(99 days)
No
The summary describes a dental implant abutment system and its manufacturing process, with no mention of AI or ML technology.
No
The device is a dental implant abutment system, which functions as a support for dental prosthetics. It does not actively treat a disease or medical condition.
No
The device, Sherlock abutments, is an implant abutment system intended to provide support for prosthetic restorations. It does not perform any diagnostic function.
No
The device description clearly states that Sherlock is a dental implant abutment system that includes physical abutment designs and screws made from Ti-6Al-4V alloy. While it mentions digitally designed CAD/CAM customizations, these are sent to a milling center for manufacture of physical components. The performance studies also focus on biocompatibility and mechanical testing of physical devices.
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 such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that Sherlock abutments are dental implant abutments used in conjunction with dental implants to support prosthetic restorations in the mouth (maxillary or mandibular arch).
- 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 Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
The device is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic.
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:
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Biomet 3i Certain | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| Straumann Bone Level | 3.3 | 3.3 (NC) |
| 4.1, 4.8 | 4.1, 4.8 (RC) | |
| Zimmer TSV | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Sherlock is a dental implant abutment system that includes four (4) abutment designs compatible with three (3) OEM implant systems. The Subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: Titanium blank, multi-unit angled 17°, and multiunit angled 30°. The system also includes corresponding abutment screws.
The following table shows the Subject device abutments for each of the Compatible implant platforms.
| Sherlock Platform Diameter/
| Compatible Implant System | Subject Device Abutment Designs | ||||
|---|---|---|---|---|---|
| Titanium Blank | Multi-unit Straight | Multi-Unit Angled 17° | Multi-Unit Angled 30° | Titanium Screws | |
| Biomet 3i Certain | |||||
| 3.4 mm | X | X | X | X | X |
| 4.1 mm | X | X | X | X | X |
| 5.0 mm | X | X | X | X | X |
| 6.0 mm | X | X | X | X | X |
| Straumann Bone Level | |||||
| 3.3 mm (NC) | X | X | X | X | X |
| 4.1 mm (RC) | X | X | X | X | X |
| 4.8 mm (RC) | X | X | X | X | X |
| Zimmer TSV | |||||
| 3.5 mm | X | X | X | X | X |
| 4.5 mm | X | X | X | X | X |
| 5.7 mm | X | X | X | X |
All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided nonsterile to the end user. All digitally designed customized Titanium Blank abutments are to an Open Implants-validated milling center for manufacture.
The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness – 0.41 to 1.6 mm (varies by implant line); Minimum post height for single-unit restoration - 4.0 mm; Maximum Correction Angle - 30°; Minimum gingival height - 0.5 mm to 0.8 mm (varies by implant line); Maximum gingival height - 5 mm.
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 data submitted to demonstrate substantial equivalence included: biocompatibility according to ANSI/AAMI ST72; biocompatibility testing of the K193335 Predicate device to ISO 10993-5 in support of the Subject device; reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and static compression fatigue testing according to ISO 14801; sterilization validations of the K193335 Predicate device in support of the Subject device. For each compatible OEM implant line, worst-case constructs were subjected to static compression fatigue testing. No animal or clinical data is included in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K191609, K101608, K150899, K143505
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Open Implants, LLC % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor, Michigan 48105
Re: K212664
Trade/Device Name: Sherlock Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 29, 2021 Received: November 1, 2021
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 (QS) 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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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:
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Biomet 3i Certain | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| Straumann Bone Level | 3.3 | 3.3 (NC) |
| 4.1, 4.8 | 4.1, 4.8 (RC) | |
| Zimmer TSV | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
Compatibility Table
| 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 Open Implants, LLC Sherlock K212664 November 30, 2021
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 | Gregg Gellman, CEO |
| Email: | ggellman@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 |
|---|---|---|
| K193335 | Sherlock | Open Implants, LLC |
| 510(k) | Reference Device Name | Company Name |
| K191609 | Freadoll ® Patient Specific Dental Abutments | Biomet 3i, Inc. |
| 510(k) | Reference Device Name | Company Name |
|---|---|---|
| K101608 | Encode® Patient Specific Dental Abutments | Biomet 3i, Inc |
| K150899 | Straumann® CARES® Titanium Alloy (TAN) Abutment | Straumann USA, LLC |
| K143505 | Zimmer® Patient Specific Abutment, Internal Hex, Titanium | Zimmer Dental, Inc |
4
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:
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Biomet 3i Certain | 3.25 | 3.4 |
| Biomet 3i Certain | 4.0 | 4.1 |
| Biomet 3i Certain | 5.0 | 5.0 |
| Biomet 3i Certain | 6.0 | 6.0 |
| Straumann Bone Level | 3.3 | 3.3 (NC) |
| Straumann Bone Level | 4.1, 4.8 | 4.1, 4.8 (RC) |
| Zimmer TSV | 3.7, 4.1 | 3.5 |
| Zimmer TSV | 4.7 | 4.5 |
| Zimmer TSV | 6.0 | 5.7 |
Compatibility Table
DEVICE DESCRIPTION
Sherlock is a dental implant abutment system that includes four (4) abutment designs compatible with three (3) OEM implant systems. The Subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: Titanium blank, multi-unit angled 17°, and multiunit angled 30°. The system also includes corresponding abutment screws.
The following table shows the Subject device abutments for each of the Compatible implant platforms.
| Sherlock Platform Diameter/
| Compatible Implant System | Subject Device Abutment Designs | ||||
|---|---|---|---|---|---|
| Titanium Blank | Multi-unit Straight | Multi-Unit Angled 17° | Multi-Unit Angled 30° | Titanium Screws | |
| Biomet 3i Certain | |||||
| 3.4 mm | X | X | X | X | X |
| 4.1 mm | X | X | X | X | X |
| 5.0 mm | X | X | X | X | X |
| 6.0 mm | X | X | X | X | X |
| Straumann Bone Level | |||||
| 3.3 mm (NC) | X | X | X | X | X |
| 4.1 mm (RC) | X | X | X | X | X |
| 4.8 mm (RC) | X | X | X | X | X |
| Zimmer TSV | |||||
| 3.5 mm | X | X | X | X | X |
| 4.5 mm | X | X | X | X | X |
| 5.7 mm | X | X | X |
All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided nonsterile to the end user. All digitally designed customized Titanium Blank abutments are to an Open Implants-validated milling center for manufacture.
The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness – 0.41 to 1.6 mm (varies by implant line); Minimum post height for single-unit restoration - 4.0 mm;
5
Maximum Correction Angle - 30°; Minimum gingival height - 0.5 mm to 0.8 mm (varies by implant line); Maximum gingival height - 5 mm.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: biocompatibility according to ANSI/AAMI ST72; biocompatibility testing of the K193335 Predicate device to ISO 10993-5 in support of the Subject device; reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and static compression fatigue testing according to ISO 14801; sterilization validations of the K193335 Predicate device in support of the Subject device. For each compatible OEM implant line, worst-case constructs were subjected to static compression fatigue testing. No animal or clinical data is included in this premarket notification.
EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is substantially equivalent in indications and design principles to the Predicate device listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the Subject, Predicate device, and Reference devices.
The Indications for Use Statement (IFUS) of the Subject device is substantially equivalent to that of the K193335 Predicate device. Differences in the list of compatible implant systems do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.
Similarly, the differences between the Subject device IFUS and that of each of the Reference devices are related to the specific device names and design features, validated milling centers, and the compatible implant lines. None of these minor differences impact substantial equivalence because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
Subject device abutments are substantially equivalent in intended use and abutment designs to the sponsor's K193335 Predicate device. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Reference devices introduce additional restorative interfaces and restorative platform and implant diameters with similar intended uses.
The Subject device and K193335 Predicate devices are for single-unit or multi-unit restorations, have internal implant interface connections, and are made of Ti-6Al-4V ELI alloy (abutment screws). The Subject device abutment designs are substantially equivalent to that of the K193335 Predicate device designs: Titanium Blank; Straight or Angled 17° and Angled 30° Multi-Unit abutments.
The Subject device includes abutment designs for implant restorative platforms ranging from 3.3 mm. The K19335 Predicate included implant platform sizes of 3.5 mm to 3.9 mm. Substantial equivalence of the smaller and larger implant restorative platform diameters of the Subject device are supported by the Reference devices K101608, K150899, and K143505 and through performance testing of the Subject device.
The Subject device is to be sterilized by the end-user, using the same methods as previously validated for the sponsor's K19335 Predicate device.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines between the Predicate device, and the Reference devices do not affect substantial equivalence. Additional implant/abutment interfaces and dimensions are supported by Reference devices. The Subject, Predicate and Reference devices encompass the same range of physical dimensions. These minor differences are related to the compatible OEM implant designs and are mitigated by mechanical performance testing.
6
CONCLUSION
Overall, the Indications for Use statements for the Subject and Predicate devices are substantially equivalent differing only in the list of compatible implant system systems.
Overall, the Technological Characteristics, mode of operation and materials of the Subject device are substantially equivalent to that of the Predicate device with additional compatible implant systems supported by Reference devices.
Overall, the data included in this premarket notification demonstrate substantial equivalence of Subject device to the sponsor's Predicate device.
The basis for the belief that the Subject device is substantially equivalent to the Predicate device and is summarized in the following comparison tables.
7
| Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sherlock | |||||||||||||||||||||||||||||||||||||||||||
| Open Implants, LLC | Sherlock | ||||||||||||||||||||||||||||||||||||||||||
| Open Implants, LLC | |||||||||||||||||||||||||||||||||||||||||||
| K193335 | Encode® Patient Specific Dental | ||||||||||||||||||||||||||||||||||||||||||
| Abutments | |||||||||||||||||||||||||||||||||||||||||||
| Biomet 3i, Inc | |||||||||||||||||||||||||||||||||||||||||||
| K101608 |
BIOMET 3i Dental Abutments are
intended for use as accessories to
endosseous dental implant to
support a prosthetic device in a
partially or completely edentulous
patient. A dental abutment is
intended for use to support single
and multiple tooth prosthesis, in
the mandible or maxilla. The
prosthesis can be screw retained or
cement retained to the abutment.
Restorative Components:
· Temporary Healing Abutments
are intended for use to shape and
maintain the soft tissue opening
during healing.
· Castable restorative components
are intended for use as accessories
to endosseous dental implants to
aid in the fabrication of dental
prosthetics.
· Screw components are intended
for use as accessories to
endosseous dental implants for
retention of screw retained
abutments to the dental implant. | Straumann® CARES® Titanium Alloy
(TAN) Abutments
Straumann USA, LLC
K150899
The Straumann CARES® TAN
abutments are indicated for single
tooth replacement and multiple
tooth restorations. The prosthetic
restoration can be cemented or
directly veneered/screw-retained. | Zimmer® Patient Specific Abutment,
Internal Hex, Titanium
Zimmer Dental, Inc
K143505
The Zimmer® Patient Specific
Abutment is used as a terminal or
intermediate abutment for a cemented
prosthesis. The abutment can be used
for a single or multiple-unit
restoration. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 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: | Sherlock abutments are
compatible with the implant
systems listed in the
Compatibility Table: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Compatibility Table Compatible
Implant
Systems Implant
Body
Diameter
(mm) Implant
Platform
Diameter
(mm) Biomet 3i 3.25 3.4 Certain 4.0 4.1 5.0 5.0 6.0 6.0 Straumann 3.3 3.3 (NC) Bone Level 4.1, 4.8 4.1, 4.8 (RC) 3.7, 4.1 3.5 Zimmer TSV 4.7 4.5 6.0 5.7 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Compatible
Implant
Systems Implant
Body
Diameter
(mm) Implant
Platform
Diameter
(mm) NobelActive® 3.5 3.5 (NP) 4.3, 5.0 3.9 (RP) | | | | | | | | | | | |
Comparison of Indications for Use Statement
8
| Comparison | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|
| Sherlock | Sherlock | Encode®@ Patient Specific Dental Abutments | Straumann® CARES® Titanium Alloy (TAN) Abutments | Zimmer® Patient Specific Abutment, Internal Hex, | |
| Open Implants | Open Implants, LLC | Biomet 3i, Inc | Straumann USA, LLC | Titanium | |
| K193335 | K101608 | K150899 | Zimmer Dental, Inc | ||
| K143505 | |||||
| Intended Use | Functional and esthetic rehabilitation of | ||||
| the edentulous maxilla and mandible | Functional and esthetic rehabilitation of the | ||||
| edentulous maxilla and mandible | Functional and esthetic rehabilitation of the | ||||
| edentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulous | ||||
| maxilla and mandible | Functional and esthetic rehabilitation of the | ||||
| edentulous maxilla and mandible | |||||
| Reason for | |||||
| Predicate/Reference | Not Applicable | Abutment configurations listed, material, | |||
| sterilization, biocompatibility, CAD/CAM | |||||
| abutment technology | Implant/abutment interface, prosthetic | ||||
| diameters, CAD/CAM abutment technology | Implant/abutment interface, prosthetic diameters, CAD/CAM | ||||
| abutment technology | Implant/abutment interface, prosthetic diameters, | ||||
| CAD/CAM abutment technology | |||||
| Titanium Blank | Titanium Blank | Abutment types, not specified, but consistent | |||
| with Titanium Blank or Ti-Base/Hybrid | |||||
| abutment. | Titanium Blank / Stock | Titanium Blank / Stock | |||
| Minimum wall thickness - 0.41 - 0.65 mm | |||||
| (varies by implant line); | Minimum wall thickness - 0.42 mm; | Minimum wall thickness - not specified; | Minimum wall thickness - 0.4 mm; | Minimum wall thickness - not specified; | |
| Minimum post height for single-unit | |||||
| restoration - 4.0 mm; | Minimum post height for single-unit | ||||
| restoration - 4.0 mm; | Minimum post height for single unit | ||||
| restoration - not specified | Minimum post height for single unit restoration - not specified | Minimum post height for single unit restoration - not | |||
| specified | |||||
| Maximum Correction Angle - 30°; | Maximum Correction Angle - 30°; | Maximum correction angle - 30°; | Maximum correction angle - NC - 0°, RC - 30°; | Maximum correction angle - 30°; | |
| Gingival height - 0.5 to 5 mm; | Gingival Height - 0.5 mm to 5 mm; | Gingival Height - 0.25 minimum (3.4 mm | |||
| internal connection) | Maximum gingival height - no limit; | Maximum gingival height - no limit; | |||
| Gingival Diameter - 3.0 - 11.9 mm (varies | |||||
| by implant line) | Gingival Diameter – 3.4 – 11.9 mm | Gingival Diameter - 3.8 - 16 mm | Gingival Diameter - not specified | Gingival Diameter: | |
| 3.5mm Platform: 3.5- 9.0 mm | |||||
| 4.5mm Platform: 4.5- 10.0 mm | |||||
| 5.7mm Platform: 5.7- 12.0 mm | |||||
| Abutment height - 6.4 - 15 mm (varies by | |||||
| implant line) | Abutment height - 7.3 - 15 mm | Abutment height - 4.75 - 15 mm | Abutment Height- not specified | Abutment Height- not specified | |
| Multi-Unit Straight | Multi-Unit Straight | ||||
| PD = 3.3 - 4.8 mm | PD = 3.5, 3.9 mm | ||||
| GH = 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 mm | GH = 1.5, 2, 3, 5 mm | ||||
| GD = 4.8 mm | GD = 4.8 mm | ||||
| PH = 4.4 mm (includes insert) | PH = 4.4 mm (includes insert) | ||||
| AH = 7.4 - 12.5 mm (includes insert) | AH = 7.5 -11 mm (includes insert) | ||||
| Multi-Unit 17° | Multi-Unit 17° | ||||
| PD = 3.3 - 4.8 mm | PD = 3.5, 3.9 mm | ||||
| GH = 2, 2.5, 3, 3.5, 4 mm | GH = 3.5, 5 mm | ||||
| GD = 4.8 mm | GD = 4.8 mm | ||||
| PH = 4.4 mm (includes insert) | PH = 4.4 mm (includes insert) | ||||
| AH = 7.9 - 12.1 mm (includes insert) | |||||
| Multi-Unit 30° | AH = 7.3 - 10.8 mm (includes insert) | ||||
| Multi-Unit 30° | |||||
| PD = 3.3 - 4.8 mm | PD = 3.5, 3.9 mm | ||||
| GH = 3, 3.5, 4, 4.5, 5 mm | GH = 3.5, 5 mm | ||||
| GD = 4.8 mm | GD = 4.8 mm | ||||
| PH = 4.4 mm (includes insert) | PH = 4.4 mm (includes insert) | ||||
| AH = 8.3 - 12.5 mm (includes insert) | AH = 7.7 - 11.2 mm (includes insert) | ||||
| Abutment/Implant | |||||
| Platform Diameter (mm) | 3.3 - 6.0 | 3.5, 3.9 | 3.4, 4.1, 5.0, 6.0 | 3.3, 4.1, 4.8 | 3.5, 4.5, 5.7 mm |
| Material | |||||
| (Abutment and Screw) | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | Titanium Alloy or Biocompatible Zirconia TZP | Titanium Alloy (Ti-6AL-7NB) | Titanium 6Al-4V Alloy |
| Abutment/Implant | |||||
| Interface | Internal Connection | Internal Connection | Internal Connection and External Connection | Internal Connection | Internal Connection |
| Prosthesis Attachment | Cement-retained | ||||
| Screw-retained | Cement-retained | ||||
| Screw-retained | Cement-retained | ||||
| Screw-retained | Cement-retained | ||||
| Screw-retained | Cement-retained | ||||
| Restoration | Single-unit | ||||
| Multi-unit | Single-unit | ||||
| Multi-unit | Single-unit | ||||
| Multi-unit | Single-unit | Single-unit | |||
| Multi-unit |
Comparison of Technological Characteristics
PD = Abutment/Implant Platform (Restorative) Diameter
GH = Gingival Height
GD = Gingival Diameter
PH = Post Height
AH = Abutment Height