MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two- piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Tibase abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.

MIS Ti-base abutments are intended for use with the following MIS implants:

C1 conical connection implant system
V3 conical connection implant system
SEVEN internal hex implant system
M4 internal hex implant system
Lance+ internal hex implant system

Device Description

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.

The top-half custom ceramic coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block, IPS e.max® CAD ceramic block, or from IPS e.max® CAD ceramic block or VITA ENAMIC® (IS) ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm for inCoris ZI and e.max materials and 0.8mm for VITA ENAMIC material.

It is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject, pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

AI/ML Overview

This document describes a 510(k) premarket notification for the MIS Ti-base abutment. This is an FDA submission for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and similar technological characteristics. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrating this substantial equivalence through non-clinical performance data, rather than a clinical trial with specific performance metrics like sensitivity or specificity for an AI algorithm.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (dental abutment) and not an AI algorithm, the "acceptance criteria" are related to demonstrating that the device performs as safely and effectively as a legally marketed predicate device. The performance is assessed through non-clinical testing against established standards.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Non-clinical Testing)
Biocompatibility	The subject device is manufactured using identical methods, facility, and raw material as the predicate (K191152). Patient contact duration and type are the same. IPS e.max® and VITA ENAMIC® (IS) mesostructure materials are cleared under K191382 and K153645 respectively, and no modifications to these materials are included. No new biocompatibility testing was required.
Fatigue Testing (Mechanical Performance)	Withstand 2,000,000 cycles without failure at a substantially equivalent load to the cited predicates, as per ISO 14801:2016. Worst-case abutments (narrowest, 20° mesostructure, various materials) were tested.
Sterilization Testing	Validated steam sterilization parameters (gravity displacement and pre-vacuum) for inCoris ZI mesostructure according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009. For IPS e.max and VITA ENAMIC (IS) mesostructures, recommended parameters are based on predicate clearances K191382 and K153645.
Software Verification and Validation (CAD/CAM Integration)	Software verification and validation testing for the abutment design library demonstrated that restrictions prevent design of the mesostructure component outside of design limitations. The encrypted design library was validated to ensure established limitations are locked and cannot be modified. (For CEREC SW version 4.6.1).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a "test set" in the context of clinical data for AI. For the non-clinical fatigue testing, "worst case abutments" were chosen. The exact number of samples tested for each worst-case configuration (e.g., number of narrowest abutments, number of specific mesostructures) is not explicitly stated but implied to be sufficient for ISO 14801:2016 compliance.
Data Provenance: Not applicable in the context of clinical or retrospective data for an AI algorithm. The performance data comes from laboratory non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is a non-clinical device submission for a physical component, not an AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable for a non-clinical device submission.

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 diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical dental abutment. The software mentioned (CEREC SW version 4.6.1) is for design and milling, not a standalone AI diagnostic algorithm.

7. The Type of Ground Truth Used

For fatigue testing, the "ground truth" is defined by the mechanical strength and durability requirements of the ISO 14801:2016 standard, ensuring the device can withstand chewing forces.
For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and prior clearances of materials used.
For sterilization, the "ground truth" is effective sterilization as demonstrated by ANSI/AAMI/ISO 17665 standards.
For software verification, the "ground truth" is the established design limitations and the software's ability to enforce them.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set. The software mentioned (CEREC SW) is a CAD/CAM design software, not a machine learning model developed with a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no training set for an AI algorithm.

Summary

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July 28, 2021

Dentsply Sirona Rebecca Sporer Regulatory Affairs Specialist 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K211225

Trade/Device Name: MIS Ti-base abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 28, 2021 Received: June 30, 2021

Dear Rebecca Sporer:

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.

for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name MIS Ti-base abutment

Indications for Use (Describe)

MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cementretained or screw retained single or multiple-unt restorations. It is used with a digitally designed mesostructure. MIS Tibase and the mesostructure make up a two- piece abutment used in conjunction with MIS dental in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandbular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.

MIS Ti-base abutments are intended for use with the following MIS implants:

· C1 conical connection implant system
· V3 conical connection implant system
SEVEN internal hex implant system
M4 internal hex implant system
Lance+ internal hex implant system

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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

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510(k) SUMMARY for MIS Ti-base abutment (K211225)

1. Submitter:

Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person:	Rebecca Sporer
Telephone Number:	717-849-4793
Fax Number:	717-849-4343
Email:	rebecca.sporer@dentsplysirona.com

Date Prepared: June 28, 2021

2. Device Name:

Trade/Proprietary Name: MIS Ti-base abutment ●
. Common/Usual Name: Dental abutment
Classification Name: Endosseous dental implant abutment
Regulation Number: 872.3630
. Product Code: NHA
Device Class: Class II
. Classification Panel: Dental Devices Panel

3. Predicate Device(s):

Primary predicate device:

. MIS Ti-base abutment cleared under K191152. Reference devices:
- IPS e.max® CAD Abutment Solutions clearedunder K191382
- . VITA ENAMIC® Implant Solutions (IS) cleared underK153645
- Multilink Hybrid Abutment Cement cleared under K130436
- . Sirona Dental CAD/CAM System cleared under K181520

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4. Device Description:

MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.

lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

5. Indications for Use:

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

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MIS Ti-base abutments are intended for use with the following MIS implants:

C1 conical connection implant system
. V3 conical connection implant system
SEVEN internal hex implant system
M4 internal hex implant system
. Lance+ internal hex implant system

6. Substantial Equivalence Discussion:

The subject MIS Ti-base abutments have the same intended use as the predicate MIS Ti-base abutments cleared under K191152. They are intended for use in partially or fully edentulous mandibles in support of single or multiple-unit cement retained restorations, in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity.

The difference between the subject and predicate Ti-base is the material from which the CAD/CAM mesostructure is to be fabricated. The predicate MIS Ti-base abutments are indicated for use with an inCoris mesostructure designed and milled with Sirona Dental CAD/CAM System, while the subject MIS Ti-base abutments are indicated for use with an IPS e.max CAD or VIRA ENAMIC (IS) mesostructure. Both subject and predicate MIS Ti-base abutments are indicated for use with the same MIS dental implants.

The principal of operation of the predicate and subject MIS Ti-base abutments is the digitally designed mesostructure is cemented to the Ti-base to make up a two-piece abutment. This two-piece abutment is attached to the implant by a prosthetic screw.

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Table 1 – Comparison of MIS Ti-base abutment Characteristics

Trade Name	MIS Ti-base abutments	MIS Ti-base abutments
510(k) Number	Subject	K191152
Manufacturer	MIS Implants Technologies Ltd.	MIS Implants Technologies Ltd.
Device Class	Class II	Class II
Product Code(s)	NHA	NHA
RegulationDescription	Endosseous dental implant abutment	Endosseous dental implant abutment
Regulation Number	872.3630	872.3630
Indications for use:	MIS Ti-base abutment is a titanium base placed onto MIS dentalimplants to provide support for customized cement-retained orscrew retained single or multiple-unit restorations.It is used with a digitally designed mesostructure. MIS Ti-base andthe mesostructure make up a two-piece abutment used inconjunction with MIS dental implants, to be placed in the upper orlower jaw arches, in order to restore masticatory function.Narrow platform Ti-bases are indicated for use only in themandibular central, lateral incisor and maxillary lateral incisorregions of partially edentulous jaws.MIS short implants are to be used only with straight abutments.Mesostructures for use with the MIS Ti-base abutment are to bemade from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC®(IS), designed and manufactured using Sirona CEREC SW version4.6.1 Software.MIS Ti-base abutments are intended for use with the following MISimplants:C1 conical connection implant system, V3 conical connectionimplant system, SEVEN internal hex implant system, M4 internalhex implant system and Lance+ internal hex implant system.	MIS Ti-base abutment is a titanium base placed onto MISdentalimplants to provide support for customized cement-retained orscrew retained single or multiple-unit restorations.It is used with a digitally designed mesostructure. MIS Ti-base andthe mesostructure make up a two-piece abutment used inconjunction with MIS dental implants, to be placed in the upper orlower jaw arches, in order to restore masticatory function.Narrow platform Ti-bases are indicated for use only in themandibular central, lateral incisor and maxillary lateral incisorregions of partially edentulous jaws.MIS short implants are to be used only with straight abutments.Mesostructures for use with the MIS Ti-base abutment are to bemade from inCoris ZI, designed and manufactured using SironaCEREC SW version 4.6.1 Software.MIS Ti-base abutments are intended for use with the following MISimplants:C1 conical connection implant system, V3 conical connectionimplant system, SEVEN internal hex implant system, M4 internalhex implant system and Lance+ internal hex implant system.
Ti-base Material	Abutment and Abutment screw Ti 6Al 4V ELI per ASTM	Abutment and Abutment screw Ti-6Al-4V per ASTM F136
Implant toabutmentConnection	Conical connection Internal hex connection	Conical connection Internal hex connection
Restoration	Single-unit Multiple-unit	Single-unit Multiple-unit
Trade Name	MIS Ti-base abutments	MIS Ti-base abutments
ProsthesisAttachment	Cement-retainedScrew-retained●	Cement-retainedScrew-retained●
Platforms	NP 3.3●SP 3.75, 3.9, 4.2, 4.3, 5.0●WP 5.0, 6.0●	NP 3.3●SP 3.75, 3.9, 4.2, 4.3, 5.0●WP 5.0, 6.0●
Gingiva Height	NP: 0.5, 1.5 mm●SP: 0.5, 1.5, 3.0 mm●WP: 0.5, 1.5, 3.0 mm●	NP: 0.5, 1.5 mm●SP: 0.5, 1.5, 3.0 mm●WP: 0.5, 1.5, 3.0 mm●
Post Height	Minimum 4.0 mm	Minimum 4.0 mm
Compatibleimplant system	MIS C1 Conical Connection●MIS V3 Conical Connection●MIS SEVEN Internal Hex●MIS M4 Internal Hex●MIS Lance+ Internal Hex●	MIS C1 Conical Connection●MIS V3 Conical Connection●MIS SEVEN Internal Hex●MIS M4 Internal Hex●MIS Lance+ Internal Hex●
Compatibleimplant diameter(mm)	NP:●C1/V3/ SEVEN/M4/Lance+: 3.3SP:●C1/ SEVEN/M4/Lance+: 3.75, 4.2V3: 3.9, 4.3, 5.0WP:●C1: 5.0SEVEN/M4/Lance+: 5.0, 6.0	NP:●C1/V3/ SEVEN/M4/Lance+: 3.3SP:●C1/ SEVEN/M4/Lance+: 3.75, 4.2V3: 3.9, 4.3, 5.0WP:●C1: 5.0SEVEN/M4/Lance+: 5.0, 6.0
Finished CAD/CAMAbutmentAngulation	0° - 20°	0° - 20°
Two-pieceAbutmentMesostructureMaterial	inCoris ZI●IPS e.max●VITA ENAMIC (IS)●	InCoris ZI zirconium oxide
SterilizationMethod	Product provided non-sterile	Product provided non-sterile
Sterilization byend user	Moist steam sterilization	Moist steam sterilization

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7. Non-Clinical Performance Data:

As part of demonstrating the substantial equivalence of MIS Ti-base abutments to the predicate device (K191152) listed in this 510(k) submission, MIS Implants Technologies completed a number of non-clinical performance tests:

. Biocompatibility - The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared predicate device, K191152. The subject device has the same patient contact duration and type as the identified predicate device. For these reasons, biocompatibility testing was not required to support substantial equivalence of the subject device. Consideration of biocompatibility requirements was made with reference to Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
. Biocompatibility (two-piece abutments mesostructure) – The final two-piece CAD/CAM abutments which are constructed utilizing the subject MIS Ti-base components are completed with CAM milled mesostructures composed of the IPS e.max or VITA ENAMIC (IS) material. The IPS e.max material is cleared under K191382 the VITA ENAMIC (IS) material is cleared under K153645. No modifications to the materials are included in this premarket notification. Therefore, no new biocompatibility data relating to the IPS e.max or VITA ENAMIC (IS) material was included in this submission in support of substantial equivalence.
. Fatigue Testing - Mechanical testing of MIS Ti-base abutments in accordance to ISO 14801:2016 was conducted. The worst case abutments chosen for the tests were the narrowest abutments from both narrow and standard platforms, with a 20° mesostructure which is the maximum angulation possible in the Sirona Dental CAD/CAM System. Both IPS e.max and VITA ENAMIC (IS) mesostructures were tested. The test articles were able to withstand 2,000,000 cycles without failure at a substantially equivalent load to the cited predicates. The fatigue test conducted on the standard platform worst case abutment supports the wide platform abutments as the SP is a worst case in terms of diameter and wall thickness, and both SP and WP abutments are made of the same material. The results of fatigue testing support substantialequivalence. Fatigue testing was conducted with reference to the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
. Sterilization Testing - MIS Ti-base abutments are supplied non-sterile and intended to be steam sterilized by the user.
- O For inCoris ZI mesostructure: the steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665- 1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization validation of the recommended sterilization process for the subject devices was conducted with reference to Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

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For IPS e.max and VITA ENAMIC (IS) mesostructures: the recommended steam sterilization o parameters are according to the parameters that were validated in the predicate K191382 and K153645 respectively.
Reverse engineering analysis was not conducted in support of substantial equivalence due to the fact that the subject MIS Ti-base Abutments are proposed for compatibility only with MIS dental implant systems. Dentsply Sirona is the sponsor/applicant of this premarket notification as the Owner/Operator of MIS Implants Technologies, Ltd.
. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the "chairside" CAD/CAM software, CEREC SW version 4.6.1. Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations are locked and cannot be modified within the abutment design library.

8. Clinical Performance Data:

There was no human clinical data included in support of substantial equivalence. The non-clinical testing detailed in this submission support the substantial equivalence of the device.

9. Summary:

The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials are the same. The results of non- clinical performance testing support a conclusion that the subject device is at least equivalent to the predicate devices with respect to dynamic fatigue performance.

10. Conclusion Regarding Substantial Equivalence:

The subject MIS Ti-base abutments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate (K191152). Test data to verify the performance of MIS Ti- base abutments has been provided including: dynamic fatigue and sterilization validation and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.

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.)