What is the regulatory pathway for PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)?

OsseoSpeed Plus (K120414); DS Implants abutments with EV Connection (K213449).

Who can help prepare an FDA 510(k) submission like PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)?

Dentsply Sirona filed the 510(k) submission for PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (K220841).

Q: What is the FDA product code for PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

K220841 · Dentsply Sirona · DZE · Nov 16, 2022 · Dental

Device Facts

Record ID	K220841
Device Name	PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
Applicant	Dentsply Sirona
Product Code	DZE · Dental
Decision Date	Nov 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Root-form endosseous dental implants and compatible prosthetic abutments; used by dental clinicians for prosthetic restoration of chewing function in edentulous/partially edentulous human jaws. Implants (Ø3.0 mm) feature tapered, threaded design with TiO2 blasted/acid-etched surface and EV conical connection. Abutments (XS size) include TiDesign, MultiBase, TempAbutment, Healing Abutment, HealDesign, Cover Screw, and Abutment Screw. Devices are placed surgically in clinic; abutments support crowns, bridges, or overdentures. Provides stable foundation for prosthetic rehabilitation; benefits patients with limited alveolar space requiring narrow-diameter implants. MRI conditional.

Clinical Evidence

No new human clinical studies performed. Substantial equivalence supported by bench testing and literature review of 200 narrow-diameter implants (3.0 mm) across four clinical trials (1-5 year follow-up). Literature reported mean survival rates >98% and stable marginal bone levels, supporting safety/efficacy for narrow-diameter implants in limited alveolar space.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67-13) for implants; Titanium alloy for abutments/screws; PEEK for abutment holders. Design: Tapered, threaded root-form implant with TiO2 blasted/acid-etched surface. Connection: Internal conical with indexes (EV). Dimensions: Ø3.0 mm implant; XS abutment size. Sterilization: E-beam irradiation (sterile) or steam sterilization (non-sterile).

Indications for Use

Indicated for patients requiring dental implants for single or multiple tooth replacement in mandible or maxilla, including immediate placement/loading. PrimeTaper EV Ø3.0 limited to maxillary lateral and mandibular incisors. Abutments indicated for support of crowns, bridges, or overdentures in fully or partially edentulous arches.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

OsseoSpeed Plus (K120414)
DS Implants abutments with EV Connection (K213449)

Reference Devices

PrimeTaper EV Dental Implant (K210610)
OsseoSpeed Narrow (K080396)
Esthetic Abutment Conical Connection 3.0 (K111581)
Atlantis Healing Abutment (K193529)

Related Devices

K221094 — OmniTaper EV Dental Implants, DS Implants abutments with EV connection · Dentsply Sirona · Nov 16, 2022
K191443 — MSDI Dental Implants System · Medical Systems and Devices International , Ltd. · Jun 26, 2020
K200329 — IDCAM Dental Implants · Implants Diffusion International · Apr 22, 2021
K161497 — Dental Implants and Abutments · Ditron Precision, Ltd. · Oct 28, 2016
K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCa · B.T.I. Biotechnology Institute, Sl. · Jul 21, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |--------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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: > 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." {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K220841 Device Name DS Implants abutments with EV Connection XS Indications for Use (Describe) 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. 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: > 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." {4}------------------------------------------------ # 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: 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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: > 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." {5}------------------------------------------------ ### 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 - 2. Device Name: | • | Proprietary Name: | PrimeTaper EV Dental Implants Ø3.0 DS Implants abutments with EV connection (XS | |---|------------------------|------------------------------------------------------------------------------------| | • | Classification Name: | Implant, Endosseous, Root-form Abutment, Implant, Dental Endosseous | | • | Classification Number: | 872.3640 | | • | Device Class: | Class II | | • | Product Codes: | Primary product code: DZE Secondary 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. {6}------------------------------------------------ | Reference Device Name | 510(k) | Company Name | Reason for inclusion | |------------------------------------------------------|---------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PrimeTaper EV Implant | K210610 | Dentsply Sirona | Same implant design, labeling, biocompatibility, packaging and sterilization as proposed (A) implants | | OsseoSpeed Plus - Astra Tech EV Abutments Ø3.0 | K120414 | Dentsply Sirona (formerly: Astra Tech AB) | Same EV conical connection, materials, and diameter as proposed (B) abutments | | OsseoSpeed Narrow | K080396 | Dentsply Sirona (formerly: Astra Tech AB) | Published clinical data on this smaller sized implant is included to support performance and safety of implants smaller than 3.25 mm, such as the proposed (A) implants | | Esthetic Abutment Conical Connection 3.0 | K111581 | Nobel Biocare AB | Has the same narrow diameter (3.0 mm) and range of gingiva heights (1.5 - 4.5 mm) as proposed (B) TiDesign EV (XS) abutments | | Atlantis Healing Abutment | K193529 | Dentsply Sirona | Compatible with proposed (A) dental Implant Ø3.0. | ### 4. Description of Device: 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 {7}------------------------------------------------ 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. 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: 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 Abutment EV (XS): 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. {8}------------------------------------------------ #### 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. {9}------------------------------------------------ | Device | Indications for Use* | Comparison Discussion | |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Proposed device (A) PrimeTaper EV Dental Implants 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 {10}------------------------------------------------ # 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 (EV Connection) | 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 lateral incisors and mandibular incisors | Limited to maxillary lateral incisors 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 mm Ø4.2 x L 6.5, 8, 9, 11, 13, 15 and 17 mm Ø4.8 x L 6.5, 8, 9, 11, 13, 15 and 17 mm Ø5.4 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 in K120414, K130999, K193529) | Ø3.0: 0°, 15° (compatible abutments cleared in K120414, K130999, K193529) | Ø3.6-4.8: 0°, 15°, 17°, 20°, 30° Ø5.4: 0° (compatible abutments cleared in K120414, 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 | | | | | {11}------------------------------------------------ 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 Healing Abutment | Reference device | Comparison | |----------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Dentsply Sirona EV connection Ø3.0 interface | Dentsply Sirona Atlantis Healing Abutment (K193529) | | | Material | Titanium alloy, Gold-Shaded Titanium (Gold Hue) | Titanium alloy, Gold-Shaded Titanium (Gold Hue) | Same | | Surface treatment | N/A | N/A | Same | | Connection type | Conical connection with indexes (EV Connection) | Conical connection | Different; The compatible Atlantis healing abutment is connected to an implant with an EV connection. | | Neck design | Small abutment core | Small abutment core | Same | | Sites in body | Limited to maxillary lateral incisors and mandibular incisors | Upper and lower jaw arches Narrow implants only: Limited to mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws | Different; The compatible Atlantis healing abutment is intended to be connected to a Ø3.0 implant and therefore follows the same limitations of use as the proposed (A) implant. | | Compatible devices | Compatible with proposed (A) implant | Platform NP/SP/WP of MIS conical Connection Implants (K172505, K163349) | Different; The compatible Atlantis healing abutment has an interface that is compatible only with the proposed (A) implant. | | Screw access to implant | Straight | Straight and angled | Different; The compatible Atlantis healing abutment can only be connected to the proposed (A) implant via a straight access screw. | Table 3: Similarities and Differences between the Atlantis Healing Abutment compatible with the Proposed (A) implant and Reference Device (K193529) {12}------------------------------------------------ | Item | Compatible Atlantis Healing Abutment Dentsply Sirona EV connection Ø3.0 interface | Reference device Dentsply Sirona Atlantis Healing Abutment (K193529) | Comparison | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Packaging | Option 1: Abutment and screw in blister pack (plastic); Sealed blister pack placed in Casesafe box with foam Option 2: Flex-top box (plastic box) with foam | Option 1: Abutment and screw in blister pack (plastic);Sealed blister pack placed in Casesafe box with foam Option 2: Flex-top box (plastic box) with foam | Same | | Sterility state | Non-sterile – Steam Sterilized by end user | Non-sterile – Steam Sterilized by end user | Same | | Sterilization method | Non-sterile – Steam Sterilized by end user | Non-sterile – Steam Sterilized by end user | Same | {13}------------------------------------------------ | Item | Proposed device (B) | Predicate device (A) | Reference devices | Reference devices | Comparison Discussion | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Dentsply Sirona DS Implants Abutments with EV connection (XS) (K220841) | Dentsply Sirona DS Implants Abutments with EV connection (K213449) | Dentsply Sirona AstraTech EV Abutments size $Ø3.0$ (K120414) | Nobel Biocare AB Esthetic Abutment Conical Connection 3.0 (K111581) | | | Indications for Use | DS Implants abutments with EV connection XS: 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 Abutment EV (XS): 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. | DS Implants abutments with EV connection: 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 Abutment 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. | Not applicable for substantial equivalence discussion. | Not applicable for substantial equivalence discussion. | Same as predicate device. | | Connection Type | Internal conical implant- abutment connection with indexes (EV connection) | Internal conical implant- abutment connection with indexes (EV connection) | Internal conical implant- abutment connection with indexes (EV connection) | Internal Conical Connection | Same as predicate device and reference device (K120414). | | Connection Sizes | XS | S, M, L | 3.0 | 3.0 | Expansion of offering to include XS abutments | | Item | Proposed device (B) | Predicate device (A) | Reference devices | Reference devices | Comparison Discussion | | | Dentsply Sirona DS Implants Abutments with EV connection (XS) (K220841) | Dentsply Sirona DS Implants Abutments with EV connection (K213449) | Dentsply Sirona AstraTech EV Abutments size Ø3.0 (K120414) | Nobel Biocare AB Esthetic Abutment Conical Connection 3.0 (K111581) | compatible with Proposed (A) device. Substantial equivalence supported by fatigue testing. | | Prosthesis attachment | Cement-retained Screw-retained | Cement-retained Screw-retained | Cement-retained Screw-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). | | Abutment angulation | TiDesign EV (XS): 0°, 15° | TiDesign EV: 0°, 15° | TiDesign EV (3.0): 0°, 15° | Esthetic abutment 0°, 15° | Same | | Abutment design | 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. | | Gingiva height | Healing Abutment EV: 2, 3, 4, 6 mm HealDesign EV: 2.5, 3.5, 4.5, 6.5 mm TiDesign EV: 1.5, 2.5, 3.5, 4.5 mm MultiBase Abutment EV: 1.5, 2.5, 3.5 mm | Healing Abutment EV: 2, 3, 4, 6 mm HealDesign EV: 2.5, 3.5, 4.5, 6.5 mm TiDesign EV: 1.5, 2.5, 3.5, 4.5 mm MultiBase Abutment EV: 1.5, 2.5, 3.5, 4.5 mm | Healing Abutment EV: 2, 3, 4, 6 mm HealDesign EV: 3.5, 4.5 mm TiDesign EV: 1.5, 2.5 mm | Esthetic abutment 1.5, 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 Sirona DS Implants Abutments with EV connection (XS) (K220841) | Dentsply Sirona DS Implants Abutments with EV connection (K213449) | Dentsply Sirona AstraTech EV Abutments size Ø3.0 (K120414) | Nobel Biocare AB Esthetic Abutment Conical Connection 3.0 (K111581) | | | Materials | Abutments: Titanium Alloy Abutment screws: Titanium Alloy Abutment holder: PEEK | Abutments: Titanium Alloy Abutment screws: Titanium Alloy Abutment holder: PEEK | Abutments: Titanium Alloy Abutment screws: Titanium Alloy | Abutments: Titanium Alloy Abutment screws: Titanium Alloy | Same as predicate device and reference devices. | | Manufactur ing Process | Milling | Milling | Milling | Milling | Same | | Surface treatment | Anodization (abutment + abutment screw) | Anodization (abutment + abutment screw) | Anodization (abutment + abutment screw) | Unknown | Same as predicate device and reference device (K120414) | | Reusability | Single use | Single use | Single use | Single use | Same | | Sterility state | Sterile or non-sterile | Sterile or non-sterile | Sterile or non-sterile | Non-sterile | Same as predicate device and reference devices.…