The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants

Device Description

The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

. Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
. Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.

AI/ML Overview

Here's an analysis of the provided text regarding the CreoDent Solidex® Customized Abutment, focusing on acceptance criteria and study details:

Preamble:
This document describes a 510(k) premarket notification for a medical device, the CreoDent Solidex® Customized Abutment. As such, the purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel clinical efficacy or safety standards through extensive clinical trials. The "acceptance criteria" here refer to demonstrating that the new device performs comparably to the predicate device, particularly in terms of mechanical strength and compatibility, and is therefore deemed safe and effective for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" and "reported device performance" for this 510(k) submission is the demonstration of similar mechanical properties to predicate devices and compatibility with specific implant systems. The study cited is non-clinical static/fatigue testing in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the test results demonstrate comparable or superior performance to the predicate under the defined standard. The text doesn't provide numerical acceptance thresholds or specific performance metrics from the predicate devices with which to compare. Instead, it makes a qualitative statement that the device has "sufficient mechanical strength."

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical strength for intended clinical application (comparable to predicate device, as defined by ISO 14801:2007E).	"These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application."
Compatibility with specific Nobel Replace™ TiUnite Endosseous implant system (as defined by ISO 14801:2007E results).	"and are compatible with the Nobel Replace™ TiUnite Endosseous implant system for which they are intended."
Compatibility with specific Nobel Active™ Internal Connection implant system (as defined by ISO 14801:2007E results).	"These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Nobel Active™ Internal Connection implant system for which they are intended."
Compatibility with specific Zimmer Tapered Screw-Vent implant system (as defined by ISO 14801:2007E results).	"These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Zimmer Tapered Screw-Vent implant system for which they are intended."
Material composition (CP Ti Gr4 unalloyed titanium for abutment, Ti-6Al-4V Eli titanium alloy for screw) comparable to predicate.	Reported materials match the description in the predicate comparison tables (e.g., "Abutment: CP Ti Gr4 unalloyed titanium for surgical implants applications meets ASTM F67/Gr 04-06 Standard - Abutment Screw: Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard"). Predicates use "Comparable Titanium alloy."
Indications for Use, Performance Characteristics (cemented or screw-retained prosthesis, abutment screw secures abutment to implant), Dimensions, and Angulations comparable to predicate.	Detailed comparison tables explicitly state that the device's Indications for Use, Performance Characteristics, Dimensions, and Angulations are comparable or the same as the predicate devices.

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact number of units tested. ISO 14801 typically defines sample sizes (e.g., n=5 or n=10 per group). The phrase "worst case scenario for the Solidex® Customized Abutment connection platform" suggests that specific configurations were selected for testing. Without the full test report, the precise sample size is unknown.
- Data Provenance: Not explicitly stated, but as a premarket notification to the US FDA, the testing was likely conducted in an accredited lab, potentially within the US or a country with recognized testing standards. This would be a prospective set of tests designed specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable to the type of study performed. The study was a non-clinical mechanical engineering test (static/fatigue testing) following an international standard (ISO 14801:2007E). The "ground truth" is established by the standardized test methodology and objective measurements, not by expert consensus on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This was a non-clinical mechanical test with objective measurements guided by a standard.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in its primary function or assessment for this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this question is not applicable. This device is a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this non-clinical study is defined by the ISO 14801:2007E standard itself, which provides a scientifically validated methodology for dynamic fatigue testing of dental implants. The "truth" is the objective measurement of load cycles to failure, maximum force, stiffness, etc., as determined by the specified test method. It's an engineering ground truth, not a biological or clinical one based on consensus or pathology.
The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing for demonstrating substantial equivalence. The device design and manufacturing processes are established based on engineering principles and materials science, not machine learning or AI training.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set.

Summary

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KI13738

Premarket Notification Section 5: Page - 4

510(k) Summarv

CreoDent Prosthetics, Ltd. Solidex® Customized Abutment

SEP 17 2013

Submitter Information

Company Name: Company Address:

Company Telephone: Company Fax: Contact Person:

CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 July 27, 2012

Date Summary Prepared:

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Product Code: Classification Panel: Reviewing Branch:

CreoDent Solidex® Customized Abutment Endosseous Dental Implant Abutment. 21 CFR 872,3630 NHA Dental Products Panel Dental Devices Branch

INDICATIONS FOR USE

The CreoDent Solidex® Customized Abutment is compatible with the following:

Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants

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Premarket Notification Section 5: Page - 5

DEVICE DESCRIPTION

. Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
. Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and � 6.0mm diameter Implants (510K#013227)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.

EQUIVALENCE TO MARKETED DEVICE

The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:

. Nobel TDS Abutment for Nobel Biocare Replace and Abutment Screw 510K#091026
Nobel Procera Ti Abutment and Abutment Screw 510K#091756 .
Zimmer Patient-Specific Abutment, Internal Hex Titanium and Abutment Screw . 510K#071439

Conclusion:

The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in this 510K Summary.

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Premarket Notification Section 5: Page – 6

Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:

TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment ScrewK#113738	Predicate Device for claimedequivalence: Nobel TDS Abutmentfor Nobel Biocare Replace andAbutment Screw 510K#091026
Material	-Abutment: CP Ti Gr4 unalloyed titaniumfor surgical implants applications meetsASTM F67/Gr 04-06 Standard-Abutment Screw: Ti-6Al-4V Elititanium alloy meets ASTM F-136Standard	-Abutment: Comparable Titaniumalloy-Abutment Screw: ComparableTitanium alloy
PerformanceCharacteristics	Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.	Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant.
Indications forUse	The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Nobel Replace™ TiUnite Endosseous3.5mm, 4.3mm, and 5.0mm diameterImplants Nobel Active™ Internal Connection3.5mm and 4.3mm diameter Implants Zimmer Screw-Vent 3.7mm, 4.7mm;Zimmer Tapered Screw-Vent 3.7mm,4.7mm and 6.0mm diameter Implants	TDS Abutment for Nobel BiocareReplace is intended for use with dentalimplants as support for single ormultiple tooth prosthesis in themaxilla or mandible of a partially orfully edentulous patient.
DimensionsandAngulations	Abutment sizes for Nobel Replace™ TiUniteEndosseous 3.5mm (NP), 4.3mm (RP), and5.0mm (WP) diameter implants.	Abutment sizes for Nobel Replace ™TiUnite Endosseous 3.5mm (NP), 4.3mm(RP), and 5.0mm (WP) diameter implants.
	Angles not to exceed up to 20 degrees from	Angles not to exceed up to 20 degrees from

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the implant axis.			from the implant axis.
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Nobel Replace™ TiUnite Endosseous implant system for which they are intended. Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:						Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007EDentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario forthe Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex®customized Abutment have sufficient mechanical strength for their intended clinical application and arecompatible with the Nobel Active™ Internal Connection implant system for which they are intended.Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:
TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment ScrewK#113738	Predicate Device for claimedequivalence: Nobel Procera TiAbutment and Abutment Screw510K#091756	TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment ScrewK#113738	Predicate Device for claimedequivalence: Zimmer Patient-Specific Abutment, Internal HexTitanium and Abutment Screw510K#071439
Material	-Abutment: CP Ti Gr4 unalloyed titanium for surgical implantsapplications meets ASTM F67/Gr 04-06 Standard-Abutment Screw: Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard	-Abutment: Comparable Titanium alloy-Abutment Screw: Comparable Titanium alloy	Material	-Abutment: CP Ti Gr4 unalloyedtitanium for surgical implantsapplications meets ASTM F67/Gr04-06 Standard-Abutment Screw: Ti-6Al-4V Elititanium alloy meets ASTM F-136Standard	-Abutment: Comparable Titaniumalloy-Abutment Screw: ComparableTitanium alloy
PerformanceCharacteristics	Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant.	Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant.	PerformanceCharacteristics	Allows the prosthesis to becemented or screw retained to theabutment. The abutment screw isdesigned to secure the abutment tothe endosseous implant.	Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant.
Indications forUse	The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.The CreoDent Solidex® Customized Abutment is compatible with the following:Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants	The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.	Indications for Use	The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support aprosthetic device in patients who arepartially or completely edentulous. Thedevice can be used for single ormultiple-unit restorations. Theprosthesis can be cemented or screwretained to the abutment. An abutmentscrew is used to secure the abutmentto the endosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with thefollowing:• Nobel Replace™ TiUniteEndosseous 3.5mm, 4.3mm,and 5.0mm diameter Implants• Nobel Active™ InternalConnection 3.5mm and 4.3mmdiameter Implants• Zimmer Screw-Vent 3.7mm,4.7mm; Zimmer TaperedScrew-Vent 3.7mm, 4.7mm	The Zimmer® Patient-Specific Abutmentis used as a terminal or intermediateabutment for a cemented prosthesis. Theabutment can be used for a single ormultiple-unit restoration.
Dimensions andAngulations	Abutment sizes for Nobel Active™ Internal Connection 3.5mm (NP) and 4.3mm (RP) diameter implants.Angles not to exceed up to 20 degrees	Abutment sizes for Nobel Active™ Internal Connection 3.5mm (NP) and 4.3mm (RP) diameter implants.

. . . . . . . . .

・

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Angulations	Screw-Vent 3.7mm (NP), 4.7mm (RP) and 6.0mm diameter implants.Angles not to exceed up to 20 degrees from the implant axis.	3.7mm (NP), 4.7mm (RP) and 6.0mm diameter implants.Angles not to exceed up to 30 degrees from the implant axis.
-------------	--------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for thended clinical application and are compatible with the Zimmer Tapered Screw-Vent implant system for which they are intended.

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Table #4 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:

Compatible Device	Implant Diameters	Implant Lengths
Nobel ReplaceTM TiUnite	3.5mm	10.0mm
Endosseous Implant	3.5mm	13.0mm
510K#023113	3.5mm	16.0mm
Nobel ReplaceTM TiUnite	4.3mm	10.0mm
Endosseous Implant	4.3mm	13.0mm
510K#023113
Nobel ReplaceTM TiUnite	5.0mm	10.0mm
Endosseous Implant	5.0mm	13.0mm
510K#023113

Table #5 Legally marketed predicate device (Implant) to which compatibility for the Solidex® Customized Abutment:

Compatible Device	Implant Diameters	Implant Lengths
Nobel Active™ InternalConnection Implant510K#071370	3.5mm	10.0mm
Nobel Active™ InternalConnection Implant510K#071370	3.5mm	11.5mm
Nobel Active™ InternalConnection Implant510K#071370	3.5mm	13.0mm
Nobel Active™ InternalConnection Implant510K#071370	3.5mm	15.0mm
Nobel Active™ InternalConnection Implant510K#071370	4.3mm	10.0mm
Nobel Active™ InternalConnection Implant510K#071370	4.3mm	11.5mm
Nobel Active™ InternalConnection Implant510K#071370	4.3mm	13.0mm
Nobel Active™ InternalConnection Implant510K#071370	4.3mm	15.0mm

Table #6 Legally marketed predicate device (Implant) to which compatibility for the Solidex® Customized Abutment:

Compatible Device	Implant Diameters	Implant Lengths
Zimmer Screw-Vent , TaperedScrew-Vent Implant510K#013227	3.7mm	8.0mm – 16.0mm
Zimmer Screw-Vent , TaperedScrew-Vent Implant510K#013227	4.7mm	8.0mm – 16.0mm
Zimmer Tapered Screw-VentImplant 510K#013227	6.0mm	8.0mm – 16.0mm

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Image /page/7/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 1 7 2013

CreoDental Prosthetics, Limited Mr. Calvin Shim Managing Director 29 West 30th Street, 11th floor NEW YORK NY 10001

Re: K113738

Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 9, 2013 Received: September 11, 2013

Dear Mr. Shim:

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.

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Page 2 - Mr. Shim

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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KII3738

Premarket Notification Section 4: Page - 3

Indications for Use

510(k) Number (if known) K113738

Device Name: CreoDent Solidex® Customized Abutment

Indication for Use:

The CreoDent Solidex® Customized Abutment is compatible with the following:

Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants

Prescription Use X · (Part 21 CFR 801 Subpart D)

AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S f 2013.09.17 14:33:09 -0

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number:

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.)