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

Device Description

The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.

AI/ML Overview

This document describes a 510(k) premarket notification for the ATLANTIS™ Crown, a patient-specific dental prosthetic component. The information provided heavily focuses on comparing the proposed device to predicate devices to establish substantial equivalence, rather than detailing a specific clinical study with acceptance criteria for a novel device.

Therefore, it is important to note that the input document does NOT describe the acceptance criteria and a study that proves the device meets those acceptance criteria in the typical sense for an AI/ML device.

Instead, the document demonstrates that the ATLANTIS™ Crown is substantially equivalent to a legally marketed predicate device based on its intended use, technological characteristics (material, design, manufacturing), and non-clinical performance data (flexural strength, fracture toughness, chemical solubility, radioactivity concentration, and coefficient of thermal expansion).

Here's an analysis based on the available information, addressing the requested points where possible, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of a performance study for the ATLANTIS™ Crown as a new device with novel performance claims to be evaluated. Instead, it relies on demonstrating that the ATLANTIS™ Crown meets the established performance characteristics of its predicate devices and complies with relevant standards.

Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance (ATLANTIS™ Crown)
Material: Y-TZP	Material: Y-TZP (Same as primary predicate Cercon® ht and reference predicate ATLANTIS™ Crown Abutment in Zirconia)
Primary Predicate Performance (Cercon® ht, K112152):	Substantially Equivalent to Predicate: The ATLANTIS™ Crown "can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer," which is the same as the Cercon® ht.
**Reference Predicate Performance (ATLANTIS™ Crown Abutment in	Substantially Equivalent to Predicate: Material and CAD/CAM milling process are identical to the ATLANTIS™ Crown Abutment in Zirconia (K110356).
Zirconia, K110356):
Flexural Strength: Must meet ISO 6872 requirements.	Flexural Strength: "Results showed that the requirements of the standard ISO 6872 Dentistry Ceramic Materials were fulfilled." (Testing done according to ISO 14704 and ASTM C1161 on the Zirconia material).
Fracture Toughness: Tested according to ISO 6872 requirements.	Fracture Toughness: "Tested and completed according to the requirements specified in ISO 6872."
Chemical Solubility: Tested according to ISO 6872 requirements.	Chemical Solubility: "Tested and completed according to the requirements specified in ISO 6872."
Radioactivity Concentration: Tested according to ISO 6872	Radioactivity Concentration: "Tested and completed according to the requirements specified in ISO 6872."
requirements.
Coefficient of Thermal Expansion: Tested according to ISO 6872	Coefficient of Thermal Expansion: "Tested and completed according to the requirements specified in ISO 6872."
requirements.
Biocompatibility: Demonstrated by equivalence.	Biocompatibility: "The material used for the ATLANTIS™ Crown and the manufacturing process is the same as used for the predicate device ATLANTIS™ Crown Abutment in Zirconia, K 110356. Therefore no additional biocompatibility testing has been performed." (Implies it meets the biocompatibility established for K110356 due to identical material and manufacturing).

Regarding the remaining points:

The provided document is a 510(k) summary for a medical device (ATLANTIS™ Crown) which is a physical product, not an AI/ML diagnostic or assistive tool. Therefore, many of the requested points related to AI/ML device studies (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable and are not found in this document.

Specific responses to the remaining points based on the understanding that this is not an AI/ML device document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document reports non-clinical material characterization data (flexural strength, fracture toughness, etc.) against established standards (ISO, ASTM), not a clinical trial with a test set of patient data.
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 the context of clinical or diagnostic AI/ML studies is not relevant here. Material properties are measured against physical standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing involves scientific measurement and comparison to quantitative standards, not expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical prosthetic device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical prosthetic device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for material properties is the defined limits and test methods of international standards like ISO 6872.
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth establishment process.

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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with the profiles overlapping to create a sense of depth. The profiles are black against a white background.

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

January 29, 2016

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

Re: K152247

Trade/Device Name: ATLANTISTM Crown Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 16, 2015 Received: December 22, 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 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 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/Resourcesfor You/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 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 vours.

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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INDICATIONS FOR USE STATEMENT

K152247 510(k) Number (if known):

Device Name: ATLANTIS™ Crown

Indications for Use:

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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510(k) SUMMARY

for

ATLANTISTM Crown

Image /page/3/Picture/3 description: The image shows the word "Dentsply" in a bold, sans-serif font. The letters are all capitalized and black. The word is slightly angled upwards from left to right. The background is white.

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: 04 August 2015

2. Device Name:

. Proprietary Name: ATLANTISTM Crown
classification Name: Porcelain powder for clinical use .
CFR Number: .
Device Class: .
- Product Code: .

3. Predicate Device:

Primary Predicate:	Cercon ® ht, K112152 (DENTSPLY International Inc.)
Reference Predicate:	ATLANTIS TM Crown Abutment in Zirconia, K110356 (DENTSPLY Implants, formerly ASTRA TECH Inc.)

21 CFR 872.6600

Class II

EIH

The ATLANTIS™ Crown Abutment in Zirconia, (K110356) has been chosen as reference predicate regarding biocompatibility since the material and CAD/CAM milling process is identical to the proposed device.

4. Description of Device:

5. Indications for Use:

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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	Comparison of the Technological Characteristics:
	Proposed Device	Primary Predicate Device	Reference Predicate Device
	ATLANTISTM Crown	Cercon® ht (K112152)	ATLANTISTM Crown Abutment in Zirconia (K110356)
Indications for use	The ATLANTIST™ Crown is intended for usewith an ATLANTIST™ Abutment and anendosseous implant to function as asubstructure that also serves as the finalrestoration, in a partially or completelyedentulous patient.	Cercon® ht is indicated in the anterior andposterior segments for:* crowns* telescopic primary crowns* multi-unit bridges (with no more than twopontics between abutment crowns)Cercon® ht can be used as a substructure(framework) which is then veneered with adental veneering ceramic or can be used forfull-contour application (without veneering)as well. In the case of telescopic primarycrowns the substructure is notveneered.	The Atlantis Crown Abutment in Zirconiais intended for use with an endosseousimplant to function as a substructure thatalso serves as the final restoration, in apartially or completely edentulous patient.The prosthesis is screw retained. Theabutment screw is intended to secure thecrown abutment to the endosseousimplant.This device is compatible with thefollowing manufacturers' implant systems:Astra - Microthread ST 3.5mm, 4.0mm,4.5mm and 5.0mm.Please note: This device may be used in anearly load situation, but is dependent onthe specific implant system and protocolused by the dental professional. Highlyangled abutments on small diameterimplants are intended for the anteriorregion of the mouth only.
Design	Provided to the customer as patient-specificfull contour crown or cut-back substructure.	Provided as blank to the dental laboratory tocreate a patient-specific full contour crownor substructure	Provided as a patient-specific abutment,available in the diameters: 3.5 mm, 4.0mm, 4.5 mm, 5.0 mm
Manufacturingmethod	1. pre-sintered blanks2. milling of crown by DENTSPLYImplants3. final sintering by DENSPLY Implants	1. pre-sintered blanks2. machining of crown by dentallaboratory3. final sintering by dental laboratory	1. pre-sintered blanks2. milling of abutment by DENTSPLYImplants3. final sintering by DENTSPLYImplants
Material	Y-TZP	Y-TZP	Y-TZP

Substantial Equivalence:

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7. Non-Clinical Performance Data.

Flexural strength testing were conducted on the Zirconia material used for the ATLANTIS™ Crown according to the standards ISO 14704 and ASTM C1161. The results showed that the requirements of the standard ISO 6872 Dentistry Ceramic Materials were fulfilled. Fracture toughness, chemical solubility, radioactivity concentration and coefficient of thermal expansion were tested and completed according to the requirements specified in ISO 6872.

The material used for the ATLANTIS™ Crown and the manufacturing process is the same as used for the predicate device ATLANTIS™ Crown Abutment in Zirconia, K 110356. Therefore no additional biocompatibility testing has been performed.

8. Conclusion Regarding Substantial Equivalence

The ATLANTIS™ Crown is a patient-specific restorative device which is intended to be used with an ATLANTIS™ Abutment and an endosseous implant. The ATLANTIS™ Crown and the primary predicate, Cercon ht (K112152), can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. Thus, it can be concluded that the ATLANTIS™ Crown has the same intended use. incorporates the same fundamental technology, and has similar indications for use as the primary predicate device Cercon® ht (K112152).

Thus, it can be concluded that the proposed ATLANTIS™ Crown is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.