ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:

IMPLANT BRANDNAME	PLATFORM	Manufacturer	Implant TradeName	ImplantLine/Connection	ImplantDiameter
Nobel Biocare ReplaceSelect	6.0mm	Nobel Biocare USA	Nobel ReplaceTaperedConicalConnection	Nobel ReplaceInternal ConicalConnection WP	6.0mm
Nobel Biocare Active	3.5mm	Nobel Biocare AB	NobelActiveInternalConnectionImplant	Nobel ActiveInternal Conn.RP and NP	3.0, 3.5, 4.3,5.0mm
Nobel Biocare Active	4.3/5.0mm	Nobel Biocare AB	NobelActiveInternalConnectionImplant	Nobel ActiveInternal Conn.RP and NP	3.0, 3.5, 4.3,5.0mm
Straumann Bone Level	3.3mm	Straumann USA	StraumannBone LevelTaperedImplants	Bone LevelInternal Conn.NC	3.3mm
Straumann Bone Level	4.1/4.8mm	Straumann USA	StraumannBone LevelTaperedImplants	Bone LevelInternal Conn.RC	4.1, 4.8mm
Straumann Synocta	4.8mm	Institut StraumannAG	StraumannDental Implant	Synocta ImplantInternal Conn.4.8mm RN (Reg.Neck)	4.8, 6.5mm
Straumann Synocta	6.5mm	Institut StraumannAG	StraumannDental Implant	Synocta ImplantInternal Conn.6.5mm (WideNeck)	4.8, 6.5mm
Astra Tech OsseoSpeed	3.5/4.0mm	Astra Tech AB	AstraTechImplantOsseoSpeed	OsseoSpeedInternal ConicalConnection RP	3.6, 4.2, 4.8mm
Astra Tech OsseoSpeed	4.5/5.0mm	Astra Tech AB	AstraTechImplantOsseoSpeedPlus	OsseoSpeed PlusInternal ConicalConnection RP	3.0, 3.5, 4.0, 4.5,5.0mm

Device Description

Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.

Minimum and Maximum Gingival Height is 0-6mm

Minimum diameter at abutment/implant interface is 3.5mm to interface base

Maximum length of abutment from abutment/implant interface is 12.5mm

Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.

Minimum wall thickness at abutment/implant interface is 0.65mm

Maximal angle in relationship to the long axis of implant is 30°

The available range of diameters and connection type is summarized on the table below:

AI/ML Overview

This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.

Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.

Feature	Acceptance Criteria (Implied / Predicate Comparison)	Reported Device Performance
Material	Predicate devices use Titanium-6AL-4 Vanadium ELI Alloy or CP Titanium.	ArgenIS Titanium Abutments use Titanium-6AL-4 Vanadium ELI Alloy. (Consistent with predicate K143051 and functionally equivalent to CP Titanium for this application).
Intended Use	Similar to predicate devices: construction of dental restorations supported by endosseous dental implants, single use, prescription only, designed to fit individual patient needs.	ArgenIS Titanium Abutments share the same intended use: single-use, prescription-only for dental restorations supported by endosseous dental implants, designed for individual patient needs. "Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device."
Prosthetic Connection	Compatibility with specific implant systems (Nobel Biocare, Straumann, Astra Tech) as listed for predicate devices and the new device.	ArgenIS Titanium Abutments are compatible with a range of Nobel Biocare, Straumann, and Astra Tech implant systems, similar to the scope covered by the various predicate devices.
Implant Diameters/Lengths	Within the range of existing predicate devices.	ArgenIS supports diameters 3.3mm, 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm, which are covered by the collective range of the predicate devices.
Type of Retention	Screw-retained to the implant; prosthesis cement-retained to the abutment, consistent with predicate devices.	ArgenIS Titanium Abutments are screw-retained to the implant, with the prosthesis cement-retained to the abutment. (Identical to all predicates shown).
Manufacturing Process	Machining, consistent with predicate devices.	ArgenIS Titanium Abutments are manufactured via machining. (Identical to all predicates shown).
Abutment Sterilization	Moist Heat (Steam), consistent with predicate devices.	ArgenIS Titanium Abutments use Moist Heat (Steam) for sterilization. (Identical to all predicates shown).
Abutment Angulation	Within the range of predicate devices (0°-30°).	ArgenIS Titanium Abutments have an angulation range of 0° - 30°. (Consistent with primary predicate K143051, and overlaps with/encompasses other predicates' ranges).
Dimensional Compatibility	Demonstrated through tolerance analysis and functional fit checks.	"Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance."
Mechanical Performance (Fatigue)	Conformance to ISO 14801 for worst-case scenarios (smallest diameter, shortest length from each platform). This implicitly means meeting at least the performance levels of predicate devices that would also conform to ISO 14801.	"Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801." (The document asserts conformance to performance specifications, implying successful completion of these tests in line with relevant standards and predicate performance).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.

3. 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)

Not applicable. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and standards.

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 device is a dental implant abutment, not an AI diagnostic tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

August 5, 2016

Argen Corporation % Ms. Maria Rao Regulatory Consultant Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703

Re: K160248

Trade/Device Name: ArgenIS Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 30, 2016 Received: July 1, 2016

Dear Ms. Rao:

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 - Ms. Maria Rao

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting 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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510(k) Number (if known):

Device Name: ArgenIS Titanium Abutments

Indications for Use:

IMPLANT BRANDNAME	PLATFORM	Manufacturer	Implant TradeName	ImplantLine/Connection	ImplantDiameter
Nobel Biocare ReplaceSelect	6.0mm	Nobel Biocare USA	Nobel ReplaceTaperedConicalConnection	Nobel ReplaceInternal ConicalConnection WP	6.0mm
Nobel Biocare Active	3.5mm	Nobel Biocare AB	NobelActiveInternalConnectionImplant	Nobel ActiveInternal Conn.RP and NP	3.0, 3.5, 4.3,5.0mm
Nobel Biocare Active	4.3/5.0mm	Nobel Biocare AB	NobelActiveInternalConnectionImplant	Nobel ActiveInternal Conn.RP and NP	3.0, 3.5, 4.3,5.0mm
Straumann Bone Level	3.3mm	Straumann USA	StraumannBone LevelTaperedImplants	Bone LevelInternal Conn.NC	3.3mm
Straumann Bone Level	4.1/4.8mm	Straumann USA	StraumannBone LevelTaperedImplants	Bone LevelInternal Conn.RC	4.1, 4.8mm
Straumann Synocta	4.8mm	Institut StraumannAG	StraumannDental Implant	Synocta ImplantInternal Conn.4.8mm RN (Reg.Neck)	4.8, 6.5mm
Straumann Synocta	6.5mm	Institut StraumannAG	StraumannDental Implant	Synocta ImplantInternal Conn.6.5mm (WideNeck)	4.8, 6.5mm
Astra Tech OsseoSpeed	3.5/4.0mm	Astra Tech AB	AstraTechImplantOsseoSpeed	OsseoSpeedInternal ConicalConnection RP	3.6, 4.2, 4.8mm
Astra Tech OsseoSpeed	4.5/5.0mm	Astra Tech AB	AstraTechImplantOsseoSpeedPlus	OsseoSpeed PlusInternal ConicalConnection RP	3.0, 3.5, 4.0, 4.5,5.0mm

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subparts D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

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510(k) Summary

1. Sponsor: The Argen Corporation 5855 Oberlin Drive San Diego, CA 92121
1. Contact: Paul Cascone Senior Vice-President of Research & Development Phone: 858-455-7900
1. Date: August 3, 2016
1. Trade Name: ArgenIS Titanium Abutments
1. Common Name: Implant Abutment
1. Classification Name: Endosseous Dental Implant Abutment
1. Classification: 872.3630, Class II
1. Product Code: NHA
1. Legally Marketed Device to which Equivalence is claimed (Predicate Devices):

9.1 Primary Predicate:

Trade Name: ArgenIS 510(k) Number: K143051 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment

9.2 Reference Device No. 2

Trade Name: Nobel Biocare Replace 510(k) Number: K022424 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form

9.3 Reference Device No. 3

Trade Name: Nobel Biocare Active 510(k) Number: K102436, K071370, K142260 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form

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9.4 Reference Device No. 4

Trade Name: Straumann Bone Level 510(k) Number: K083550, K121131 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form

9.5 Reference Device No. 5

Trade Name: Straumann Dental Implant System 510(k) Number: K033243 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form

9.6 Reference Device No. 6

Trade Name: Astra Tech Implants OsseoSpeed 510(k) Number: K024111 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Endosseous Dental Implant Abutment

10.0 Description of Device:

Argen IS Titanium Abutments are designed specifically for an Individual patient and then

milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.

Minimum and Maximum Gingival Height is 0-6mm

Minimum diameter at abutment/implant interface is 3.5mm to interface base

Maximum length of abutment from abutment/implant interface is 12.5mm

Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.

Minimum wall thickness at abutment/implant interface is 0.65mm

Maximal angle in relationship to the long axis of implant is 30°

The available range of diameters and connection type is summarized on the table below:

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11. Intended Use

The ArgenIS Titanium Abutments are compatible with the following implant systems:

IMPLANT BRAND NAME	PLATFORM	Manufacturer	Implant Trade Name	Implant Line/Connection	Implant Diameter
Nobel Biocare Replace Select	6.0mm	Nobel Biocare USA	Nobel Replace Tapered Conical Connection	Nobel Replace Internal Conical Connection WP	6.0mm
Nobel Biocare Active	3.5mm	Nobel Biocare AB	NobelActive Internal Connection Implant	Nobel Active Internal Connection RP and NP	3.0, 3.5, 4.3, 5.0mm
Nobel Biocare Active	4.3/5.0mm	Nobel Biocare AB	NobelActive Internal Connection Implant	Nobel Active Internal Connection RP and NP	3.0, 3.5, 4.3, 5.0mm
Straumann Bone Level	3.3mm	Straumann USA	Straumann Bone Level Tapered Implants	Bone Level Internal Connection NC	3.3mm
Straumann Bone Level	4.1/4.8mm	Straumann USA	Straumann Bone Level Tapered Implants	Bone Level Internal Connection RC	4.1, 4.8mm
Straumann Synocta	4.8mm	Institut Straumann AG	Straumann Dental Implant	Synocta Implant Internal Connection 4.8mm RN (Reg. Neck)	4.8, 6.5mm
Straumann Synocta	6.5mm	Institut Straumann AG	Straumann Dental Implant	Synocta Implant Internal Connection 6.5mm (Wide Neck)	4.8, 6.5mm
Astra Tech OsseoSpeed	3.5/4.0mm	Astra Tech U.S.A.	AstraTech Implant OsseoSpeed	OsseoSpeed Internal Conical Connection RP	3.5/4.0mm
Astra Tech OsseoSpeed	4.5/5.0mm	Astra Tech U.S.A.	AstraTech Implant System OsseoSpeed	OsseoSpeed Plus Internal Conical Connection RP	4.5/5.0mm

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12. Technological Characteristics

The Argen IS Titanium Abutments are substantially equivalent to the currentlmarketed predicate devices. The intended use, basic design, fundamental operating principles, materials, technology and processes are the same as other Sterngold dental devices previously cleared by FDA.

13. Substantial Equivalence

The Argen IS Titanium Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and materials are the same as the predicate devices. Compatibility and substantial equivalency was determined by comparing the design features including diameters, lengths, materials, implant-to-abutment connection platform and intended use of proposed devices to predicate devices. Indications for Use and abutment design parameters are the same or similar to the predicate devices. Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device. Any differences between the proposed devices and predicate devices do not render the device NSE. See Substantial Equivalence Comparison table below.

14. Performance Data

Bench testing was conducted to evaluate and determine conformance to performance specifications and functionality according to its intended use.

Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance. Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801.

The Argen IS Titanium Abutments have the same sterilization process and parameters, and biocompatibility as previous cleared Sterngold devices. As a result, they are substantial equivalent to its predicates. No changes were made that would affect the bio-compatibility and sterilization validation previously conducted.

Non-clinical test data was used to support the substantially equivalence claim. The non- clinical testing consisted of tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant mating checks. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

The summary of technological characteristics, tolerance analysis, and functional testing indicate that the device is substantially equivalent for its intended use and performs as well as the predicate devices.

15. Conclusion

Based on the above analysis, technological characteristics and performance testing, the Argen IS Titanium Abutments are substantially equivalent in intended use, material, design and performance to its predicate devices. The Argen IS Titanium Abutments do not create any new risks or increased risks compared to the predicate devices. The summary of technological characteristics and performance testing indicate that the device is substantially equivalent to its predicate devices.

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The Argen Corporation

Abbreviated 510(k) Premarket Notification

ArgenIS Titanium Abutment Blanks

Features	New Device	Primary Predicate	Reference 2	Reference 3	Reference 4	Reference 5	Reference 6
	ArgenIS Titanium AbutmentsThe Argen Corporation	Argen IS TitaniumAbutmentsK143051The Argen Corporation	Nobel Replace TaperedConical ConnectionNobel Biocare U.S.A.K022424	Nobel Active ImplantsNobel Biocare US.A.K102436, K071370,K142260	Straumann BoneLevelK083550, K121131Straumann USA	Synocta ImplantsK033243Straumann USA	Astra Tech ImplantsOsseoSpeedK024111Astra Tech
Material	Titanium-6AL-4 VanadiumELI Alloy	Titanium-6AL-4Vanadium ELI Alloy	CP Titanium	CP Titanium	CP Titanium	CP Titanium	CP Titanium
ProstheticConnection	Nobel Biocare Replace Select6.0mmNobel Biocare ActiveStraumann Bone Level,Straumann Synocta,Astra Tech OsseoSpeed	Nobel Biocare ReplaceSelectBiomet 3i CertainStraumann SynOctaZimmer Tapered Screw-Vent	Nobel Replace TaperedConical Abutments	Nobel Biocare Active	Straumann BoneLevel	Straumann SynOcta	Astra OsseoSpeed3.5/4.0mm and 4.5/5.0mm
Indications for Use	ArgenIS TitaniumAbutments are intendedto be single use availableby prescription only inthe construction of dentalrestorations supported bythe endosseuos dentalimplant. The ArgenIsTitanium abutments aredesigned to specificallyfit an individual patient'sneeds of final restoration.All digitally designedabutment files areintended to be sent toArgen manufacturer formilling.	ArgenIS patient specificabutments are intended tobe single use available byprescription only todental professionals(dental technicians andDentists) in theconstructions of dentalrestorations supported byendosseuos dentalimplants. The Argen ISAbutment is designed tospecifically fit anindividual pateints needsin order to more naturallysupport the tissue,esthetics, and functionsof the final restoration.	The Replace HA Coated Implantis both for single-stage or two-stage surgical procedures andcement or screw retainedrestorations. The Replace HACoated Implant is intended forimmediate placement andfunction on single tooth and/ormultiple tooth applications ingood quality bone (type I ortype II bone), to restorechewing function. Multipletooth applications may besplinted with a bar. .	Intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices,such as an artificialtooth, in order torestore patientesthetics and chewingfunction.	Intended for thetreatment of oralendostealimplantation in theupper and lower jawand for functionaland esthetic oralrehabilitation ofedentulous andpartially dentatepatients.	Abutments areintended to beplaced into dentalimplants to providesupport forprostheticreconstruction suchas crowns orbridges. The ITIsynOcta Measoabutments areindicated forcementedrestorations inesthetic areas of themouth. Theabutment can beused in single toothreplacements andmultiple toothrestorations.	Intended for endosseousimplantation in themandible and maxillasupporting single-toothreplacements, partial andtotal fixed/fixed detachablebridges and overdentures.One or two stage surgicalprocedure can be used.When using one stagesurgical protocol,immediate loading may beapplied in the anteriormandibular region if atleast four implants aresplinted with a bar, or acontinuous suprastructure.
Implant Diameters,Lengths	3.3mm , 3.5mm, 4.0mm,4.1mm, 4.3mm, 4.5mm,4.8mm, 6.0mm, 6.5mm	3.25mm - 6.0mm	Diameters 3.5mm, 4.3mm,5.0mm, 6.0mmLengths 10mm, 13mm, 16mm	Diameters 3.0mm,3.5mm, 4.3mm,5.0mmLengths: 10- 15mm	Diameters 3.3mm,4.1mm, 4.8mmLengths 8mm,10mm, 12mm, 14mm	Diameters 4.8mm,6.5mm	Diameters 3.5mm, 4.0mm,4.5 mm, 5.0mmLengths 8mm, - 19mm,
Type of Retention	Screw-retained to the implant.The prosthesis can be cement-retained to the abutment.	Screw-retained to theimplant. The prosthesiscan be cement-retained tothe abutment.	Screw-retained to the implant.The prosthesis can be cement-retained to the abutment.	Screw-retained to theimplant. Theprosthesis canbe cement-retained tothe abutment.	Screw-retained to theimplant. Theprosthesis canbe cement-retained tothe abutment.	Screw-retained tothe implant. Theprosthesis canbe cement-retainedto the abutment.	Screw-retained to theimplant. The prosthesis canbe cement-retained to theabutment.
ManufacturingProcess	Machining	Machining	Machining	Machining	Machining	Machining	Machining
AbutmentSterilization	Moist Heat (Steam)	Moist Heat (Steam)	Moist Heat (Steam)	Moist Heat (Steam)	Moist Heat (Steam)	Moist Heat (Steam)	Moist Heat (Steam)
AbutmentAngulation	0° - 30°	0° - 30°	0° - 30°	0° - 30°	0° - 25°	0° - 20°	0° - 20°

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.)