(238 days)
No
The 510(k) summary describes dental implants and abutments, which are mechanical devices. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and clinical outcomes of the physical implants.
No.
The device is described as a dental implant system intended for replacing missing teeth and supporting dental prostheses, which are restorative functions, not therapeutic.
No
The device description clearly states its purpose as "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." Its function is to replace missing teeth and provide support for crowns, bridges, or overdentures, which are restorative, not diagnostic.
No
The device description clearly outlines physical components such as dental implants and abutments, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the device as dental implants and abutments intended for surgical procedures to replace missing teeth and support prosthetic restorations (crowns, bridges, overdentures) in the mouth.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the oral cavity.
Therefore, this device falls under the category of a surgical implant and prosthetic component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PrimeTaper EV Dental Implant Ø3.0: 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla.
Maxillary lateral incisors and mandibular incisors.
Maxillary and/or mandibular arches.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Sterilization Validation and Shelf Life: Validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2013. No new steam heat sterilization required. LAL test performed for pyrogen limit. Shelf life is five (S) years, meeting ISO 11607-1: 2019.
- Biocompatibility Testing: Performed in accordance with ISO 10993-1:2018 and FDA guidance. Results of cytotoxicity (ISO 10993-5:2009), gas chromatography (GC-MS) and Fourier transformation infrared spectrometry (FT-IR) (ISO 10993-18:2020), and pyrogenicity testing via monocyte activation testing confirm biocompatibility.
- Fatigue Testing: Dynamic fatigue testing conducted according to ISO 14801:2016. Test results demonstrate that the proposed devices perform as intended and support substantial equivalence to the predicate devices.
- MRI Testing: Performance tests based on ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07 (2013) were conducted. RF Induced Heating Simulation performed using Computational modeling and simulation (CM&S). Device labeling will indicate MRI Conditional based on these results.
Clinical Performance Data:
No human clinical studies were performed on the device to support substantial equivalence. Published literature on dental implants with a diameter less than 3.25 mm was evaluated.
- Study Type: Literature review of clinical follow-up data from clinical trials.
- Sample Size: 200 narrow diameter implants (reference device, OsseoSpeed 3.0 mm. Astra Tech Implant System (K080396)) in over 160 patients.
- Key Results: High survival rates (mean >98%) and well-maintained marginal bone around the implants, supporting that the narrow 3.0 mm implant is a reliable treatment option for patients with limited alveolar space.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K210610, K120414, K080396, K111581, K193529
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
|---|
| ☑ 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."
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)
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) | |
|---|---|
| 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."
5
510(k) SUMMARY for
K220841- PrimeTaper EV Dental Implants Ø3.0 and Abutments (XS)
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
Contact Person: Courtney Clark Telephone Number: 248-895-4379 Fax number: 717-849-4343
Date Prepared: November 10, 2022
-
- 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.
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| 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.
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| 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
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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 (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)
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| 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. |
| Sterilization
method for
sterile
products | E-beam irradiation | E-beam irradiation | E-beam irradiation | Not applicable | Same as predicate device |
| Sterilization
for non-
sterile
products | 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
14
15
16
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 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).
17
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)
18
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.