(99 days)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
| 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 |
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.
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.
The provided document is a 510(k) summary for a dental implant abutment system named "Sherlock" (K212664). It details the device's technical specifications and compares it to predicate and reference devices to demonstrate substantial equivalence.
However, the document does NOT contain information about an AI/ML-based device or a study proving its performance against acceptance criteria using clinical data, reader studies, ground truth establishment, or sample sizes for AI training/testing. The "Performance Data" section explicitly states: "No animal or clinical data is included in this premarket notification." The tests performed are non-clinical, focusing on biocompatibility, reverse engineering for compatibility, and static compression fatigue.
Therefore, I cannot provide the requested information for an AI/ML device study. The content of the document pertains to the regulatory clearance of a physical medical device (dental abutments) based on substantial equivalence to existing devices, primarily through non-clinical performance data.
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
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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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510(k) Summary Open Implants, LLC Sherlock K212664 November 30, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Open Implants, LLC800 West Cummings Ave, Suite 4900Woburn, MA 01801Telephone: +1 781-587-3242Fax: 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 |
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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;
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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.
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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.
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| Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SherlockOpen Implants, LLC | SherlockOpen Implants, LLCK193335 | Encode® Patient Specific DentalAbutmentsBiomet 3i, IncK101608BIOMET 3i Dental Abutments areintended for use as accessories toendosseous dental implant tosupport a prosthetic device in apartially or completely edentulouspatient. A dental abutment isintended for use to support singleand multiple tooth prosthesis, inthe mandible or maxilla. Theprosthesis can be screw retained orcement retained to the abutment.Restorative Components:· Temporary Healing Abutmentsare intended for use to shape andmaintain the soft tissue openingduring healing.· Castable restorative componentsare intended for use as accessoriesto endosseous dental implants toaid in the fabrication of dentalprosthetics.· Screw components are intendedfor use as accessories toendosseous dental implants forretention of screw retainedabutments to the dental implant. | Straumann® CARES® Titanium Alloy(TAN) AbutmentsStraumann USA, LLCK150899The Straumann CARES® TANabutments are indicated for singletooth replacement and multipletooth restorations. The prostheticrestoration can be cemented ordirectly veneered/screw-retained. | Zimmer® Patient Specific Abutment,Internal Hex, TitaniumZimmer Dental, IncK143505The Zimmer® Patient SpecificAbutment is used as a terminal orintermediate abutment for a cementedprosthesis. The abutment can be usedfor a single or multiple-unitrestoration. | |||||||||||||||||||||||||||||||||||||||
| Sherlock abutments are intendedto be used in conjunction withendosseous dental implants inthe maxillary or mandibular archto provide support for single-unitor multi-unit prostheticrestorations.All digitally designed CAD/CAMcustomizations for Sherlockabutments are to be sent to anOpen Implants-validated millingcenter for manufacture. | Sherlock abutments are intendedto be used in conjunction withendosseous dental implants inthe maxillary or mandibular archto provide support for single-unitor multi-unit prostheticrestorations.All digitally designed CAD/CAMcustomizations for Sherlockabutments are to be sent to anOpen Implants-validated millingcenter for manufacture. | ||||||||||||||||||||||||||||||||||||||||||
| Sherlock abutments arecompatible with the implantsystems listed in theCompatibility Table: | Sherlock abutments arecompatible with the implantsystems listed in theCompatibility Table: | ||||||||||||||||||||||||||||||||||||||||||
| Compatibility Table CompatibleImplantSystems ImplantBodyDiameter(mm) ImplantPlatformDiameter(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 | CompatibleImplantSystems ImplantBodyDiameter(mm) ImplantPlatformDiameter(mm) NobelActive® 3.5 3.5 (NP) 4.3, 5.0 3.9 (RP) |
Comparison of Indications for Use Statement
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| 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 ofthe edentulous maxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | Functional and esthetic rehabilitation of the edentulousmaxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible |
| Reason forPredicate/Reference | Not Applicable | Abutment configurations listed, material,sterilization, biocompatibility, CAD/CAMabutment technology | Implant/abutment interface, prostheticdiameters, CAD/CAM abutment technology | Implant/abutment interface, prosthetic diameters, CAD/CAMabutment technology | Implant/abutment interface, prosthetic diameters,CAD/CAM abutment technology |
| Titanium Blank | Titanium Blank | Abutment types, not specified, but consistentwith Titanium Blank or Ti-Base/Hybridabutment. | 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-unitrestoration - 4.0 mm; | Minimum post height for single-unitrestoration - 4.0 mm; | Minimum post height for single unitrestoration - not specified | Minimum post height for single unit restoration - not specified | Minimum post height for single unit restoration - notspecified | |
| 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 mminternal connection) | Maximum gingival height - no limit; | Maximum gingival height - no limit; | |
| Gingival Diameter - 3.0 - 11.9 mm (variesby 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 mm4.5mm Platform: 4.5- 10.0 mm5.7mm Platform: 5.7- 12.0 mm | |
| Abutment height - 6.4 - 15 mm (varies byimplant 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/ImplantPlatform 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/ImplantInterface | Internal Connection | Internal Connection | Internal Connection and External Connection | Internal Connection | Internal Connection |
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retained |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unit | Single-unitMulti-unit |
Comparison of Technological Characteristics
PD = Abutment/Implant Platform (Restorative) Diameter
GH = Gingival Height
GD = Gingival Diameter
PH = Post Height
AH = Abutment Height
§ 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.)