(123 days)
No
The document describes a dental implant abutment system and its physical characteristics, materials, and testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The "digitally designed CAD/CAM customizations" refer to standard computer-aided design and manufacturing processes, not AI/ML.
No
This device is an abutment system used to support prosthetic restorations on dental implants, not to treat a medical condition or disease.
No
Explanation: The device, Sherlock abutments, is an implant abutment system intended to provide support for prosthetic restorations. Its purpose is structural and restorative, not diagnostic. There is no mention of it being used to detect, monitor, or diagnose any medical condition.
No
The device description clearly states that Sherlock is a dental implant abutment system that includes physical components (titanium bases, screws, and zirconia superstructures) manufactured from specific materials (Ti-6Al-4V ELI alloy and zirconia). While digital design is mentioned, 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:
- Intended Use: The intended use clearly states the device is for providing support for dental prosthetic restorations in conjunction with dental implants. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and design of a dental implant abutment system, which is a physical component used in dental surgery and restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device, specifically a dental implant abutment system, but it does not fit the definition of 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 mandbular 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) |
|---|---|---|
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| Nobel Biocare NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| 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 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Sherlock is a dental implant abutment system that is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile.
In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center.
| Sherlock Platform Diameter/
| Compatible Implant System | Subject Device Abutment Designs | |
|---|---|---|
| Titanium Base | ASC Titanium Base | |
| Nobel Biocare Nobel Active® | ||
| 3.5 mm (NP) | X | X |
| 3.9 mm (RP) | X | X |
| Straumann Bone Level | ||
| 3.3 mm (NC) | X | X |
| 4.1 mm (RC) | X | X |
| 4.8 mm (RC) | X | X |
| Zimmer TSV | ||
| 3.5 mm | X | X |
| 4.5 mm | X | X |
| 5.7 mm | X | X |
The following table shows the Subject device abutments for each of the Compatible implant platforms.
All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.
All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.
The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are:
Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30°
The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.
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:
For each compatible OEM implant line, worst-case constructs of each compatible implant system in the premarket notification were subjected to static and fatigue testing according to ISO 14801.
Reverse engineering studies of OEM implant bodies, abutment screws to demonstrate compatibility with the implant systems listed in this premarket notification are leveraged from the K19335 (Nobel Active) and K212664 (Straumann Bone Level and Zimmer TSV) submissions.
Biocompatibility cytotoxicity testing to ISO 10993-5 for the titanium bases is leveraged from the K193335 Reference device.
Cleaning validation testing to AAMI TIR30 for a titanium and zirconia construct is leveraged from the K193335 Reference device. Sterilization validation testing to ISO 14937 for a titanium and zirconia construct is leveraged from the K193335 Reference device.
Non-clinical worst-case MRI review was performed to evaluate the metallic Sherlock devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
No clinical or animal testing 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.
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: K220482
Trade/Device Name: Sherlock Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 15, 2022 Received: May 16, 2022
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 Ouality 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 mandbular 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) |
|---|---|---|
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| Nobel Biocare NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| 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
Type of Use (Select one or both, as applicable)
| Remediation Use (Part 21 CFR 221.2, Level B) | ☒ |
|---|---|
| Source Tissue Standard Use (21 CFR 221.2, Level C) | ☐ |
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 K220482 Sherlock June 17, 2022
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 technological characteristics to the following Predicate device shares technological characteristics with the following Reference devices.
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K212664 | Sherlock | Open Implants, LLC |
| 510(k) | Reference Device Name | Company Name |
| K193335 | Sherlock | Open Implants, LLC |
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) |
|---|---|---|
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| 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 |
4
DEVICE DESCRIPTION
Sherlock is a dental implant abutment system that is being expanded to include two (2) new abutment designs compatible with three (3) OEM implant systems. The Subject device implant platform diameters range from 3.3 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm. The Subject device includes the following two-piece abutment designs: Titanium Base with angulated screw channel (ASC) and are provided with corresponding abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile.
In final, finished form, the Subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (titanium base) with a cemented/bonded CAD-CAM zirconia top-portion. Each patientspecific zirconia superstructure is individually prescribed by the clinician and manufactured milling center.
| Sherlock Platform Diameter/
| Compatible Implant System | Subject Device Abutment Designs | |
|---|---|---|
| Titanium Base | ASC Titanium Base | |
| Nobel Biocare Nobel Active® | ||
| 3.5 mm (NP) | X | X |
| 3.9 mm (RP) | X | X |
| Straumann Bone Level | ||
| 3.3 mm (NC) | X | X |
| 4.1 mm (RC) | X | X |
| 4.8 mm (RC) | X | X |
| Zimmer TSV | ||
| 3.5 mm | X | X |
| 4.5 mm | X | X |
| 5.7 mm | X | X |
The following table shows the Subject device abutments for each of the Compatible implant platforms.
All Subject device abutments are provided in a straight design with no angulation in the titanium base post and with an indexed/engaging implant connection for crowns or a non-engaging/non-indexed implant connections for bridges. The standard Titanium base abutments are provided in gingival heights ranging from 0.25 mm and abutment post lengths of 8 mm or 10 mm. The ASC Titanium Base abutments are provided in gingival heights ranging 0.8 mm to 1.8 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC Titanium Base abutments are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard Titanium Base and ASC Titanium Base posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.
All digitally designed zirconia copings (mesostructures) for use with the Subject device titanium base abutments will be made at an Open Implants validated milling center under FDA quality system regulations, and the zirconia material will conform to ISO 13356.
The overall design parameters for the two-part Standard and ASC CAD/CAM Titanium Base customized abutments with zirconia mesostructure are:
Minimum Zirconia Wall Thickness – 0.5 mm Minimum Post Height for single-unit restoration – 4.0 mm for Straumann implant line Minimum Overall Gingival Height – 0.5 mm (titanium base plus zirconia) Maximum Overall Gingival Height – 5 mm Maximum Correction Angle - 30°
The recommended cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.
5
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included:
For each compatible OEM implant line, worst-case constructs of each compatible implant system in the premarket notification were subjected to static and fatigue testing according to ISO 14801.
Reverse engineering studies of OEM implant bodies, abutment screws to demonstrate compatibility with the implant systems listed in this premarket notification are leveraged from the K19335 (Nobel Active) and K212664 (Straumann Bone Level and Zimmer TSV) submissions.
Biocompatibility cytotoxicity testing to ISO 10993-5 for the titanium bases is leveraged from the K193335 Reference device.
Cleaning validation testing to AAMI TIR30 for a titanium and zirconia construct is leveraged from the K193335 Reference device. Sterilization validation testing to ISO 14937 for a titanium and zirconia construct is leveraged from the K193335 Reference device.
Non-clinical worst-case MRI review was performed to evaluate the metallic Sherlock devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
No clinical or animal testing 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 K212664 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. The K212108 which includes a new abutment design technology has a similarly worded Indications for Use statement, specific to the implant system of that premarket notification. 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 to the sponsor's K212664 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, abutment designs with similar intended uses.
The Subject and K212664 Predicate devices are intended for single-unit or multi-unit restorations, have internal implant interface connections, and are made of Ti-6Al-4V ELI alloy (abutment screws) and are intended for cement-retained restorations. Biocompatibility of the Subject device is substantially equivalent to and supported by the Predicate device being fabricated from the same materials.
6
The Subject device includes abutment designs for implant platform diameters range from 3.3 mm, with the corresponding compatible implant body diameters ranging from 3.0 mm. Similarly, the K212664 Predicate device abutment designs supported implant platform diameters range from 3.3 mm to 6.0 mm, with the corresponding compatible implant body diameters ranging from 3.25 mm to 6.0 mm. The Subject device and K212664 Predicate devices both include abutments which may include up to a 30° post correction angle.
Compatibility with the listed implant systems is supported by the K212664 Predicate and K193335 Reference devices and through non-clinical performance testing of the Subject device.
The Subject device abutment designs are highly similar to the K212108 Reference device Titanium Base design including similar design parameters. Both the Subject and K212108 Reference devices are two-piece abutments with a titanium base and a zirconia mesostructure. Both the Subject and K212108 Reference device Titanium Base abutments have a straight titanium post with no angulation built into the post. The Subject and K212108 Reference device abutments are both offered with a cut-out portion in the post to support an angulated screwdriver access channel. The Subject device is also offered in a titanium base configuration without the cut-out providing additional post surface area for cementation. The two-piece titanium base/zirconia mesostructure abutment design is supported by the K212108 Reference device.
The Subject device is to be sterilized by the end-user, using the same methods as previously validated for the sponsor's K212664 Predicate device.
Minor differences in the abutment designs and dimensions between the Subject and Predicate do not affect substantial equivalence. These minor differences do not impact safety or effectiveness are related to the compatible OEM implant designs and are mitigated by mechanical performance testing. The new abutment designs are supported by the K212108 Reference device and mechanical performance testing of worstcase constructs.
CONCLUSION
The Indications for Use statements are highly similar, differing only in the list of compatible implant system systems.
Overall, the Technological Characteristics of the Subject device are highly similar to the Predicate device.
The Subject device, the Predicate device, and the Reference devices have intended use, have similar technological characteristics, and are materials. The Subject device, the Predicate, and Reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this premarket notification demonstrate substantial equivalence to the Predicate device listed above.
Overall, the Sherlock Abutments Subject device is substantially equivalent to the Predicate device.
7
Comparison of Indications for Use Statement
| Subject Device | Predicate Device | Reference Device | Reference Device | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sherlock | Sherlock | Sherlock | Dynamic TiBase | |||||||||||||||
| Open Implants, LLC | Open Implants, LLC | Open Implants, LLC | Talladium Espana | |||||||||||||||
| K212664 | K193335 | K212108 | ||||||||||||||||
| Sherlock abutments are intended to be used in conjunction with | Sherlock abutments are intended to be used in conjunction with | Sherlock abutments are intended to be used in | Dynamic TiBase abutments are | |||||||||||||||
| endosseous dental implants in the maxillary or mandibular arch to | endosseous dental implants in the maxillary or mandibular arch to | conjunction with endosseous dental implants in the | intended for use with dental implants as | |||||||||||||||
| provide support for single-unit or multi-unit prosthetic restorations. | provide support for single-unit or multi-unit prosthetic restorations. | maxillary or mandibular arch to provide support for | a support for single-unit or multi-unit | |||||||||||||||
| single-unit or multi-unit prosthetic restorations. | prostheses in the maxillary or | |||||||||||||||||
| All digitally designed CAD/CAM customizations for Sherlock | All digitally designed CAD/CAM customizations for Sherlock | mandibular arch of a partially or fully | ||||||||||||||||
| abutments are to be sent to an Open Implants-validated milling | abutments are to be sent to an Open Implants-validated milling | All digitally designed CAD/CAM customizations for | edentulous patient. | |||||||||||||||
| center for manufacture. | center for manufacture. | Sherlock abutments are to be sent to an Open | ||||||||||||||||
| Implants-validated milling center for manufacture. | Implant Body | Implant | ||||||||||||||||
| Sherlock abutments are compatible with the implant systems listed | Implant | Diameter | Platform, | |||||||||||||||
| Sherlock abutments are compatible with the implant systems listed | ||||||||||||||||||
| in the Compatibility Table: | in the Compatibility Table: | Sherlock abutments are compatible with the | Compatibility | mm | mm | |||||||||||||
| Compatibility Table | Compatibility Table | implant systems listed in the Compatibility Table: | 2.7 | 3.5 | ||||||||||||||
| Implant | ||||||||||||||||||
| Implant | Compatible | |||||||||||||||||
| Implant | ||||||||||||||||||
| Implant | SPI® Contact | 3.5 | 4.0 | |||||||||||||||
| Compatible | Body | Platform | Implant | Body | Platform | Compatibility Table | Dental | |||||||||||
| Implant | 3.5 | 4.5 | ||||||||||||||||
| Implant | Diameter | Diameter | Systems | Diameter | Diameter | Compatible | Implant | Implant | 4.2 | 5.0 | ||||||||
| Systems | (mm) | (mm) | (mm) | (mm) | Implant | Body | Platform | |||||||||||
| Nobel Biocare | 3.5 | 3.5 (NP) | 3.25 | 3.4 | Systems | Diameter | Diameter | All digitally designed custom abutments | ||||||||||
| NobelActive® | 4.3, 5.0 | 3.9 (RP) | Biomet 3i | 4.0 | 4.1 | (mm) | (mm) | for use with Dynamic TiBase abutments | ||||||||||
| Straumann | 3.3 | 3.3 (NC) | Certain | 5.0 | 5.0 | NobelActive® | 3.5 | 3.5 (NP) | are to be sent to a Thommen Medical | |||||||||
| Bone Level | 4.1, 4.8 | 4.1, 4.8 (RC) | 6.0 | 6.0 | 4.3, 5.0 | 3.9 (RP) | validated milling center for | |||||||||||
| 3.7, 4.1 | ે. કે | Straumann | 3.3 | 3.3 (NC) | manufacture. | |||||||||||||
| Zimmer TSV | 4.7 | 4.5 | Bone Level | 4.1, 4.8 | 4.1, 4.8 (RC) | |||||||||||||
| 6.0 | 5.7 | Zimmer TSV | 3.7, 4.1 | |||||||||||||||
| 4.7 | ે. કે | |||||||||||||||||
| 4.5 | ||||||||||||||||||
| 60 | 57 |
Comparison of Technological Characteristics
| Comparison | Subject Device | Predicate Device | Reference Device | Reference Device | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sherlock | Sherlock | Sherlock | Dynamic TiBase | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Open Implants | Open Implants | Open Implants, LLC | Talladium Espana | |||||||||||||||||||||||||||||||||||||||||||||||||||
| K212664 | K193335 | K212108 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reason for Predicate/Reference | Not Applicable | Material, sterilization, biocompatibility, CAD/CAM | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| abutment technology, implant compatibility | Material, sterilization, biocompatibility, CAD/CAM abutment | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| technology, implant compatibility | CAD/CAM abutment technology, abutment design | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abutment Design | Titanium Base | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Platform Diameter: 3.3 - 5.7 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Minimum post height: 4.0 mm, 5.0 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Gingival Height: 0.5 to 3 mm* | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Straight Ti-Base, no post angle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post without cut-out design | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post w/cut-out design for angulated screw channel | Titanium Blank | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Platform Diameter: 3.3 - 6.0 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Minimum post height: 4.0 mm | Titanium Blank | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Platform Diameter: 3.5, 3.9 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Minimum post height: 4.0 mm | Titanium Base | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Platform Diameter: 3.5, 4.0, 4.5, 5.0 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Minimum post height: 4.0 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Gingival Height: 0.7 to 5 mm# | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Straight Ti-Base, no post angle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post w/cut-out design for angulated screw channel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| CAD/CAM Design Parameters IP** Min WT Min PH** GH PD CA 3.3-5.7 0.5 4.0, 5.0 0.5-5.0 4.4-11.9 0-30° * 0.5 mm minimum total GH (including mesostructure) |
- 5 mm maximum total GH (including mesostructure)
varies by implant line | | | | | | | | | | | | | CAD/CAM Design Parameters IP Min WT** Min PH GH PD CA 3.3-6.0 0.41-0.65 4.0 0.5-5.0 3-11.9 0-30° **varies by implant line | | | | | | | | | | | | | CAD/CAM Design Parameters IP Min WT Min PH GH PD CA 3.5-3.9 0.42 4.0 0.5-5.0 3.4-11.9 0-30° | | | | | | | | | | | | | CAD/CAM Design Parameters IP Min WT Min PH Min GH Max GH PD CA 3.5-5.0 0.43 4.0 0.7 5.83 n/s 0-30° | | | | | | | | | | | | | | |
| Material | Ti-6AL-4V ELI Alloy (Abutment and Screw)
Zirconia (Mesostructure) | Ti-6AL-4V ELI Alloy (Abutment and Screw) | Ti-6AL-4V ELI Alloy (Abutment and Screw) | Ti-6AL-4V ELI Alloy (Abutment and Screw)
Zirconia (Mesostructure)
*Based on product labeling/literature | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abutment/Implant Interface | Internal connection, engaging and non-engaging | Internal connection, engaging | Internal connection, engaging | Internal connection, engaging and non-engaging | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Prosthesis Attachment | Cement-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
Multi-unit | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
IP = Implant Platform Diameter (mm)
WT = Wall thickness (mm)
PH = Post Height (mm)
GH = Gingival Height (mm) PD = Prosthetic/Ginigval Diameter (mm)
CA = Post Correction angle (degrees) n/s = not specified