The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Device Description

The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:

. Straumann® Variobase® C (Ti-base)
. Prosthetic Restoration (patient specific coping or crown)
. Basal Screw

The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, the "Straumann® Variobase® C." It details the device's characteristics, intended use, indications for use, and a comparison to predicate devices. The section titled "Performance Testing 1.8" provides information on the studies conducted to demonstrate the device meets acceptance criteria.

Here's an analysis of the provided information against your requested criteria:

Based on the provided text, there is no information related to an AI/ML-based medical device performance study. The device described, Straumann® Variobase® C, is a dental abutment, which is a physical component used with dental implants. The performance testing mentioned (Dynamic fatigue and static strength tests, biocompatibility, sterilization process) are standard pre-market tests for physical medical devices and do not involve AI/ML.

Therefore, I cannot fulfill your request for details on:

A table of acceptance criteria and reported device performance (for AI/ML): The document doesn't provide this for an AI/ML device. The performance tests are for mechanical properties and sterility.
Sample sizes used for the test set and data provenance: Not applicable in the context of AI/ML. The provided text refers to physical testing (e.g., fatigue tests, which would have sample sizes for individual abutments).
Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI/ML model requiring ground truth from experts. The software mentioned (Sirona CEREC Software) is a CAD/CAM design software, not an AI diagnostic tool.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not done, as there's no AI component for human readers to interact with.
Standalone (algorithm only without human-in-the-loop performance): Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of relevant information from the document (not AI/ML related):

Device Type: Endosseous Dental Implant Abutment (physical component)
Performance Tests Mentioned:
- Dynamic fatigue and static strength tests (according to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
- Biocompatibility (stated that materials are identical to predicate, so no new issues).
- Sterilization process validation (according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1, ISO 17665-2).
Conclusion of Performance Testing: "demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices." This implies the device meets the performance characteristics of previously cleared similar devices.

In conclusion, the provided FDA 510(k) summary document pertains to a physical dental implant abutment and does not contain information about an AI/ML medical device or its acceptance criteria and study proving its performance.

Summary

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Institut Straumann AG % Jennifer Jackson Directory, Regulatory Affairs Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K192742

Trade/Device Name: Straumann® Variobase® C Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: January 14, 2021 Received: January 15, 2021

Dear Jennifer Jackson:

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 Steen Assistant Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192742

Device Name:

Straumann® Variobase® C

Indications for Use (Describe)

The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED

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Straumann® Variobase® C

510(k) Summary

1 510(k) Summary

Submitter's Contact Information 1.1

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
	On behalf of:
	Institut Straumann AGPeter Merian Weg, 12CH-4002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By &Alternate Contact:	Gordon DoddsManager Design Control QMEtkon GmbHPhone number: +49 89 30 90 75 291
Date of Submission:	February 12, 2021

1.2 Name of the Device

Trade Names:	Straumann® Variobase® C
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	§872.3630
Device Classification:	II
Product Code(s):	NHA, PNP
Classification Panel:	Dental

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Straumann® Variobase® C

510(k) Summary

Predicate Device(s) 1.3

Primary Predicate:

K151324 Variobase for CEREC (Institut Straumann AG) .
Reference Devices:
K181520 Sirona Dental CAD/CAM System (Sirona Dental) .
K171773 Straumann n!ce Glas Ceramic A14 Blocks (Institut Straumann AG) .
. K173961 – Straumann BLX Implant System (Institut Straumann AG)
K142890 Straumann Variobase (Institut Straumann AG) .
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut . Straumann AG)

1.4 Device Description

The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:

. Straumann® Variobase® C (Ti-base)
. Prosthetic Restoration (patient specific coping or crown)
. Basal Screw

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Straumann® Variobase® C

510(k) Summary

1.5 Intended Use

Straumann® Variobase C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns.

1.6 Indications for Use

The Straumann® Variobase®C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

1.7 Comparison of Technological Characteristics and Indications for Use

The subject and primary predicate Indications for Use differ only in the removal of the software version and the change in trade name. The software version validated as part of this submission is captured in Table 1 below, and the removal of this information from the Indications for Use statement does not change the intended use of the subject device system.

As outlined in Table 1, the subject system includes a combination of previously-cleared technologies that are now being implemented into one system. The Variobase technology has received prior clearance for each implant body compatibility. The ceramic materials have received prior clearance for use as the second piece of a two-piece abutment under product code NHA and for use with the Sirona CAD/CAM digital workflow. Performance testing has addressed any differences resultant from these new combinations of technologies.

The technological characteristics of the subject devices are compared to the primary predicate device in Table 1. The reference device K190662 is included for reference to MRI compatibility.

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Straumann® Variobase® C

510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCEDEVICE	REFERENCE DEVICE
K Number	K192742	K151324	K181520	K142890	K171773	K173961
Indications forUse	The Straumann®Variobase® Caretitanium alloy abutmentsplaced onto Straumanndental implants toprovide support forcustomized prostheticrestorations. Straumann®Variobase® Cabutmentsare indicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations.All digitally designedcopings and/or crownsfor use with theStraumann® Variobase®C abutments are to bedesigned using SironaCEREC Software andmanufactured using aSirona CEREC or inLabMC X or MC XL millingunit.	The Straumann®Variobase® for CEREC®are titanium alloyabutments placed ontoStraumann dentalimplants to providesupport for customizedprosthetic restorations.Straumann® Variobase®for CEREC® abutmentsare indicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations.All digitally designedcopings and/or crownsfor use with theStraumann® Variobase®for CEREC® abutmentsare to be designed usingSirona inLab software(Version 3.65 or higher)or Sirona CERECSoftware (Version 4.2 orhigher) andmanufactured using aSirona CEREC or inLabMC X or MC XL millingunit.	The Sirona Dental CAD/CAMSystem is intended for use inpartially or fully edentulousmandibles and maxillae insupport of single or multiple-unit cement retainedrestorations. For the BH 3.0S, SSO 3.5 L and SBL 3.3 Ltitanium bases, the indicationis restricted to thereplacement of single lateralincisors in the maxilla andlateral and central incisors inthe mandible. The systemconsists of three major parts:TiBase, inCorismesostructure, and CAD/CAMsoftware. Specifically, theinCoris mesostructure andTiBase components make upa two-piece abutment which isused in conjunction withendosseous dental implantsto restore the function andaesthetics in the oral cavity.The inCoris mesostructuremay also be used inconjunction with the CamlogTitanium base CAD/CAM(types K2244.XXXX)(K083496) in the CamlogImplant System. TheCAD/CAM software isintended to design andfabricate the inCorismesostructured. The inCorismesostructure and TiBasetwo-piece abutment iscompatible with the followingimplant systems:	The Straumann®Variobase™ Abutment isa titanium base placedonto Straumann dentalimplants to providesupport for customizedprosthetic restorations.Straumann® Variobase™Abutments are indicatedfor screw-retained singletooth or cement-retainedsingle tooth and bridgerestorations. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase™Abutment system areintended to be sent toStraumann formanufacture at avalidated milling center.	The Straumann® niceGlass Ceramic A14Blocks are intendedto be ceramicmesostructurescemented to the Ti-base for a two-piecehybrid abutment forsingle toothrestorations orhybrid abutmentcrowns, used inconjunction withendosseous dentalimplant to restorechewing function.The followingcompatibilitiesapply:Straumann RCVariobase forCEREC - 022.0024 -Block Size LStraumann NCVariobase forCEREC - 022.0025 -Block Size LStraumann RNVariobase forCEREC - 022.0019 -Block Size LStraumann WNVariobase forCEREC - 022.0020 -Block Size L	Straumann® BLX ImplantsStraumann® BLX Implants are suitable for endostealimplantation in the upper and lower jaw and for thefunctional and esthetic oral rehabilitation of edentulousand partially edentulous patients. BLX Implants canbe placed with immediate function on single-toothapplications when good primary stability is achievedand with appropriate occlusal loading to restorechewing function. The prosthetic restorations areconnected to the implants through the correspondingabutment components.Straumann® BLX Closure Caps and HealingAbutmentsStraumann® Closure Caps and Healing Abutments areindicated to be placed in the patient's mouth at the endof the implant placement to protect the innerconfiguration of the implant and to shape, maintainand stabilize the soft tissue during the healing process.Closure caps and healing abutments should be usedonly with suitable implant connections. StraumannClosure Caps and Healing Abutments have amaximum duration of usage of 6 months.Straumann® BLX Basal Screws and TemporaryAbutmentsProsthetic components directly or indirectly connectedto the endosseous dental implant are intended for useas an aid in prosthetic rehabilitations. Temporarycomponents can be used prior to the insertion of thefinal components to maintain, stabilize and shape thesoft tissue during the healing phase; they may not beplaced into occlusion. Final abutments may be placedinto occlusion when the implant is fullyosseointegrated. BLX Temporary Abutments have amaximum duration of usage of 180 days.Straumann® BLX VariobasesThe Straumann® Variobase® prosthetic componentsdirectly or indirectly connected to the endosseousdental implant are intended for use as an aid inprosthetic rehabilitations. The prosthetic restoration(crowns) can be cemented onto the Straumann®Variobase® prosthetic components. A temporaryrestoration can be used prior to the insertion of thefinal components to maintain, stabilize and shape thesoft tissue during the healing phase; they must beplaced out of occlusion. Final abutments andrestorations may be placed into occlusion when theimplant is fully osseointegrated. All digitally designedcopings and/or crowns for use with the Straumann®Variobase® Abutment system are intended to be sentto Straumann for manufacture at a validated millingcenter.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCEDEVICE	REFERENCE DEVICE
K Number	K192742	K151324	K181520	K142890	K171773	K173961
CompatibleImplants	Straumann Bone Levelimplantshaving the NCand RC implant-to-abutment interfacegeometries.Straumann Tissue Levelimplantshavingthe NNCimplant-to-abutmentinterface geometries.Straumann BLX implantshaving the RB/WB andWB implant-to-abutmentinterface geometries.	Straumann Bone Levelimplantshaving the NCand RC implant-to-abutment interfacegeometries.Straumann Tissue Levelimplantshaving the RNand WN implant-to-abutment interfacegeometries.	Nobel Biocare - Replace,Active, and BranemarkStraumann - Sy nocta andBone Lev elDentsply Sirona Implants –Osseospeed, Xive,Osseospeed EV, andAnky losBiomet 3i – Osseotite andCertainZimmer – Tapered Screw-VentThommen Medical - SPIElement, SPI Element Inicell,SPI Contact InicellOsstem/Hiossen – OsstemTS Implant System andHiossen Implant SystemBiohorizons (InternalConnection	Straumann Bone Levelimplantshaving the NCand RC implant-to-abutment interfacegeometries.Straumann Tissue LevelimplantshavingtheNNC, RN, and WNimplant-to-abutmentinterface geometries.	Straumann BoneLevel implantshaving the NC andRC implant-to-abutment interfacegeometries.Straumann TissueLevel implantshaving the RN andWN implant-to-abutment interfacegeometries.	Straumann BLX implantshaving theRB/WB and WB implant-to-abutmentinterface geometries.
CompatibleRestorationMaterials	Sirona inCorisZi meso(S and L) – K181520Ivoclar IPS e.max CAD(S and L) – K151324Straumann n!ce GlassCeramic A14 Blocks (L) –K171773	Sirona inCorisZi (L) –K062509 and K123664Ivoclar IPS e.max CAD(S and L) – K132209Ivoclar TelioCAD (S andL) – K093708	Sirona inCorisZi (S andL)	Traditional Workflow:Type 4 Metals (ISO22674)IPS e.max® PressCeramicDigital Workflow:polycon® ae (temporary)zerion® (permanent)IPS e.max® CADCeramic (permanent)coron® (permanent)	Straumann n!ceGlass Ceramic A14Blocks (L)	Digital Workflow:polycon® ae (temporary)IPS e.max® CAD Ceramic (permanent)
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCEDEVICE	REFERENCE DEVICE
K Number	K192742	K151324	K181520	K142890	K171773	K173961
CoronalDiameters	NC:2.98 mm (Size S or L)RC:3.38 mm (Size L)NNC:2.98 mm (Size S)RB/WB:2.98 mm (Size S) and3.38 mm (Size L)WB:3.38 mm (Size L)	NC: 3.38 mm (Size L)RC: 3.38 mm (Size L)RN: 3.38 mm (Size L)WN: 3.38 mm (Size L)	NC: 3.38 mm (Size L)RC: 3.38 mm (Size L)	NC: 2.80 mmRC: 2.90 mmNNC: 2.80 mm	N/A	RB/WB:2.80 mm (3.8 mm diameter platform)2.90 mm (4.5 mm diameter platform)WB: 2.90 mm
AbutmentPlatformDiameters	NC:3.8 mmRC:4.6 mmNNC:3.9 mmRB/WB: 3.8 mm &4.5mmWB:5.5 mm	NC: 4.5 mmRC: 4.6 mmRN: 5.0 mmWN: 7.0 mm	3.0-7.0 mm	3.8 mm - 7.0 mm	NC: 4.5 mmRC: 4.6 mmRN: 5.0 mmWN: 7.0 mm	RB/WB: 3.8 mm & 4.5mmWB: 5.5 mm
Stock TitaniumBase Material	Titanium alloy(Ti-6Al-7Nb or TAN)	Titanium alloy(Ti-6Al-7Nb or TAN)	Titanium alloy	Titanium alloy(Ti-6Al-7Nb or TAN)	Titanium alloy(Ti-6Al-7Nb or TAN)	Titanium alloy(Ti-6Al-7Nb or TAN)
Construction	Two-piece abutmentbase with bondedprosthesis produced viathe Sirona DentalCAD/CAM System digitalworkflow.	Two-piece abutmentbase with bondedprosthesis produced viathe Sirona DentalCAD/CAM System digitalworkflow.	Two-piece abutmentbase with bondedprosthesis produced viathe Sirona DentalCAD/CAM System digitalworkflow.	Two-piece abutmentbase with bondedprosthesis produced viatraditional or CARESCAD/CAM digitalworkflow.	Two-piece abutmentbase with bondedprosthesis producedvia the SironaDental CAD/CAMSystem digitalworkflow.	Two-piece abutment base with bondedprosthesis produced via traditional orCARES CAD/CAM digital workflow.
MaximumAngulation	20° controlledin designsoftware	20° controlledin designsoftware	20° controlledin designsoftware	30°	20° controlled indesign software	30°
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCEDEVICE	REFERENCE DEVICE
K Number	K192742	K151324	K181520	K142890	K171773	K173961
Software	Sirona CEREC SoftwareVersion 4.6.1	Sirona inLab softwareVersion 3.65 or higherSirona CEREC SoftwareVersion 4.2 or higher	CEREC SW version4.6.1	N/A	Sirona inLabsoftware Version3.65Sirona CERECSoftware Version4.2	N/A
Sterility	Provided non-sterile -terminally sterilized viaautoclave prior toimplantation.	Provided non-sterile -terminally sterilized viaautoclave prior toimplantation.	Provided non-sterile -terminally sterilized viaautoclave prior toimplantation.	Provided non-sterile -terminally sterilized viaautoclave prior toimplantation.	Provided non-sterile- terminallysterilized viaautoclave prior toimplantation.	Provided non-sterile - terminallysterilized via autoclave prior toimplantation.

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Straumann® Variobase® C

510(k) Summary

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Straumann® Variobase® C

510(k) Summary

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Straumann® Variobase® C

510(k) Summary

Table 1 – Comparison of subject device versus primary predicate device – two-piece abutment

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Straumann® Variobase® C

510(k) Summary

Performance Testing 1.8

Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The fatigue testing protocols developed using ISO 14801:2016 demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices.

The subject device materials are identical in formulation and manufacturing process to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.

The sterilization process for the Straumann Variobase C as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015"and ISO 17665-1 and ISO 17665-2.

Conclusion 1.9

The documentation submitted in this premarket notification demonstrates the Straumann Variobase C are substantially equivalent to the primary predicate devices.

Regulation Number and Section

§ 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.)