(90 days)
No
The description focuses on the physical design, materials, and mechanical properties of dental abutments and their compatibility with existing implant systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to support single-unit or multi-unit prostheses for partially or fully edentulous patients, which serves a therapeutic purpose by restoring function and aesthetics.
No
The device is an abutment for dental implants, intended to support prostheses, not to provide diagnostic information.
No
The device description clearly outlines physical components made of titanium alloy and zirconia, and the performance studies focus on material properties and mechanical testing, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental prostheses in the mouth of a patient. This is a direct medical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the physical components and materials of a dental abutment, which is a mechanical part used in dental restorations.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, sterilization, and MR safety – all relevant to a physical implantable device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Product codes
NHA
Device Description
Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.
For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration.
The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.
All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:
| Implant Compatibility (1) | Minimum Wall Thickness | Maximum Gingival Height | Minimum Gingival Height (2) | Maximum Angulation |
|---|---|---|---|---|
| Astra Tech OsseoSpeed TX | 0.32 mm | 5.18 mm | 1 mm | 30° |
| Biomet 3i OSSEOTITE® Certain® | 0.32 mm | 5.0 mm | 0.3 mm | 25° |
| MegaGen AnyRidge | 0.32 mm | 5.18 mm | 1.7 mm | 30° |
| Nobel Biocare NobelActive® | 0.32 mm | 5.03 mm | 1.3 mm | 25° |
| Zimmer Tapered Screw-Vent® | 0.32 mm | 5.05 mm | 0.4 mm | 25° |
(1) for the compatible sizes listed in the Indications for Use Statement
(2) minimum gingival height in the titanium base, not the zirconia superstructure
The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- referenced from K221966 was non-clinical analysis to evaluate the metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- referenced from K221966 (provided in K212108) was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10% by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- referenced from K221966 (provided in K212108) was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment materials ASTM F136 and ISO 13356;
- provided in this submission was reverse engineering analysis (of OEM implants, OEM abutments, and ● OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement; and
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the ● performance of the subject device abutments in conjunction with the compatible OEM implants.
No clinical data were included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K22288, K101732, K063341, K110955, K142260, K013227, K072589
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
Talladium España, SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K232151
Trade/Device Name: Dynamic TiBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 19, 2023 Received: July 19, 2023
Dear Kevin Thomas:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232151
Device Name
Dynamic TiBase
Indications for Use (Describe)
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech OsseoSpeed TX | 3.5, 4.0 | 3.5/4.0 |
| 4.5, 5.0 | 4.5/5.0 | |
| Biomet 3i OSSEOTITE® Certain® | 4.0 | 3.4 |
| 4.0, 5.0 | 4.1 | |
| MegaGen AnyRidge | 4.0, 4.4, 4.9, 5.4 | 3.5 |
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| 5.5 | 5.1 (WP) | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium validated milling center for manufacture.
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."
4
510(k) Summary K232151 Talladium España, SL Dynamic TiBase
October 13, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Talladium España, SL
Virginia Woolf, 17
Lleida, Lleida, ES 25005
Telephone +34 973-289-580 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Xavier Soca Filella, General Manager |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email kthomas@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Dynamic TiBase |
|---|---|
| Common Names | Endosseous dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 |
| (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K221966, Dynamic TiBase, Talladium España, SL
Reference Devices K22288, DESS® Dental Smart Solutions, Terrats Medical SL K101732, Astra Tech Implant System, Astra Tech AB K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. K110955, AnyRidge Internal Implant System, MegaGen Implant Company, Ltd. K142260, NobelActive®, Nobel Biocare AB K013227, Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.
5
INDICATIONS FOR USE STATEMENT
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech OsseoSpeed TX | 3.5, 4.0 | 3.5/4.0 |
| 4.5, 5.0 | 4.5/5.0 | |
| Biomet 3i OSSEOTITE® Certain® | 4.0 | 3.4 |
| 4.0, 5.0 | 4.1 | |
| MegaGen AnyRidge | 4.0, 4.4, 4.9, 5.4 | 3.5 |
| Nobel Biocare NobelActive® | 3.5 | 3.5 (NP) |
| 4.3, 5.0 | 3.9 (RP) | |
| 5.5 | 5.1 (WP) | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
Compatible Implant Systems
All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.
For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration.
The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.
All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:
6
| Implant Compatibility (1) | Minimum
Wall Thickness | Maximum
Gingival Height | Minimum
Gingival Height (2) | Maximum
Angulation |
|-------------------------------|---------------------------|----------------------------|--------------------------------|-----------------------|
| Astra Tech OsseoSpeed TX | 0.32 mm | 5.18 mm | 1 mm | 30° |
| Biomet 3i OSSEOTITE® Certain® | 0.32 mm | 5.0 mm | 0.3 mm | 25° |
| MegaGen AnyRidge | 0.32 mm | 5.18 mm | 1.7 mm | 30° |
| Nobel Biocare NobelActive® | 0.32 mm | 5.03 mm | 1.3 mm | 25° |
| Zimmer Tapered Screw-Vent® | 0.32 mm | 5.05 mm | 0.4 mm | 25° |
(1) for the compatible sizes listed in the Indications for Use Statement
(2) minimum gingival height in the titanium base, not the zirconia superstructure
The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- referenced from K221966 was non-clinical analysis to evaluate the metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- . referenced from K221966 (provided in K212108) was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10% by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- referenced from K221966 (provided in K212108) was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment materials ASTM F136 and ISO 13356;
- provided in this submission was reverse engineering analysis (of OEM implants, OEM abutments, and ● OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement; and
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the ● performance of the subject device abutments in conjunction with the compatible OEM implants.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device K221966, and the reference device K222288.
The primary predicate device K221966 is for support of substantial equivalence in terms of abutment designs, materials, manufacturing, biocompatibility, and sterilization. The reference device K22288 is for support of substantial equivalence in terms of abutment designs. The reference devices K101732. K063341. K110955. K142260, K013227, and K072589 are for the OEM implant sizes.
The subject device abutments are substantially equivalent in intended use to the abutments cleared in primary predicate device K221966 and the reference device K222288. All are intended for use with endosseous dental
7
Traditional 510(k) Premarket Notification Page 4 of 7
implants in the maxilla and mandible to provide functional and esthetic rehabilitation. The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate device K221966 except for the marketing names and the list of compatible OEM implants. The IFUS for the subject device also is similar to that of the reference device K22288 except for the marketing names and the list of compatible OEM implants.
All subject device titanium base abutments are similar in design, materials, and technological characteristics to the titanium base abutments cleared in the primary predicate device K221966 and the reference device K22288.
The subject device abutments and abutment screws are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Talladium España, SL abutments and abutment screws previously cleared in the primary predicate device K221966.
The subject device titanium base abutments and the titanium base abutments in the primary predicate device K221966 and the reference device K222288 have similar or identical ranges of implant-abutment platform diameter, prosthetic platform diameter, and gingival height.
The subject device titanium base abutments are to be used with a zirconia superstructure with similar design parameters as the primary predicate K221966. The zirconia material and recommended cement to bond the superstructure to the prosthetic component are the same as the primary predicate K221966.
All abutment screws are similar in design, materials, and technological characteristics to those cleared in the primary predicate device K221966, except for the threads and lengths.
The subject device components are provided non-sterile and are to be sterilized by the same moist heat cycle as in the primary predicate K221966. The subject devices are provided in pouches manufactured from a polyethylene terephthalate (PET) and cast polypropylene (CPP) laminate, identical to the primary predicate K221966.
The subject device titanium base abutments are to be used with a zirconia superstructure to create the final two-piece abutment. The risks associated with the use of an angled zirconia superstructure bonded to the subject device titanium base abutments are mitigated by mechanical testing performed according to ISO 14801.
Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate device K221966, and the reference device K222288 do not affect substantial equivalence. These minor differences do not impact safety or effectiveness because these differences are related to the compatible implant designs and are mitigated by the mechanical performance testing.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device and the primary predicate device encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate device listed above.
8
| Indications for Use Statement | |||
|---|---|---|---|
| Subject Device | |||
| Dynamic TiBase | |||
| Talladium España, SL | Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit | ||
| prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. | |||
| Compatible Implant Systems | |||
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm | |
| Astra Tech OsseoSpeed TX | 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | ||
| Biomet 3i OSSEOTITE® | 4.0 | 3.4 | |
| Certain® | 4.0, 5.0 | 4.1 | |
| MegaGen AnyRidge | 4.0, 4.4, 4.9, 5.4 | 3.5 | |
| Nobel Biocare | |||
| NobelActive® | 3.5 | 3.5 (NP) | |
| 4.3, 5.0 | 3.9 (RP) | ||
| 5.5 | 5.1 (WP) | ||
| Zimmer Tapered Screw- | |||
| Vent® | 3.7, 4.1 | 3.5 | |
| 4.7 | 4.5 | ||
| 6.0 | 5.7 | ||
| All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium | |||
| validated milling center for manufacture. | |||
| Primary Predicate Device | |||
| K221966 | |||
| Dynamic TiBase | |||
| Talladium España, SL | Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit | ||
| prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. | Implant Body Diameter, mm | Implant Platform, mm | |
| Kontact™ Dental Implant | |||
| System | 3.6 | 3.6 | |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| Reference Device | |||
| K222288 | |||
| Terrats Medical SL | |||
| DESS® Dental Smart Solutions | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in | ||
| the maxillary or mandibular arch to provide support for prosthetic restorations. | |||
| All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be | |||
| sent to a Terrats Medical validated milling center for manufacture. | |||
| Compatible Implant Systems | |||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | |
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 | |
| 3.0 | 3.0 | ||
| Astra Tech EV | 3.6 | 3.6 | |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | |
| 3.5/4.0 | 3.5/4.0 | ||
| 4.5/5.0 | 4.5/5.0 | ||
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 | |
| 3.8, 4.6 | 3.5 | ||
| 4.6, 5.8 | 4.5 | ||
| 5.8 | 5.7 | ||
| Biomet 3i Certain® | 3.25 | 3.4 | |
| 4.0 | 4.1 | ||
| 5.0 | 5.0 | ||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 | |
| 3.75, 4.0 | 4.1 | ||
| 5.0 | 5.0 | ||
| Camlog | 3.8 | 3.8 | |
| 4.3 | 4.3 | ||
| 5.0 | 5.0 | ||
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | |
| FRIADENT XIVE® | 3.4 | 3.4 | |
| 3.8 | 3.8 | ||
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | |
| NobelActive®, NobelParallel Conical | 3.0 | 3.0 | |
| 3.5 | NP | ||
| 4.3, 5.0 | RP | ||
| NobelReplace® Trilobe | 3.5 | NP | |
| 4.3 | RP | ||
| 5.0 | WP | ||
| 6.0 | 6.0 | ||
| Nobel Brånemark System® | 3.3 | NP | |
| 3.75, 4.0 | RP | ||
| 5.0 | WP | ||
| Osstem TS | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | |
| 5.0, 5.5, 6.5 | WB | ||
| Straumann® Bone Level | 3.3 | NC | |
| 4.1/4.8 | RC | ||
| Straumann® Tissue Level | 3.3 | NNC, RN | |
| 4.1 | RN | ||
| 4.8 | RN, WN | ||
| Zimmer Eztetic | 3.1 | 2.9 | |
| Zimmer Screw Vent®/ Tapered Screw- | 3.3, 3.7, 4.1 | 3.5 | |
| Vent® | 4.7 | 4.5 | |
| 6.0 | 5.7 | ||
| Zimmer Spline | 3.25, | 3.25 | |
| 3.75, 4.0 | 3.75/4.0 | ||
| 5.0 | 5.0 | ||
| Zimmer SwissPlus | 3.7 | 3.8 | |
| 4.8 | 4.8 | ||
Substantial Equivalence – Indications for Use Statements
9
Substantial Equivalence – Indications for Use Statements
10
510(k) Summary
Page 7 of 7
Table of Substantial Equivalence – Technological Characteristics
| Comparison | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Dynamic TiBase | |||
| Talladium España, SL | K221966 | ||
| Dynamic TiBase | |||
| Talladium España, SL | K222288 | ||
| Terrats Medical SL | |||
| DESS® Dental Smart Solutions | |||
| Reason for Predicate Device | Not applicable | Abutment designs, materials, manufacturing, biocompatibility, | |
| and sterilization | Abutment designs | ||
| Product Codes | NHA | NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of the edentulous mandible | ||
| or maxilla | Functional and esthetic rehabilitation of the edentulous mandible | ||
| or maxilla | Functional and esthetic rehabilitation of the edentulous mandible | ||
| or maxilla | |||
| Abutment Designs | |||
| Abutment Types | CAD-CAM titanium base abutments | CAD-CAM titanium base abutments | Various types, including CAD-CAM titanium base abutments |
| Prosthesis Attachment | Cement-retained, screw-retained | Cement-retained, screw-retained | Cement-retained, screw-retained |
| Restoration | Single-unit and multi-unit | Single-unit and multi-unit | Single-unit and multi-unit |
| Prosthetic Interface Connections | Internal | Internal | Internal and external hex |
| Implant-Abutment Platform Diameter | 3.4 mm - 5.7 mm | 3.6 mm - 5.4 mm | 2.52 mm - 5.7 mm |
| Prosthetic Platform Diameter | 4.3 mm - 5.9 mm | 4.0 mm, 4.5 mm | 4.5 mm - 6.5 mm |
| Gingival Height (in the base) | 0.3 mm - 5 mm | 1 mm (minimum) | 0.3 mm - 3.0 mm (titanium base abutments) |
| Abutment Angulation, degrees (in the base) | Straight (0°) | Straight (0°) | Straight (0°) (titanium base abutments) |
| Zirconia Superstructure Design Parameters | |||
| Minimum wall thickness | 0.32 mm | 0.55 mm | 0.4 mm |
| Minimum post height for single-unit | |||
| restorations | 4.0 mm | 4.0 mm | 4.2 mm |
| Minimum gingival height (GH) of the | |||
| superstructure | 0 mm; all bases have minimum GH 0.3 mm | 0 mm; all bases have minimum GH of 1 mm | 0.5 mm |
| Maximum gingival height (of the | |||
| superstructure) | 5.18 mm | 5.37 mm | 6.0 mm |
| Angulation of Finished Abutment | Up to 30° | Up to 30° | 0°, 30° |
| Cement to bond zirconia superstructure to | |||
| the abutment base | G-CEM LinkAce™ (cleared as GAM-200 in K120243) | G-CEM LinkAce™ (cleared as GAM-200 in K120243) | Multi Link Hybrid Abutment Cement (K130436) |
| Abutment Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 (titanium base abutments) |
| Abutment Screw Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 |
| Superstructure Material | Zirconia, ISO 13356 | Zirconia, ISO 13356 | Zirconia, ISO 13356 |
| How Provided | |||
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Usage - All Components | Single patient, single use | Single patient, single use | Single patient, single use |