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 tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to 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 attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.

ATLANTISTM products are compatible with the implants shown in the table below.

Implant Manufacturer	Trade Name	Implant Diameter	Abutment Platform Diameter
Altatec GmbH	CONELOG SCREW-LINE Implant	Ø3.3, 3.8, 4.3, 5.0 mm	Ø3.3, 3.8, 4.3, 5.0 mm

Device Description

The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screwretained, 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 ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the CONELOG implants from the CONELOG Implant System (K113779).

The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 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

The provided text describes a 510(k) premarket notification for the "ATLANTIS™ Abutment for CONELOG implant," a dental implant abutment. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. While the document details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format typically used for AI/ML medical devices.

Instead, the provided text focuses on:

Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing intended use, technological characteristics, and performance data.
Non-Clinical Performance Data: The document mentions "mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801." These are standard engineering tests for dental implants to demonstrate structural integrity and durability.
Biocompatibility and Sterility: These aspects are addressed by referencing prior testing conducted for a primary predicate device, stating that the materials and sterilization processes are the same.

Therefore, I cannot populate the table or answer the specific questions below as they pertain to acceptance criteria, clinical study design, ground truth establishment, or human-in-the-loop performance, which are not detailed in this regulatory submission for a physical implant component.

Here's a breakdown of why I cannot answer each point based solely on the provided text:

A table of acceptance criteria and the reported device performance: The document mentions "mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use" and "compatibility analysis shows that the ATLANTIS™ Abutment for CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants." However, it does not state specific quantitative acceptance criteria (e.g., "must withstand X N of force") nor detailed numerical reported device performance in a table. It refers to ISO 14801, which outlines testing methodologies but not necessarily specific pass/fail values that would be reported in this summary.
Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components for mechanical testing, not a dataset of patient images or clinical data. No details on the number of physical samples tested are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical evaluation or ground truth for AI/ML models, which is not the subject of this submission. The "ground truth" for mechanical properties would be derived from physical measurements and engineering standards, not expert clinical consensus.
Adjudication method: Not applicable. This is for clinical or AI model evaluation.
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 physical dental abutment, not an AI/ML algorithm for image interpretation or diagnosis.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For mechanical testing, the "ground truth" would be the predefined engineering specifications (e.g., material strength requirements, dimensional tolerances) and the observed performance of the tested physical components against these specifications. The document implies compliance with ISO 14801.
The sample size for the training set: Not applicable. This is for AI/ML models, not a physical device.
How the ground truth for the training set was established: Not applicable. This is for AI/ML models.

In summary, the provided document is a regulatory submission for a physical medical device (dental abutment) and outlines its demonstration of substantial equivalence through non-clinical mechanical testing, biocompatibility, and sterility, rather than clinical efficacy studies with human subjects or AI/ML model performance evaluation.

Summary

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

August 26, 2016

Dentsply Sirona Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K161030

Trade/Device Name: ATLANTISTM Abutment for CONELOG Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2016 Received: July 29, 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 -

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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Indications for Use

510(k) Number (if known) K161030

Device Name

ATLANTISTM Abutment for CONELOG implant

Indications for Use (Describe)

ATLANTISTM products are compatible with the implants shown in the table below.

Implant Manufacturer	Trade Name	Implant Diameter	Abutment Platform Diameter
Altatec GmbH	CONELOG SCREW-LINE Implant	Ø3.3, 3.8, 4.3, 5.0 mm	Ø3.3, 3.8, 4.3, 5.0 mm

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

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SECTION 5. 510(k) SUMMARY

for

ATLANTISTM Abutment for CONELOG implant

1. Submitter Information:
  Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

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

August 18, 2016 Date Prepared:

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

Predicate Device Name	510(k)	Company Name
ATLANTIS™ Abutment forNobelActive 3.0 (PrimaryPredicate Device)	K151039	DENTSPLY IMPLANTSMANUFACTURING GMBH
Osseospeed™ Profile EV(Reference Predicate Device)	K130999	DENTSPLY IMPLANTSMANUFACTURING GMBH
CONELOG Implant System(Reference Predicate Device)	K113779	Altatec GmbH

21 CFR 872.3630

ATLANTISTM Abutment for CONELOG implant

Endosseous dental implant abutment

1. Description of Device:
  The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screwretained, cement-retained or friction fit prosthesis.

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Table 5-1: Compatibility table (The ATLANTIS Abutment Titanium and Gold-shaded are compatible with CONELOG implant interface (Ø3.3, 3.8, 4.3 and 5.0 mm)

ImplantManufacturer	Interface	ATLANTISTMAbutment forCONELOGimplant	ATLANTISTMCrownAbutmentfor CONELOGimplant	ATLANTISTMConusAbutment forCONELOGimplant(Custom)	ATLANTISTMConus Abutmentfor CONELOGimplant(Overdenture)
Altatec GmbH	CONELOGImplantSystem(SCREW-LINE) (Ø3.3,3.8, 4.3 and5.0 mm)	Titanium,Gold-shadedtitanium(Gold-Hue)	Titanium	Titanium	Titanium

న. Indications for Use:
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 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™ 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.

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ATLANTIS™ products are compatible with the implants shown in the table below.

ImplantManufacturer	Trade Name	Implant Diameter	Abutment Platform Diameter
Altatec GmbH	CONELOG SCREW-LINE Implant	Ø3.3, 3.8, 4.3, 5.0 mm	Ø3.3, 3.8, 4.3, 5.0 mm

1. Substantial Equivalence:
  Technological Characteristics

ATLANTIS™ Abutment for CONELOG implant is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology.

Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.

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Table 5-2: Indications for use for the proposed and the predicate devices

ATLANTISTM Abutment forCONELOG implant (Proposed	ATLANTISTM Abutmentfor NobelActive 3.0	OsseoSpeed Profile EV(K130999)	CONELOG Implant System(K113779)	Summary of differences inthe indications for use
Device)	(K151039)(Primary Predicate)	(Reference Predicate)	(Reference Predicate)
The ATLANTISTM Abutment isintended for use with an endosseousimplant to support a prosthetic devicein a partially or completelyedentulous patient. It is intended foruse to support single and multipletooth prosthesis, in mandible ormaxilla. The prosthesis can becemented or screw retained to theabutment. The abutment screw isintended to secure the ATLANTISAbutment to the endosseous implant.The ATLANTISTM CrownAbutment is intended for use with anendosseous implant to function as asubstructure that also serves as thefinal restoration, in a partially orcompletely edentulous patient. Theabutment screw is intended to securethe ATLANTIS Crown Abutment tothe endosseous implant.The ATLANTISTM ConusAbutment is intended for use with anendosseous implant to support aprosthetic device in partially orcompletely edentulous patients. It isintended for use to support aremovable multiple tooth prosthesis,in the mandible or maxilla. Theprosthesis is attachment-retained byfriction fit to the abutment. Theabutment screw is intended to securethe ATLANTIS Conus Abutment tothe endosseous implant.	The ATLANTISTMAbutment is intended foruse with an endosseousimplant to support aprosthetic device in apartially or completelyedentulous patient. It isintended for use to supportsingle and multiple toothprosthesis, in the mandibleor maxilla. The prosthesiscan be cemented or screwretained to the abutment.The abutment screw isintended to secure theATLANTISTMAbutment to the endosseousimplant.The ATLANTISTM CrownAbutment is intended foruse with an endosseousimplant to function as asubstructure that also servesas the final restoration, in apartially or completelyedentulous patient. Theabutment screw is intendedto secure the ATLANTISTMCrownAbutment to the endosseousimplant.The ATLANTISTM ConusAbutment is intended foruse with an endosseousimplant to support aprosthetic device in partially	Implants:The ASTRA TECH ImplantSystem – OsseoSpeed ProfileEV implants are intended forboth one- and two-stagesurgical procedures in thefollowing situations and withthe following clinicalprotocols:Replacing missing teethin single or multiple unitapplications in themandible or maxilla. Immediate placement inextraction sites and insituations with a partiallyor completely healedalveolar ridge Especially indicated forus in soft boneapplications whereimplants with otherimplant surfacetreatment may be lesseffective Immediate and earlyloading for allindications Together with immediateloading protocol in allindications, except insingle tooth situations insoft bone (type IV)where implant stabilitymay be difficult toobtain and immediateloading may not be	CONELOG® Implant SystemImplants are intended for immediateor delayed placement in the bone ofthe maxillary or mandibular arch.CONELOG® Implant SystemAbutments are intended for use assupport for crowns, bridges oroverdentures. When a one-stagesurgical approach is applied, theimplant may be immediately loadedwhen good primary stability isachieved and the functional load isappropriate.CONELOG® Implants with Ø3.3mm diameter have the followingadditional specific indications:These are an alternative in caseswhere the alveolar ridge width isonly 5 - 6 mm. Because of theirlower mechanical strengthcompared with larger diameterimplants, they should only be usedunder the following conditions:As single implants, theyshould be used only to replacemandibular incisors and/ormaxillary lateral incisors. An edentulous arch can onlybe restored with a bar retainedsuperstructure with at leastfour implants of Ø3.3 mmdiameter without distalextensions. Implants of Ø3.3 mm aresuitable for a partiallyedentulous arch when	The indications for use of theproposed device are identicalto the indications for use ofthe primary predicate device.The indications for use of theproposed device are similar tothe indications for use of thereference predicate device(K130999). The difference isthat the reference predicatedevice (K130999) alsoincludes the indications foruse of the implants, which isnot the subject of thissubmission.The indications for use of thesecond reference predicatedevice cover the CONELOGimplant system (K113779).The indications for use aresimilar. The differencebetween the proposed deviceand the reference predicatedevice (K113779) is that theprosthesis, in addition toscrew-retained restoration orcement-retained restoration,can be attachment-retained(by friction-fit) to theproposed device.

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ATLANTIS™ products are compatible with the implants shown in the table below.

ImplantManufacturer	TradeName	ImplantDiameter	AbutmentPlatformDiameter
Altatec GmbH	CONELOGSCREW-LINEImplant	Ø3.3, 3.8,4.3, 5.0mm	Ø3.3, 3.8,4.3, 5.0mm

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.

appropriate

●

Only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components

Abutments:

ASTRA TECH Implant System™-OsseoSpeed EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™-OsseoSpeed EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.

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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the 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 partially or completely edentulous patients. The prosthesis is

combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø3.3 mm must be taken into account.

. Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø3.3 mm implants.
. The healing time for Ø3.3 mm implants is at least 12 weeks.

CONELOG® Implants with 7 mm length have the following additional specific indications:

CONELOG® SCREW-LINE

Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

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	screw retained. The abutmentscrew is intended to secure theATLANTIS™ Abutment tothe endosseous implant.The ATLANTIS ConusAbutment is intended for usewith an endosseous implant tosupport a prosthetic device inpartially or completelyedentulous patients. It isintended for use to support aremovable multiple toothprosthesis, in the mandible ormaxilla. The prosthesis isattachment-retained byfriction fit to the abutment.The abutment screw isintended to secure theATLANTIS Abutment to theendosseous implant.ATLANTISTM Abutment,ATLANTIS™ CrownAbutment and ATLANTISTMConus Abutment arecompatible with ASTRATECH Implant System ProfileEV
--	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

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Table 5-3: Similarities and differences between the proposed and the predicate devices

Element	Proposed DeviceATLANTISTMAbutment forCONELOG implant	Primary PredicateDeviceATLANTISTMAbutment forNobelActive 3.0	Reference PredicateDeviceOsseoSpeed ProfileEV	Reference PredicateDeviceCONELOG ImplantSystem	Summary of differences
510(k)	To be assigned	K151039	K130999	K113779	-
ProsthesisAttachment	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retained	No difference between theproposed device and the primarypredicate and the reference device(K130999).
Restoration	Single orMulti-unit	Single orMulti-unit	Single or	Single orMulti-unit	No difference.
Abutment PlatformDiameter	3.3, 3.8, 4.3, 5.0	3.0	3.0, 4.2, 4,8	3.3, 3.8, 4.3, 5.0	The proposed abutment platformis designed to fit the referencepredicate device (K113779).The proposed deviceencompasses the same range ofphysical dimensions; diameter,height and angle of abutments forthe primary predicate as for thereference predicate (K113779).The subject abutment platform isnot designed to fit the primarypredicate device (K151039) or thereference predicate device(K130999).
Abutment angle	Straight, up to 30°	Straight, up to 30°	Straight, up to 30°	Straight, up to 30°	No difference.
Element	Proposed DeviceATLANTISTMAbutment forCONELOG implant	Primary PredicateDeviceATLANTISTMAbutment forNobelActive 3.0	Reference PredicateDeviceOsseoSpeed ProfileEV	Reference PredicateDeviceCONELOG ImplantSystem	Summary of differences
Connection	Internal conicalconnection	Internal conical connection	Internal conicalconnection	Internal conicalconnection	The internal conical connection issimilar for the proposed devicewhen compared to the primarypredicate device (K151037) or thereference predicate device(K130999).The connection of the proposeddevice is designed to fit thereference predicate (K113779).
Material Implant	NA	NA	Titanium	Titanium	The proposed device and primarypredicate is an abutment.
Material: Abutment	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy	No difference.
Material: Screw	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy	No difference.

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7. Biocompatibility

The results of biocompatibility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), are valid because the material composition of the proposed device is the same when compared to the primary predicate device, ATLANTISTM Abutment for NobelActive 3.0 (K151039). Atlantis abutments are made of titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4Vandadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). As per our biological evaluations on the titanium materials used for the ATLANTIS Abutment (RP-00054490), the following tests were performed: Cytotoxicity, Sensitization, Irritation of Intracutaneous reactivity, Acute systemic toxicity, Subchronic toxicity, Genotoxicity - AMES, and Hemolysis. Since the material composition of the proposed devices is identical to the predicate devices, the result of referenced biocompatibility testing is still valid. Therefore, no additional biocompatibility testing has been performed.

Sterility 8.

The sterility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for CONELOG implant.

9. Non-Clinical Performance Data

Non-clinical testing data submitted, 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 CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants. Mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use.

9. Conclusion Regarding Substantial Equivalence

The ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS™ Abutment for CONELOG implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates ATLANTIS™ Abutment for NobelActive 3.0 (K151039), Osseospeed Profile EV (K130999) and CONELOG Implant System (K113779).

Test data to verify the performance of the ATLANTIS™ Abutment for CONELOG implant has been provided including: mechanical testing and compatibility analysis. The results of this testing, combined with the design, and intended use comparison with 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.)