Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.

DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

Device Description

The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).

The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:

TempBase EV, and its accessory component TempBase Cap
Cover Screw EV
Healing Abutment EV
HealDesign EV
TempAbutment EV
TiDesign EV
CastDesign EV
MultiBase Abutment EV
Abutment Screw EV

The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are:

Compatible with the proposed (A) OmniTaper EV implants,
Represent an additional abutment type (TempBase EV abutment and cap),
Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).

The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).

The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.

The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.

The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.

AI/ML Overview

This response addresses the requested information based on the provided text, but it's important to note that the document describes a dental implant and abutment system, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable and will be marked as "Not Applicable (N/A)".

Device Name: OmniTaper EV Dental Implants and DS Implants abutments with EV connection

Device Type: Endosseous Dental Implants and Abutments

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the "acceptance criteria" are demonstrated through substantial equivalence to predicate and reference devices, supported by non-clinical performance data (e.g., sterilization, biocompatibility, fatigue, MRI testing) and clinical literature review. There are no explicit performance metrics in the format of a typical diagnostic device's acceptance criteria, but rather a demonstration that the new devices are as safe and effective as existing legally marketed devices.

Acceptance Criteria Category	Specific Criteria (Implicitly met by substantial equivalence)	Reported Device Performance
Material Composition	Commercially pure titanium (Grade 4) for implants (A)	Same as predicate (A) device (K120414), differs from reference device (Grade 2).
Surface Treatment	TiO2 blasted and acid etched for implants (A)	Same as predicate (A) device (K120414).
Connection Type	Conical connection with indexes (EV Connection) for implants (A)	Same as predicate (A) device (K120414).
Implant Design	Cylindrical, threaded, self-tapping apical thread, (micro)extended implant shoulder (for implants A)	Same as reference device (K073075). Supported by fatigue testing compared to predicate.
Dimensions (Implants)	Specific diameters and lengths for OmniTaper EV (A)	Same as reference device (K073075) with minor material thickness modification for certain 8mm implants. Supported by fatigue testing compared to predicate.
Abutment Connection Size	Compatibility with XS, S, M, L, XL sizes for abutments (B)	Expansion of offering to include XS and XL. TempBase EV abutment and Cap in all sizes. Supported by fatigue testing.
Prosthesis Attachment	Cement-retained and Screw-retained for abutments (B)	Same as predicate (B) device (K213449).
Abutment Angulation	TiDesign EV: 0°, 15°; MultiBase EV: 0°; TempBase EV: 0°; CastDesign EV: 0° (for abutments B)	TiDesign EV and CastDesign EV same as predicate. TempBase EV same as reference. MultiBase EV (XS, XL) not available as angulated abutment.
Sterility Assurance Level (SAL)	10^-6 for sterile devices	Validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2013 (E-beam irradiation).
Biocompatibility	Conformance with ISO 10993-1, -5, -18	Confirmed by cytotoxicity, gas chromatography (GC-MS), Fourier transformation infrared spectroscopy (FT-IR), and pyrogenicity testing.
Dynamic Fatigue Performance	Meet requirements of ISO 14801:2016 for worst-case implant-abutment combinations	Test results demonstrate performance as intended, comparable to predicate devices.
MRI Safety	MRI Conditional for implant and abutments, MR Safe for TempBase Cap	Supported by testing for magnetically induced displacement force, torque, image artifact, and RF Induced Heating Simulation.
Shelf Life	5 years for implants and sterile/non-sterile abutments	Packaging integrity confirmed by testing to ASTM F 1929-15, ISO 11607-1:2019, EN 868-10:2018 for implants; existing validation for abutments.
Pyrogenicity	Meet established pyrogen limit	Confirmed by Limulus amebocyte lysate (LAL) test (USP <85>).
Cleaning/Disinfection (TempBase Cap)	Efficacy of cleaning and disinfection processes	Validation performed according to ASTM E 1837:2014 and ASTM E 2314:2014, leveraging reference device validation.

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

Non-Clinical Test Set: The document describes various non-clinical tests (sterilization, biocompatibility, fatigue, MRI) but does not specify numerical sample sizes for these tests. It indicates that "worst-case" implant-abutment combinations were tested. The provenance of this data is internal to Dentsply Sirona or their contracted labs, as it states "Non-clinical testing data submitted, referenced, or relied upon..."
Clinical Literature Review (Test Set): For the clinical relevance of the Ø3.0 implant, four peer-reviewed scientific publications were referenced. These studies presented 1 to 4 years of prospective clinical follow-up data on over 580 Xive S Plus D 3.0 implants. The country of origin for these publications is not specified, but they are peer-reviewed scientific literature.

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)

N/A. This device is a dental implant system, not a diagnostic AI device requiring expert-established ground truth for a test set. Clinical relevance was supported by published peer-reviewed literature.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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 information is for AI performance evaluation. The device is a physical medical device.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

Non-Clinical Testing: Ground truth is established by standardized testing protocols and existing predicate device performance, ensuring properties like sterility, biocompatibility, and mechanical strength meet established engineering and safety standards.
Clinical Literature Review: The clinical "ground truth" for the 3.0mm implant's effectiveness and safety (survival rates, stable marginal bone) is derived from outcomes data reported in multiple peer-reviewed scientific publications with prospective clinical follow-up.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its development and validation rely on engineering design, materials science, and non-clinical testing, followed by comparisons to predicate devices and review of existing clinical literature.

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

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Dentsply Sirona Courtney Clark Senior Director of Regulatory Affairs, Corporate 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K221094

Trade/Device Name: OmniTaper EV Dental Implants, DS Implants abutments with EV connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 20, 2022 Received: October 20, 2022

Dear Courtney Clark:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221094

Device Name OmniTaper EV Dental Implants

Indications for Use (Describe)

The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

· Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
· Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
· Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.

· Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

· The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known)

K221094

Device Name DS Implants abutments with EV Connection

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.

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Indications for Use

510(k) Number (if known)

K221094

Device Name DS Implants abutments with EV Connection

Indications for Use (Describe)

MultiBase Abutments EV:

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.

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.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY for K221094 - OmniTaper EV Dental Implants and Abutments

1. Submitter Information:
  Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person: Courtney Clark Telephone Number: 248-895-4379 Fax number: 717-849-4343

Date Prepared: November 10, 2022

1. Device Name:

•	Proprietary Name:	OmniTaper EV Dental Implants,DS Implants abutments with EV connection
•	Classification Name:	Implant, Endosseous, Root-formAbutment, Implant, Dental Endosseous
•	Classification Number:	872.3640
•	Device Class:	Class II
•	Product Codes:	Primary product code: DZESecondary product code: NHA

3. Predicate and Reference Devices:

The proposed devices in this bundled 510(k) include bundles (A) and (B):

(A) OmniTaper EV Dental Implants, and
(B) DS Implants abutments with EV Connection

There are two predicate devices identified relating to the substantial equivalence for the proposed devices (A) and (B), as referred to above as bundles (A) and (B):

Predicate Device (A) Name	510(k)	Company Name
OsseoSpeed Plus Implants*	K120414	Dentsply Sirona(Formerly: Astra Tech AB)
Predicate Device (B) Name	510(k)	Company Name

*NOTE: The OsseoSpeed Plus K120414 clearance included the Astra Tech OsseoSpeed Plus Implants, which are currently marketed as Astra Tech OsseoSpeed EV Implants, and Astra Tech Implant System Plus abutments, which are currently marketed as Astra Tech Implant EV abutments. Therefore, this submission will hereafter refer to the implants cleared under OsseoSpeed Plus (K120414) as predicate

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(A) Astra Tech EV Implants (K120414) and the abutments cleared under the same 510(k) as compatible Astra Tech EV Abutments (K120414)

In addition, four reference devices are identified to support any differences in technological characteristics:

Reference Device Name	510(k)	Company Name
Xive S Plus Dental ImplantSystem	K073075	Dentsply Sirona(formerly: Dentsply International)
PrimeTaper EV Dental ImplantSystem	K210610	Dentsply Sirona
Xive Dental Implant System
Friadent TempBase EV Abutment(Ø3.5 - Ø5.5)	K013867	Dentsply Sirona(formerly: Friadent GmbH)
Xive 3.0 Dental Implant System
Friadent TempBase EV Abutment(Ø3.0)	K030639	Dentsply Sirona(formerly: Friadent GmbH)

4. Description of Device:

The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:

TempBase EV, and its accessory component TempBase Cap ●
Cover Screw EV ●
Healing Abutment EV ●
HealDesign EV ●
TempAbutment EV
TiDesign EV ●
CastDesign EV ●
MultiBase Abutment EV ●
Abutment Screw EV ●

Compatible with the proposed (A) OmniTaper EV implants, ●
Represent an additional abutment type (TempBase EV abutment and cap),

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Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to . the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).
The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).

The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.

Risk analysis for the proposed devices was conducted in accordance with ISO 14971:2019, "Medical Devices: Application of Risk management to medical devices". Risks listed in the FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Class II Special Controls Guidance Document Guidance for Industry and FDA Staff" were addressed and all risks associated with the proposed implants and abutments were acceptable and as low as possible.

5. Indications for Use:

The Indications for Use for the proposed (A) OmniTaper EV Dental Implants are:

The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

Replacing missing teeth in single or multiple unit applications in the mandible or . maxilla.
Immediate placement in extraction sites and in situations with a partially or . completely healed alveolar ridge.
Especially indicated for use in soft bone applications where implants with other . implant surface treatments may be less effective.
Immediate and early loading for all indications, except in single tooth situations on . implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate.
The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of . maxillary lateral incisors and mandibular incisors.

All proposed (B) DS Implants abutments with EV connection, with the exception of the MultiBase Abutment EV, fall under the first indications for Use statement below. The second Indications for Use statement applies to the proposed (B) MultiBase Abutment EV.

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DS Implants abutments with EV connection:

MultiBase Abutments EV:

6. Comparison of Technological Characteristics:

The proposed (A) OmniTaper EV implants are a new line of endosseous dental implants which are identical with regards to material, surface treatment and internal implantabutment connection geometry (i.e. the EV connection) as the predicate (A) Astra Tech EV Implants (K120414). The implant dimensions and outer implant design with thread design properties, thread pitch, self-tapping apical thread, condensing upper section and microextended implant shoulder of the proposed (A) OmniTaper EV implants are the same or very similar to reference device Xive S Plus implants (K073075). The proposed (A) OmniTaper EV implant also shares the same packaging as the reference device (K073075).

The proposed (B) DS Implants abutments with EV connection are based on the design of the predicate (B) DS Implants Abutments (K213449). It is a line extension of the assortment of compatible EV abutments by:

. adding an abutment type (TempBase EV abutment and Cap) and
adding abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS . Implants abutments with EV Connection (K213449).

The design of the proposed (B) TempBase EV abutment is similar to reference device Friadent TempBase Abutments (K030639, K013867) in that the proposed (B) TempBase EV abutment has an EV connection, while the reference device Friadent TempBase Abutments (K030639, K013867) are designed for a hexagonal implant connection. The proposed (B) TempBase EV is pre-mounted on the proposed (A) OmniTaper EV Implant and are packaged together in very similar packaging as reference device Xive S Plus implant (K073075). The proposed (B) accessory component TempBase Cap has identical design and material as reference device Friadent TempBase Cap (K013867) and is cleaned and disinfected in the same way.

The proposed (B) DS Implants abutments with EV connection (XS, XL) and predicate (B) DS Implants abutments with EV connection (K213449) have the same intended use, same Indications for Use, same materials, same design (one-piece or two-piece), same prosthesis attachment method (screw-retained or cement-retained), same manufacturing, same packaging (sterile and non-sterile) and same sterilization method as the predicate (B) abutments (K213449).

An overview of the similarities and differences between the proposed devices (A) and (B) and predicate (A) and (B) devices, including reference devices, are given in Table 1 through Table 4 below.

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Item	Proposed device (A)	Predicate device (A)	Comparison Discussion
	Dentsply Sirona	Dentsply Sirona
	OmniTaper EV Dental Implants	Astra Tech EV Implants (K120414)
Indications for Use	The implants are intended for both one- and two-stage surgical procedures in the followingsituations and with the following clinicalprotocols:Replacing missing teeth in single ormultiple unit applications in the mandibleor maxilla. Immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge. Especially indicated for use in soft boneapplications where implants with otherimplant surface treatments may be lesseffective. Immediate and early loading for allindications, except in single toothsituations on implants shorter than 8 mmor in soft bone (type 4) where implantstability may be difficult to obtain, andimmediate loading may not beappropriate. The intended use for OmniTaper EV Ø3.0implant is limited to replacement ofmaxillary lateral incisors and mandibularincisors.	The Astra Tech Dental Implants are intended forboth one- and two-stage surgical procedures in thefollowing situations and with the following clinicalprotocols:Replacing single and multiple missingteeth in the mandible and maxilla, Immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge, Especially indicated for use in soft boneapplications where implants with otherimplant surface treatments may be lesseffective, Immediate loading in all indications,except in single tooth situations onimplant shorter than 8 mm or in soft bone(type IV) where implant stability may bedifficult to obtain and immediate loadingmay not be appropriate. The intended use for OsseoSpeed Plus 3.0S is limited to replacement of maxillarylateral incisors and mandibular incisors.	The Indications for Use of the proposed andpredicate implants are similar.The indications of the proposed and predicatedevice have slight differences in wording, forclarification only.For the proposed (A) device, "early loading" wasadded to describe the loading protocol of theimplant in more detail.The differences in the proposed and predicateIndications for Use do not substantively alter themeaning.

Table 1: Similarities and Differences between the Proposed (A) and Predicate (A) Dental Implants Indications for Use

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Table 2: Similarities and Differences between the Proposed devices (A), and Reference Device Device Dental Implants Technological Characteristics

Item	Proposed devices (A)	Predicate devices (A)	Reference devices	Comparison Discussion
	Technological Characteristics
	Dentsply SironaOmniTaper EV Dental Implants	Dentsply SironaAstraTech EV Dental Implants(K120414)	Dentsply SironaXive S Plus implants(K073075)
Implantmaterial	Commercially pure titanium (Grade 4)(ASTM F67-13 (2017))	Commercially pure titanium (Grade 4)(ASTM F67-13 (2017))	Commercially pure titanium (Grade 2)(ASTM F67-13 (2017))	Same as predicate device (A) (K120414).
Surfacetreatment	TiO2 blasted and acid etched	TiO2 blasted and acid etched	Grit blasted and acid etched	Same as predicate device (A) (K120414).
Connectiontype	Conical connection with indexes (EVConnection)	Conical connection with indexes (EVConnection)	Internal hexagonal connection	Same as predicate device (A) (K120414).
Implantdesign	Cylindrical, threaded, self-tappingapical thread	Cylindrical, threaded	Cylindrical, threaded, self-tappingapical thread	Same as reference device (K073075).
Neck design	(Micro)extended implant shoulder	Cylindrical with micro-threads	(Micro)extended implant shoulder	Same as reference device (K073075).
Type ofimplantation	Bone level implant	Bone level implant	Bone level implant	Same.
Sites in body	Mandible/maxilla	Mandible/maxilla	Mandible/maxilla	Same.
Implantdiameter andlength	Ø 3.0 diameter implant: Limited tomaxillary lateral incisors andmandibular incisorsØ 3.0 x L 11, 13 and 15 mmØ 3.4 x L 9.5, 11, 13, 15 and 18 mmØ 3.8 x L 8, 9.5, 11, 13, 15 and 18 mmØ 4.5 x L 8, 9.5, 11, 13, 15 and 18 mmØ 5.5 x L 8, 9.5, 11, 13 and 15 mm	Ø 3.0 diameter implant: Limited tomaxillary lateral incisors andmandibular incisorsØ 3.0 x L 8, 9, 11, 13 and 15 mmØ 3.6 x L 6, 8, 9, 11, 13, 15 and 17 mmØ 4.2 x L 6, 8, 9, 11, 13, 15 and 17 mmØ 4.8 x L 6, 8, 9, 11, 13, 15 and 17 mmØ 5.4 x L 6, 8, 9, 11, 13 and 15 mm	Ø 3.0 diameter implant: Limited tomaxillary lateral incisors andmandibular incisorsØ 3.0 x L 11, 13 and 15 mmØ 3.4 x L 9.5, 11, 13, 15 and 18 mmØ 3.8 x L 8, 9.5, 11, 13, 15 and 18 mmØ 4.5 x L 8, 9.5, 11, 13, 15 and 18 mmØ 5.5 x L 8, 9.5, 11, 13 and 15 mm	Same as reference device (K073075) withminor modification to the outer geometrythickness of material for 8 mm lengthimplants (Ø 3.8, 4.5, and 5.5) only, whichdo not represent new worst case implants.Substantial equivalence is supported byfatigue testing with similar results comparedto predicate device (A) (K120414).
Item	Proposed devices (A)Dentsply SironaOmniTaper EV Dental Implants	Predicate devices (A)Dentsply SironaAstraTech EV Dental Implants(K120414)	Reference devicesDentsply SironaXive S Plus implants(K073075)	Comparison Discussion
Angulation ofcompatibleabutments	XS (Ø3.0): 0°, 15°S – L (Ø3.4-4.5): 0°, 15°, 17°, 20°, 30°XL (Ø5.5): 0°, 15°(Compatible abutments cleared inK120414, K121810, K163350,K111287, K130999, K112138,K213449)	Ø3.0: 0°, 15°Ø3.6-4.8: 0°, 15°, 17°, 20°, 30°Ø5.4: 0°(Compatible abutments cleared inK120414, K121810, K163350,K183079, K111287, K130999,K112138, K213449)	Ø3.0: 0°, 15°Ø3.4-5.5: 0°, 15°, 30°(Compatible abutments cleared inK945847, K980630, K982576,K994174, K994376, K013438,K013867, K030639, K072730,K093780, K122268, K183079)	Proposed (A) device is compatible withabutments within the same range ofangulation as the reference implants(K073075).Substantial equivalence is supported byfatigue testing with similar results comparedto predicate device (A) (K120414).
Reusability	Single use	Single use	Single use	Same.
Sterility state	Sterile	Sterile	Sterile	Same.
Sterilizationmethod	Electron-beam irradiation	Electron-beam irradiation	Gamma irradiation	Same as predicate device (A) (K120414)

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Item	Proposed device (B)	Predicate device (A)	Comparison Discussion
	Dentsply Sirona	Dentsply Sirona
	DS Implants Abutments with EV connection	DS Implants Abutments with EV connection(K213449)
Indications for Use	DS Implants abutments with EV connection:DS Implants abutments provided with the EVconnection are intended to be used in conjunctionwith implants with the EV connection in fullyedentulous or partially edentulous maxillary and/ormandibular arches to provide support for crowns,bridges or overdentures.MultiBase Abutment EV:DS Implants abutments provided with the EVconnection are intended to be used in conjunctionwith implants with the EV connection in fullyedentulous or partially edentulous maxillary and/ormandibular arches to provide support for bridgesor overdentures.	DS Implants abutments with EV connection:DS Implants abutments provided with the EVconnection are intended to be used in conjunctionwith implants with the EV connection in fullyedentulous or partially edentulous maxillary and/ormandibular arches to provide support for crowns,bridges or overdentures.MultiBase Abutment EV:DS Implants abutments provided with the EVconnection are intended to be used in conjunctionwith implants with the EV connection in fullyedentulous or partially edentulous maxillary and/ormandibular arches to provide support for bridgesor overdentures.	Same.
Item	Proposed device (B)	Predicate device (A)	Reference devices	Comparison Discussion
	Dentsply SironaDS Implants Abutments with EVconnection	Dentsply SironaDS Implants Abutments withEV connection(K213449)	Dentsply SironaXive Dental Implant SystemAbutments and Accessories(K013867, K030639)
Connection Size	XS, XLTempBase EV Abutment and Cap:XS, S, M, L, XL	S, M, L	Friadent TempBase Abutmentand TempBase Cap:D3.0, D3.4, D3.8, D4.5, D5.5	Expansion of offering to include XS andXL abutments compatible with proposed(A) device. Addition of TempBase EVabutment and Cap in all sizes.Substantial equivalence supported byfatigue testing.
Prosthesisattachment	Cement-retainedScrew-retained	Cement-retainedScrew-retained	TempBase Abutment:Screw-retained	Same
Abutmentangulation	TiDesign EV:0°, 15°MultiBase EV:0°TempBase EV:0°CastDesign EV:0°	TiDesign EV:0°, 15°MultiBase EV:0°, 17°, 30°CastDesign EV:0°	TempBase Abutment:0°	TiDesign EV: Same as predicate deviceTempBase EV: Same as reference deviceMultiBase EV: Proposed (B) MultiBaseabutments (XS) and (XL) are notavailable as an angulated abutment.CastDesign EV: Straight abutment, noangular correction. Same as predicatedevice.
Abutmentdesign	One-piece (0°),Two-piece (0°,15°)	One-piece (0°),Two-piece (0°,15°)	TempBase Abutment:One-piece (0°)	Same
Gingiva height	Healing Abutment EV:2, 3, 4, 6 mmHealDesign EV:2.5, 3.5, 4.5, 6.5 mmTiDesign EV:	Healing Abutment EV:2, 3, 4, 6 mmHealDesign EV:2.5, 3.5, 4.5, 6.5 mmTiDesign EV:	Not applicable for substantialequivalence	Same as predicate device.
Item	Proposed device (B)	Predicate device (A)	Reference devices	Comparison Discussion
	Dentsply SironaDS Implants Abutments with EVconnection	Dentsply SironaDS Implants Abutments withEV connection(K213449)	Dentsply SironaXive Dental Implant SystemAbutments and Accessories(K013867, K030639)
	1.5, 2.5, 3.5, 4.5 mmMultiBase Abutment EV:1.5, 2.5, 3.5, 4.5 mm	1.5, 2.5, 3.5, 4.5 mmMultiBase Abutment EV:1.5, 2.5, 3.5, 4.5 mm
Materials	Abutments:Titanium Alloy or Gold AlloyAbutment screws:Titanium AlloyAbutment holder:PEEKBurn-out sleeve and TempBaseCap:Plastic	Abutments:Titanium Alloy or Gold AlloyAbutment screws:Titanium AlloyAbutment holder:PEEKBurn-out sleevePlastic	TempBase Abutment:Titanium AlloyTempBase Cap:Plastic	Same
ManufacturingProcess	Milling	Milling	Milling	Same
Surfacetreatment	Anodization(abutment + abutment screw)	Anodization(abutment + abutment screw)	Anodization(abutment)	Same
Reusability	Single use	Single use	Single use	Same
Sterility state	Sterile or non-sterile	Sterile or non-sterile	Sterile or non-sterile	Same
Sterilizationmethod forsterile products	E-beam irradiation	E-beam irradiation	Gamma irradiation	Same as predicate device
Sterilization fornon-sterileproducts	Moist heat (steam) sterilization	Moist heat (steam) sterilization	Moist heat (steam) sterilization	Same
Cleaning ofTempBase Cap	Clean/disinfect with Cidex OPAprior to use	Not applicable	Clean/disinfect with Cidex OPAprior to use	Same as reference device

Table 3: Similarities and Differences between the Proposed (B) and Predicate (B) Dental Abutments Indications for Use

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Table 4: Similarities and Differences between the Proposed (B), and Reference Dental Abutments

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7. Non-Clinical Performance Data

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

Sterilization Validation and Shelf Life:

The proposed sterile (A) OmniTaper EV Dental Implants, with pre-mounted proposed (B) TempBase EV, and proposed sterile (B) DS Implants abutments with EV Connection, which include the proposed (B) Cover Screw EV, Healing Abutment EV, HealDesign EV and MultiBase Abutment EV, are provided sterile via Electronic-Beam (E-beam) irradiation. The sterilization process for the proposed sterile devices (A) and (B) was validated to a sterility assurance level (SAL) of 10-6 in accordance with:

. ISO 11137-1:2006, "Sterilization of health care products --Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and
ISO 11137-2:2013, "Sterilization of health care products -- Radiation -- Part 2: . Establishing the sterilization dose".

No new steam heat sterilization was required on the proposed non-sterile (B) DS Implants abutments with EV connection as the modifications do not introduce a new worst-case scenario to sterilize. The proposed (B) abutments are adopted into the existing sterilization validation performed according to:

. ISO 17665-1:2006, "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices".
The proposed non-sterile (B) TempBase Cap is not heat resistant and must not be steam sterilized. The proposed (B) TempBase Cap must be cleaned and disinfected in a cold disinfectant solution. Since the reference device Friadent TempBase Cap (K013867) is identical to the proposed cap, the cleaning and chemical disinfection validation of the reference device (K013867) remains valid for the proposed (B) TempBase Cap. The existing cleaning validation was performed according to:
. ASTM E 1837:2014, "Standard Test Method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)"
ASTM E 2314:2014. "Standard Test Method for Determination of Effectiveness of ● Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (simulated use test)".

The proposed devices (A) and (B) will not be marketed as non-pyrogenic. During routine production, the method used to determine that the proposed sterile devices (A) and (B) meet the established pyrogen limit is the Limulus amebocyte lysate (LAL) test according to the United States Pharmacopeial Convention, Inc. USP <85> "Bacteria Endotoxins Test".

Both the proposed (A) OmniTaper EV Implants (with pre-mounted proposed (B) TempBase EV abutment) and reference Xive S Plus (K073075) devices have a shelf life of five years and share very similar packaging. To ensure packaging integrity after simulated distribution and accelerated aging, the packaging of the reference device (K073075) was tested for dye penetration and seal strength according to the following standards and validation remains the same for the proposed (A) implants:

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. ASTM F 1929-15, "Standard test method for detecting seal leaks in porous medical packaging by dye penetration",
ISO 11607-1:2019, "Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems", and
. EN 868-10:2018, "Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods".

The packaging materials, configuration, and shelf life (5 years) for the proposed (B) sterile and non-sterile devices are the same as predicate (B) devices (K213449). The existing packaging validation remains valid according to:

. ISO 11607-1: 2019, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems".
The proposed (B) non-sterile TempBase Cap is identical in product material, manufacturing process, and packaging when compared to the reference device Friadent TempBase Cap (K013867) and therefore no new testing is provided in this pre-market submission. The proposed non-sterile TempBase Cap is composed of the inherently stable plastic material Polypropylene which is not adversely affected by aging and known to be stable at room temperature.

Biocompatibility Testing:

Biocompatibility evaluation assessment for the proposed devices (A) and (B) was performed in accordance with ISO 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing with a risk management process" and FDA guidance document, "Use of International Standard ISO 10993-1, '"Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process'".

Results of biocompatibility testing, which include cytotoxicity according to ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity", gas chromatography (GC-MS) and Fourier transformation infrared spectroscopy (FT-IR) according to ISO 10993-18:2020 "Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process", and results of pyrogenicity testing via monocyte activation testing, confirm that the proposed (A) and (B) devices are biocompatible.

Fatigue Testing:

Dynamic fatigue testing was conducted according to ISO 14801:2016 "Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants". The worst-case implant-abutment combination of the proposed (A) and (B) devices was selected based on the FDA Guidance, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and test results were compared with predicate (A) and (B) devices. Test results demonstrate that the proposed devices (A) and (B) perform as intended and do not raise new questions regarding safety and performance. Fatigue testing was also performed on other compatible abutments to confirm compatibility.

MRI Testing:

The following testing or analysis was performed on the worst-case implant combination for Dentsply Sirona implant products:

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. Magnetically induced displacement force, according to ASTM F2052-21, Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
Magnetically induced torque, according to ASTM F2213-17, Standard test method for . measurement of magnetically induced torque on medical devices in magnetic resonance environment
. Image Artifact, according to ASTM F2119-07 (2013), Standard test method for evaluation of MR image artifacts from passive implants
RF Induced Heating Simulation using Computational modeling and simulation (CM&S)

Based on the test or analysis results, proposed device labeling for the proposed (A) OmniTaper EV Dental Implants implant and (B) DS Implants abutments will indicate MRI Conditional. The TempBase Cap (B) will be labeled as MR Safe.

The performance of the proposed devices (A) OmniTaper EV Dental Implants and (B) DS Implants abutments with EV Connection satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.

8. Clinical Performance Data

No human clinical studies were performed on the device to support substantial equivalence.

However, published literature on reference Xive S Plus D 3.0 implant (K073075), which has the same narrow implant outer design, can be used to support clinical relevance and safe longterm use of the proposed (A) OmniTaper EV implant Ø3.0. Four (4) peer-reviewed scientific publications presented 1 to 4 years of prospective clinical follow-up data on reference Xive S Plus D 3.0 implants (K073075). More than 580 implants have been placed in upper lateral- and lower incisal positions, as well as in the posterior regions. Based on high survival rates (mean >99%) and stable marginal bone around the implants, the studies confirm that the narrow 3.0 mm implant is a reliable treatment option for replacing missing teeth.

9. Conclusion

The information included in this bundled premarket notification supports the substantial equivalence of the proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV Connection with the predicate (A) Astra Tech EV Implants (K120414) and predicate (B) DS Implants Abutments with EV connection (K213449), respectively. The proposed devices (A) and (B) have the same intended use, incorporate the same fundamental technology, and have similar or same indications for use as the predicate devices (A) and (B). The non-clinical testing data and clinical data (literature review) do not raise new questions regarding the safety and performance of the proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV Connection as compared to predicates (A) and (B) and reference devices (K073075, K210610, K013867, K030639), which support a conclusion of substantial equivalence.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.