· 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 implant 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 PrimeTaper EV Ø3.0 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) PrimeTaper EV Dental Implant Ø3.0 is a root form endosseous implant which is intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. It represents an additional extra small implant diameter implant) to reference device PrimeTaper EV Dental Implants (K210610).

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 has the identical implant-abutment connection geometry as the predicate (A) Astra Tech EV Implant (K120414), and is therefore compatible with the reference device Astra Tech EV Abutments (K120414) with 3.0 mm diameter of the Astra Tech Implant System EV (K120414).

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

TiDesign EV (XS) ●
MultiBase Abutment EV (XS) ●
. TempAbutment EV (XS)
Healing Abutment EV (XS) ●
HealDesign EV (XS) ●
Cover Screw EV (XS)
Abutment Screw EV (XS) ●

The proposed (B) DS Implants abutments with EV connection XS 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 compatible with the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and represent an additional extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).

The proposed (B) abutments have the identical implant-abutment connection geometry as the reference device Astra Tech EV Abutments (K120414) and are therefore compatible with the predicate (A) Astra Tech EV Implants (K120414) with 3.0 mm diameter.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are provided sterile by electron-beam irradiation except for TiDesign EV (XS). TempAbutment EV (XS) and Abutment Screw (XS), which are provided non-sterile. Devices provided as non-sterilized by the end user via steam sterilization.

AI/ML Overview

The document provided is a 510(k) summary for Dentsply Sirona's PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection (XS). It describes the devices, their intended use, and substantial equivalence to predicate and reference devices based on non-clinical performance data and published literature.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner with specific thresholds. Instead, it relies on demonstrating that the proposed devices (PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection XS) are substantially equivalent to legally marketed predicate devices. The performance is assessed by confirming that the proposed devices satisfactorily meet the requirements of non-clinical bench testing and aligning with published clinical data on similar devices.

However, based on the non-clinical testing performed, we can infer performance criteria against established standards:

Acceptance Criteria (Inferred from testing standards)	Reported Device Performance
Sterility Assurance Level (SAL) of 10⁻⁶ (ISO 11137-1:2006, ISO 11137-2:2013)	Proposed sterile devices (implants and certain abutments) were validated to a SAL of 10⁻⁶ via Electron-Beam (E-beam) irradiation. No changes to sterilization method compared to reference/predicate.
Biocompatibility (ISO 10993-1:2018; ISO 10993-5:2009; ISO 10993-18:2020)	Devices confirmed to be biocompatible through cytotoxicity testing, gas chromatography (GC-MS), Fourier transformation infrared spectrometry (FT-IR), and pyrogenicity testing (monocyte activation testing). Materials, body contact, duration, packaging, and sterilization method are consistent with reference/predicate devices.
Dynamic Fatigue Performance (ISO 14801:2016)	Worst-case implant-abutment combinations were tested. Test results demonstrate that the proposed devices perform as intended and support substantial equivalence to the predicate devices.
Pyrogenicity (USP <85> Bacteria Endotoxins Test)	During routine production, the method used (LAL test) confirms that the proposed sterile devices meet the established pyrogen limit. They will not be marketed as non-pyrogenic.
Packaging Integrity & Shelf Life (ISO 11607-1:2019)	Packaging and materials are the same as reference/predicate devices. A shelf life of five (5) years is applicable, supported by existing packaging validation.
MRI Safety (Conditional) (ASTM F2052-21, ASTM F2213-17, ASTM F2119-07(2013) and Computational modeling & simulation)	Testing confirmed: magnetically induced displacement force, magnetically induced torque, and image artifact. RF Induced Heating Simulation using Computational modeling and simulation (CM&S) was performed. Based on these results, proposed device labeling will indicate "MRI Conditional." (Specific performance values for MRI compatibility are not detailed in this summary, but the "MRI Conditional" designation indicates regulatory acceptance).
Clinical Performance (Inferred from literature) (High survival rates, well-maintained marginal bone)	Published literature on similar 3.0 mm dental implants (reference device, OsseoSpeed 3.0 mm. Astra Tech Implant System (K080396)) showed high survival rates (mean >98%) and well-maintained marginal bone around the implants, supporting reliability for limited alveolar space.

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 Testing (Bench Tests): The document refers to "worst-case implant-abutment combination" for fatigue testing but does not specify the exact number of samples tested for each non-clinical performance test (e.g., fatigue, biocompatibility, sterilization validation, MRI). It is implied that sufficient samples were tested to meet the requirements of the respective ISO and ASTM standards.
Clinical Literature:
- Sample Size: 200 narrow diameter implants (OsseoSpeed 3.0 mm, Astra Tech Implant System (K080396)) were evaluated. These implants were placed in "over 160 patients."
- Data Provenance: The data is from "six peer-reviewed scientific publications" presenting "1 to 5 years of clinical follow-up data from four (4) different clinical trials." The country of origin is not specified but it relates to published peer-reviewed scientific literature. The studies were prospectively followed up.

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)

This section is not applicable to this submission. The "ground truth" in this context is established through compliance with recognized international standards (ISO, ASTM) for non-clinical testing and clinical outcomes reported in peer-reviewed literature, rather than expert adjudication of a test set in the way one might see for an AI algorithm.

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

Not applicable. This is not an AI/imaging device where expert adjudication for ground truth establishment is typically performed.

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 submission is for dental implants and abutments, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an AI/algorithm-based device.

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

Non-clinical Testing: The "ground truth" for non-clinical performance (sterilization, biocompatibility, fatigue, MRI safety, pyrogenicity, packaging) is defined by established international standards (ISO, ASTM) and FDA guidance documents. The device's performance is measured against these technical standards.
Clinical Performance (via literature): The "ground truth" is based on outcomes data (survival rates, marginal bone maintenance) reported in peer-reviewed clinical literature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K220841

Trade/Device Name: PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) 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 mediation-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)

K220841

Device Name PrimeTaper EV Dental Implant Ø3.0

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 implant 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 PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.

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.

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:

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"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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Indications for Use

510(k) Number (if known)

K220841

Device Name DS Implants abutments with EV Connection XS

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.

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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Indications for Use

510(k) Number (if known)

K220841

Device Name DS Implants abutments with EV Connection XS

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

K220841- PrimeTaper EV Dental Implants Ø3.0 and Abutments (XS)

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:	PrimeTaper EV Dental Implants Ø3.0DS Implants abutments with EV connection (XS
•	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) PrimeTaper EV Dental Implants Ø3.0, and

(B) DS Implants abutments with EV Connection XS.

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*	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 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 (A) device Astra Tech EV Implants (K120414) and the abutments cleared under the same 510(k) as reference device Astra Tech EV Abutments (K120414) to the proposed (A) abutments. The implant system (implants and abutments) will be referred to as Astra Tech Implant System EV (K120414).

In addition, there are five reference devices identified and listed below.

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Reference DeviceName	510(k)	Company Name	Reason for inclusion
PrimeTaper EVImplant	K210610	Dentsply Sirona	Same implant design, labeling,biocompatibility, packaging andsterilization as proposed (A)implants
OsseoSpeed Plus -Astra Tech EVAbutments Ø3.0	K120414	Dentsply Sirona(formerly: AstraTech AB)	Same EV conical connection,materials, and diameter as proposed(B) abutments
OsseoSpeedNarrow	K080396	Dentsply Sirona(formerly: AstraTech AB)	Published clinical data on thissmaller sized implant is included tosupport performance and safety ofimplants smaller than 3.25 mm, suchas the proposed (A) implants
Esthetic AbutmentConical Connection3.0	K111581	Nobel Biocare AB	Has the same narrow diameter (3.0mm) and range of gingiva heights(1.5 - 4.5 mm) as proposed (B)TiDesign EV (XS) abutments
Atlantis HealingAbutment	K193529	Dentsply Sirona	Compatible with proposed (A)dental Implant Ø3.0.

4. Description of Device:

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

TiDesign EV (XS) ●
MultiBase Abutment EV (XS) ●
. TempAbutment EV (XS)
Healing Abutment EV (XS) ●
HealDesign EV (XS) ●
Cover Screw EV (XS)
Abutment Screw EV (XS) ●

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extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).

Risk Analysis - 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 proposed Indications for Use for the proposed (A) PrimeTaper EV Dental Implant Ø3.0 is:

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 . implant 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 PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.

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

DS Implants abutments with EV connection XS:

MultiBase Abutment EV (XS):

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6. Comparison of Technological Characteristics:

The proposed (A) PrimeTaper EV Dental Implants size Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are a line extension to and are based on the design of the reference device PrimeTaper EV Dental Implant cleared in K210610 and the Predicate (B) DS Implants Abutments cleared in K213449, respectively, to add a new small diameter size (Ø 3 mm).

For the proposed (B) abutments, a new worst-case abutment is introduced. Although the proposed (B) TiDesign EV abutment (XS) comes in the same angulation (maximum of 15°) and specifications as the predicate (B) abutments, the smaller XS diameter makes it a new worst-case abutment. In addition, the TempAbutment has a smaller abutment height compared with the predicate (B) abutments. All other design features remain unchanged and the remaining proposed (B) abutments are within the range of the predicate (B) abutments.

An overview of the similarities and differences between the proposed devices (A) and (B) and predicate devices (A) and (B) is given in Table 1 through Table 3 below. A discussion of the similarities and differences follows the tables.

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Device	Indications for Use*	Comparison Discussion
Proposed device (A)PrimeTaper EV DentalImplants size Ø3.0(K220841)	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 implant 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 PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.	The Indications for Use of the proposed and predicate implants are very similar.The addition of "early loading" does not change the intended use nor represent an expansion of the indications for use since "early loading" includes any loading occurring after the immediate placement of the implant.Besides branding and slight rewording, there are no other changes to the indications for use statement.
Predicate device (A)AstraTech EV Implant size Ø3.0(K120414)	The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:Replacing single and multiple missing teeth in the mandible and 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 loading in all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain, and immediate loading may not be appropriate. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors

Table 1: Similarities and Differences between the Proposed (A) and Predicate (A)

*Note: Differences are in bold and underline

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

	Proposed devices (A)	Predicate devices (A)	Reference devices	Comparison Discussion
Item
	Dentsply Sirona	Dentsply Sirona	Dentsply Sirona
	PrimeTaper EV Dental	AstraTech EV Implants	PrimeTaper EV Dental Implants
	Implants size Ø3.0 (K220841)	size Ø3.0 (K120414)	(K210610)
Implant	Commercially pure titanium(Grade 4) (ASTM F67-13(2017))	Commercially pure titanium(Grade 4) (ASTM F67-13 (2017))	Commercially pure titanium (Grade 4)(ASTM F67-13 (2017))	Same
Surface	TiO₂ blasted and acid etched	TiO₂ blasted and acid etched	TiO₂ blasted and acid etched	Same
treatment
Connection	Conical connection with indexes(EV Connection)	Conical connection with indexes(EV Connection)	Conical connection with indexes (EVConnection)	Same
type
Implant design	Tapered design, threaded	Cylindrical, threaded	Tapered design, threaded	Same as reference device.
Neck design	Cylindrical with micro-threads	Cylindrical with micro-threads	Cylindrical with micro-threads	Same
Type of	Bone level implant	Bone level implant	Bone level implant	Same
implantation
Sites in body	Limited to maxillary lateralincisors and mandibular incisors	Limited to maxillary lateralincisors and mandibular incisors	Mandible/maxilla	Same as predicate device.
Implant	Ø 3.0 x L 8, 9, 11, 13 and 15 mm	Ø 3.0 x L 8, 9, 11, 13 and 15 mm	Ø3.6 x L 8, 9, 11, 13, 15 and 17 mmØ4.2 x L 6.5, 8, 9, 11, 13, 15 and 17 mmØ4.8 x L 6.5, 8, 9, 11, 13, 15 and 17 mmØ5.4 x L 6.5, 8, 9, 11, 13 and 15 mm	Same as predicate device.
diameter and
length
Angulation of	Ø3.0: 0°, 15°(compatible abutments cleared inK120414, K130999, K193529)	Ø3.0: 0°, 15°(compatible abutments cleared inK120414, K130999, K193529)	Ø3.6-4.8: 0°, 15°, 17°, 20°, 30°Ø5.4: 0°(compatible abutments cleared inK120414, K121810, K163350, K111287,K193529)	Same as predicate device.
compatible
abutments
Reusability	Single use	Single use	Single use	Same
Sterility state	Sterile	Sterile	Sterile	Same
Sterilization	Electron-beam irradiation	Electron-beam irradiation	Electron-beam irradiation	Same
method

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The proposed (A) PrimeTaper EV Dental Implants size Ø3.0 and the predicate (A) Astra Tech EV Implants Ø3.0 (K120414) have the same intended use, very similar indications for use and similar manufacturing, packaging, and sterilization processes. The minor modifications for use does not alter the intended use of the proposed (A) devices as compared to predicate (A) devices (K120414). The proposed (A) PrimeTaper EV Dental Implants size Ø3.0 and the Predicate (A) Astra Tech EV Implants Ø3.0 (K120414) encompass the same range of technological characteristics, including implant length, surface treatment and the abutment connection interface. The proposed (A) PrimeTaper EV Dental Implants size Ø3.0 share the same overall implant design. including outer thread design, as the reference device PrimeTaper EV Dental Implant (K210610).

Table 3 compares the Atlantis healing abutment that is compatible with the proposed (A) implant to the Atlantis healing abutment that was cleared in K193529, compatible with the MIS NP/SP/WP implants. K193529 was specific to compatibility with the MIS Conical Connection implants but besides the implant interface connection of the healing abutment and additional screw access for the MIS implants, there are no differences between the Atlantis Healing Abutment cleared in K193529 and the Atlantis Healing Abutment that is compatible with the proposed (A) implant.

	Compatible Atlantis HealingAbutment	Reference device	Comparison
Item	Dentsply SironaEV connection Ø3.0 interface	Dentsply SironaAtlantis Healing Abutment(K193529)
Material	Titanium alloy, Gold-ShadedTitanium (Gold Hue)	Titanium alloy, Gold-ShadedTitanium (Gold Hue)	Same
Surfacetreatment	N/A	N/A	Same
Connectiontype	Conical connection with indexes(EV Connection)	Conical connection	Different; The compatibleAtlantis healing abutment isconnected to an implant withan EV connection.
Neck design	Small abutment core	Small abutment core	Same
Sites in body	Limited to maxillary lateralincisors and mandibular incisors	Upper and lower jaw archesNarrow implants only: Limited tomandibular central, lateral incisorand maxillary lateral incisorregions of partially edentulousjaws	Different; The compatibleAtlantis healing abutment isintended to be connected to aØ3.0 implant and thereforefollows the same limitations ofuse as the proposed (A)implant.
Compatibledevices	Compatible with proposed (A)implant	Platform NP/SP/WP of MISconical Connection Implants(K172505, K163349)	Different; The compatibleAtlantis healing abutment hasan interface that is compatibleonly with the proposed (A)implant.
Screw accessto implant	Straight	Straight and angled	Different; The compatibleAtlantis healing abutment canonly be connected to theproposed (A) implant via astraight access screw.

Table 3: Similarities and Differences between the Atlantis Healing Abutment compatible with the Proposed (A) implant and Reference Device (K193529)

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Item	Compatible Atlantis HealingAbutmentDentsply SironaEV connection Ø3.0 interface	Reference deviceDentsply SironaAtlantis Healing Abutment(K193529)	Comparison
Packaging	Option 1: Abutment and screw inblister pack (plastic); Sealedblister pack placed in Casesafebox with foamOption 2: Flex-top box (plasticbox) with foam	Option 1: Abutment and screw inblister pack (plastic);Sealedblister pack placed in Casesafebox with foamOption 2: Flex-top box (plasticbox) with foam	Same
Sterility state	Non-sterile – Steam Sterilized byend user	Non-sterile – Steam Sterilized byend user	Same
Sterilization method	Non-sterile – Steam Sterilized byend user	Non-sterile – Steam Sterilized byend user	Same

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Item	Proposed device (B)	Predicate device (A)	Reference devices	Reference devices	Comparison Discussion
	Dentsply SironaDS Implants Abutmentswith EV connection (XS)(K220841)	Dentsply SironaDS Implants Abutments withEV connection (K213449)	Dentsply SironaAstraTech EV Abutmentssize $Ø3.0$ (K120414)	Nobel Biocare ABEsthetic Abutment ConicalConnection 3.0 (K111581)
Indicationsfor Use	DS Implants abutments withEV connection XS:DS Implants abutmentsprovided with the EVconnection are intended to beused in conjunction withimplants with the EVconnection in fully edentulousor partially edentulousmaxillary and/or mandibulararches to provide support forcrowns, bridges oroverdentures.MultiBase Abutment EV (XS):DS Implants abutmentsprovided with the EVconnection are intended to beused in conjunction withimplants with the EVconnection in fully edentulousor partially edentulousmaxillary and/or mandibulararches to provide support forbridges or overdentures.	DS Implants abutments with EVconnection:DS Implants abutmentsprovided with the EVconnection are intended to beused in conjunction withimplants with the EVconnection in fully edentulousor partially edentulousmaxillary and/or mandibulararches to provide support forcrowns, bridges oroverdentures.MultiBase Abutment EV:DS Implants abutmentsprovided with the EVconnection are intended to beused in conjunction withimplants with the EVconnection in fully edentulousor partially edentulousmaxillary and/or mandibulararches to provide support forbridges or overdentures.	Not applicable for substantialequivalence discussion.	Not applicable for substantialequivalence discussion.	Same as predicate device.
ConnectionType	Internal conical implant-abutment connection withindexes (EV connection)	Internal conical implant-abutment connection withindexes (EV connection)	Internal conical implant-abutment connection withindexes (EV connection)	Internal Conical Connection	Same as predicate device andreference device (K120414).
ConnectionSizes	XS	S, M, L	3.0	3.0	Expansion of offering toinclude XS abutments
Item	Proposed device (B)	Predicate device (A)	Reference devices	Reference devices	Comparison Discussion
	Dentsply SironaDS Implants Abutmentswith EV connection (XS)(K220841)	Dentsply SironaDS Implants Abutments withEV connection (K213449)	Dentsply SironaAstraTech EV Abutmentssize Ø3.0 (K120414)	Nobel Biocare ABEsthetic Abutment ConicalConnection 3.0 (K111581)	compatible with Proposed (A) device.Substantial equivalence supported by fatigue testing.
Prosthesisattachment	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retained	Same as predicate device and reference devices.Note: TiDesign EV is a cement retained abutment and therefore has the same prosthesis attachment type as reference device (K111581).
Abutmentangulation	TiDesign EV (XS):0°, 15°	TiDesign EV:0°, 15°	TiDesign EV (3.0):0°, 15°	Esthetic abutment0°, 15°	Same
Abutmentdesign	One-piece (0°),Two-piece (0°,15°)	One-piece (0°),Two-piece (0°,15°)	One-piece (0°),Two-piece (0°, 15°)	Two-piece (0°, 15°)	Same as predicate device and reference devices.Note: TiDesign EV is a two-piece abutment.
Gingivaheight	Healing Abutment EV:2, 3, 4, 6 mmHealDesign EV:2.5, 3.5, 4.5, 6.5 mmTiDesign EV:1.5, 2.5, 3.5, 4.5 mmMultiBase Abutment EV:1.5, 2.5, 3.5 mm	Healing Abutment EV:2, 3, 4, 6 mmHealDesign EV:2.5, 3.5, 4.5, 6.5 mmTiDesign EV:1.5, 2.5, 3.5, 4.5 mmMultiBase Abutment EV:1.5, 2.5, 3.5, 4.5 mm	Healing Abutment EV:2, 3, 4, 6 mmHealDesign EV:3.5, 4.5 mmTiDesign EV:1.5, 2.5 mm	Esthetic abutment1.5, 3.0, 4.5 mm	Same as predicate device for Healing Abutment EV, HealDesign EV, and MultiBase Abutment EV.Note: Proposed MultiBase abutment is not available in 4.5 mm gingival height.TiDesign EV is within size range of reference device esthetic abutment (K111581).
Item	Proposed device (B)	Predicate device (A)	Reference devices	Reference devices	Comparison Discussion
	Dentsply SironaDS Implants Abutmentswith EV connection (XS)(K220841)	Dentsply SironaDS Implants Abutments withEV connection (K213449)	Dentsply SironaAstraTech EV Abutmentssize Ø3.0 (K120414)	Nobel Biocare ABEsthetic Abutment ConicalConnection 3.0 (K111581)
Materials	Abutments:Titanium AlloyAbutment screws:Titanium AlloyAbutment holder:PEEK	Abutments:Titanium AlloyAbutment screws:Titanium AlloyAbutment holder:PEEK	Abutments:Titanium AlloyAbutment screws:Titanium Alloy	Abutments:Titanium AlloyAbutment screws:Titanium Alloy	Same as predicate device andreference devices.
Manufacturing Process	Milling	Milling	Milling	Milling	Same
Surfacetreatment	Anodization(abutment + abutment screw)	Anodization(abutment + abutment screw)	Anodization(abutment + abutment screw)	Unknown	Same as predicate device andreference device (K120414)
Reusability	Single use	Single use	Single use	Single use	Same
Sterilitystate	Sterile or non-sterile	Sterile or non-sterile	Sterile or non-sterile	Non-sterile	Same as predicate device andreference devices.
Sterilizationmethod forsterileproducts	E-beam irradiation	E-beam irradiation	E-beam irradiation	Not applicable	Same as predicate device
Sterilizationfor non-sterileproducts	Moist heat (steam)sterilization	Moist heat (steam) sterilization	Moist heat (steam)sterilization	Moist heat (steam)sterilization	Same

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

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The proposed (B) DS Implants abutments with EV connection (XS) have the same intended use and indications for use, same prosthesis attachment method (screw-retained or cement-retained), and same manufacturing, packaging, and sterilization processes as the predicate (B) DS Implants abutments with EV connection (K213449). The proposed (B) and predicate (B) abutments and accessories (K213449) are either one-piece or two-piece abutment designs, have the same abutment-implant connection interface (EV Connection) and are made of the same materials. Differences include the additional abutment diameter (XS) and changes in abutment height, where applicable. The reference devices (K120414 and K111581) have the same implant platform diameter as the proposed XS abutments and share similar technological characteristics, including gingival height, design, angulation and attachment method.

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) PrimeTaper EV Dental Implants Ø3.0 and (B) DS Implants abutments with EV Connection XS, which include the proposed Cover Screw EV (XS), Healing Abutment EV (XS), HealDesign EV (XS) and MultiBase Abutment EV (XS), 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 106 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.

There are no changes to the sterilization method or processes of the proposed (A) and (B) devices when compared to the reference device (K210610) and predicate (B) device (K213449), respectively.

No new steam heat sterilization was required on the proposed (B) DS Implants abutments with EV connection non-sterile devices as the modifications do not introduce a new worst-case scenario to sterilize. The existing validation for predicate device (B) (K213449) 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) remains valid.

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.

For proposed devices (A) and (B), packaging and materials are the same as used for the reference device (K210610) and predicate (B) device (K213449), respectively, and the shelf life is five (S) years. Therefore, the same shelf life is applicable for the proposed sterile devices (A) and (B), including existing packaging validation which meets the requirements of ISO 11607-1: 2019 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems).

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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". The proposed devices (A) and (B) have the same nature of body contact, contact duration, material, packaging, and sterilization method compared to the reference device (K210610) and predicate (B) device (K213449), respectively.

Results of biocompatibility testing which includes 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 spectrometry (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) and reference devices was chosen based on the FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Test results demonstrate that the proposed devices (A) and (B) perform as intended and support substantial equivalence to the predicate devices.

MRI Testing:

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

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 will indicate MRI Conditional.

The performance of the proposed devices (A) PrimeTaper EV Dental Implant Ø3.0 and (B) DS Implants abutments with EV Connection XS 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 dental implants with a diameter less than 3.25 mm was evaluated to support clinical relevance and safe long-term use of the proposed (A) PrimeTaper EV Dental Implant Ø3.0. Six peer-reviewed scientific publications present 1 to 5 years of clinical follow-up data from four (4) different clinical trials. Two hundred narrow diameter implants (reference device, OsseoSpeed 3.0 mm. Astra Tech Implant System (K080396)), that are similar to the proposed (A)

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PrimeTaper EV Dental Implant Ø3.0, were placed in the upper lateral and lower incisor spaces, in over 160 patients, and followed up prospectively.

Based on high survival rates (mean >98%) and well-maintained marginal bone around the implants, the authors conclude that the narrow 3.0 mm implant is a reliable treatment option for patients where the alveolar space is limited.

Conclusion 9.
The information included in this bundled premarket notification supports the substantial equivalence of the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV Connection XS with the predicate (A) device Astra Tech EV Implants Ø 3.0 (K120414) and (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 provided to support a decision of substantial equivalence of the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV Connection XS with predicates (A) and (B) do not raise additional questions of safety and effectiveness.

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.