The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

ATLANTIS™ 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™ Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: (list of compatible implants and abutments follows in the document)

Device Description

The subject of this bundled 510(k) consists of the proposed Multibase Abutments EV with accompanying accessories and the corresponding ATLANTIS™ Suprastructures, which are currently marketed under premarket notification K160207 and are proposed for modification under this submission to include compatibility with the proposed Multibase Abutments EV. The proposed devices are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible.

The subject Multibase Abutments EV are additional components for the existing OsseoSpeed™ EV implants (cleared in K120414 under the name OsseoSpeed™ Plus) and the OsseoSpeed™ Profile EV implants (K130999). The subject Multibase Abutments EV are designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. They are provided in three platform diameters (3.6. 4.2 and 4.8 mm) and available as straight version and in two angles (17° and 30°). The straight abutments are one-piece abutments and provided in three gingival heights (1.5, 2.5 and 3.5 mm). They have a nonindexed interface. All abutments with a 17° or 30° angle represent two-piece abutments and are available in two gingival heights (1.5 and 2.5 mm) with an indexed or non-indexed interface. The two-piece, angled variants of the Multibase Abutment EV devices consist of the abutment body and a screw channel cap which is threaded to the abutment body to cover the abutment body's connection screw channel. The screw channel cap features internal threads to facilitate connection of screw-retained restorations. The subject Multibase Abutment EV devices are also designed for compatibility with the temporary prosthetic cylinder and bridge screw components of the reference predicate NobelActive Multi-Unit Abutment system (K072570).

The ATLANTIS™M Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTISTM Suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The proposed abutment-interface of the ATLANTIS™ Suprastructures, compatible with the proposed Multibase Abutments EV. are available in the same design types as cleared for the predicate ATLANTISTM ISUS Implant Suprastructures in K160207:

Bar Intended as a fixed supporting structure for a removable dental prosthesis.
Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
Hybrid Intended as a fixed denture framework.
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 screwretained connection.

Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided text describes a 510(k) premarket notification for dental implant components (Multibase Abutments EV and ATLANTISTM Suprastructures). This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and effectiveness de novo through a clinical trial with specific performance criteria for a novel device.

Therefore, the concept of "acceptance criteria" for a new, standalone device's performance in a clinical study, and a "study that proves the device meets the acceptance criteria" in that context, is not directly applicable to this document.

Instead, the "acceptance criteria" here are essentially the demonstration that the new device shares fundamental technological characteristics and indications for use with the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" is the collection of non-clinical data (e.g., sterilization validation, fatigue testing, geometric analysis) showing substantial equivalence.

Given this, I will reframe the requested information to align with the provided document's nature as a 510(k) submission for dental implant abutments and suprastructures.

Dental Implant Abutments and Suprastructures (K163350)

1. Table of Acceptance Criteria (Substantial Equivalence) and the Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary from Non-Clinical Data)
Similar Indications for Use	Multibase Abutments EV: Indications for use are identical to the primary predicate OsseoSpeed™ Angled Abutment EV (K121810). They are intended for use with Astra Tech Implant System EV in fully or partially edentulous arches to support bridges or overdentures. ATLANTIS™ Suprastructures: Indications for use are identical to the predicate ATLANTISTM ISUS Implant Suprastructures (K160207), with the addition of compatibility with the Multibase Abutment EV device. They are indicated for attachment to dental implants or abutments in partially or totally edentulous jaws for restoring chewing function, intended for attachment to a minimum of two implants, and compatible with a listed range of implant and abutment systems.
Similar Fundamental Technology	Multibase Abutments EV: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design features (screw-retained, multi-unit restoration, internal interface) and material (Ti-6Al-4V) are consistent with predicate devices (OsseoSpeed™ Angled Abutment EV and NobelActive Multi Unit Abutment). Differences in abutment design (one-piece/two-piece) and angulation/gingival height ranges addressed by testing. ATLANTIS™ Suprastructures: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design types (Bar, Bridge, Hybrid, 2 in 1), prosthesis attachment (screw-retained, friction-fit), platform diameter, interface (internal, external), and materials (CPTi, CoCr for suprastructure; Ti-6Al-4V ELI for screw) are consistent with the predicate ATLANTISTM ISUS Implant Suprastructures.
Biocompatibility	The materials used for both devices and their accompanying screws, as well as the manufacturing process, are unchanged compared to their respective primary predicate devices (OsseoSpeed™ Angled Abutment EV (K121810) and ATLANTIS™ ISUS Implant Suprastructures (K160207)). No additional biocompatibility testing was performed, relying on the predicates' established biocompatibility.
Performance (Non-Clinical)	Sterilization: Validated for sterile, straight Multibase Abutments EV variants by equivalence to existing validations conforming to ISO 11137-1/2 (SAL of 10^-6). Angled variants were specifically validated to ISO 11137-1/2 (SAL of 10^-6). Moist heat sterilization for non-sterile components validated by equivalence to ISO 17665-1/2 (SAL of 10^-9). Packaging and Shelf Life: Validated per ISO 11607 and ASTM F1980 (referenced, no details provided). Fatigue Testing: Dynamic fatigue testing performed on the worst-case construct (angled, two-piece assembly) of Multibase Abutments EV devices according to ISO 14801. Results support substantial equivalence. Geometric Compatibility: Geometric measurement data and statistical compatibility analysis for Multibase Abutments EV with temporary prosthetic cylinder and bridge screw components of predicate (K072570) support compatibility. Cross-sectional Material Analysis: For ATLANTIS™ Suprastructures' interface with Multibase Abutments EV; compared to existing worst-case interface geometry. Analysis showed the new interface does not present a new worst case, supporting substantial equivalence.
Safety and Effectiveness	Based on the above, the differences in technological characteristics do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of a clinical trial. The "test set" here comprises the various physical configurations and conditions tested in the non-clinical studies.
- For fatigue testing (ISO 14801), multiple samples of the "worst case construct" (angled Multibase Abutments EV) would have been used. The exact number is not specified, but typically this standard requires a minimum of 5-10 samples per test group.
- For sterilization validation, the sample sizes would depend on the specific validation protocol (e.g., bioburden testing, dose mapping) but are not explicitly stated.
- For geometric measurements, the "sample size" would refer to the number of individual components measured to ensure dimensional compliance and compatibility, but this is not specified.
Data Provenance: The studies are non-clinical engineering and laboratory tests performed by the manufacturer, Dentsply Sirona. No specific country of origin or retrospective/prospective status is relevant as these are not human subject studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a 510(k) submission based on non-clinical data, not a study requiring expert consensus for diagnostic "ground truth." The "ground truth" is typically defined by engineering standards (e.g., ISO 14801 for fatigue limits, ISO 11137 for sterilization) and internal design specifications.

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

Not applicable. Adjudication methods are used in clinical studies for interpreting human data or images amongst multiple readers. This document refers to non-clinical engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical dental implant component, not an AI-assisted diagnostic or treatment planning system for which human reader performance would be assessed.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the non-clinical tests is established by recognized international and industry standards, such as:
- ISO 14801: Dentistry - Implants - Dynamic loading test for endosseous dental implants. This standard defines the method for fatigue testing.
- ISO 11137-1/2: Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 17665-1/2: Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process.
- ISO 11607: Packaging for terminally sterilized medical devices.
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
- Internal engineering specifications and CAD models: For geometric compatibility and interface analysis.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this 510(k) submission as it is for a physical device, not a machine learning algorithm.

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

Not applicable, as there is no training set for this type of device submission.

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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a cascading manner, representing the department's focus on people and health.

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

March 31, 2017

Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404

Re: K163350

Trade/Device Name: Multibase Abutments EV and ATLANTIS Suprastructures Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 24, 2017 Received: February 27, 2017

Dear Karl Nittinger:

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.

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

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Page 2 - Karl Nittinger

related 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.

Michael J. Ryan -S

for 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

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Indications for Use

510(k) Number (if known)

Device Name

Multibase Abutments EV

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

ATLANTIS™ Suprastructures

Indications for Use (Describe)

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

Manufacturer	Name of Implant	Size
Biomet 3i	Certain	3.25, 4/3 – Prevail 3/4/3, 4/3
	Certain	4.0, 5/4 – Prevail 4/5/4. 5/4
	Certain	5.0, XP 4/5 – Prevail 5/6/5, 6/5
	Certain	6.0, XP 5/6
BioHorizons	Internal/Tapered	3.5, 4.5, 5.7
Camlog	Screw-line Implant	3.3
	Screw-line / Root-line Implant	3.8, 4.3, 5.0, 6.0
DENTSPLY Implants	XiVE	S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
	OsseoSpeed™ TX	3.0, 3.5/4.0, 4.5/5.0
	Osseospeed™ Profile TX	4.5/5.0
	Osseospeed™ EV	3.0, 3.6, 4.2, 4.8, 5.4
	Osseospeed™ Profile EV	4.2, 4.8
Keystone Dental	PrimaConnex	SD 3.3/3.5
	PrimaConnex	RD 4.0/4.1
	PrimaConnex	WD 5.0
	Genesis	3.8, 4.5, 5.5/6.5
Nobel Biocare	NobelActive	NP 3.5 – RP 4.3, 5.0
	NobelReplace	NP-3.5 – RP 4.3 – WP 5.0 – 6.0
Straumann	Bone Level	3.3 NC – 4.1, 4.8 NC
	Standard Plus	3.5 NN
	Standard / Standard Plus	4.8 RN – 4.8 WN
Zimmer Dental	Tapered Screw Vent/Screw Vent	Tapered S-V 3.5/S-V 3.3, 3.7/Tapered S-V 4.5/ S-V 4.5
	Tapered Screw Vent	5.7

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Abutments:
Manufacturer	Name of Abutment
Biomet 3i	Low Profile Abutment
DENTSPLY	ATIS Uni Abutment EV
DENTSPLY	ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY	ATIS Angled Abutment EV
DENTSPLY	ATIS Angled Abutment 20°
DENTSPLY	ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY	ATIS Multibase Abutment EV
DENTSPLY	XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY	XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare	Multi-Unit Abutment RP
Straumann	Bone Level Multi-Base Angled Abutment
Straumann	Bone Level Multi-Base Abutment D3.5, D4.5
Straumann	RN Abutment Level, WN Abutment Level
Straumann	Screw-Retained Abutment 3.5, 4.6
Zimmer Dental	Tapered Abutment

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

ا Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 FF

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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

Multibase Abutments EV and ATLANTIS™ Suprastructures

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

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: 30 March 2017

1. Device Name:
- Multibase Abutments EV and ATLANTIS™ ● Proprietary Name:
  - Suprastructures Classification Name: Endosseous dental implant abutment
    - 21 CFR 872.3630
- . CFR Number: Class II
- Device Class: ●
- Product Code: NHA ●

Predicate Device: 3.

The predicate devices for the Multibase Abutments EV and ATLANTISTM Suprastructures, subject to this bundled 510(k) submission, are as follows:

Predicate Device Name	510(k)	Company Name
OsseoSpeed™ Angled Abutment EV(Primary Predicate Device)	K121810	Dentsply Sirona(formerly ASTRA TECH)
NobelActive Multi Unit Abutment(Reference Predicate Device)	K072570	Nobel Biocare
OsseoSpeed™ Plus(Reference Predicate Device)	K120414	Dentsply Sirona(formerly Astra Tech AB)
OsseoSpeed™ Profile EV(Reference Predicate Device)	K130999	Dentsply Sirona

Predicate devices for the proposed Multibase Abutments EV:

Predicate device for the modifications relating to the proposed compatibility of the ATLANTIS™ Suprastructures with the proposed Multibase Abutments EV:

Predicate Device Name	510(k)	Company Name
ATLANTIS™ ISUS Implant Suprastructures(Primary Predicate Device)	K160207	Dentsply Sirona

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4. Description of Device:

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 screwretained connection.

Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.

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న. Indications for Use:

Multibase Abutments EV

ATLANTIS™ Suprastructures

ATLANTISTM 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.

ATLANTISTM Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Manufacturer	Name of Implant	Size
Biomet 3i	Certain	3.25, 4/3 – Prevail 3/4/3, 4/3
	Certain	4.0, 5/4 – Prevail 4/5/4. 5/4
	Certain	5.0, XP 4/5 – Prevail 5/6/5, 6/5
	Certain	6.0, XP 5/6
BioHorizons	Internal/Tapered	3.5, 4.5, 5.7
Camlog	Screw-line Implant	3.3
	Screw-line / Root-line Implant	3.8, 4.3, 5.0, 6.0
DENTSPLY Implants	XiVE	S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
	OsseoSpeed™ TX	3.0, 3.5/4.0, 4.5/5.0
	OsseoSpeed™ Profile TX	4.5/5.0
	OsseoSpeed™ EV	3.0, 3.6, 4.2, 4.8, 5.4
	OsseoSpeed™ Profile EV	4.2, 4.8
Keystone Dental	PrimaConnex	SD 3.3/3.5
	PrimaConnex	RD 4.0/4.1
	PrimaConnex	WD 5.0
	Genesis	3.8, 4.5, 5.5/6.5
Nobel Biocare	NobelActive	NP 3.5 – RP 4.3, 5.0
	NobelReplace	NP-3.5 – RP 4.3 – WP 5.0 – 6.0
Straumann	Bone Level	3.3 NC – 4.1, 4.8 NC
	Standard Plus	3.5 NN
	Standard / Standard Plus	4.8 RN – 4.8 WN
Zimmer Dental	Tapered Screw Vent/Screw Vent	Tapered S-V 3.5/S-V 3.3, 3.7/Tapered S-V 4.5/ S-V 4.5
	Tapered Screw Vent	5.7

Implants:

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Abutments:

Manufacturer	Name of Abutment
Biomet 3i	Low Profile Abutment
DENTSPLY	ATIS Uni Abutment EV
	ATIS UniAbutment 20°, ATIS UniAbutment 45°
	ATIS Angled Abutment EV
	ATIS Angled Abutment 20°
	ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
	ATIS Multibase Abutment EV
	XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
	XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare	Multi-Unit Abutment RP
Straumann	Bone Level Multi-Base Angled Abutment
	Bone Level Multi-Base Abutment D3.5, D4.5
	RN Abutment Level, WN Abutment Level
	Screw-Retained Abutment 3.5, 4.6
Zimmer Dental	Tapered Abutment

1. Substantial Equivalence:

Technological Characteristics

An overview of the similarities and differences between the subject and predicate devices is given in Table 1/ Table 3: Indications for Use for the proposed and the predicate Abutments/ Suprastructures and in Table 2/ Table 4: Similarities and Differences between the proposed and the predicate Abutments/ Suprastructures

Biocompatibility

The material used for the Multibase Abutments EV and the ATLANTISTM Suprastructures, including the corresponding screws, and the manufacturing process remained unchanged compared to the corresponding primary predicate devices, OsseoSpeed™ Angled Abutment EV (K121810) and ATLANTIS™ ISUS Implant Suprastructures (K160207). Therefore, no additional biocompatibility testing has been performed.

7. Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:

Sterilization: Sterilization validation of the sterile, straight variants of the subject ● Multibase Abutments EV is referenced by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1 and ISO 11137-2 which conclude that a sterility assurance level (SAL) of 106 is achieved under the sterilization process parameters utilized. Sterilization validation of the angled variants of the subject Multibase Abutments EV was conducted to validate an SAL of 10- according to ISO 11137-1 and ISO 11137-2 and the results are summarized in this premarket notification.
. Moist heat sterilization parameters of non-sterile components included with the subject Multibase Abutments EV were validated by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 17665-1 and ISO17665-2 demonstrating a sterility assurance level (SAL) of 10-9.

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Packaging and shelf life validation according to ISO 11607 and ASTM F1980 were ● conducted and the results are referenced to support substantial equivalence.
Fatigue Testing: Dynamic fatigue testing conducted on the worst case construct of ● the subject Multibase Abutments EV devices according to ISO 14801 is included to support substantial equivalence.
Geometric measurement data and statistical compatibility analysis is included to support the compatibility of the subject Multibase Abutments EV devices with the temporary prosthetic cylinder and bridge screw components of the reference predicate system (K072570).
. Cross-sectional material analysis of the ATLANTIS™ Suprastructures interface with the subject Multibase Abutments EV devices is included and compared to existing worst case interface geometry to support substantial equivalence.

8. Conclusion Regarding Substantial Equivalence

The proposed Multibase Abutments EV and the proposed abutment-interface of the ATLANTISTM Suprastructures, subject of this bundled 510(k), are endosseous dental implant abutments which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The proposed Multibase Abutments EV and the proposed corresponding ATLANTISTM Suprastructures have the same intended use, incorporates the same fundamental technology, and have similar indications for use as the predicate devices for the Multibase Abutments EV (K121810, K072750, K120414, K130999) and the predicate device for the ATLANTIS™ Suprastructures (K160207), respectively.

Thus, it can be concluded that the proposed Multibase Abutments EV and ATLANTISTM Suprastructures are substantially equivalent to the predicate devices.

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Proposed Device	Primary Predicate Device	Reference Predicate Device
Dentsply SironaMultibase Abutments EV	Dentsply SironaOsseoSpeed™ Angled Abutment EVK121810	Nobel BiocareNobelActive Multi Unit AbutmentK072570
The Multibase Abutments EV areintended to be used in conjunctionwith Astra Tech Implant SystemEV in fully edentulous or partiallyedentulous maxillary and/ormandibular arches to providesupport for bridges oroverdentures.	OsseoSpeed™ Angled Abutment EV isintended to be used in conjunction withAstra Tech implant System EV in fullyedentulous or partially edentulousmaxillary and/or mandibular arches toprovide support for bridges oroverdentures.The Atlantis™ Abutment is intended for usewith an endosseous implant to support aprosthetic device in a partially or completelyedentulous patient. It is intended for use tosupport single and multiple tooth prostheses,in the mandible or maxilla. The prosthesis canbe cemented, screw retained or friction fit tothe abutment. The abutment screw is intendedto secure the abutment to the endosseousimplant.The Atlantis™ Crown Abutment in Zirconia isintended for use with an endosseous implantto function as a substructure that also servesas the final restoration, in partially orcompletely edentulous patients. The prosthesisis screw retained. The abutment screw isintended to secure the crown abutment to theendosseous implant.Atlantis™ Abutment and Atlantis™ CrownAbutment are compatible with Ø5.4 AstraTech Implant System EV	NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implantand is intended for use as an aid prostheticrehabilitation.

The indications for use of the subject Multibase Abutments EV devices are identical to the cleared indications for use of the primary predicate Osseospeed™ Angled Abutment EV devices cleared in premarket notification K121810. Also cleared in K121810 with the primary predicate Osseospeed™ Angled Abutment EV were the Atlantis™ Abutment and the Atlantis™ Crown Abutment in Zirconia. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia were cleared in K121810 with indications for use which are independent from the cleared indications for use of the primary predicate Osseospeed™ Angled Abutment EV (K121810) as shown in Table 1 above. Comparison to the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia was not included to support the substantial equivalence of the subject Multibase Abutments EV devices.

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	Proposed Device	Primary Predicate Device	Reference Predicate Device
	Dentsply SironaMultibase Abutments EV	Dentsply SironaOsseoSpeedTMAngled Abutment EVK121810	Nobel BiocareNobelActiveMulti Unit AbutmentK072570
Design
Prosthesis Attachment	Screw-retained	Screw-retained	Screw-retained
Restoration	Multi-unit	Multi-unit	Multi-unit
Abutment design	One-piece (0°),Two-piece (17°, 30°)	One-piece	One-piece
Abutment Angulation	0°, 17°, 30°	20°, 30°	0°, 17°, 30°
Gingiva Height	1.5, 2.5, 3.5 mm	1.0, 2.0, 3.0 mm	1.5, 2.5, 3.5, 4.5 mm
Interface abutment-implant	Internal	Internal	Internal
Material
Abutment	Ti-6Al-4V	Ti-6Al-4V	Ti6Al4V
Screw	Ti-6Al-4V	Ti-6Al-4V	Ti6Al4V
Delivery	sterile	sterile	sterile

Table 2: Similarities and Differences between the proposed and the predicate Abutments

The "two-piece" abutment design of the subject angled Multibase Abutments EV devices refers to the threaded superior cap which facilitates the closure of the abutment body's attachment screw channel. When the cap is assembled to the subject angled Multibase Abutments EV abutment body, the superior portion of the abutment device is geometrically identical to that of the one-piece "straight" (0°) abutment design.

Dynamic fatigue testing conducted according to ISO 14801 and referenced in Section 7 of this 510(k) Summary was conducted on the worst case (angled) construct of the subject Multibase Abutments EV devices, which included the two-piece assembly with attached screw channel cap as described above. The results of the dynamic fatigue testing conducted according to ISO 14801 and included in this premarket notification support the substantial equivalence of the subject Multibase Abutments EV.

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			Table 3: Indications for Use for the proposed and the predicate Suprastructures

Proposed Device			Predicate Device
Dentsply Sirona			Dentsply Sirona
ATLANTIST™ Suprastructures			ATLANTIST™ Implant Suprastructures
			K160207
ATLANTIST™ Suprastructures are indicated for attachment to dental			ATLANTIST™ Suprastructures are indicated for attachment to dental
implants or abutments in the treatment of partially or totally edentulous			implants or abutments in the treatment of partially or totally edentulous
jaws for the purpose of restoring chewing function.			jaws for the purpose of restoring chewing function.
ATLANTIST™ Suprastructures are intended for attachment to a minimum			ATLANTIST™ Suprastructures are intended for attachment to a minimum
of two (2) implants and are indicated for compatibility with the			of two (2) implants and are indicated for compatibility with the following
following implant and abutment systems:			implant and abutment systems:
Implants:			Implants:
Manufacturer	Name of Implant	Size	Manufacturer	Name of Implant	Size
Biomet 3i	Certain	3.25, 4/3 - Prevail 3/4/3, 4/3	Biomet 3i	Certain	3.25, 4/3 - Prevail 3/4/3, 4/3
	Certain	4.0, 5/4 - Prevail 4/5/4. 5/4		Certain	4.0, 5/4 - Prevail 4/5/4. 5/4
	Certain	5.0, XP 4/5 - Prevail 5/6/5, 6/5		Certain	5.0, XP 4/5 - Prevail 5/6/5, 6/5
	Certain	6.0, XP 5/6		Certain	6.0, XP 5/6
BioHorizons	Internal/Tapered	3.5, 4.5, 5.7	BioHorizons	Internal/Tapered	3.5, 4.5, 5.7
Camlog	Screw-line Implant	3.3	Camlog	Screw-line Implant	3.3
	Screw-line / Root-line	3.8, 4.3, 5.0, 6.0		Screw-line / Root-line	3.8, 4.3, 5.0, 6.0
DENTSPLYImplants	XiVE	S 3.0, S 3.4, S 3.8, S 4.5, S 5.5	DENTSPLYImplants	XiVE	S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
	OsseoSpeed™ TX	3.0, 3.5/4.0, 4.5/5.0		OsseoSpeed™ TX	3.0, 3.5/4.0, 4.5/5.0
	OsseoSpeed™ Profile TX	4.5/5.0		OsseoSpeed™ Profile TX	4.5/5.0
	OsseoSpeed™ EV	3.0, 3.6, 4.2, 4.8, 5.4		OsseoSpeed™ EV	3.0, 3.6, 4.2, 4.8, 5.4
	OsseoSpeed™ Profile EV	4.2, 4.8		OsseoSpeed™ Profile EV	4.2, 4.8
KeystoneDental	PrimaConnex	SD 3.3/3.5	KeystoneDental	PrimaConnex	SD 3.3/3.5
	PrimaConnex	RD 4.0/4.1		PrimaConnex	RD 4.0/4.1
	PrimaConnex	WD 5.0		PrimaConnex	WD 5.0
	Genesis	3.8, 4.5, 5.5/6.5		Genesis	3.8, 4.5, 5.5/6.5
Nobel Biocare	NobelActive	NP 3.5 - RP 4.3, 5.0	Nobel Biocare	NobelActive	NP 3.5 - RP 4.3, 5.0
	NobelReplace	NP-3.5 - RP 4.3 - WP 5.0 -		NobelReplace	NP-3.5 - RP 4.3 - WP 5.0 -
Straumann	Bone Level	3.3 NC - 4.1, 4.8 NC	Straumann	Bone Level	3.3 NC - 4.1, 4.8 NC
	Standard Plus	3.5 NN		Standard Plus	3.5 NN
	Standard / Standard Plus	4.8 RN - 4.8 WN		Standard / Standard Plus	4.8 RN - 4.8 WN
Zimmer DentalScrew Vent	Tapered Screw Vent /	Tapered S-V 3.5/S-V 3.3, 3.7 /Tapered S-V 4.5/ S-V 4.5	Zimmer DentalScrew Vent	Tapered Screw Vent	Tapered S-V 3.5/S-V 3.3, 3.7 /S-V 4.5/ S-V 4.5
	Tapered Screw Vent	5.7		Tapered Screw Vent	5.7
Abutments:			Abutments:
Manufacturer	Name of Abutment		Manufacturer	Name of Abutment
Biomet 3i	Low Profile Abutment		Biomet 3i	Low Profile Abutment
DENTSPLY	ATIS Uni Abutment EV		DENTSPLY	ATIS Uni Abutment EV
	ATIS UniAbutment 20°, ATIS UniAbutment 45°			ATIS UniAbutment 20°, ATIS UniAbutment 45°
	ATIS Angled Abutment EV			ATIS Angled Abutment EV
	ATIS Angled Abutment 20°			ATIS Angled Abutment 20°
	ANKYLOS Balance Base Narrow D4.2, Balance			ANKYLOS Balance Base Narrow D4.2, Balance
	ATIS Multibase Abutment EV			XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
	XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5			XiVE TG 3.4, TG 3.8, TG 4.5
	XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare	Multi-Unit Abutment RP		Nobel Biocare	Multi-Unit Abutment RP
Straumann	Bone Level Multi-Base Angled Abutment		Straumann	Bone Level Multi-Base Angled Abutment
	Bone Level Multi-Base Abutment D3.5, D4.5RN Abutment Level, WN Abutment LevelScrew-Retained Abutment 3.5, 4.6			Bone Level Multi-Base Abutment D3.5, D4.5RN Abutment Level, WN Abutment LevelScrew-Retained Abutment 3.5, 4.6
Zimmer Dental	Tapered Abutment		Zimmer Dental	Tapered Abutment

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As shown in Table 3, the modification to the indications for use of the ATLANTISTM Suprastructures which is subject to this premarket notification consists of the addition of the Astra Tech Implant System (ATIS) Multibase Abutment EV device to the list of compatible abutments. There are no other changes to the indications for use of the ATLANTIS™ Suprastructures as compared to the indications for use cleared previously under premarket notification K160207.

In order to support the substantial equivalence of the addition of compatibility with the Multibase Abutment EV devices to the indications for use of the ATLANTIS™ Suprastructures, geometric analysis of the abutment interface was included. The results of the analysis showed that the interface which facilitates compatibility with the Multibase Abutment EV devices does not present a new worst case with respect to cross-sectional material geometry and the modification therefore does not affect the substantial equivalence of the ATLANTISTM Suprastructures.

	Proposed Device	Predicate Device
	Dentsply SironaATLANTIS™ Suprastructures	Dentsply SironaATLANTIS™ ISUS ImplantSuprastructuresK160207
Design
Prosthesis Attachment	Screw-retained, Friction-fit	Screw-retained, Friction-fit
Design of Suprastructure	Bar,BridgeHybrid2 in 1	Bar,BridgeHybrid2 in 1
Platform diameter	3.0-6.5	3.0-6.5
Interface suprastructure-implant/ abutment	Internal, External	Internal, External
Material
Suprastructure	CPTi, CoCr	CPTi, CoCr
Screw	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Delivery	sterile	sterile

Table 4: Similarities and Differences between the proposed and the predicate Suprastructures

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.)