(168 days)
The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.
LOCATOR® RTx Attachment System is compatible with the following implant systems.
| Implant Manufacturer: | System: |
|---|---|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm)External Hex (3.5, 4.0, 5.0 mm) |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm)External Hex (3.4, 4.1, 5.0, 6.0 mm) |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm)iSy (3.8, 4.4, 5.0 mm) |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm)XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm)Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm),NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm),Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm)Bone Level (3.3, 4.1, 4.8 mm) |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm)Spline (3.25, 4.0, 5.0 mm)Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
LOCATOR® RTx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR® as a resilient attachment for endosseous implants. All LOCATOR RTx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.
This document describes the regulatory approval for a medical device called "LOCATOR® RTx". It is a Premarket Notification (510(k)) submission to the FDA. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than proving performance against specific acceptance criteria for a novel device.
Therefore, the information typically requested in your prompt regarding acceptance criteria, performance data from a study, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for AI/ML device performance is not directly applicable or available in this type of regulatory submission for a dental implant abutment system.
Here's a breakdown of why the requested information isn't present and what is provided:
-
Acceptance Criteria and Reported Device Performance (Table 1): This document does not list quantitative acceptance criteria or corresponding performance scores for the device's clinical efficacy or accuracy in the way an AI/ML device would. Instead, it demonstrates equivalence through design, materials, intended use, and compatibility with existing implant systems. The "performance data" refers to non-clinical testing.
- What is provided: A comparison table (page 6) outlines design parameters (Abutment Diameter, Abutment Angle, Abutment/Implant Interface, Divergence Allowance, Prosthesis Attachment Type, Material) between the subject device (LOCATOR® RTx) and its primary and additional predicate devices. The "performance" is implicitly considered equivalent if these parameters are similar and non-clinical tests (sterilization, biocompatibility, coating characterization) pass.
-
Sample sizes for test set and data provenance: Not applicable. This wasn't a clinical performance study with a test set of patient data. The "performance data" was non-clinical testing.
- What is provided: Mention of non-clinical testing: "sterilization testing, biocompatibility testing of the TiCN coating, and characterization testing of the TiCN coating." No sample sizes for these tests are explicitly stated in this summary.
-
Number of experts and qualifications for ground truth: Not applicable. Ground truth typically refers to objective labels for a dataset used to evaluate diagnostic or prognostic performance (e.g., confirmed disease status for an AI model). This is not that type of study.
-
Adjudication method for the test set: Not applicable.
-
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device or a device where human interpretation of medical images is involved.
-
Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
-
Type of ground truth used: Not applicable in the context of an AI/ML device. For this device, "ground truth" might be considered to be established engineering specifications and material standards that the device must meet during manufacturing and testing.
-
Sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
-
How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Acceptance (as presented in a 510(k) context):
The "acceptance criteria" for the LOCATOR® RTx are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through the following:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Feature/Parameter | Implied Acceptance Criteria (Equivalence to Predicates) | Reported Device Performance (LOCATOR® RTx) |
|---|---|---|
| Indications for Use | Must be substantially equivalent to predicates, showing suitability for overdentures or partial dentures retained by endosseous implants in the mandible or maxilla. | "The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla." This aligns with the primary predicate and is broadened slightly in the reference device but remains fundamentally equivalent in use. |
| Design: Abutment Diameter | Comparable range to predicates. | 3.0 to 7.0 mm (Wider range than primary predicate (3.25-6.5mm) but within/overlapping with ranges of multiple compatible implant systems listed). |
| Design: Abutment Angle | Straight (like predicates). | Straight |
| Design: Abutment/Implant Interface | Compatible with common implant interfaces used by predicates. | Conical, External Hex, Internal Hex, Internal Multi Lobe (Similar to primary predicate; reference device has "Internal Taper"). |
| Design: Divergence Allowance | Comparable to or improved upon predicates while still being safe and effective. | 30°/60° (except when prohibited by implant manufacturer) (Greater than primary predicate's 20°/40°, but similar to reference device's 33°/66°. This indicates a design improvement while staying within accepted medical practice for dental implants). |
| Design: Prosthesis Attachment Type | Similar attachment mechanism (e.g., retention cap). | Nylon or PEEK male retention cap (Primary predicate uses "Nylon male retention cap". The use of PEEK is noted as a similarity). While the reference device uses "Screw-retained", the subject device clearly aligns with the primary predicate's attachment method. |
| Material: Abutment | Biocompatible and strong material (e.g., Titanium alloy). | Ti-6Al-4V ELI (Identical to both predicates). |
| Material: Prosthetic Retention Component | Biocompatible polymer (e.g., Nylon). | Nylon or PEEK (Primary predicate uses "Nylon". The addition of PEEK is within acceptable material performance for this component). |
| Sterilization | Must meet validated sterilization standards. | Validated to ISO 17665-1 and ISO 17665-2. (Demonstrated by "sterilization testing"). |
| Biocompatibility | Must be biocompatible (non-toxic, non-irritating, non-sensitizing). | Tested to ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization). Results indicated biocompatibility. (Demonstrated by "biocompatibility testing of the TiCN coating"). |
| Coating Characterization | The TiCN coating must be characterized to ensure its safety and performance. | "characterization testing of the TiCN coating" was performed. |
2. Sample Sized used for the test set and the data provenance:
* As explained, this was a 510(k) for substantial equivalence based on design, materials, and non-clinical performance testing (sterilization, biocompatibility, coating characterization). There isn't a "test set" in the context of clinical data for performance evaluation. Data provenance would be from internal lab testing for the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth in this context is based on established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for demonstrating substantial equivalence and safety/effectiveness in a 510(k) for this type of device relies on:
* Compliance with recognized standards: ISO 17665 (sterilization) and ISO 10993 (biocompatibility).
* Comparison to predicate devices: The established safety and effectiveness of the primary and reference predicate devices serve as the benchmark.
* Engineering and materials specifications: Ensuring the device meets its design specifications and material properties.
8. The sample size for the training set:
* Not applicable. No "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
* Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, one behind the other, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24,2015
Zest Anchors, LLC % Linda Schulz Regulatory Affairs Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K150295
Trade/Device Name: LOCATOR RTx Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 17, 2015 Received: June 18, 2015
Dear Linda Schulz:
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. 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.
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 (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K150295
Device Name
LOCATOR® RTx
Indications for Use (Describe)
The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.
LOCATOR® RTx Attachment System is compatible with the following implant systems.
| Implant Manufacturer: | System: |
|---|---|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm)External Hex (3.5, 4.0, 5.0 mm) |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm)External Hex (3.4, 4.1, 5.0, 6.0 mm) |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm)iSy (3.8, 4.4, 5.0 mm) |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm)XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm)Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm),NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm),Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm)Bone Level (3.3, 4.1, 4.8 mm) |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm)Spline (3.25, 4.0, 5.0 mm)Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary Zest Anchors, LLC LOCATOR® RTx K150295
July 23, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Zest Anchors, LLC2061 Wineridge PlaceEscondido, CA 92029 |
|---|---|
| Telephone: | +1 (760) 743-7744 ext. 140 |
| Fax: | +1 (760) 743-7975 |
| Official Contact | Annie WrightRegulatory Affairs Manager |
| Representative/Consultant | Linda K. Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 |
| Telephone: | +1 (858) 792-1235 |
| Fax: | +1 (858) 792-1236 |
| Email: | lschulz@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | LOCATOR® RTx |
|---|---|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulation | Class II, 21 CFR 872.3630 |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
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510(k) Summary LOCATOR® RTx
INTENDED USE
The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.
LOCATOR® RTx Attachment System is compatible with the following implant systems.
| ImplantManufacturer | Connection |
|---|---|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm) |
| External Hex (3.5, 4.0, 5.0 mm) | |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm) |
| External Hex (3.4, 4.1, 5.0, 6.0 mm) | |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm) |
| iSy (3.8, 4.4, 5.0 mm) | |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm) |
| XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm) | |
| Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) | |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm) |
| Biocare | NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm) |
| Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) | |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm) |
| Bone Level (3.3, 4.1, 4.8 mm) | |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm) |
| Spline (3.25, 4.0, 5.0 mm) | |
| Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
DEVICE DESCRIPTION
LOCATOR® RTx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR® as a resilient attachment for endosseous implants. All LOCATOR RTx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.
PERFORMANCE DATA
Performance testing to demonstrate substantial equivalence included methods described in the following standards: ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity; and
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ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization testing, biocompatibility testing of the TiCN coating, and characterization testing of the TiCN coating. The performance data included in this submission demonstrate substantial equivalence to the predicate devices listed below.
EQUIVALENCE TO MARKETED DEVICE
LOCATOR RTx is substantially equivalent to LOCATOR in that it uses the identical interface for compatible implant systems and it is a nylon or PEEK liner overdenture system with varying cuff heights.
Primary predicate: Zest Anchors, Inc., Modification to Locator Implant Anchor cleared under K072878.
Reference Device: Astra Tech AB, OsseoSpeed Plus cleared under K120414.
| 510(k) Number | Implant System Compatibility |
|---|---|
| K063341 | Biomet 3i Osseotite® Certain® |
| K063286 | Biomet 3i Osseotite® |
| K061410 | Zimmer Tapered Screw-vent® |
| K010073 | Zimmer Spline |
| K082639 | Zimmer SwissPlus |
| K103089 | MIS |
| K062129 | Straumann Bone Level |
| K130222 | Straumann Standard |
| K020646 | Nobel Biocare Replace™ Select |
| K071370 | Nobel Biocare NobelActive™ |
| K102436 | Nobel Biocare NobelActive™ |
| K022562 | Nobel Biocare Brånemark |
| K041509 | Dentsply Friadent® Ankylos® |
| K073075 | Dentsply Friadent® Frialit/XiVE® |
| K120414 | Astra Tech OsseoSpeed Plus (EV) |
| K000100 | Camlog Rootform Implant System |
| K083496 | Camlog Implant System |
| K113779 | Conelog Implant System |
| K133991 | Camlog iSy Implant System |
| K071638 | Camlog iSy Implant System |
| K093321 | BioHorizons Internal |
| K143022 | BioHorizons Internal |
| K030463 | BioHorizons External Hex |
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| Subject Device | Primary Predicate Device | Additional Predicate Device | |
|---|---|---|---|
| Zest Anchors, Inc. | Astra Tech AB | ||
| Zest Anchors, LLCLOCATOR® RTx | LOCATOR Implant AnchorAbutment for EndosseousDental ImplantK072878 | OsseoSpeed PlusK120414 | |
| Indications for Use | The LOCATOR® RTx ImplantAttachment System is designedfor use with overdentures orpartial dentures, retained inwhole or in part, by endosseousimplants in the mandible ormaxilla. | The LOCATOR Implant AnchorAbutment for Endosseous DentalImplants is appropriate for usewith overdentures or partialdentures retained in whole or inpart by endosseous implants inthe mandible or maxilla. | Astra Tech Implant System Plusabutments are intended to beused in conjunction with AstraTech Implant System Plus infully edentulous or partiallyedentulous maxillary and/ormandibular arches to providesupport for crowns, bridges oroverdentures. |
| Design | |||
| AbutmentDiameter, mm | 3.0 to 7.0 | 3.25 to 6.5 | 3.0 to 5.4 |
| Abutment Angle | Straight | Straight | Straight |
| Abutment/ImplantInterface | Conical, External Hex, InternalHex, Internal Multi Lobe | Conical, External Hex, InternalHex, Internal Multi Lobe | Internal Taper |
| DivergenceAllowance | 30°/60°(except when prohibitedby implant manufacturer) | 20°/40° | 33°/66° |
| ProsthesisAttachment Type | Nylon or PEEK maleretention cap | Nylon male retention cap | Screw-retained |
| Material | |||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| ProstheticRetentionComponent | Nylon or PEEK | Nylon | NA |
The subject device is the same in all features as the primary predicate with the exception of the compatible implant/abutment interface. The subject device has the same divergence allowance as the reference device. The subject device has a resilient overdenture prosthesis attachment and the reference device is for a screw-retained prosthesis.
CONCLUSION
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same processes.
§ 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.)