(216 days)
No
The summary describes dental implants and abutments, focusing on materials, design, sterilization, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is intended for "prosthetic restoration of chewing function" and supports crowns, bridges, or overdentures, which are restorative measures to replace missing teeth and improve oral function, falling under the umbrella of therapeutic intervention.
No
Explanation: The device described is a dental implant system (implants and abutments) intended for replacing missing teeth and supporting prosthetic restorations. It is designed for therapeutic or restorative purposes, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as dental implants and abutments, which are hardware. The performance studies also focus on physical properties like sterilization, biocompatibility, and fatigue testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures to replace missing teeth and provide support for dental prosthetics. This is a direct therapeutic intervention within the human body.
- Device Description: The device is described as dental implants and abutments, which are physical components implanted into the jawbone.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening.
The device is a medical device used for surgical and prosthetic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
OmniTaper EV Dental Implants:
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
- Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
- The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).
The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:
- TempBase EV, and its accessory component TempBase Cap
- Cover Screw EV
- Healing Abutment EV
- HealDesign EV
- TempAbutment EV
- TiDesign EV
- CastDesign EV
- MultiBase Abutment EV
- Abutment Screw EV
The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are:
- Compatible with the proposed (A) OmniTaper EV implants,
- Represent an additional abutment type (TempBase EV abutment and cap),
- Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).
The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).
The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.
The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.
The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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:
- Sterile devices (A) and (B) validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2013.
- Proposed non-sterile (B) abutments adopted into existing steam heat sterilization validation per ISO 17665-1:2006.
- Proposed non-sterile (B) TempBase Cap cleaning and chemical disinfection validation remains valid from reference device (K013867) per ASTM E 1837:2014 and ASTM E 2314:2014.
- Shelf Life:
- Proposed (A) implants have a shelf life of five years, identical to reference device (K073075). Packaging integrity confirmed with dye penetration (ASTM F 1929-15), and seal strength (ISO 11607-1:2019, EN 868-10:2018).
- Proposed (B) devices have the same packaging and shelf life (5 years) as predicate (B) devices (K213449), validated per ISO 11607-1:2019.
- Pyrogenicity Testing: Limulus amebocyte lysate (LAL) test according to USP .
- Biocompatibility Testing: Performed in accordance with ISO 10993-1:2018 and FDA guidance. Results confirm biocompatibility, including cytotoxicity (ISO 10993-5:2009), chemical characterization (ISO 10993-18:2020), and pyrogenicity via monocyte activation testing.
- Fatigue Testing: Conducted according to ISO 14801:2016. Worst-case implant-abutment combinations selected based on FDA Guidance. Test results demonstrate performance as intended, similar to predicate (A) and (B) devices, not raising new questions regarding safety and performance.
- MRI Testing: Performed on worst-case implant combination, including:
- Magnetically induced displacement force (ASTM F2052-21).
- Magnetically induced torque (ASTM F2213-17).
- Image Artifact (ASTM F2119-07 (2013)).
- RF Induced Heating Simulation using Computational modeling and simulation (CM&S).
- Labeling will indicate MRI Conditional for (A) OmniTaper EV Dental Implants and (B) DS Implants abutments, and MR Safe for TempBase Cap (B).
Clinical Performance Data:
- No human clinical studies were performed on the device to support substantial equivalence.
- Published literature on reference Xive S Plus D 3.0 implant (K073075) used to support clinical relevance and safe long-term use of the proposed (A) OmniTaper EV implant Ø3.0. Four (4) peer-reviewed scientific publications presented 1 to 4 years of prospective clinical follow-up data. More than 580 implants placed in upper lateral- and lower incisal positions, and posterior regions. High survival rates (mean >99%) and stable marginal bone around implants confirmed.
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.
K073075, K210610, K013867, K030639
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dentsply Sirona Courtney Clark Senior Director of Regulatory Affairs, Corporate 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K221094
Trade/Device Name: OmniTaper EV Dental Implants, DS Implants abutments with EV connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 20, 2022 Received: October 20, 2022
Dear Courtney Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221094
Device Name OmniTaper EV Dental Implants
Indications for Use (Describe)
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- · Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
- · Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- · Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
· Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
· The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Device Name DS Implants abutments with EV Connection
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
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 K221094 - OmniTaper EV Dental Implants and Abutments
-
- 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: | OmniTaper EV Dental Implants,
DS Implants abutments with EV connection |
|---|------------------------|---------------------------------------------------------------------------|
| • | 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) OmniTaper EV Dental Implants, and
- (B) DS Implants abutments with EV Connection
There are two predicate devices identified relating to the substantial equivalence for the proposed devices (A) and (B), as referred to above as bundles (A) and (B):
| Predicate Device (A) Name | 510(k) | Company Name |
|---|---|---|
| OsseoSpeed Plus Implants* | K120414 | Dentsply Sirona |
| (Formerly: Astra Tech AB) | ||
| Predicate Device (B) Name | 510(k) | Company Name |
*NOTE: The OsseoSpeed Plus K120414 clearance included the Astra Tech OsseoSpeed Plus Implants, which are currently marketed as Astra Tech OsseoSpeed EV Implants, and Astra Tech Implant System Plus abutments, which are currently marketed as Astra Tech Implant EV abutments. Therefore, this submission will hereafter refer to the implants cleared under OsseoSpeed Plus (K120414) as predicate
6
(A) Astra Tech EV Implants (K120414) and the abutments cleared under the same 510(k) as compatible Astra Tech EV Abutments (K120414)
In addition, four reference devices are identified to support any differences in technological characteristics:
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| Xive S Plus Dental Implant | ||
| System | K073075 | Dentsply Sirona |
| (formerly: Dentsply International) | ||
| PrimeTaper EV Dental Implant | ||
| System | K210610 | Dentsply Sirona |
| Xive Dental Implant System | ||
| Friadent TempBase EV Abutment | ||
| (Ø3.5 - Ø5.5) | K013867 | Dentsply Sirona |
| (formerly: Friadent GmbH) | ||
| Xive 3.0 Dental Implant System | ||
| Friadent TempBase EV Abutment | ||
| (Ø3.0) | K030639 | Dentsply Sirona |
| (formerly: Friadent GmbH) |
4. Description of Device:
The proposed (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).
The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:
- TempBase EV, and its accessory component TempBase Cap ●
- Cover Screw EV ●
- Healing Abutment EV ●
- HealDesign EV ●
- TempAbutment EV
- TiDesign EV ●
- CastDesign EV ●
- MultiBase Abutment EV ●
- Abutment Screw EV ●
The proposed (B) DS Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments that are:
- Compatible with the proposed (A) OmniTaper EV implants, ●
- Represent an additional abutment type (TempBase EV abutment and cap),
7
- Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to . the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).
The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).
The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.
The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.
The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.
Risk analysis for the proposed devices was conducted in accordance with ISO 14971:2019, "Medical Devices: Application of Risk management to medical devices". Risks listed in the FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Class II Special Controls Guidance Document Guidance for Industry and FDA Staff" were addressed and all risks associated with the proposed implants and abutments were acceptable and as low as possible.
5. Indications for Use:
The Indications for Use for the proposed (A) OmniTaper EV Dental Implants are:
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- Replacing missing teeth in single or multiple unit applications in the mandible or . maxilla.
- Immediate placement in extraction sites and in situations with a partially or . completely healed alveolar ridge.
- Especially indicated for use in soft bone applications where implants with other . implant surface treatments may be less effective.
- Immediate and early loading for all indications, except in single tooth situations on . implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate.
- The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of . maxillary lateral incisors and mandibular incisors.
All proposed (B) DS Implants abutments with EV connection, with the exception of the MultiBase Abutment EV, fall under the first indications for Use statement below. The second Indications for Use statement applies to the proposed (B) MultiBase Abutment EV.
8
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 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.
6. Comparison of Technological Characteristics:
The proposed (A) OmniTaper EV implants are a new line of endosseous dental implants which are identical with regards to material, surface treatment and internal implantabutment connection geometry (i.e. the EV connection) as the predicate (A) Astra Tech EV Implants (K120414). The implant dimensions and outer implant design with thread design properties, thread pitch, self-tapping apical thread, condensing upper section and microextended implant shoulder of the proposed (A) OmniTaper EV implants are the same or very similar to reference device Xive S Plus implants (K073075). The proposed (A) OmniTaper EV implant also shares the same packaging as the reference device (K073075).
The proposed (B) DS Implants abutments with EV connection are based on the design of the predicate (B) DS Implants Abutments (K213449). It is a line extension of the assortment of compatible EV abutments by:
- . adding an abutment type (TempBase EV abutment and Cap) and
- adding abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS . Implants abutments with EV Connection (K213449).
The design of the proposed (B) TempBase EV abutment is similar to reference device Friadent TempBase Abutments (K030639, K013867) in that the proposed (B) TempBase EV abutment has an EV connection, while the reference device Friadent TempBase Abutments (K030639, K013867) are designed for a hexagonal implant connection. The proposed (B) TempBase EV is pre-mounted on the proposed (A) OmniTaper EV Implant and are packaged together in very similar packaging as reference device Xive S Plus implant (K073075). The proposed (B) accessory component TempBase Cap has identical design and material as reference device Friadent TempBase Cap (K013867) and is cleaned and disinfected in the same way.
The proposed (B) DS Implants abutments with EV connection (XS, XL) and predicate (B) DS Implants abutments with EV connection (K213449) have the same intended use, same Indications for Use, same materials, same design (one-piece or two-piece), same prosthesis attachment method (screw-retained or cement-retained), same manufacturing, same packaging (sterile and non-sterile) and same sterilization method as the predicate (B) abutments (K213449).
An overview of the similarities and differences between the proposed devices (A) and (B) and predicate (A) and (B) devices, including reference devices, are given in Table 1 through Table 4 below.
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| Item | Proposed device (A) | Predicate device (A) | Comparison Discussion |
|---|---|---|---|
| Dentsply Sirona | Dentsply Sirona | ||
| OmniTaper EV Dental Implants | Astra Tech EV Implants (K120414) | ||
| Indications for Use | The implants are intended for both one- and two- | ||
| stage surgical procedures in the following | |||
| situations and with the following clinical | |||
| protocols: | |||
| Replacing missing teeth in single or | |||
| multiple unit applications in the mandible | |||
| or maxilla. Immediate placement in extraction sites | |||
| and in situations with a partially or | |||
| completely healed alveolar ridge. Especially indicated for use in soft bone | |||
| applications where implants with other | |||
| implant surface treatments may be less | |||
| effective. Immediate and early loading for all | |||
| indications, except in single tooth | |||
| situations on implants shorter than 8 mm | |||
| or in soft bone (type 4) where implant | |||
| stability may be difficult to obtain, and | |||
| immediate loading may not be | |||
| appropriate. The intended use for OmniTaper EV Ø3.0 | |||
| implant is limited to replacement of | |||
| maxillary lateral incisors and mandibular | |||
| incisors. | 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 | |||
| implant 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 3.0 | |||
| S is limited to replacement of maxillary | |||
| lateral incisors and mandibular incisors. | The Indications for Use of the proposed and | ||
| predicate implants are similar. |
The indications of the proposed and predicate
device have slight differences in wording, for
clarification only.
For the proposed (A) device, "early loading" was
added to describe the loading protocol of the
implant in more detail.
The differences in the proposed and predicate
Indications for Use do not substantively alter the
meaning. |
Table 1: Similarities and Differences between the Proposed (A) and Predicate (A) Dental Implants Indications for Use
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Table 2: Similarities and Differences between the Proposed devices (A), and Reference Device Device Dental Implants Technological Characteristics
| Item | Proposed devices (A) | Predicate devices (A) | Reference devices | Comparison Discussion |
|---|---|---|---|---|
| Technological Characteristics | ||||
| Dentsply Sirona | ||||
| OmniTaper EV Dental Implants | Dentsply Sirona | |||
| AstraTech EV Dental Implants | ||||
| (K120414) | Dentsply Sirona | |||
| Xive S Plus implants | ||||
| (K073075) | ||||
| Implant | ||||
| material | Commercially pure titanium (Grade 4) | |||
| (ASTM F67-13 (2017)) | Commercially pure titanium (Grade 4) | |||
| (ASTM F67-13 (2017)) | Commercially pure titanium (Grade 2) | |||
| (ASTM F67-13 (2017)) | Same as predicate device (A) (K120414). | |||
| Surface | ||||
| treatment | TiO2 blasted and acid etched | TiO2 blasted and acid etched | Grit blasted and acid etched | Same as predicate device (A) (K120414). |
| Connection | ||||
| type | Conical connection with indexes (EV | |||
| Connection) | Conical connection with indexes (EV | |||
| Connection) | Internal hexagonal connection | Same as predicate device (A) (K120414). | ||
| Implant | ||||
| design | Cylindrical, threaded, self-tapping | |||
| apical thread | Cylindrical, threaded | Cylindrical, threaded, self-tapping | ||
| apical thread | Same as reference device (K073075). | |||
| Neck design | (Micro)extended implant shoulder | Cylindrical with micro-threads | (Micro)extended implant shoulder | Same as reference device (K073075). |
| Type of | ||||
| implantation | Bone level implant | Bone level implant | Bone level implant | Same. |
| Sites in body | Mandible/maxilla | Mandible/maxilla | Mandible/maxilla | Same. |
| Implant | ||||
| diameter and | ||||
| length | Ø 3.0 diameter implant: Limited to | |||
| maxillary lateral incisors and | ||||
| mandibular incisors | ||||
| Ø 3.0 x L 11, 13 and 15 mm | ||||
| Ø 3.4 x L 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 3.8 x L 8, 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 4.5 x L 8, 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 5.5 x L 8, 9.5, 11, 13 and 15 mm | Ø 3.0 diameter implant: Limited to | |||
| maxillary lateral incisors and | ||||
| mandibular incisors | ||||
| Ø 3.0 x L 8, 9, 11, 13 and 15 mm | ||||
| Ø 3.6 x L 6, 8, 9, 11, 13, 15 and 17 mm | ||||
| Ø 4.2 x L 6, 8, 9, 11, 13, 15 and 17 mm | ||||
| Ø 4.8 x L 6, 8, 9, 11, 13, 15 and 17 mm | ||||
| Ø 5.4 x L 6, 8, 9, 11, 13 and 15 mm | Ø 3.0 diameter implant: Limited to | |||
| maxillary lateral incisors and | ||||
| mandibular incisors | ||||
| Ø 3.0 x L 11, 13 and 15 mm | ||||
| Ø 3.4 x L 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 3.8 x L 8, 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 4.5 x L 8, 9.5, 11, 13, 15 and 18 mm | ||||
| Ø 5.5 x L 8, 9.5, 11, 13 and 15 mm | Same as reference device (K073075) with | |||
| minor modification to the outer geometry | ||||
| thickness of material for 8 mm length | ||||
| implants (Ø 3.8, 4.5, and 5.5) only, which | ||||
| do not represent new worst case implants. |
Substantial equivalence is supported by
fatigue testing with similar results compared
to predicate device (A) (K120414). |
| Item | Proposed devices (A)
Dentsply Sirona
OmniTaper EV Dental Implants | Predicate devices (A)
Dentsply Sirona
AstraTech EV Dental Implants
(K120414) | Reference devices
Dentsply Sirona
Xive S Plus implants
(K073075) | Comparison Discussion |
| Angulation of
compatible
abutments | XS (Ø3.0): 0°, 15°
S – L (Ø3.4-4.5): 0°, 15°, 17°, 20°, 30°
XL (Ø5.5): 0°, 15°
(Compatible abutments cleared in
K120414, K121810, K163350,
K111287, K130999, K112138,
K213449) | Ø3.0: 0°, 15°
Ø3.6-4.8: 0°, 15°, 17°, 20°, 30°
Ø5.4: 0°
(Compatible abutments cleared in
K120414, K121810, K163350,
K183079, K111287, K130999,
K112138, K213449) | Ø3.0: 0°, 15°
Ø3.4-5.5: 0°, 15°, 30°
(Compatible abutments cleared in
K945847, K980630, K982576,
K994174, K994376, K013438,
K013867, K030639, K072730,
K093780, K122268, K183079) | Proposed (A) device is compatible with
abutments within the same range of
angulation as the reference implants
(K073075).
Substantial equivalence is supported by
fatigue testing with similar results compared
to predicate device (A) (K120414). |
| Reusability | Single use | Single use | Single use | Same. |
| Sterility state | Sterile | Sterile | Sterile | Same. |
| Sterilization
method | Electron-beam irradiation | Electron-beam irradiation | Gamma irradiation | Same as predicate device (A) (K120414) |
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| Item | Proposed device (B) | Predicate device (A) | Comparison Discussion | |
|---|---|---|---|---|
| Dentsply Sirona | Dentsply Sirona | |||
| DS Implants Abutments with EV connection | DS Implants Abutments with EV connection | |||
| (K213449) | ||||
| Indications for Use | DS Implants abutments with EV connection: | |||
| DS Implants abutments provided with the 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. | 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. | Same. | |
| Item | Proposed device (B) | Predicate device (A) | Reference devices | Comparison Discussion |
| | Dentsply Sirona
DS Implants Abutments with EV
connection | Dentsply Sirona
DS Implants Abutments with
EV connection
(K213449) | Dentsply Sirona
Xive Dental Implant System
Abutments and Accessories
(K013867, K030639) | |
| Connection Size | XS, XL
TempBase EV Abutment and Cap:
XS, S, M, L, XL | S, M, L | Friadent TempBase Abutment
and TempBase Cap:
D3.0, D3.4, D3.8, D4.5, D5.5 | Expansion of offering to include XS and
XL abutments compatible with proposed
(A) device. Addition of TempBase EV
abutment and Cap in all sizes.
Substantial equivalence supported by
fatigue testing. |
| Prosthesis
attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | TempBase Abutment:
Screw-retained | Same |
| Abutment
angulation | TiDesign EV:
0°, 15°
MultiBase EV:
0°
TempBase EV:
0°
CastDesign EV:
0° | TiDesign EV:
0°, 15°
MultiBase EV:
0°, 17°, 30°
CastDesign EV:
0° | TempBase Abutment:
0° | TiDesign EV: Same as predicate device
TempBase EV: Same as reference device
MultiBase EV: Proposed (B) MultiBase
abutments (XS) and (XL) are not
available as an angulated abutment.
CastDesign EV: Straight abutment, no
angular correction. Same as predicate
device. |
| Abutment
design | One-piece (0°),
Two-piece (0°,15°) | One-piece (0°),
Two-piece (0°,15°) | TempBase Abutment:
One-piece (0°) | Same |
| Gingiva height | Healing Abutment EV:
2, 3, 4, 6 mm
HealDesign EV:
2.5, 3.5, 4.5, 6.5 mm
TiDesign EV: | Healing Abutment EV:
2, 3, 4, 6 mm
HealDesign EV:
2.5, 3.5, 4.5, 6.5 mm
TiDesign EV: | Not applicable for substantial
equivalence | Same as predicate device. |
| Item | Proposed device (B) | Predicate device (A) | Reference devices | Comparison Discussion |
| | Dentsply Sirona
DS Implants Abutments with EV
connection | Dentsply Sirona
DS Implants Abutments with
EV connection
(K213449) | Dentsply Sirona
Xive Dental Implant System
Abutments and Accessories
(K013867, K030639) | |
| | 1.5, 2.5, 3.5, 4.5 mm
MultiBase Abutment EV:
1.5, 2.5, 3.5, 4.5 mm | 1.5, 2.5, 3.5, 4.5 mm
MultiBase Abutment EV:
1.5, 2.5, 3.5, 4.5 mm | | |
| Materials | Abutments:
Titanium Alloy or Gold Alloy
Abutment screws:
Titanium Alloy
Abutment holder:
PEEK
Burn-out sleeve and TempBase
Cap:
Plastic | Abutments:
Titanium Alloy or Gold Alloy
Abutment screws:
Titanium Alloy
Abutment holder:
PEEK
Burn-out sleeve
Plastic | TempBase Abutment:
Titanium Alloy
TempBase Cap:
Plastic | Same |
| Manufacturing
Process | Milling | Milling | Milling | Same |
| Surface
treatment | Anodization
(abutment + abutment screw) | Anodization
(abutment + abutment screw) | Anodization
(abutment) | Same |
| Reusability | Single use | Single use | Single use | Same |
| Sterility state | Sterile or non-sterile | Sterile or non-sterile | Sterile or non-sterile | Same |
| Sterilization
method for
sterile products | E-beam irradiation | E-beam irradiation | Gamma irradiation | Same as predicate device |
| Sterilization for
non-sterile
products | Moist heat (steam) sterilization | Moist heat (steam) sterilization | Moist heat (steam) sterilization | Same |
| Cleaning of
TempBase Cap | Clean/disinfect with Cidex OPA
prior to use | Not applicable | Clean/disinfect with Cidex OPA
prior to use | Same as reference device |
Table 3: Similarities and Differences between the Proposed (B) and Predicate (B) Dental Abutments Indications for Use
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Table 4: Similarities and Differences between the Proposed (B), and Reference Dental Abutments
14
15
7. Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes the following:
Sterilization Validation and Shelf Life:
The proposed sterile (A) OmniTaper EV Dental Implants, with pre-mounted proposed (B) TempBase EV, and proposed sterile (B) DS Implants abutments with EV Connection, which include the proposed (B) Cover Screw EV, Healing Abutment EV, HealDesign EV and MultiBase Abutment EV, are provided sterile via Electronic-Beam (E-beam) irradiation. The sterilization process for the proposed sterile devices (A) and (B) was validated to a sterility assurance level (SAL) of 10-6 in accordance with:
- . ISO 11137-1:2006, "Sterilization of health care products --Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and
- ISO 11137-2:2013, "Sterilization of health care products -- Radiation -- Part 2: . Establishing the sterilization dose".
No new steam heat sterilization was required on the proposed non-sterile (B) DS Implants abutments with EV connection as the modifications do not introduce a new worst-case scenario to sterilize. The proposed (B) abutments are adopted into the existing sterilization validation performed according to:
-
. ISO 17665-1:2006, "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices".
The proposed non-sterile (B) TempBase Cap is not heat resistant and must not be steam sterilized. The proposed (B) TempBase Cap must be cleaned and disinfected in a cold disinfectant solution. Since the reference device Friadent TempBase Cap (K013867) is identical to the proposed cap, the cleaning and chemical disinfection validation of the reference device (K013867) remains valid for the proposed (B) TempBase Cap. The existing cleaning validation was performed according to: -
. ASTM E 1837:2014, "Standard Test Method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)"
-
ASTM E 2314:2014. "Standard Test Method for Determination of Effectiveness of ● Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (simulated use test)".
The proposed devices (A) and (B) will not be marketed as non-pyrogenic. During routine production, the method used to determine that the proposed sterile devices (A) and (B) meet the established pyrogen limit is the Limulus amebocyte lysate (LAL) test according to the United States Pharmacopeial Convention, Inc. USP "Bacteria Endotoxins Test".
Both the proposed (A) OmniTaper EV Implants (with pre-mounted proposed (B) TempBase EV abutment) and reference Xive S Plus (K073075) devices have a shelf life of five years and share very similar packaging. To ensure packaging integrity after simulated distribution and accelerated aging, the packaging of the reference device (K073075) was tested for dye penetration and seal strength according to the following standards and validation remains the same for the proposed (A) implants:
16
- . ASTM F 1929-15, "Standard test method for detecting seal leaks in porous medical packaging by dye penetration",
- ISO 11607-1:2019, "Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems", and
- . EN 868-10:2018, "Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods".
The packaging materials, configuration, and shelf life (5 years) for the proposed (B) sterile and non-sterile devices are the same as predicate (B) devices (K213449). The existing packaging validation remains valid according to:
- . ISO 11607-1: 2019, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems".
The proposed (B) non-sterile TempBase Cap is identical in product material, manufacturing process, and packaging when compared to the reference device Friadent TempBase Cap (K013867) and therefore no new testing is provided in this pre-market submission. The proposed non-sterile TempBase Cap is composed of the inherently stable plastic material Polypropylene which is not adversely affected by aging and known to be stable at room temperature.
Biocompatibility Testing:
Biocompatibility evaluation assessment for the proposed devices (A) and (B) was performed in accordance with ISO 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing with a risk management process" and FDA guidance document, "Use of International Standard ISO 10993-1, '"Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process'".
Results of biocompatibility testing, which include cytotoxicity according to ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity", gas chromatography (GC-MS) and Fourier transformation infrared spectroscopy (FT-IR) according to ISO 10993-18:2020 "Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process", and results of pyrogenicity testing via monocyte activation testing, confirm that the proposed (A) and (B) devices are biocompatible.
Fatigue Testing:
Dynamic fatigue testing was conducted according to ISO 14801:2016 "Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants". The worst-case implant-abutment combination of the proposed (A) and (B) devices was selected based on the FDA Guidance, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and test results were compared with predicate (A) and (B) devices. Test results demonstrate that the proposed devices (A) and (B) perform as intended and do not raise new questions regarding safety and performance. Fatigue testing was also performed on other compatible abutments to confirm compatibility.
MRI Testing:
The following testing or analysis was performed on the worst-case implant combination for Dentsply Sirona implant products:
17
- . Magnetically induced displacement force, according to ASTM F2052-21, Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
- Magnetically induced torque, according to ASTM F2213-17, Standard test method for . measurement of magnetically induced torque on medical devices in magnetic resonance environment
- . Image Artifact, according to ASTM F2119-07 (2013), Standard test method for evaluation of MR image artifacts from passive implants
- RF Induced Heating Simulation using Computational modeling and simulation (CM&S)
Based on the test or analysis results, proposed device labeling for the proposed (A) OmniTaper EV Dental Implants implant and (B) DS Implants abutments will indicate MRI Conditional. The TempBase Cap (B) will be labeled as MR Safe.
The performance of the proposed devices (A) OmniTaper EV Dental Implants and (B) DS Implants abutments with EV Connection satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
8. Clinical Performance Data
No human clinical studies were performed on the device to support substantial equivalence.
However, published literature on reference Xive S Plus D 3.0 implant (K073075), which has the same narrow implant outer design, can be used to support clinical relevance and safe longterm use of the proposed (A) OmniTaper EV implant Ø3.0. Four (4) peer-reviewed scientific publications presented 1 to 4 years of prospective clinical follow-up data on reference Xive S Plus D 3.0 implants (K073075). More than 580 implants have been placed in upper lateral- and lower incisal positions, as well as in the posterior regions. Based on high survival rates (mean >99%) and stable marginal bone around the implants, the studies confirm that the narrow 3.0 mm implant is a reliable treatment option for replacing missing teeth.
9. Conclusion
The information included in this bundled premarket notification supports the substantial equivalence of the proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV Connection with the predicate (A) Astra Tech EV Implants (K120414) and predicate (B) DS Implants Abutments with EV connection (K213449), respectively. The proposed devices (A) and (B) have the same intended use, incorporate the same fundamental technology, and have similar or same indications for use as the predicate devices (A) and (B). The non-clinical testing data and clinical data (literature review) do not raise new questions regarding the safety and performance of the proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV Connection as compared to predicates (A) and (B) and reference devices (K073075, K210610, K013867, K030639), which support a conclusion of substantial equivalence.