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental | |||
| implant | Endosseous dental | |||||
| implant | Substantially Equivalent with Predicate | |||||
| Product | ||||||
| Code | 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 - Titanium | |||
| Ti-6Al-4V ELI (ASTM | ||||||
| F136) and PEEK | Abutments - Titanium | |||||
| Ti-6Al-4V ELI (ASTM | ||||||
| F136) | Substantially Equivalent with Predicate | |||||
| Surface | ||||||
| Finish | Non-coated | Non-coated | Abutments – non- | |||
| coated | Abutments – non- | |||||
| coated | Substantially Equivalent with Predicate | |||||
| Abutment/ | ||||||
| Implant | ||||||
| Interface | Internal connection conical hex | |||||
| Multi-unit and temp abutments include non- | ||||||
| engaging | Internal connection conical hex (for NobelActive | |||||
| Connection) | Internal hex and conical | |||||
| hex connections | ||||||
| Multi-unit and temp | ||||||
| abutments include non- | ||||||
| engaging | Internal conical hex | |||||
| connection | Substantially Equivalent | |||||
| Multi-unit and temp non-engaging is | ||||||
| Substantially equivalent with Reference | ||||||
| Device | ||||||
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat Abutments | |||||
| Preat Corporation | ||||||
| K183518 | Avinent Implant | |||||
| System | ||||||
| Avinent Implant | ||||||
| System, S.L.U. | ||||||
| K121873 | NobelActive Internal | |||||
| Connection Implant | ||||||
| Nobel Biocare | ||||||
| K071370 | ||||||
| Abutment | ||||||
| platform | ||||||
| diameter | 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 Equivalent | |||
| Predicate and reference device dimensions | ||||||
| listed which are outside of the Nobel Active | ||||||
| NP and RP connections are for other implant | ||||||
| systems, not part of the Subject device | ||||||
| submission and do not change the intended | ||||||
| use of the devices. Any differences in | ||||||
| dimensions have been validated through | ||||||
| performance testing and support substantial | ||||||
| equivalence. | ||||||
| Prosthesis | ||||||
| Attachment | Cement-retained | |||||
| Screw-retained | Cement-retained | |||||
| Screw-retained | Cement retained | |||||
| Screw-retained | Cement retained | |||||
| Screw-retained | Substantially Equivalent | |||||
| Abutment | ||||||
| Designs | Ti-Blank | Ti-Blank | Stock, fixed angulation | |||
| 0°, 17° | Stock, fixed angulation | |||||
| 0°, 15° | Substantially Equivalent | |||||
| Differences in available abutment design | ||||||
| configurations do not change the intended | ||||||
| use of the devices. Subject and Predicate | ||||||
| devices may be customized. Customizations | ||||||
| have limitations which have been validated | ||||||
| through performance testing and support | ||||||
| substantial equivalence. | ||||||
| Multi-Unit Straight | ||||||
| Multi-Unit Angled 17°, 24°, 30° | Multi-Unit Straight | |||||
| Multi-Unit Angled 17° | Multi-Unit Straight | |||||
| Multi-Unit Angled 17°, 24°, 30° | Multi-Unit Straight | |||||
| Multi-Unit Angled 17°, 30° | Substantially Equivalent | |||||
| Substantially Equivalent | ||||||
| Multiple correction angle options of the | ||||||
| Subject device not change the intended use of | ||||||
| the device. Any differences in correction | ||||||
| angles have been validated through | ||||||
| performance testing and support substantial | ||||||
| equivalence. | ||||||
| Restoration | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Substantially Equivalent | |
| Mode of | ||||||
| operation | Used in conjunction with endosseous dental | |||||
| implants to provide support for single and | ||||||
| multi-unit prostheses. | Used in conjunction with endosseous dental | |||||
| implants to provide support for single and multi- | ||||||
| unit prostheses. | Used in conjunction | |||||
| with endosseous dental | ||||||
| implants to provide | ||||||
| support for prosthetic | ||||||
| reconstructions. | Used in conjunction | |||||
| with endosseous dental | ||||||
| implants to provide | ||||||
| support for single and | ||||||
| multi-unit prostheses. | Substantially Equivalent with Predicate | |||||
| Slight differences in wording does not change | ||||||
| that all devices are used to provide support | ||||||
| for dental prosthesis. | ||||||
| Sterility | Provided non-sterile | Provided non-sterile | Sterile | Sterile Multi-unit | ||
| Non-sterile stock | ||||||
| abutments. | Substantially Equivalent with Predicate | |||||
| Sterilization | ||||||
| method | Steam Sterilization | Steam sterilization | Gamma radiation | Not specified | Substantially Equivalent with Predicate | |
| Abutment | ||||||
| Design | ||||||
| Parameters | Minimum wall thickness: 0.42 mm | |||||
| Maximum angulation: 30° | ||||||
| Minimum post height: 4 mm | ||||||
| Minimum gingival height: 0.5mm | ||||||
| Maximum gingival height: 5 mm | Minimum wall thickness: 0.5 mm | |||||
| Maximum angulation: 30° (Ti-Blank) | ||||||
| Minimum post height: 4 mm | ||||||
| Maximum gingival height: 1.5 to 2.65mm (varies | ||||||
| by implant line) | Minimum wall | |||||
| thickness: not | ||||||
| specified | ||||||
| Maximum angulation: | ||||||
| 30° | ||||||
| Minimum post height: | ||||||
| not specified | ||||||
| Minimum gingival | ||||||
| height: 0.5mm | Minimum wall | |||||
| thickness: not specified | ||||||
| Maximum angulation: | ||||||
| 30° | ||||||
| Minimum post height: | ||||||
| not specified | ||||||
| Minimum gingival | ||||||
| height: 1.5 mm | Substantially Equivalent | |||||
| Slight differences in abutment design | ||||||
| parameters do not change the intended use | ||||||
| of the device. Differences in Subject Device | ||||||
| specified parameters have been validated by | ||||||
| fatigue testing a worst-case construct of the | ||||||
| Subject device and support substantial | ||||||
| equivalence. | ||||||
| Parameter | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence Discussion | |
| Sherlock | Preat Abutments | |||||
| Preat Corporation | ||||||
| K183518 | Avinent Implant | |||||
| System | ||||||
| Avinent Implant | ||||||
| System, S.L.U. | ||||||
| K121873 | NobelActive Internal | |||||
| Connection Implant | ||||||
| Nobel Biocare | ||||||
| K071370 | ||||||
| Maximum gingival | ||||||
| height: 5 mm | Maximum gingival | |||||
| height: 4.5 mm |
7
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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.