DESS Dental Smart Solutions

K253804 · Terrats Medical SL · NHA · Apr 16, 2026 · Dental

Device Facts

Record IDK253804
Device NameDESS Dental Smart Solutions
ApplicantTerrats Medical SL
Product CodeNHA · Dental
Decision DateApr 16, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesReal-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
K253804 · Apr 16, 2026DESS Dental Smart SolutionsTerrats Medical SLPublished clinical literature (Woods, Terry O., et al., 2019)The sponsor used a literature review of clinical/scientific data to assess the safety of metallic device components in an MRI environment, specifically evaluating magnetically induced displacement force and torque.MRI safety; Literature review; Metallic implants

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

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 are dental implant abutments (DESSLoc) used to attach removable overdentures to endosseous dental implants. The system includes titanium alloy abutments with zirconium nitride (ZrN) coating, denture housings, and polyamide retention inserts. The device is operated by dental professionals in a clinical setting. The abutment is screwed into the dental implant; the denture housing with a retention insert is embedded into the patient's prosthesis. The system provides a resilient, snap-fit attachment, allowing the prosthesis to be retained on the implants while distributing loading to the surrounding gingival tissue. The current submission expands the line to include 18° angled abutments and additional gingival height options for specific OEM connections. The device benefits patients by providing a secure, removable prosthetic restoration to restore masticatory function.

Clinical Evidence

Bench testing only. Evidence includes leveraged sterilization validation (ISO 17665-1/2), non-clinical MRI safety assessment based on scientific literature, reverse engineering analysis of OEM implant connections, and fatigue testing of worst-case angled abutment configurations.

Technological Characteristics

Materials: Titanium alloy (ASTM F136) with Zirconium Nitride (ZrN) coating. Components: Abutments, denture housings, and polyamide (Polynil/Vestamid) retention inserts. Interface: Internal thread for connection to OEM implants. Sterilization: Provided non-sterile; validated for end-user steam sterilization. Connectivity: Mechanical attachment only; no software or electronics.

Indications for Use

Indicated for patients requiring prosthetic restoration support via endosseous dental implants in the maxillary or mandibular arch. Compatible with various OEM implant systems (Ankylos, Astra Tech, BioHorizons, Biomet 3i, Keystone, MegaGen, MIS, Neodent, Nobel Biocare, Straumann, Zimmer).

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} FDA U.S. FOOD & DRUG ADMINISTRATION April 16, 2026 Terrats Medical SL % Melissa Burbage Principal Regulatory Consultant Enerxen Consulting, Inc. 1155 Metcalfe St. Suite 1572 Montreal, Quebec H3B2V6 CANADA Re: K253804 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: November 28, 2025 Received: March 19, 2026 Dear Melissa Burbage: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253804 - Melissa Burbage Page 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K253804 - Melissa Burbage Page 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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K253804 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 Systems | Implant System Compatibility | Implant Diameter (mm) | Implant Platform Name | | --- | --- | --- | | Ankylos C/X | 3.5, 4.5, 5.5 | 3.5, 4.5, 5.5 | | 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 Internal | 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 | | Keystone Prima Connex | 3.3, 3.5 | 3.5 | | | 4.0, 4.1 | 4.1 | | | 5.0 | 5.0 | | MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | | MIS CI | 3.30 | NP | | | 3.75, 4.20 | SP | | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | | NobelActive® NobelReplace/ NobelParallel Conical | 3.5 | NP (3.5) | | | 4.3, 5.0 | RP (3.9) | | | 5.5 | WP (5.1) | | NobelReplace® Trilobe | 3.5 | NP (3.5) | | | 4.3 | RP (4.3) | | | 5.0 | WP | | Nobel Brånemark System® | 3.3 | NP | | | 3.75, 4.0 | RP | | | 5.0 | WP | | 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 | | Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) {4} 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 (8/14) Page 1 of 2 PSC Publishing Services (301) 443-6740 {5} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 # 510(k) Summary Terrats Medical SL # DESS® Dental Smart Solutions K253804 April 16, 2026 ## ADMINISTRATIVE INFORMATION Manufacturer Name Terrats Medical SL Carrer Mogoda 75-99 Barberà del Vallès 08210 Barcelona, Spain Telephone: +34 935 646 006 Fax: +34 935 647 317 Official Contact Roger Terrats, CEO Representative/Consultant Melissa Burbage Enerxen Consulting, Inc. 1155 Metcalfe Street, Suite 1572 Montreal, Quebec H3B 2V6 Telephone: +1 619-480-7733 Email: melissa.burbage@enerxen.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 Primary Product Code NHA Classification Panel Dental Products Panel Reviewing Division DHT1B: Division of Dental and ENT Devices ## PREDICATE DEVICE INFORMATION Primary Predicate Device K251547, DESS Dental Smart Solutions, Terrats Medical SL Reference Device K170588, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K222269, DESS Dental Smart Solutions, Terrats Medical SL K242340, DESS Dental Smart Solutions, Terrats Medical SL K233587, LOCATOR® Angled Abutment (Various), Zest Anchors, LLC Reference Devices for OEM implant body clearances K140347, ANKYLOS C/X Implant System, Dentsply International Inc. K111287, Astra Tech Implant System Plus, Astra Tech AB Page 1 of 7 {6} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 K120414, OsseoSpeed™ Plus, Astra Tech AB K101732, Astra Tech Implant System, Astra Tech AB K042429, BioHorizons The Prodigy System™ Endosseous Implants, BioHorizons Implant Systems K071638, BioHorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. K063286, OSSEOTITE Dental Implants, Implant Innovations, Inc. K051614, PrimaConnex Internal Connection, Lifecore Biomedical (Keystone) K072768, Restore®, Stage-1®, Renova®, PrimaSolo®, and PrimaConnex® Dental Implants, Lifecore Biomedical, Inc. K101545, Genesis Implant System, Keystone Dental, Inc. K172505, MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection, MIS Implants Technologies Ltd K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários K142260, NobelActive®, Nobel Biocare AB K102436, NobelActive® 3.0, Nobel Biocare AB K173418, NobelParallel™ Conical Connection, Nobel Biocare AB K050705, TiUnite Implants®, Nobel Biocare AB K050406, NOBELSPEEDY™ Implants, Nobel Biocare USA LLC K022562, Various Brånemark System Implants–Immediate Function Indication, Nobel Biocare K173961, Straumann® BLX Implant System, Institut Straumann AG K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann K011028, Screw-Vent Implant; Tapered Screw-Vent Implant, Sulzer Dental, Inc. K112160, Tapered Screw-Vent X Implant, Zimmer Dental, Inc. Page 2 of 7 {7} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 # 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 Systems | Implant System Compatibility | Implant Diameter (mm) | Implant Platform Name | | --- | --- | --- | | Ankylos C/X | 3.5, 4.5, 5.5 | 3.5, 4.5, 5.5 | | 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 Internal | 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 | | Keystone Prima Connex | 3.3, 3.5 | 3.5 | | | 4.0, 4.1 | 4.1 | | | 5.0 | 5.0 | | MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | | MIS C1 | 3.30 | NP | | | 3.75, 4.20 | SP | | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | | NobelActive® NobelReplace/ NobelParallel Conical | 3.5 | NP (3.5) | | | 4.3, 5.0 | RP (3.9) | | | 5.5 | WP (5.1) | | NobelReplace® Trilobe | 3.5 | NP (3.5) | | | 4.3 | RP (4.3) | | | 5.0 | WP | | Nobel Brånemark System® | 3.3 | NP | | | 3.75, 4.0 | RP | | | 5.0 | WP | | 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 | | Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 | # SUBJECT DEVICE DESCRIPTION The purpose of this submission is to expand the DESS Dental Smart Solutions to include an angled version of the DESSLoc abutment and to include straight DESSLoc abutments for the 3.0 mm implant-abutment platform diameter for BioHorizons, as well as additional gingival height options for straight DESSLoc abutments BioHorizons (Implant-Abutment Platform 3.5mm and 4.5mm), Straumann Bone Level (Implant-Abutment Platform NC (3.3mm)), and Zimmer (Implant-Abutment Platform 3.5mm and 4.5mm) connections, as outlined in the tables below. Page 3 of 7 {8} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. The design of the DESSLoc abutments has been changed to provide an $18^{\circ}$ angled abutment with various OEM connections that have been previously cleared. The abutments are made of titanium alloy and are coated with zirconium nitride (ZrN). The system uses existing retention inserts manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12), and existing denture housings made of titanium alloy with a machined or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below. Table 1 Summary of OEM Compatibilities for Angled DESSLoc Attachment System | Compatible Implant Lines | DESS Abutment System Name | Implant-Abutment Platform Ø, mm | Implant Body Ø, mm | Gingival Height, mm | | --- | --- | --- | --- | --- | | Ankylos C/X | Internal Ank | 2.52 | 3.5, 4.5, 5.5 | 1, 2, 3, 4, 5 | | Astra Tech EV | Conic EVO | 2.9 | 3.6 | 1, 2, 3, 4, 5 | | | | 3.5 | 4.2 | 1, 2, 3, 4, 5 | | | | 4.1 | 4.8 | 1, 2, 3, 4, 5 | | | | 5.4 | 5.4 | 1, 2, 3, 4, 5 | | Astra Tech OsseoSpeedTM | Internal Hex Conic | 3.5 | 3.5 | 1, 2, 3, 4, 5 | | | | 4.0 | 4.0 | 1, 2, 3, 4, 5 | | BioHorizons Internal | Internal Hex BH | 3.5 | 3.8, 4.6 | 1, 2, 3, 4, 5 | | | | 4.5 | 4.6, 5.2, 5.8 | 1, 2, 3, 4, 5 | | | | 5.7 | 5.8, 7, 8 | 1, 3, 5 | | Biomet 3i Certain® | Internal Hex “Click” | 3.4 | 3.25 | 1, 2, 3, 4, 5 | | | | 4.1 | 4.0 | 1, 2, 3, 4, 5 | | Biomet 3i OSSEOTITE® | External Hex USA | 3.4 | 3.25 | 1, 2, 3, 4, 5 | | Keystone Prima Connex | Internal Tilobe | 3.5, 3.8 | 3.3, 3.5, 3.8 | 1, 3, 5 | | | | 4.1, 4.5 | 4.0, 4.1, 4.5 | 1, 3, 5 | | | | 5.0, 5.5, 5.7, 6.0, 6.5 | 5.0, 5.5, 6.0, 6.5 | 1, 3, 5 | | MegaGen AnyRidge | Conic Anyr | 3.5 | 3.5, 4.0, 4.5, 5.0, 5.5 | 1.5, 3, 4.5 | | MIS C1 | MIS C1 Internal | NP (3.3) | 3.3 | 1, 2, 3, 4, 5 | | | | SP | 3.75, 4.2 | 1, 2, 3, 4, 5 | | Neodent Grand Morse | Neo GM | Grand Morse (GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 1, 2, 3, 4, 5 | | NobelActive®, NobelParallel Conical | Active Hex | NP (3.5) | 3.5 | 1, 2, 3, 4, 5 | | | | RP (4.3) | 4.3, 5.0 | 1, 2, 3, 4, 5 | | NobelReplace® Trilobe | Tri-lobe | NP (3.5) | 3.5 | 1, 3, 5 | | | | RP (4.3), | 4.3 | 1, 3, 5 | | Nobel Brånemark System® | External Hex Universal | NP (3.5) | 3.3 | 1, 2, 3, 4, 5 | | | | RP (4.1) | 3.75, 4.0 | 1, 2, 3, 4, 5 | | Straumann BLX | Conical BLX | RB/WB | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | 1, 2, 3, 4, 5 | | Straumann® Bone Level | Conical BL | NC (3.3) | 3.3 | 1, 2, 3, 4, 5 | | | | RC (4.1) | 4.1, 4.8 | 1, 2, 3, 4, 5 | | Zimmer Screw-Vent / Tapered Screw-Vent | Internal Hex USA | 3.5 | 3.7, 4.1 | 1, 2, 3, 4, 5 | | | | 4.5 | 4.7 | 1, 2, 3, 4, 5 | | | | 5.7 | 6.0 | 1, 3, 5 | {9} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 Table 2 Summary of OEM Compatibilities for Straight DESSLoc Attachment System | Compatible Implant Lines | DESS Abutment System Name | Implant-Abutment Platform Ø, mm | Implant Body Ø, mm | Gingival Height, mm | | --- | --- | --- | --- | --- | | BioHorizons Internal | Internal Hex BH | 3.0 | 3.0, 3.4, 3.8 | 1, 2, 3, 4, 5, 6 | | | | 3.5 | 3.8, 4.6 | 0.5 | | | | 4.5 | 4.6, 5.2, 5.8 | 0.5 | | Straumann® Bone Level | Conical BL | NC (3.3) | 3.3 | 1 | | Zimmer Screw-Vent / Tapered Screw-Vent | Internal Hex USA | 3.5 | 3.7, 4.1 | 0.5 | | | | 4.5 | 4.7 | 0.5 | ## MATERIAL COMPOSITION All abutments and metal denture housing are manufactured from titanium alloy conforming to the requirements of ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). ## PERFORMANCE DATA Non-clinical testing data submitted to demonstrate substantial equivalence included: - Leveraged sterilization validation from K251547 according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 for the subject device abutments. - Non-clinical worst-case MRI review to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the subject device components and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. - Leveraged reverse engineering analysis of OEM implant bodies from K170588, K191986, K212628, K222269, K242340, and K251547, OEM abutments, and OEM abutment screws to confirm compatibility for new OEM connections. - Fatigue testing of OEM implant bodies with abutments at worst-case angled conditions. Page 5 of 7 {10} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 # EQUIVALENCE TO MARKETED DEVICES Table 3 Table of Substantial Equivalence | Comparison | Subject Device | Predicate Device | Reference Device | | --- | --- | --- | --- | | | DESS Dental Smart Solutions Terrats Medical SL | K251547 DESS Dental Smart Solutions Terrats Medical SL | K233587 LOCATOR Angled Abutment Zest Anchors, LLC | | Product Code | NHA | NHA | NHA | | Reason for predicate/reference | n/a | Indications, Abutment design, OEM Connections | Angled Abutment Design | | Intended Use | Support of a prosthesis to restore chewing function | Support of a prosthesis to restore chewing function | Support of a prosthesis to restore chewing function | | Indications | 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. | 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. | The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient. | | Design | | | | | Abutment Diameter, mm | 2.9 – 5.7 | 2.9 – 5.7 | 3.25 – 6.5 | | Gingival Height, mm | 0.5 – 6 | 0 – 6 | 1 – 6 | | Abutment Angulation | Straight, Angled | Straight | Angled | | Abutment/Implant Interface | Internal Thread | Internal Thread | Internal Thread | | Restoration type | Overdenture | Overdenture | Overdenture | | Divergence Allowance | 18°/36° | 0° | 15°/30° | | Prosthesis Attachment Type | Nylon Insert retained in Denture Housing | Nylon Insert retained in Denture Housing | Nylon Insert retained in Denture Housing | | Material | | | | | Abutment | Ti 6Al-4V ELI | Ti 6Al-4V ELI | Ti 6Al-4V ELI | | Abutment Coronal Surface Coating | Zirconium Nitride (ZrN) | Zirconium Nitride (ZrN) | Titanium Nitride (TiN) | | Denture Housing | Titanium | Titanium | Titanium | | Nylon Insert | Polynil® (polyamide 6.6) or Vestamid® | Polynil® (polyamide 6.6) or Vestamid® | Nylon | | Reprocessing | | | | | Abutment | End user steam sterilization | End user steam sterilization | End user steam sterilization | | Denture Housing | Titanium: End user steam sterilization | End user steam sterilization | End user steam sterilization | | Nylon Insert | Polynil: Disinfectant Vestamid: End user steam sterilization | Polynil: Disinfectant Vestamid: End user steam sterilization | Not included | Page 6 of 7 {11} Traditional 510(k) Premarket Notification 510(k) Summary DESS Dental Smart Solutions K253804 The indications for use of the subject device abutments are identical to the predicate device K251547, with the exception of the table of compatibilities. Both are intended for use with endosseous dental implants to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. All OEM device compatibilities included in the subject device indications for use were included in the primary predicate, but not all primary predicate compatibilities are included in the subject system. The subject device consists of abutments for attachment of prostheses to endosseous implants similar to predicate devices. The subject device is similar in its indication for use, sizes, shapes, and surface coating. It is identical the predicate devices in coronal geometry such that the mechanism for overdenture retention is the same and similar angled design as reference device K233587. The ability of the attachment system to accommodate abutment divergence is similar to the reference device K233587. The diameters offered are same to those of the predicate devices and are dependent on the implant compatibility. All DESSLoc abutments have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit similar to that of the predicate device. Retention inserts are fixed within a denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention similar to the reference device K233587. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The subject device abutments are manufactured from the same material, titanium alloy, and have same surface coating that are applied above the implant/abutment interface. The zirconium nitride (ZrN) coating is the same the predicate devices with a thickness of approximately 2 and 3 µm. As with the primary predicate device, the coating is non-porous, the surface roughness of the machined abutment surface is maintained, and the coating is not applied to enhance tissue attachment to the device. The subject device is provided non-sterile to the end user for the end user to sterilize prior to use, the same as the primary predicate. The subject device denture housing is manufactured from titanium, the same material as the primary predicate K251547. The nylon inserts (Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12)) are the same components previously cleared under K251547. The subject device denture housing and retention inserts are provided non-sterile to the end user for the end user to sterilize or disinfect prior to use, the same as the primary predicate. ## CONCLUSION The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate, and additional predicate devices encompass the same range 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. Page 7 of 7
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