The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.

The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS™ Crown Abutment to the endosseous implant.

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

Device Description

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATLANTIS™ Abutment for NobelActive 3.0.

Important Note: The provided document is a 510(k) premarket notification for a medical device (dental implant abutment). These types of submissions typically focus on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance criteria or conducting extensive effectiveness studies for a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this type of traditional medical device submission.

The "studies" described are primarily non-clinical engineering tests to ensure mechanical integrity and compatibility with the predicate device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength (ISO 14801): The ATLANTIS™ Abutment for NobelActive 3.0 must demonstrate sufficient strength for its intended use, as evaluated by static and dynamic compression-bending testing according to ISO 14801.	"Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 has sufficient strength for its intended use." (Specific quantitative values are not provided in the summary, but the conclusion states sufficiency.)
Compatibility: The ATLANTIS™ Abutment for NobelActive 3.0 must be compatible with the NobelActive 3.0 implant.	"Compatibility analysis shows that the ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant."
Biocompatibility: The device must be biocompatible.	"The results of biocompatibility testing conducted for the predicate devices... are valid, therefore, no additional biocompatibility testing has been performed." (Inherited from predicate devices).
Sterility: The device, if supplied sterile, must meet sterility requirements.	"The results from the previous sterility testing are valid for the proposed device... The sterility testing conducted for the predicate devices... was conducted with the same materials and same sterilization cycle." (Inherited from predicate devices).
Dimensional Analysis: The device must meet specified dimensional parameters.	Mentioned as performed: "dimensional analysis" (Specific details or limits are not provided in this summary).
Design Integrity: The mechanical design must be sound.	Mentioned as performed: "mechanical design analysis" (Specific details or limits are not provided in this summary).

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

Sample Size: Not explicitly stated in the summary. For mechanical testing (ISO 14801), devices are typically tested in small batches to statistical significance or to demonstrate compliance with a specific load rating. The exact number of abutments tested is not provided.
Data Provenance: The "Non-Clinical Performance Data" section (Section 7) describes testing performed by DENTSPLY International, Inc., the manufacturer/submitter, and references predicate devices. This would be considered prospective testing conducted specifically for this 510(k) submission or in support of prior predicate device approvals. The country of origin of the data is implied to be within the company's testing facilities, likely in the US as the submitter is a US company.

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

N/A. This device is a physical medical device (dental abutment), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" for its performance is established through quantitative mechanical testing and engineering analyses against defined standards (like ISO 14801).

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are relevant for human evaluation processes, especially in clinical trials or AI performance evaluations involving multiple readers. This is a physical device undergoing mechanical and engineering tests, not an interpretive task.

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

N/A. This is not an AI-powered diagnostic or assistive device. It is a physical dental implant abutment.

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

N/A. This is a physical dental implant abutment, not an algorithm.

7. The Type of Ground Truth Used

For Mechanical Strength & Compatibility: The "ground truth" is defined by engineering standards and specifications (e.g., ISO 14801, material properties, dimensional tolerances, fit with the corresponding implant). Performance is measured against these objective standards.
For Biocompatibility & Sterility: The "ground truth" is derived from established regulatory standards and validated testing protocols (e.g., ISO 10993 for biocompatibility, ISO 11137 or AAMI standards for sterility assurance levels).

8. The Sample Size for the Training Set

N/A. This is not an AI algorithm that requires a training set. The design of the ATLANTIS™ Abutment is based on CAD/CAM technology, but the "training" in this context refers to the manufacturing process, not machine learning.

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

N/A. As there is no AI training set, this question is not applicable. The design and manufacturing process for the CAD/CAM abutment are governed by engineering principles and quality control, not ground truth derived from annotated data.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.

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

January 14, 2016

DENTSPLY International, Inc. Ms. Helen Lewis Director of Corporate Regulatory Affairs Susquehanna Commerce Center 221 W. Philadelphia St., Suite 60 York, Pennsylvania 17401

Re: K151039

Trade/Device Name: ATLANTISTM Abutment for NobelActive 3.0 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 10, 2015 Received: December 14, 2015

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 (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 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

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

K151039 510(k) Number (if known):

Device Name: ATLANTISTM Abutment for NobelActive 3.0

Indications for Use:

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

Prescription Use (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/1 description: The image shows the word "DENTSPLY" in large, bold, black letters. The letters are closely spaced together, creating a strong visual impact. A thin gray line is positioned above the word, adding a subtle contrast to the overall design.

510(k) SUMMARY for ATLANTISTM Abutment for NobelActive 3.0

1. Submitter Information:
  DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Ste. 60 York, PA 17401

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

Date Prepared: 12 January 2015

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

ATLANTISTM Abutment for NobelActive 3.0 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:

Table 3.1
Predicate Device Name	510(k)	Company Name
ATLANTISTM Abutment for Nobel Biocare ActiveImplant (Primary Predicate Device)	K093483	Astra Tech Inc. *
OsseoSpeed Profile EV (Reference Predicate Device)	K130999	DENTSPLY Implants
NobelActive 3.0 (Reference Predicate Device)	K102436	Nobel Biocare AB

= Astra Tech Inc. is the original applicant. 510(k) was transferred to DENTSPLY International Inc. after purchase of Astra Tech Inc.

Description of Device: 4.

Traditional 510(k) ATLANTISTM Abutment for NobelActive 3.0 DENTSPLY International

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

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Indications for Use: 5.

The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTISTM Abutment to the endosseous implant.

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

1. Substantial Equivalence:

Technological Characteristics.

ATLANTISTM Abutment for NobelActive 3.0 is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology.

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

Table 6.1					Table 6.1
	Subject Device		Predicate Devices			Subject Device	Predicate Devices
	DENTSPLYImplantsATLANTISTMAbutment forNobelActive 3.0	Astra Tech, Inc.ATLANTISTMAbutment forNobel BiocareActive ImplantK093483	DENTSPLYImplantsOsseoSpeed™Profile EVK130999	Nobel Biocare ABNobelActive 3.0K102436		DENTSPLYImplantsATLANTISTMAbutment forNobelActive 3.0	Astra Tech, Inc.ATLANTISTMAbutment forNobel BiocareActive Implant	DENTSPLYImplantsOsseoSpeedTMProfile EV	Nobel Biocare ABNobelActive 3.0K102436
Indicationsfor Use	TheATLANTISTMAbutment isintended for usewith anendosseousimplant to supporta prostheticdevice in apartially orcompletelyedentulouspatient. It isintended for useto support singleand multiple toothprosthesis, in themandible ormaxilla. Theprosthesis can becemented orscrew retained tothe abutment. Theabutment screw isintended to securethe ATLANTISTMAbutment to theendosseousimplant.TheATLANTISTMCrownAbutment isintended for usewith anendosseousimplant tofunction as asubstructure thatalso serves as thefinal restoration,in a partially or	TheATLANTISTMAbutment isintended for usewith anendosseousimplant to supporta prostheticdevice in apartially orcompletelyedentulouspatient. It isintended for useto support singleand multiple toothprosthesis, in themandible ormaxilla. Theprosthesis can becement or screwretained to theabutment. Theabutment screw isintended to securethe abutment tothe endosseousimplant.This device iscompatible withthe followingmanufacturers'implant systems:The titanitun andzirconiaabutments arecompatible withthe NobelBiocare'sNobelActiveImplants.Please note: This	Implants:The ASTRATECH ImplantSystem -OsseoSpeedProfile EVimplants areintended for bothone- and two-stage surgicalprocedures in thefollowingsituations andwith the followingclinical protocols:• replacingmissing teeth insingle or multipleunit applicationsin the mandible ormaxilla.• immediateplacement inextraction sitesand in situationswith a partially orcompletely healedalveolar ridge• especiallyindicated for usein soft boneapplicationswhere implantswith other implantsurface treatmentsmay be lesseffective• immediate andearly loading forall indications• together withimmediateloading protocol	The NobelActive3.0 mm implant isindicated for use.In the treatment ofmissing maxillarylateral incisors orthe mandibularcentral and lateralincisors to supportprosthetic devices,such as artificialteeth, In order torestore chewingfunction inpartiallyedentulouspatients. TheNobelActive 3.0implants may beput into immediatefunction providedthat stabilityrequirementsdetailed in themanual aresatisfied.			K093483	K130999
Table 6.1	Subject Device	Predicate Devices		Design
	DENTSPLYImplants	Astra Tech, Inc.ATLANTISTMAbutment forNobel BiocareActive Implant	DENTSPLYImplantsOsseoSpeed™Profile EV	Nobel Biocare ABNobelActive 3.0	ProsthesisAttachment	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retained	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retained
	ATLANTISTMAbutment forNobelActive 3.0	K093483	K130999	K102436	Restoration	Single or Multi-unit	Single or Multi-unit	Single or Multi-unit	Single or Multi-unit
	completelyedentulouspatient. Theabutment screw isintended to securethe ATLANTISTMCrown Abutmentto the endosseousimplant.TheATLANTISTMConus Abutmentis intended for usewith anendosseousimplant to supporta prostheticdevice in partiallyor completelyedentulouspatients. It isintended for useto support aremovablemultiple toothprosthesis, in themandible ormaxilla. Theprosthesis isattachment-retained byfriction fit to theabutment. Theabutment screw isintended to securethe ATLANTISTMConus Abutmentto the endosseousimplant.ATLANTISTMAbutment forNobelActive 3.0is compatible withthe Ø3.0 mm	device may beused in an earlyload situation, butis dependent onthe specificimplant systemand protocol usedby the dentalprofessional.Highly angledabutments (i.e. 30degrees) onimplants withdiameters lessthan 4 mm areintended for theanterior region ofthe mouth and arenot intended forthe posteriorregion due tolimited strength ofthe implant.	in all indications,except in singletooth situations insoft bone (typeIV) where implantstability may bedifficult to obtainand immediateloading may notbe appropriate• only togetherwith Profile EVcomponents,Implant DriverProfile EV,RadiographicImplant GuidesProfile EV andnon-IndexedprostheticcomponentsAbutments:ASTRA TECHImplantSystem™-OsseoSpeed EVabutments areintended to beused inconjunction withASTRA TECHImplantSystem™-OsseoSpeed EVin fullyedentulous orpartiallyedentulousmaxillary and/ormandibulararches.TheATLANTISTM		AbutmentDiameter	3.0	3.5, 4.3, 5.0	3.0, 4.2, 4.8	3.0
Subject Device	Predicate Devices			AbutmentAngle	Straight, up to 30°	Straight, up to 30°	Straight, up to 30°	Straight, up to 30°
DENTSPLYImplantsATLANTISTMAbutment forNobelActive 3.0	Astra Tech, Inc.ATLANTISTMAbutment forNobel BiocareActive Implant	DENTSPLYImplantsOsseoSpeed™Profile EV	Nobel Biocare ABNobelActive 3.0	Connection	Internal	Internal	Internal	Internal
	K093483	K130999	K102436	Material
NobelActiveImplant.		intended for usewith anendosseousimplant to supporta prostheticdevice in apartially orcompletelyedentulouspatient. It isintended for useto support singleand multiple toothprostheses, in themandible ormaxilla. Theprosthesis can becemented, screwretained orfriction fit to theabutment. Theabutment screw isintended to securethe abutment tothe endosseousimplant.TheATLANTISTMCrown Abutmentis intended for usewith anendosseousimplant tofunction as asubstructure thatalso serves as thefinal restoration,in partially orcompletelyedentulouspatients. Theprosthesis isscrew retained.The abutmentscrew is intendedto secure the		Implant	NA	NA	Titanium	Titanium
Subject Device	Predicate Devices			Abutment	Titanium alloy	Titanium alloy,Zirconia	Titanium alloy,Zirconia	Titanium alloy
DENTSPLYImplantsATLANTISTMAbutment forNobelActive 3.0	Astra Tech, Inc.ATLANTISTMAbutment forNobel BiocareActive ImplantK093483	DENTSPLYImplantsOsseoSpeed™Profile EVK130999	Nobel Biocare ABNobelActive 3.0K102436	Screw	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy
		to the endosseousimplant.TheATLANTISTMConus Abutmentis intended for usewith anendosseousimplant to supporta prostheticdevice in partiallyor completelyedentulouspatients. It isintended for useto support aremovablemultiple toothprosthesis, in themandible ormaxilla. Theprosthesis isattachment-retained byfriction fit to theabutment. Theabutment screw isintended to securethe ATLANTISTMAbutment to theendosseousimplant.ATLANTISTMAbutment,ATLANTISTMCrown AbutmentandATLANTISTMConus Abutmentare compatiblewith ASTRA

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Biocompatibility

The results of biocompatibility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), are valid, therefore, no additional biocompatibility testing has been performed.

Sterility

The results from the previous sterility testing are valid for the proposed device, ATLANTIS™ Abutment for NobelActive 3.0. The sterility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required.

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7. Non-Clinical Performance Data.

Non-clinical testing data, referenced, or relied upon to demonstrate substantial equivalence includes: mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. Compatibility analysis shows that the ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant. Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 has sufficient strength for its intended use.

Conclusion Regarding Substantial Equivalence

The ATLANTIS™ Abutment for NobelActive 3.0 is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTISTM Abutment for NobelActive 3.0 has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate devices ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483), OsseoSpeed Profile EV (K130999) and NobelActive 3.0 (K102436).

The subject device when compared to the predicate devices 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.)