ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:

3i Internal Connection: D3.4, D4.1, D5, D6
Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
Zimmer Screw Vent: D3.5, D4.5, D5.7

Abutments:

3i Low Profile Abutment
ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
ASTRA TECH 20° and 45° UniAbutment
Astra Tech UniAbutment EV 3.6
Friadent XiVE MP D3.8, D4.5, D5.5
Friadent XiVE TG D3.8,D 4.5, D5.5
Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
Straumann Bone Level Angled Abutment: 4.0 mm
Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
Straumann RN (4.8 mm), WN (6.5 mm)
Zimmer Tapered Abutment: 4.5 mm

Device Description

ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of ATLANTIS™ ISUS is fabricated using computer-assisted manufacturing (CAM) to produce a custom patient specific device.

ATLANTIS™ ISUS is available in four design types: Bar, Bridge, Hybrid, and 2 in 1. It also features Angulated Screw Access (ASA) allowing the screw-channel opening to be angled up to 30° off the implant/abutment axis.

AI/ML Overview

The provided text describes a medical device called ATLANTIS™ ISUS, an implant suprastructure. The document is primarily a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a new device.

Therefore, the document does not contain the detailed acceptance criteria and a study specifically designed to prove the device meets those criteria in the way one would for a new AI/software device. The information provided is for a physical medical device (dental implant suprastructure).

However, I can extract the information related to the device's "performance" characteristics and the testing performed to demonstrate its safety and effectiveness, which serves a similar purpose to acceptance criteria and performance data for this type of device.

Here's an interpretation based on the provided text, structured to align with your request for acceptance criteria and study information, noting the differences due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are not framed as statistical thresholds for an AI algorithm's output, but rather as meeting specific physical and mechanical performance standards comparable to legally marketed predicate devices. The "reported device performance" refers to the results of non-clinical bench testing.

Acceptance Criterion (Implicit)	Reported Device Performance (as demonstrated by non-clinical testing)
Mechanical Strength (Fatigue Performance): The ATLANTIS™ ISUS implant suprastructures must withstand dynamic loading conditions without failure, comparable to predicate devices and suitable for their intended use.	Non-Clinical Performance Data: Static and dynamic compression-bending testing was conducted according to ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants (2007). Result: "Results of the fatigue testing support substantial equivalence in fatigue performance."
Screw Torque Reliability (Angulated Screw Access): For designs incorporating Angulated Screw Access (ASA), the system must allow for sufficient and reliable application of torque to the prosthetic screws.	Non-Clinical Performance Data: Torque testing was performed for situations with angulated screw access. Result: "Screw torque testing shows that sufficient torque can be applied in situations with angulated screw access."
Biocompatibility: The materials used in ATLANTIS™ ISUS must be biocompatible and safe for long-term contact with human tissue.	Biocompatibility Testing: "The results of biocompatibility testing conducted for the predicate device, ISUS Implant Suprastructures (K122424) are valid, therefore, no additional biocompatibility testing has been performed." (This indicates reliance on predicate device's proven biocompatibility).
Material Composition Equivalence: The materials selected for the suprastructure and screws must be equivalent or similar to those of predicate devices, with established safety profiles for dental implants.	Material Specification: Suprastructure: Titanium, Cobalt Chromium (equivalent to predicate devices). Screw: Titanium alloy (equivalent to predicate devices).
Design and Manufacturing Process Equivalence: The device's design principles and manufacturing process (CAD/CAM) must be consistent with established methods for dental implant suprastructures, particularly those of the predicate devices.	Description of Device: "ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments... The design... is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD)... fabricated using computer-assisted manufacturing (CAM)." Technological Characteristics: "Fabricated using computer-assisted design (CAD)... Milled using computer-assisted manufacturing (CAM)... Fabricated from homogenous, single-block raw material (CPTi or CoCr alloy)."
Dimensional Compatibility: The device must be compatible with the specified implant and abutment systems, including platform diameters and connection types.	Specification: Platform Diameter: 3.0 - 6.5 mm. Connection: Internal. (These specifications are compared in Table 6.1 to predicate devices, showing substantial equivalence or justified differences.)

The following points refer to your specific questions, which are more tailored to AI/software validation studies. Given that this is a physical medical device submission (dental implant suprastructure), some of these questions are not directly applicable or the information is not present in the document.

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

Sample Size: Not explicitly stated for the non-clinical tests (e.g., how many units were fatigue tested). It refers to "testing" in general.
Data Provenance: Not applicable for non-clinical bench testing of physical devices. The testing was conducted as part of the submission package for FDA clearance.

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. "Ground truth" in this context would implicitly be the established engineering standards (like ISO 14801) and accepted dental restoration principles, not expert consensus on image interpretation or diagnosis.

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

Not applicable for non-clinical bench testing. Performance is measured against physical specifications and standard test methods.

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

No. This is a physical dental implant suprastructure, not an AI/software device involving human readers.

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

The performance assessment described is "standalone" in the sense that it's the physical device alone being subjected to tests. However, it's not an algorithm.

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

For the non-clinical tests, the "ground truth" is based on:
- International Standards: ISO 14801 (for dynamic fatigue testing).
- Engineering Principles/Specifications: Performance against specified torque requirements, material properties, and dimensional compatibility.
- Equivalence to Predicate Devices: The ultimate "truth" for 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device is manufactured using CAD/CAM based on patient dental models and clinician prescriptions. There is no explicit "training set" in the machine learning sense. The "design" is based on established engineering principles and dental prosthetics knowledge, and the "manufacturing" is automated.

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

Not applicable. There is no "training set" in the AI sense. The design process (CAD) uses patient-specific data to create a custom device according to pre-defined parameters and dental restoration best practices, rather than learning from a dataset.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The emblem is simple and modern in design.

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

February 19, 2016

Dentsply International, Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60 York, Pennsylvania 17401

Re: K151439

Trade/Device Name: Atlantis™ ISUS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2016 Received: January 21, 2016

Dear Ms. Lewis:

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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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 -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4. INDICATIONS FOR USE STATEMENT

K151439 510(k) Number:

ATLANTISTM ISUS Device Name:

ATLANTISTM ISUS:

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:

3i Internal Connection: D3.4, D4.1, D5, D6 ●
Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5 ●
. Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm) ●
. Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
Zimmer Screw Vent: D3.5, D4.5, D5.7

Abutments:

3i Low Profile Abutment ●
ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 ●
ASTRA TECH 20° and 45° UniAbutment
Astra Tech UniAbutment EV 3.6 ●
. Friadent XiVE MP D3.8, D4.5, D5.5
Friadent XiVE TG D3.8,D 4.5, D5.5 ●
. Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
Straumann Bone Level Angled Abutment: 4.0 mm ●
Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
Straumann RN (4.8 mm), WN (6.5 mm) ●
. Zimmer Tapered Abutment: 4.5 mm

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)

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Image /page/3/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, creating a solid block of text.

510(k) SUMMARY for ATLANTISTM ISUS

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com

Submitter Information: 1.

DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60W York, PA 17401

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: 28 May 2015

1. Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Section: .
- Device Class: .
- . Product Code:

ATLANTISTM ISUS Endosseous dental implant abutment 21 CFR 872.3630 Class II NHA

3. Predicate Devices:

The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices. The primary predicate device is K122424.

Predicate Device Name	510(k)	Company Name
ISUS Implant Suprastructures(Primary Predicate Device)	K122424	DENTSPLY International Inc.
Procera Implant BridgeOverdenture	K090069	Nobel Biocare USA, LLC
ANKYLOS SynConeAbutment 5°	K131644	DENTSPLY International Inc.
NobelProcera Angulated ScrewChannel Abutment Replace	K133377	Nobel Biocare USA, LLC

4. Description of Device:

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ATLANTISTM ISUS is available in four design types.

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
1. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
1. Hybrid Intended as a fixed denture framework.
1. 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screw-retained connection.

Angulated Screw Access (Screws):

The purpose of Angulated Screw Access (ASA) is to place the position of the screw-channel opening in a non-visual area by changing the angulation of the screw-channel. ASA allows the prosthetic screw access channel to be angled up to 30° off the implant/abutment axis for optimal esthetics and function. ASA screws have a hexalobular driving feature in the screw head allowing the hexalobular screwdriver to engage the screw head at a 30° angle. ASA screws are available for all compatible implant systems. (See Indications for Use Statement for compatible implant systems.)

5. Indications for Use:

ATLANTISTM ISUS:

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:

3i Internal Connection: D3.4, D4.1, D5, D6 ●
Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select ● 6.0mm
Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm) ●
. Zimmer Screw Vent: D3.5, D4.5, D5.7

Abutments:

3i Low Profile Abutment ●
ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
ASTRA TECH 20° and 45° UniAbutment
Astra Tech UniAbutment EV 3.6 ●
Friadent XiVE MP D3.8. D4.5, D5.5
Friadent XiVE TG D3.8,D 4.5, D5.5
Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
. Straumann Bone Level Angled Abutment: 4.0 mm
Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
Straumann RN (4.8 mm), WN (6.5 mm)
Zimmer Tapered Abutment: 4.5 mm ●

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6. Substantial Equivalence:

Technological Characteristics.

ATLANTIS™ ISUS is a custom restorative device with the following technological characteristics equivalent to the predicate devices:

Fabricated using computer-assisted design (CAD) according to the clinician's prescription. .
Milled using computer-assisted manufacturing (CAM). .
Fabricated from homogenous, single-block raw material (CPTi or CoCr alloy). .

Table 6.1 below describes the differences and similarities of the subject and predicate devices.

Table 6.1
	Subject Device	Predicate Devices
	DENTSPLYInternational Inc.	DENTSPLYInternational Inc.	Nobel Biocare USA,LLC	DENTSPLYInternational Inc.	Nobel Biocare USA,LLC
	Atlantis™ ISUS	ISUS ImplantSuprastructures	Procera Implant BridgeOverdenture	ANKYLOS SynConeAbutment 5°	NobelProceraAngulated ScrewChannel AbutmentReplace
		K122424	K090069	K131644	K133377
Indicationsfor Use	ATLANTIS™ ISUSimplantsuprastructures areindicated forattachment to dentalimplants orabutments in thetreatment of partiallyor totally edentulousjaws for the purposeof restoring chewingfunction.	The ISUS ImplantSuprastructures areindicated forattachment to dentalimplants or abutmentsin the treatment ofpartially or totallyedentulous jaws forthe purpose ofrestoring chewingfunction. The ISUSImplantSuprastructures areintended for	The Procera ImplantBridge Overdenture isindicated for use as anoverdenture bar thatattaches to implants orabutments in thetreatment of partially ortotally edentulous jawsfor the purpose ofrestoring chewingfunction.	Anchorage of denturesretained by taperfriction and supportedby ANKYLOSimplants.Immediate loading ofan implant supportedprosthesis in anedentulous mandiblesupported by 4ANKYLOS implants ofat least 11mm in lengthand placed	The NobelProceraAngulated ScrewChannel AbutmentReplace arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation.
Table 6.1
	Subject Device		Predicate Devices
	DENTSPLYInternational Inc.	DENTSPLYInternational Inc.	Nobel Biocare USA,LLC	DENTSPLYInternational Inc.	Nobel Biocare USA,LLC
	Atlantis™ ISUS	ISUS ImplantSuprastructuresK122424	Procera Implant BridgeOverdentureK090069	ANKYLOS SynConeAbutment 5°K131644	NobelProceraAngulated ScrewChannel AbutmentReplaceK133377
	implantsuprastructures areintended forattachment to aminimum of two (2)implants and areindicated forcompatibility with thefollowing implantand abutmentsystems:Implants:• 3i InternalConnection: D3.4,D4.1, D5, D6• Friadent XiVE S:D3.0, D3.4, D3.8,D4.5, D5.5• Nobel BiocareActive Internal: NP(3.5mm), RP(4.3mm, 5.0mm)• Nobel Biocare	attachment to aminimum of two (2)implants.ISUS ImplantSuprastructures areindicated forcompatibility with thefollowing implant andabutment systems:Implants:• Nobel BiocareReplace Select: NP(3.5mm), RP(4.3mm), WP(5.0mm), andReplace Select6.0mm• Nobel BiocareActive Internal: NP(3.5mm), RP(4.3mm, 5.0mm)• Zimmer Screw Vent:		interforaminally.
Table 6.1
	Subject Device		Predicate Devices
	DENTSPLYInternational Inc.Atlantis™ ISUS	DENTSPLYInternational Inc.ISUS ImplantSuprastructuresK122424	Nobel Biocare USA,LLCProcera Implant BridgeOverdentureK090069	DENTSPLYInternational Inc.ANKYLOS SynConeAbutment 5°K131644	Nobel Biocare USA,LLCNobelProceraAngulated ScrewChannel AbutmentReplaceK133377
	Replace Select: NP(3.5mm), RP(4.3mm), WP(5.0mm) andReplace Select 6.0 mm• Straumann BoneLevel: NC (3.3mm), RC(4.1mm, 4.8mm)• Straumann NN(3.5mm), RN(4.8mm), WN(6.0mm)• Zimmer ScrewVent: D3.5, D4.5,D5.7Abutments:• 3i Low ProfileAbutment• ANKYLOS BalanceBase Abutment D5.5and Narrow	1D3.5, D4.5, D5.7• Straumann: NN(3.5mm), RN(4.8mm), WN(6.0mm)• Straumann BoneLevel: NC (3.3mm),RC (4.1 mm,4.8mm)• 3i InternalConnection: D3.4,D4.1, D5, D6• Friadent XiVE S:D3, D3.4, D3.8,D4.5, D5.5Abutments:• Astra Tech- 20° and45° UniAbutment• Astra TechUniAbutmnent EV:3.6• ANKYLOS BalanceBase Abutment D5.5
Table 6.1
Subject Device		Predicate Devices
DENTSPLY	DENTSPLY	Nobel Biocare USA,	DENTSPLY	Nobel Biocare USA,
International Inc.	International Inc.	LLC	International Inc.	LLC
Atlantis™ ISUS	ISUS ImplantSuprastructures	Procera Implant BridgeOverdenture	ANKYLOS SynConeAbutment 5°	NobelProceraAngulated ScrewChannel Abutment
	K122424	K090069	K131644	ReplaceK133377
Abutment D4.2ASTRA TECH 20°and 45°UniAbutment• Astra TechUniAbutment EV 3.6· Friadent XiVE MPD3.8, D4.5, D5.5• Friadent XiVE TGD3.8,D 4.5, D5.5· Nobel Biocare Multi-Unit Abutment RP:4.0 mmStraumann BoneLevel AngledAbutment: 4.0 mmStraumann BoneLevel: Multi-BaseAbutment D3.5.D4.5Straumann RN (4.8mm), WN (6.5 mm)Zimmer TaperedAbutment: 4.5 mm	and NarrowAbutment D4.2• Nobel Biocare Multi-Unit Abutment RP:4.0 mm• Zimmer TaperedAbutment: 4.5mm• StraumannRN(4.8mm), WN(6.5 mm)• Straumann BoneLevel: Multi-BaseAbutment D3.5,D4.5• Straumann BoneLevel AngledAbutment:4.0 mm• 3i Low ProfileAbutment• Friadent XiVE MPD3.8, D4.5, D5.5• Friadent XiVE TGD3.8, D4.5, D5.5

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Table 6.1
	Subject Device	Predicate Devices
	DENTSPLYInternational Inc.Atlantis™ ISUS	DENTSPLYInternational Inc.ISUS ImplantSuprastructuresK122424	Nobel Biocare USA, LLCProcera Implant BridgeOverdentureK090069	DENTSPLYInternational Inc.ANKYLOS SynConeAbutment 5°K131644	Nobel Biocare USA, LLCNobelProceraAngulated ScrewChannel AbutmentReplaceK133377
Design
ProsthesisAttachment	Screw-retained,Friction-fit	Screw-retained	Screw-retained	Friction-Fit	Screw-retained
Restoration	Multi-unit	Multi-unit	Multi-unit	Multi-unit	Single, Multi-unit
PlatformDiameter	3.0 - 6.5	3.0 - 6.5	3.3 - 6.5	4.0	3.5-5.0
AbutmentAngle	Straight,up to 30°	Straight,up to 30°	Straight	Straight,up to 30°	Straight,up to 59°
ScrewAccessAngle	Straight,up to 30°	Straight	Straight	Straight	Straight,up to 30°
Connection	Internal	Internal	Internal	Internal	Internal
Material
Supra-structure	Titanium, CobaltChromium	Titanium, CobaltChromium	Titanium alloy, CobaltChromium	Gold alloy(counterpart)	Titanium alloy
Screw	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy
Table 6.1		Predicate Devices
	Subject Device
	DENTSPLYInternational Inc.Atlantis™ ISUS	DENTSPLYInternational Inc.ISUS ImplantSuprastructuresK122424	Nobel Biocare USA,LLCProcera Implant BridgeOverdentureK090069	DENTSPLYInternational Inc.ANKYLOS SynConeAbutment 5°K131644	Nobel Biocare USA,LLCNobelProceraAngulated ScrewChannel AbutmentReplaceK133377
Reason foradding thepredicatedevice	Subject Device	Primary PredicateDevice	In this referencepredicate device the 20mm cantilever wasintroduced. In theSubject Device thecantilever is 15 mm.	In this referencepredicate device theconical connection wasintroduced and it is apredicate for theFriction-Fit concept forthe 2in1 productdescribed in the SubjectDevice.	In this referencepredicate device theAngulated ScrewAccess wasintroduced and it is apredicate for thatfeature in the SubjectDevice.

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Biocompatibility

The results of biocompatibility testing conducted for the predicate device, ISUS Implant Suprastructures (K122424) are valid, therefore, no additional biocompatibility testing has been performed.

Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included static and dynamic compression-bending testing according to ISO 14801 Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants (2007) and torque testing. This includes testing of the 2in1 design. Results of the fatigue testing support substantial equivalence in fatigue performance. Screw torque testing shows that sufficient torque can be applied in situations with angulated screw access.

No clinical performance data were submitted.

Conclusion Regarding Substantial Equivalence

The data included in this submission demonstrate substantial equivalence to the predicate devices, ISUS Implant Suprastructures (K122424), Procera Implant Bridge Overdenture (K090069), ANKYLOS SynCone Abutment 5 (K131644) and NobelProcera Angulated Screw Channel Abutment Replace (K133377) listed above. The proposed device has the same intended use, is composed of the same or similar materials, and is characterized by the same fundamental product technology as the predicate devices, K122424, K090069, K131644 and K133377. Any differences in the technological characteristics between the subject and predicate devices do not raise different issues of safety or effectiveness.

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.)