(89 days)
No
The device description and performance studies focus on mechanical properties, material compatibility, sterilization, and compatibility with existing dental implants. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device, a dental abutment, is intended to provide support for prosthetic restorations in conjunction with dental implants. It does not directly treat or prevent a disease or condition, but rather serves as a structural component for dental reconstruction.
No
This device is an abutment for dental implants, providing support for prosthetic restorations. It does not perform any diagnostic function.
No
The device description explicitly states it is adding "components" which are "abutments" made of metallic material. The performance studies also focus on the physical properties and testing of these metallic devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide support for prosthetic restorations" in the mouth, which is a structural and mechanical function within the body.
- Device Description: The device is described as "abutments" used in conjunction with dental implants. These are physical components used in a surgical and restorative procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical properties, sterilization, biocompatibility, and MR compatibility, not on analyzing biological samples.
Therefore, this device falls under the category of a medical device used for surgical and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants.
This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
A summary of the subject device abutment designs and the compatible OEM implants is provided in the table Summary of Subject Device Multi-Unit Abutment Designs on the following page.
Subject device components that will be provided sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm; new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants; previously cleared multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent®, and TSX™ implants with implant platform diameters of 3.5 mm and 4.5 mm; and previously cleared prosthetic components compatible with all subject device multi-unit abutments.
Subject device components that will be provided non-sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments with Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm and new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants.
The design dimensions and tolerances of subject device abutments and screws for the Zimmer 3.1mmD Eztetic and TSX™ Implant Systems have been established on the basis of a contractual agreement and working relationship between ZimVie and Terrats Medical SL to ensure that the abutments are designed to fit the corresponding implants. Compatibility of the subject abutments and screws for Screw-Vent®, Tapered Screw-Vent®, and TSX™ implant lines was provided in the prior Terrats Medical SL submission K170588. Compatibility of the subject abutments and screws for the Biomet 3i OSSEOTITE® external hex implants was provided in the prior Terrats Medical SL submission K170588.
The Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 30°. The design of the straight Multi-Unit Abutments is similar to that of straight Multi-Unit Abutments cleared in the primary predicate device K230143 with the exception of the implant connections and platform diameters. The straight Multi-Unit Abutment is provided only in a non-engaging. threaded design that attaches directly to the implant. All straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm. Straight Multi-Unit Abutments are provided only for the compatible internal hex implants listed in the table above. The gingival height of the straight Multi-Unit Abutment ranges from 1 mm to 5 mm in 1 mm increments.
The angled Multi-Unit Abutments are provided in an engaging design that requires an abutment screw, with angulations of 17° and 30°. The angled Multi-Unit Abutments are provided for the compatible internal hex connection implants and the compatible external hex connection implants listed in the table above (on page 3). All angled Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with gingival heights from 2.5 mm to 4.5 mm. The designs of the angled Multi-Unit Abutments are similar to those of the angled Multi-Unit Abutments cleared in the primary predicate device K230143.All Multi-Unit Abutments, straight and angled, are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
This submission includes two (2) abutment screws to be used with the subject device abutment screw for the compatible internal hex implants with a platform diameter of 2.9 mm; and another abutment screw for all compatible external hex implants (with platforms of 3.4 mm). The screws have a hex or hexalobular instrument interface and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission 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);
- provided in this submission was engineering analysis to demonstrate that the subject device abutments compatible ● with the Screw-Vent", Tapered Screw-Vent", and TSX™ implants do not create a new worst-case construct in terms of mechanical testing according to ISO 14801;
- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments compatible with the Zimmer 3.1mmD Eztetic and TSX™ implants, and the performance of the subject device abutments compatible with the Biomet 3i OSSEOTITE® Implants;
- referenced from K22269 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: analysis showed that the subject devices do not create a new worst case for moist heat sterilization:
- referenced from K212538 was gamma irradiation sterility assurance level of 10° by ● selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of
§ 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.)
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Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Terrats Medical SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real Suite 400 San Diego, California 92130
Re: K231434
Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 17, 2023 Received: May 17, 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 (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)
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
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.
| Implant Systems Compatibility | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connections | ||
| Zimmer 3.1mmD Eztetic™ | 3.1 | 2.9 |
| Zimmer Screw-Vent® | 3.7 | 3.5 |
| 4.7 | 4.5 | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 |
| 5.4, 6.0 | 4.5 | |
| TSX™ Implant System, 3.1mmD | 3.1 | 2.9 |
| External Hex Connections | ||
| Biomet 3i OSSEOTITE® Implants | 3.25 | 3.4 |
| 3.75 | 4.1 | |
| 4.0 | 4.1 |
Implant Systems Compatibility
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)
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3
510(k) Summary K231434 Terrats Medical SL DESS Dental Smart Solutions August 7, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
Barberà del Vallès 08210
Barcelona, Spain |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| 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 | DESS Dental Smart Solutions |
|---|---|
| Common Name | 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 K230143, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K142082, Zimmer 3.1mmD Dental Implant System, Zimmer Dental, Inc. K013227, Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc. K220978, TSX™ Implants, Biomet 3i LLC K063286, OSSEOTITE® Dental Implants, Implant Innovations, Inc. K111216, OSSEOTTE® 2 - Dental Implants, Biomet 3i, Inc. K212538, DESS Dental Implants, Terrats Medical SL
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K170588. DESS Dental Implants. Terrats Medical SL K22269, DESS Dental Implants, Terrats Medical SL K213063, TLX SRAs and TLX Gold Abutments, Straumann USA, LLC
The reference devices K142082, K013227, K072589, K220978, K063286, K111216 are for OEM implant body clearances. The reference device K212538 is for sterilization, packaging, and shelf life for devices provided sterile to the end user. The reference device K170588 is for compatibility with the Zimmer Screw-Vent", Zimmer Tapered Screw-Vent®, and Biomet 3i OSSEOTITE® implants. The reference device K22269 is for referenced moist heat sterilization and biocompatibility data. The reference device K213063 is for the technological characteristic of multiunit abutments provided sterile.
INDICATIONS FOR USE STATEMENT
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.
| Implant Systems Compatibility | Implant Body Ø, mm | Implant Platform Ø, mm |
|---|---|---|
| Internal Hex Connections | ||
| Zimmer 3.1mmD Eztetic™ | 3.1 | 2.9 |
| Zimmer Screw-Vent® | 3.7 | 3.5 |
| 4.7 | 4.5 | |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 |
| 5.4, 6.0 | 4.5 | |
| TSX™ Implant System, 3.1mmD | 3.1 | 2.9 |
| External Hex Connections | ||
| Biomet 3i OSSEOTITE® Implants | 3.25 | 3.4 |
| 3.75 | 4.1 | |
| 4.0 | 4.1 |
| Implant Systems Compatibility | |||
|---|---|---|---|
| -- | -- | ------------------------------- | -- |
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants.
This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
A summary of the subject device abutment designs and the compatible OEM implants is provided in the table Summary of Subject Device Multi-Unit Abutment Designs on the following page.
5
| Subject Device Multi-Unit Abutments | |||||
|---|---|---|---|---|---|
| Connection and | |||||
| Compatible Implant Line | Angulation | Implant-Abutment | |||
| Platform Ø, mm | Gingival Height, | ||||
| mm | New Components, | ||||
| Provided Sterile | |||||
| and Nonsterile | Previously Cleared | ||||
| Components, | |||||
| Now provided Sterile | |||||
| Internal Hex Connections | |||||
| Zimmer 3.1mmD Eztetic™ | |||||
| TSXTM Implant System, | |||||
| 3.1mmD | 0° | 2.9 | 1, 2, 3, 4, 5 | X | |
| 17° | 2.5, 3.5 | X | |||
| 30° | 3.5, 4.5 | X | |||
| Zimmer Screw-Vent® | |||||
| TSXTM Implant System | 0° | 3.5, 4.5 | 1, 2, 3, 4, 5 | X | X |
| 17° | 2.5, 3.5 | X | X | ||
| 30° | 3.5, 4.5 | X | X | ||
| Zimmer Tapered Screw-Vent® | 0° | 3.5, 4.5, 5.7 | 1, 2, 3, 4, 5 | X | X |
| 17° | 2.5, 3.5 | X | X | ||
| 30° | 3.5, 4.5 | X | X | ||
| External Hex Connections | |||||
| Biomet 3i OSSEOTITE® | |||||
| Implants | 17° | 3.4 | 2, 3, 4 | X | |
| 30° | 4.1 | 3, 4, 5 | X |
Summary of Subject Device Multi-Unit Abutment Designs
Subject device components that will be provided sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm; new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants; previously cleared multi-unit abutments compatible with Screw-Vent", Tapered Screw-Vent®, and TSX™ implants with implant platform diameters of 3.5 mm and 4.5 mm; and previously cleared prosthetic components compatible with all subject device multi-unit abutments.
Subject device components that will be provided non-sterile include:
new (not previously cleared) multi-unit abutment screw compatible with Zimmer 3.1mmD Eztetic and TSX™ Implant System, 3.1mmD implants; new multi-unit abutments with Screw-Vent", and TSX™ implants with implant platform diameters of 4.5 mm and new multi-unit abutments compatible with Biomet 3i OSSEOTITE® implants.
The design dimensions and tolerances of subject device abutments and screws for the Zimmer 3.1mmD Eztetic and TSX™ Implant Systems have been established on the basis of a contractual agreement and working relationship between ZimVie and Terrats Medical SL to ensure that the abutments are designed to fit the corresponding implants. Compatibility of the subject abutments and screws for Screw-Vent®, Tapered Screw-Vent®, and TSX™ implant lines was provided in the prior Terrats Medical SL submission K170588. Compatibility of the subject abutments and screws for the Biomet 3i OSSEOTITE® external hex implants was provided in the prior Terrats Medical SL submission K170588.
Multi-Unit Abutments
The Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 30°. The design of the straight Multi-Unit Abutments is similar to that of straight Multi-Unit Abutments cleared in the primary predicate device K230143 with the exception of the implant connections and platform diameters. The straight Multi-Unit Abutment is provided only in a non-engaging. threaded design that attaches directly to the implant. All straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm. Straight Multi-Unit Abutments are provided only for the compatible internal hex implants listed in the table above. The gingival height of the straight Multi-Unit Abutment ranges from 1 mm to 5 mm in 1 mm increments.
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510(k) Summary Page 4 of 7
The angled Multi-Unit Abutments are provided in an engaging design that requires an abutment screw, with angulations of 17° and 30°. The angled Multi-Unit Abutments are provided for the compatible internal hex connection implants and the compatible external hex connection implants listed in the table above (on page 3). All angled Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with gingival heights from 2.5 mm to 4.5 mm. The designs of the angled Multi-Unit Abutments are similar to those of the angled Multi-Unit Abutments cleared in the primary predicate device K230143.All Multi-Unit Abutments, straight and angled, are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.
Screws
This submission includes two (2) abutment screws to be used with the subject device abutment screw for the compatible internal hex implants with a platform diameter of 2.9 mm; and another abutment screw for all compatible external hex implants (with platforms of 3.4 mm). The screws have a hex or hexalobular instrument interface and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission 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);
- provided in this submission was engineering analysis to demonstrate that the subject device abutments compatible ● with the Screw-Vent", Tapered Screw-Vent", and TSX™ implants do not create a new worst-case construct in terms of mechanical testing according to ISO 14801;
- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments compatible with the Zimmer 3.1mmD Eztetic and TSX™ implants, and the performance of the subject device abutments compatible with the Biomet 3i OSSEOTITE® Implants;
- referenced from K22269 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: analysis showed that the subject devices do not create a new worst case for moist heat sterilization:
- referenced from K212538 was gamma irradiation sterility assurance level of 10° by ● selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of