DESS Dental Smart Solutions

K233316 · Terrats Medical SL · NHA · Jan 5, 2024 · Dental

Device Facts

Record IDK233316
Device NameDESS Dental Smart Solutions
ApplicantTerrats Medical SL
Product CodeNHA · Dental
Decision DateJan 5, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesReal-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
K233316 · Jan 5, 2024DESS Dental Smart SolutionsTerrats Medical SLPublished clinical literature (Woods, Delfino, and Rajan, 2021)The document uses a published literature review to evaluate the subject devices in the MR environment, specifically addressing magnetically induced displacement force and torque.MR safety; Literature review; Magnetic resonance environment

Clinical Evidence

Study DesignPopulationComparatorKey Endpoints
Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices; Literature review / Scientific rationale; Follow-up/Duration: Not applicable; Study Period: Not applicableNot applicable; Sample Size: Not applicable; Number of Sites: Not applicableNot applicable for this studyMagnetically induced displacement force and torque in the MR environment

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.

Device Story

DESS Dental Smart Solutions abutments (healing, temporary, multi-unit) and screws provide support for prosthetic restorations in the maxillary or mandibular arch. Components are used in conjunction with various OEM endosseous dental implants. The device is used in a clinical setting by dental professionals. This submission updates the sterilization status of previously cleared components to include sterile-to-the-end-user options via gamma irradiation. The device functions as a mechanical interface between the implant and the final prosthesis. Benefits include enabling functional and esthetic rehabilitation for edentulous patients. The healthcare provider selects the appropriate abutment based on the specific implant system and clinical requirements.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including MR environment displacement/torque analysis, gamma irradiation validation (SAL 10^-6), bacterial endotoxin testing (ANSI/AAMI ST72, < 20 EU/device), and accelerated aging shelf-life testing (ASTM F1980).

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136). Surface: Anodization and SelectGrip®. Screws: Ti-6Al-4V alloy with DLC coating. Sterilization: Gamma irradiation (25 kGy) or non-sterile. Packaging: PETG blister with Tyvek® lid. Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring prosthetic restoration support in the maxillary or mandibular arch using endosseous dental implants. Compatible with specific OEM implant systems listed in the device documentation.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Reference Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 5, 2024 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: K233316 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: January 2, 2024 Received: January 2, 2024 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}------------------------------------------------ 2 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}------------------------------------------------ 3 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) K233316 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. | 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 | | | 3.6 | 3.6 | | Astra Tech EV | 4.2 | 4.2 | | | 4.8 | 4.8 | | | 5.4 | 5.4 | | Astra Tech OsseoSpeed™ | 3.5, 4.0 | 3.5/4.0 | | | 4.5, 5.0 | 4.5/5.0 | | BioHorizons Internal | 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 | | 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 | | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | | NobelActive® | 3.5 | NP | | NobelReplace Conical<br>NobelParallel Conical | 4.3, 5.0 | RP | | NobelReplace® | 3.5 | NP | | | 4.3 | RP | | | 5.0 | WP | | Nobel Brånemark System® | 3.3 | NP | | | 3.75, 4.0 | RP | | | 5.0 | WP | | Osstem TS | 3.5 | Mini | | Hiossen TS | 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, 4.1, 4.8 | RN | | | 4.8 | WN | | Zimmer Screw Vent® | 3.3, 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | Tapered Screw-Vent® | 6.0 | 5.7 | | TSXTM Implant System | 3.7, 4.1, 4.7 | 3.5 | | | 5.4, 6.0 | 4.5 | ## Compatible Implant Systems {4}------------------------------------------------ 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." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF {5}------------------------------------------------ # 510(k) Summary K233316 Terrats Medical SL DESS Dental Smart Solutions January 2, 2024 ## ADMINISTRATIVE INFORMATION | Manufacturer Name | Terrats Medical SL<br>Carrer Mogoda, 75-99<br>Barberà del Vallès 08210<br>Barcelona, Spain | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Telephone | +34 935 646 006 | | Official Contact | Roger Terrats, CEO | | Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone +1 858-792-1235<br>Fax +1 858-792-1236<br>Email kthomas@paxmed.com<br>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 K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K191986, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K222288, DESS Dental Smart Solutions, Terrats Medical SL K212538, DESS Dental Implants, Terrats Medical SL K231434, DESS Dental Smart Solutions, Terrats Medical SL {6}------------------------------------------------ Reference Devices for OEM implant body clearances - K140347, ANKYLOS C/X Implant System, Dentsply International Inc. - K120414. OsseoSpeed™ Plus, Astra Tech AB - K111287, Astra Tech Implant System Plus, Astra Tech AB - K101732, Astra Tech Implant System, Astra Tech AB - K042429, BioHorizons The Prodigy System™ Endosseous Implants, BioHorizons Implant Systems, Inc. - K071638, BioHorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. - K093321, BioHorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. - K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. - K083496, CAMLOG Implant System Modified Implants and Abutments, Altatec GmbH - K160965, SuperLine, Dentium Co., Ltd. - K073075, FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System), Dentsply International Inc. - K163194, Neodent Implant System GM Line, JJGC Indústria e Comércio de Materiais Dentários SA - K180536, Neodent Implant System GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. - K201225, Neodent Implant System GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A. - K142260, NobelActive®, Nobel Biocare AB - K173418, NobelParallel™ Conical Connection, Nobel Biocare AB - K050705, TiUnite Implants®, Nobel Biocare AB - K050406, NOBELSPEEDY™ Implants, Nobel Biocare USA LLC - K050258, Groovy Implants, Nobel Biocare AB - K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA, Inc. - K161604, OSSTEM Implant System, OSSTEM Implant Co., Ltd. - K173961, Straumann® BLX Implant System, Institut Straumann AG - K181703, Straumann® BLX Line Extension Implants, SRAs and Anatomic Abutments, Institut Straumann AG - K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG - K210855, Straumann BLX Implant System, Institut Straumann AG - K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG - K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC - K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC - K013227. Screw Vent Implant: Tapered Screw Vent Implant. Sulzer Dental. Inc. - K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc. - K220978, TSXTM Implants, Biomet 3i LLC The primary predicate device K170588, and the reference devices K191986, K212628, and K222288 are in support of substantial equivalence of the subject designs, material, manufacturing, and biocompatibility. The reference device K212538 is in support of substantial equivalence of the subject device sterilization, packaging, and shelf life. # 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. | 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 | | | 3.6 | 3.6 | | Astra Tech EV | 4.2 | 4.2 | | | 4.8 | 4.8 | | | 5.4 | 5.4 | | Astra Tech OsseoSpeed™ | 3.5, 4.0 | 3.5/4.0 | | | 4.5, 5.0 | 4.5/5.0 | | BioHorizons Internal | 3.8, 4.6 | 3.5 | | | 4.6, 5.8 | 4.5 | | | 5.8 | 5.7 | #### Compatible Implant Systems {7}------------------------------------------------ | Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | |-----------------------------------------------|------------------------------------|-----------------------| | 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 | | 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 | | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | | NobelActive® | 3.5 | NP | | NobelReplace Conical<br>NobelParallel Conical | 4.3, 5.0 | RP | | NobelReplace® | 3.5 | NP | | | 4.3 | RP | | | 5.0 | WP | | Nobel Brånemark System® | 3.3 | NP | | | 3.75, 4.0 | RP | | | 5.0 | WP | | Osstem TS | 3.5 | Mini | | Hiossen TS | 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, 4.1, 4.8 | RN | | | 4.8 | WN | | Zimmer Screw Vent® | 3.3, 3.7, 4.1 | 3.5 | | Tapered Screw-Vent® | 4.7 | 4.5 | | | 6.0 | 5.7 | | TSX™ Implant System | 3.7, 4.1, 4.7 | 4.5 | | | 5.4, 6.0 | 4.5 | ## SUBJECT DEVICE DESCRIPTION The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile. The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws. A summary of the subject components is provided in the following table. | | Subject Device Components | | | | | |------------------------|---------------------------|------------------------|-----------------------------|-----------------------------------------|--------| | OEM Implant Lines | Healing<br>Abutments | Temporary<br>Abutments | Munti-Unit<br>Abutments, 0° | Munti-Unit<br>Abutments, 17° and<br>30° | Screws | | Ankylos C/X | X | X | | | X | | Astra Tech EV | X | X | X | X | X | | Astra Tech OsseoSpeed™ | X | X | X | X | X | | BioHorizons Internal | X | | X | | | | Biomet 3i Certain® | X | X | | | X | | Biomet 3i OSSEOTITE® | X | X | X | | X | | Camlog | X | X | | | X | {8}------------------------------------------------ | | Subject Device Components | | | | | |-------------------------|---------------------------|------------------------|-----------------------------|-----------------------------------------|--------| | OEM Implant Lines | Healing<br>Abutments | Temporary<br>Abutments | Munti-Unit<br>Abutments, 0° | Munti-Unit<br>Abutments, 17° and<br>30° | Screws | | Dentium SuperLine | | | X | | | | FRIADENT XiVE® | X | X | | | X | | Neodent Grand Morse | | | X | X | | | NobelActive® | X | X | X | X | X | | NobelReplace® | X | X | X | | X | | Nobel Brånemark System® | X | X | X | | X | | Osstem TS | | X | | | X | | Hiossen TS | | X | | | X | | Straumann BLX | X | | X | X | | | Straumann® Bone Level | X | X | X | X | X | | Straumann® Tissue Level | X | X | X | | X | | Zimmer Screw Vent® | X | X | | | X | | Tapered Screw-Vent® | X | X | | | X | | TSX™ Implant System | X | X | | | X | Healing Abutments are compatible with the OEM implant lines as listed in this summary, and as protectors (healing attachments) for use with Straumann Converter Abutment for Straumann Tissue Level implants) and for DESS Multi-Unit Abutments. The Healing Abutments are provided in a range of gingival heights from 1 mm to 6.5 mm, and in a range of coronal (maximum) diameters of 3.5 mm to 7 mm. Temporary Abutments are compatible with the OEM implant lines as listed in this summary and are available for single-unit and multiple-unit restorations. Temporary Abutments are provided in a range of gingival heights from 0.35 mm to 2.5 mm, and in a range of prosthetic platform diameters from 4.5 mm to 6.8 mm. Multi-Unit Abutments are compatible with the OEM implant lines as listed in this summary in straight (00) and angled (17° and 30°) designs. Multi-Unit are provided in gingival heights from 1 mm to 6 mm for the straight (0°) designs, 2.5 mm to 4.5 mm for angled 17º designs, and 3.5 mm for the angled 30º designs. Abutment screws are compatible with the OEM implant lines as listed in this summary. There are no changes to the design of the screws cleared previously in K170588. K212628. K191986, and K222288. The subject device abutments and abutment screws have the same OEM implant compatibilities as the identical screws cleared in K170588, K212628, K191986, and K222288. # PERFORMANCE DATA Non-clinical data submitted or referenced to demonstrate substantial equivalence included: - . non-clinical analysis was performed to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque; - referenced from K212538 was gamma irradiation validation to a 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 < 20 EU/device; and shelf life testing of samples after {9}------------------------------------------------ accelerated aging equivalent to five (5) years of real time aging according to ASTM F1980, with testing of the packaging sterile barrier and sterility testing of product; - . referenced from K170588 was moist heat sterilization validated by the overkill method to a sterility assurance level (SAL) of 106 according to ISO 17665-1 and ISO/TR 17665-2; - referenced from K170588, K191986, K212628, and K222288 was biocompatibility of the subject device ● components: - . referenced from K170588. K191986. K212628. and K222288 was compatibility of the subject abutnents and the OEM implants listed in the Indications for Use Statement. No clinical data were included in this submission. # EQUIVALENCE TO MARKETED DEVICES All subject device components are identical in design, material, and technological characteristics to those of the primary predicate device K170588, and the reference devices K191986, K2126288. The subject device abutments have similar or identical ranges abutment-implant platform diameter, prosthetic platform diameter, gingival height, and angulation as the components cleared in the predicate device K170588, and the reference devices K191986. K212628, and K222288. The subject device screws are identical to the screws previously cleared in K170588, K191986, K212628, and K222288. The subject device abutments have the same compatibilities as previously cleared in the primary predicate device K170588 and in the reference devices K191986, K212628, and K222288. All subject device components are provided sterile by gamma irradiation and are packaged in a PETG blister with a Tyvek® lid. The gamma sterilization, packaging, and 5-year shelf life for sterile devices is the same as that validated in the reference device K212538. Subject devices that are provided non-sterile are packaged in PETG blister packs or PET bags. # CONCLUSION The subject device, the primary predicate device, and the reference devices have the same intended use, identical or nearly identical technological characteristics, and are material. The subject device and the primary predicate device encompass the same of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. {10}------------------------------------------------ 510(k) Summary Page 6 of 6 ## Table of Substantial Equivalence | Comparison | Subject Device | Primary Predicate Devices | Reference Device | Reference Device | Reference Device | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | DESS Dental Smart Solutions<br>Terrats Medical SL | K170588<br>DESS Dental Smart Solutions<br>Terrats Medical SL | K191986<br>DESS Dental Smart Solutions<br>Terrats Medical SL | K212628<br>DESS Dental Smart Solutions<br>Terrats Medical SL | K222288<br>DESS Dental Smart Solutions<br>Terrats Medical SL | | Product Code | NHA | NHA | NHA | NHA | NHA | | Reason for predicate/reference | n/a | Abutment designs, OEM compatibilities, manufacturing | Abutment designs, OEM compatibilities, manufacturing | Abutment designs, OEM compatibilities, manufacturing | Abutment designs, OEM compatibilities, manufacturing | | Intended Use | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | | Indications for Use Statement | DESS Dental Smart Solutions abutments are intended to be<br>used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for<br>prosthetic restorations.<br>The complete Indications for Use Statement with OEM<br>implant compatibilities is provided in this Summary. | DESS Dental Smart Solutions abutments are intended to be<br>used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for<br>prosthetic restorations.<br>All digitally designed custom abutments for use with<br>TiBase or Pre-milled Blank are to be sent to a Terrats<br>Medical validated milling center for manufacture.<br>The complete Indications for Use Statement with OEM<br>implant compatibilities is provided in the 510(k) Summary<br>for K170588. | DESS Dental Smart Solutions abutments are intended to be<br>used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for<br>prosthetic restorations.<br>All digitally designed custom abutments for use with Ti<br>Base abutments or Pre-milled (Blank) abutments are to be<br>sent to a Terrats Medical validated milling center for<br>manufacture.<br>The complete Indications for Use Statement with OEM<br>implant compatibilities is provided in the 510(k) Summary<br>for K1191986. | DESS Dental Smart Solutions abutments are intended to be<br>used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for<br>prosthetic restorations.<br>All digitally designed custom abutments for use with DESS<br>Bases or Blanks are to be sent to a Terrats Medical<br>validated milling center for manufacture.<br>The complete Indications for Use Statement with OEM<br>implant compatibilities is provided in the 510(k) Summary<br>for K212628. | DESS Dental Smart Solutions abutments are intended to be<br>used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for<br>prosthetic restorations.<br>All digitally designed custom abutments for use with Ti<br>Base abutments or Pre-milled Blank abutments are to be<br>sent to a Terrats Medical validated milling center for<br>manufacture.<br>The complete Indications for Use Statement with OEM<br>implant compatibilities is provided in the 510(k) Summary<br>for K222288. | | Designs | Healing Abutments | Healing Abutments | Healing Abutments | Healing Abutments | Healing Abutments | | | Temporary Abutments | Temporary Abutments | Temporary Abutments | | Temporary Abutments | | | Multi-unit Abutments, Straight | Multi-unit Abutments, Straight | | Multi-unit Abutments, Straight | Multi-unit Abutments, Straight | | | Multi-unit Abutments, Angled 17° and 30° | | Multi-unit Abutments, Angled 17° and 30° | | Multi-unit Abutments, Angled 17° and 30° | | | Prosthetic components for Multi-unit Abutments | Prosthetic components for Multi-unit Abutments | | | | | | Screws | Screws | Screws | Screws | Screws | | Prosthesis Attachment | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | | Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | | Abutment/Implant Platform Ø, mm | 2.52 - 5.7 | 3.4 - 5.7 | 2.52 - 6.0 | 2.3 - 6.0 | 2.52 - 6.5 | | Prosthetic Platform Ø, mm | 4.5 - 6.8 | 4.5 - 6.8 | 4.5 - 6.5 | 4.5 - 6.5 | 4.5 - 6.5 | | Abutment Angle | 0°, 17°, 30° | 0° | 0°, 17°, 30° | 0° | 0°, 17°, 30° | | Material | | | | |…
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