(204 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908 and K191986 to add additional components for previously cleared OEM platform compatibilities and to additional OEM platform compatibilities for previously cleared DESS designs. This submission includes three (3) abutments (Healing Abutments, straight Multi Unit Abutments and DESSLoc Abutments), three (3) bases, two (2) blanks, and seven (7) screws.
Among the subject devices for this submission are abutments and screws compatible with three (3) implant systems for which Terrats Medical has no prior clearance and one (1) implant system for which new platform compatibilities are included, for a total of nine (9) new platforms.
The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in the table Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems. The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
The provided document is a 510(k) premarket notification for dental implant abutments. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the manner one might see for an AI/ML medical device.
Therefore, many of the requested items related to AI/ML device studies (such as test set details, expert ground truthing, MRMC studies, or training set information) are not applicable to this submission.
However, based on the information available in the document, here's a breakdown of the relevant points:
Acceptance Criteria and Device Performance for DESS Dental Smart Solutions Abutments
The acceptance criteria for this device are largely implicit in the demonstration of substantial equivalence to predicate devices, particularly regarding material composition, design principles, intended use, and performance data (non-clinical).
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for dental implant abutments and not an AI/ML device, the acceptance criteria are not typically expressed as performance metrics (e.g., sensitivity, specificity) against a ground truth dataset. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use Equivalence: Device intended for use with endosseous dental implants to support prosthetic restorations. | Met: "Subject device abutments are substantially equivalent in intended use to the primary predicate device... All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation..." (page 9) |
| Material Composition Equivalence: Materials conform to specific ASTM/ISO standards. | Met: All abutments and screws are made of Ti-6Al-4V ELI (ASTM F136) or Co-Cr-Mo Alloy (ASTM F1537). Zirconia superstructures made of Y-TZP (ISO 13356). Cement is Multi-Link (cleared under K130436). These are "identical to those of the primary predicate device K170588 and the reference devices K173908 and K191986." (page 9) |
| Biocompatibility: Device materials are biocompatible. | Met: "biocompatibility according to ISO 10993-5 and ISO 10993-12, leveraged from K170588, K173908 and K191986;" (page 9) |
| Sterilization Efficacy: Sterilization method validated. | Met: "sterilization validation according to ISO 17665-1 and ISO 14937, leveraged from K170588;" (page 9) The device is to be sterilized by the end-user (page 10). |
| Design and Technological Characteristics Equivalence: Similar designs (e.g., healing abutments, Ti Bases, screws) and features (e.g., coatings, connection types, prosthetic dimensions). | Met: "All subject device abutments are identical in design, materials and technological characteristics to those of the primary predicate K170588 and the reference devices K173908 and K191986, except for variations in gingival height and the elliptical shape of the ELLIPTIBase post." (page 9) Minor differences in dimensions/implant lines do not affect substantial equivalence (page 10). |
| Mechanical Compatibility: Compatibility with specified OEM implant systems and platforms. | Met: "reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility." (page 9) The list of compatible implant systems is provided (pages 2, 4-5, 7, 11-13). "Substantial equivalence of new compatibilities is supported by compatibility analysis." (page 10) |
| Manufacturing Process: Device manufactured using validated processes. | Met: "All of the subject device components are manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Terrats Medical components previously cleared in K170588, K173908 and K191986." (page 10) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing (material properties, sterilization, biocompatibility, reverse engineering). There isn't a "test set" in the context of clinical performance data or AI/ML model evaluation. The "data provenance" for non-clinical testing would relate to the test reports from specific labs and the standards applied.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment by experts in a clinical context is described for this device type. The ground truth for engineering specifications and material properties would be established by relevant industry standards and validated test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" as described for clinical interpretation or AI/ML ground truth is mentioned or relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study or AI assistance is mentioned. This is a traditional medical device (dental implant abutment).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" is derived from:
- Established standards: e.g., ISO 17665-1, ISO 14937 for sterilization; ISO 10993-5, ISO 10993-12 for biocompatibility; ASTM F136, ASTM F1537, ISO 13356 for material composition.
- Reverse engineering analysis: Comparison to OEM implant bodies, OEM abutments, and OEM abutment screws to confirm mechanical compatibility (page 9).
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system and does not involve a training set.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Terrats Medical SL % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K212628
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: February 8, 2022 Received: February 9, 2022
Dear Floyd Larson:
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.
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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 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
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Indications for Use
510(k) Number (if known) K212628
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
DESS Dental Smart Solutions abutments are intendosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant Systems | ||
|---|---|---|
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
| Astra Tech EV | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| 5.4 | 5.4 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | |
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.6 | 3.5 | |
| 4.6, 5.8 | 4.5 | |
| 5.8 | 5.7 | |
| Biomet 3i Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Camlog | 3.8 | 3.8 |
| 4.3 | 4.3 | |
| 5.0 | 5.0 | |
| FRIADENT XIVE® | 3.8 | 3.8 |
| 4.5 | 4.5 | |
| 5.5 | 5.5 | |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
| NobelActive®, NobelParallel Conical | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| NobelReplace® Trilobe | 4.3 | RP |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Nobel Brånemark System® | 3.3 | NP |
| 3.75, 4.0 | RP | |
| Osstem TS | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1/4.8 | RC | |
| Straumann® Tissue Level | 3.3 | NNC |
| Zimmer Screw Vent®/ Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
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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510(k) Summary
Terrats Medical SL DESS® Dental Smart Solutions
March 10, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda, 75-9908210 Barberà del VallèsBarcelona, Spain |
|---|---|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Floyd G. Larson, MS, MBAKevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email flarson@paxmed.comkthomas@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 Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K173908, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL
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Reference Devices for New OEM Compatibilities
All compatibilities are identical to those of the primary predicate K170588 and the reference devices K173908 and K191986, except for the addition of compatibilities with three (3) new systems, seven (7) platforms, for BioHorizons, Neodent Grand Morse and Straumann BLX, and the addition of two (2) new platforms for Astra Tech EV previously cleared in K191986.
| 510(k) | Compatible Implant | Manufacturer |
|---|---|---|
| K11287,K120414 | Astra Tech EV (Cleared asOsseoSpeed Plus) | Dentsply Sirona Inc. |
| K042429K071638 | BioHorizons | BioHorizons Implant Systems, Inc. |
| K163194 | Neodent Grand Morse | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K173961 | Straumann BLX | Institut Straumann AG |
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.
All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Astra Tech EV | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| 5.4 | 5.4 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | |
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.6 | 3.5 | |
| 4.6, 5.8 | 4.5 | |
| 5.8 | 5.7 | |
| Biomet 3i Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Camlog | 3.8 | 3.8 |
| 4.3 | 4.3 | |
| 5.0 | 5.0 | |
| FRIADENT XIVE® | 3.8 | 3.8 |
| 4.5 | 4.5 | |
| 5.5 | 5.5 | |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
Compatible Implant Systems
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| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| NobelActive®, NobelParallelConical | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| 4.3 | RP | |
| NobelReplace® Trilobe | 5.0 | WP |
| 6.0 | 6.0 | |
| Nobel Brånemark System® | 3.3 | NP |
| 3.75, 4.0 | RP | |
| Osstem TS | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1/4.8 | RC | |
| Straumann® Tissue Level | 3.3 | NNC |
| Zimmer Screw Vent®/ TaperedScrew-Vent® | 3.3, 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 abutment system cleared under K170588, K173908 and K191986 to add additional components for previously cleared OEM platform compatibilities and to additional OEM platform compatibilities for previously cleared DESS designs. This submission includes three (3) abutments (Healing Abutments, straight Multi Unit Abutments and DESSLoc Abutments), three (3) bases, two (2) blanks, and seven (7) screws.
Among the subject devices for this submission are abutments and screws compatible with three (3) implant systems for which Terrats Medical has no prior clearance and one (1) implant system for which new platform compatibilities are included, for a total of nine (9) new platforms.
The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in the table Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems. The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Healing Abutment
Healing Abutments are designed to cover the implant connection during the period between implant placement and final abutment placement. Healing Abutments are provided in multiple gingival heights to aid in contouring the gingiva during healing. All healing abutments are marked to identify their gingival height and compatible implant platform. Healing abutments are made of titanium alloy (Ti-6Al-4V). Healing abutments that are the subject of this submission are identical to those cleared under K170588 but are provided for four (4) additional platform compatibilities.
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Ti Bases
Subject device Ti Bases, including Ti Base Interface, DESS Aurum Base and ELLIPTIBase, are designed for custom abutment fabrication of a CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Ti Base Interface, DESS Aurum Base and ELLIPTIBase) is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base and ELLIPTIBase will be made at a Terrats Medical validated milling center under FDA quality system regulations, and the material will conform to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The design parameters for the CAD/CAM zirconia superstructure to be used on Ti Base Interface are identical to those cleared in K170588. They are:
Minimum wall thickness – 0.4 mm Minimum post height - 4.2 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All zirconia superstructures are for straight abutments only.
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| Compatible ImplantSystemsDescription: See Section 10.1.x | DESSAbutmentSystem | HealingAbutment10.1.1 | Ti BaseInterface,Engaging | Ti BaseInterface,Non-engaging10.1.2 | DESS AurumBase,Engaging | DESS AurumBase,Non-engaging | ELLIPTIBase,Engaging | Pre-milledBlank Ti,Engaging10.1.3 | Pre-milledBlank CrCo,Engaging10.1.3 | Multi UnitAbutment10.1.4 | DESSLocAbutment10.1.5 | Screws10.1.6 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astra Tech EV | Conic EVO | 3.0, 5.4 | 5.4 | 5.4 | 3.0 | 3.0, 3.6, 4.2,4.8, 5.4 | 5.4 | 3.6, 4.2, 4.8 | ||||
| Astra Tech OsseoSpeed | Internal HexConic | 3.0, 3.5/4.0,4.5/5.0 | 3.0, 3.5/4.0,4.5/5.0 | 3.0, 3.5/4.0,4.5/5.0 | 3.5/4.0,4.5/5.0 | |||||||
| BioHorizons Internal | BH Internal | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | 3.5, 4.5,5.7 | 3.5, 4.5,5.7 | 3.0 | 3.5, 4.5, 5.7 | X | ||||
| Biomet 3i Certain | Internal HexClick | 4.1, 5.0 | 3.4, 4.1, 5.0 | |||||||||
| Biomet 3i OSSEOTITE | External HexUSA | 3.4, 4.1 | 3.4, 4.1 | 3.4, 4.1, 5.0 | ||||||||
| Camlog | InternalCAM | 3.8, 4.3, 5.0 | ||||||||||
| FRIADENT XiVE | Internal HexFD | 3.8, 4.5, 5.5 | 5.5 | |||||||||
| Neodent Grand Morse | Neo GM | GrandMorse | GrandMorse | GrandMorse | GrandMorse | Grand Morse | GrandMorse | Grand Morse | X | |||
| NobelActive,NobelParallel Conical | Active Hex | NP, RP | NP, RP | 3.0 | X | |||||||
| NobelReplace Trilobe | Tri-lobe | RP, WP, 6.0 | ||||||||||
| Nobel BranemarkSystem | External HexUniversal | NP, RP | NP, RP | |||||||||
| Osstem TS | Conic OSS | Mini, Regular | ||||||||||
| Straumann BLX | ConicalBLX | RB/WB,WB | RB/WB,WB | RB/WB,WB | RB/WB,WB | RB/WB,WB | RB/WB, WB | WB | RB/WB | X | ||
| Straumann Bone Level | Conical BL | NC, RC | NC, RC | NC | ||||||||
| Straumann Tissue Level | Octagon | NNC | NNC | |||||||||
| Zimmer Screw Vent /Tapered Screw Vent | Internal HexUSA | 3.5 | 3.5, 4.5, 5.7 |
Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems
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DESS Aurum Base is available in an engaging design and a non-engaging design and ELLIPTIBase is available in an engaging design. Before attachment of the zirconia superstructure or crown, the DESS Aurum Base and ELLIPTIBase post height is 3.0 mm. When used for a single-unit restoration the DESS Aurum Base and ELLIPTIBase are to be used with a superstructure to create a minimum post height of 4.0 mm. DESS Aurum Base and ELLIPTIBase are made of titanium alloy (Ti-6Al-4V) with a gold anodized surface.
Design of ELLIPTIBase is similar to that of Ti Base (DESS Aurum) cleared in K173908, except that the post portion is not rotationally symmetric, being elliptical in cross-section.
When the DESS Aurum Base or ELLIPTIBase is used with a zirconia superstructure, design parameters for the zirconia superstructure are:
Minimum wall thickness – 0.4 mm Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All zirconia superstructures are for straight abutments only.
Pre-milled Blank Ti and Pre-milled Blank CrCo Pre-milled Blanks are designed for custom abutment fabrication by a CAD/CAM process and are available in an engaging design. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Pre-milled Blank is made of titanium alloy (Ti-6Al-4V) or of Co-Cr-Mo Alloy (CrCo).
The design parameters for the CAD/CAM fabrication of custom abutments from Pre-milled Blank Ti and Pre-milled Blank CrCo are:
Minimum wall thickness - 0.45 mm Minimum post height for single-unit restorations - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All Pre-milled Blank Ti and Pre-milled Blank CrCo are for straight abutments only.
Manufacture of CAD/CAM custom abutments from Pre-milled Blank Ti and Pre-milled Blank CrCo is to be performed at a Terrats Medical validated milling center.
Multi Unit Abutment
Multi Unit Abutment is designed for attachment of multi-unit screw-retained restorations and is provided in a straight design. Dedicated titanium alloy screws coated with Diamond-like carbon (DLC) are available to attach the abutment to the implant and a dedicated titanium alloy prosthetic screw is available to attach the restoration to the abutment.
DESSLoc® Abutment
DESSLoc Abutment is designed for overdenture attachment. It is identical to the DESS LOC Abutment cleared in K170588, except that additional gingival heights are provided. DESSLoc Abutments are made of titanium alloy (Ti-6A1-4V) and have a zirconium nitride (ZrN) coating.
Screws
DESS Dental Smart Solutions screws are designed to attach the abutment to the implant or the prosthesis to the abutment. For previously cleared compatibilities, the screws that were cleared in K170588, K173908 and K191986 for each compatibility are used. For new compatibilities, four (4)
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subject device screws are included. Screws are available with and without a DLC (Diamond-like Carbon) coating.
MATERIAL COMPOSITION
All subject device abutments and screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). Zirconia superstructures for Ti Base Interface, DESS Aurum Base and ELLIPTIBase are made of Y-TZP conforming to ISO 13356 Implants for surgery - Ceramic materials based on vttria-stabilized tetragonal zirconia (Y-TZP). The cement recommended in labeling for bonding of superstructures is Multi-Link cement from Ivoclar Vivadent, cleared under K130436. All of these materials are identical to those of the primary predicate device K170588 and the reference devices K173908 and K191986.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 14937, leveraged from K170588; biocompatibility according to ISO 10993-5 and ISO 10993-12, leveraged from K170588, K173908 and K191986; and reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
Subject device abutments are substantially equivalent in intended use to the primary predicate device cleared in K170588 and the reference devices cleared in K173908 and K191986. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K170588, except for the list of compatible OEM implants.
All subject device abutments are identical in design, materials and technological characteristics to those of the primary predicate K170588 and the reference devices K173908 and K191986, except for variations in gingival height and the elliptical shape of the ELLIPTIBase post. Abutments with gingival heights of 1.5 mm. 3.0 mm and greater are in common use in dental implant systems such as compatible system Astra Tech EV, cleared in K111287. Subject device DESS Aurum Base is identical in design, materials and technological characteristics to Aurum Abutments cleared in reference device K173908. The SelectGrip® surface on all Ti Bases is identical to the SelectGrip surface on equivalent abutments cleared in primary predicate K170588 and reference devices K173908 and K191986. The gold anodized surface on Ti Base (DESS Aurum) is identical to the anodized surface on Aurum Abutments of the reference device K173908. The ZrN coating on DESSLoc is identical to that on DESS LOC Abutments cleared in primary predicate K170588.
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All screws are identical in design, materials and technological characteristics to those cleared in primary predicate K170588 except for threads that accommodate the new compatibilities. Diamond-like carbon (DLC) coatings on screws are identical to those on screws cleared in primary predicate K170588.
Substantial equivalence of new compatibilities is supported by compatibility analysis.
Digital files for all CAD/CAM superstructures or abutments from blanks must be sent to a validated milling center for manufacture. DESS Ti Base Interface, DESS Aurum Base, ELLIPTIBase and Premilled Blanks are for fabrication of straight custom abutments only.
The subject device is to be sterilized by the end-user, the same as primary predicate device K170588 and reference devices K173908 and K191986.
All of the subject device components are manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Terrats Medical components previously cleared in K170588, K173908 and K191986. Therefore, no new biocompatibility testing has been performed, as the subject device is substantially equivalent to the predicate devices in K170588, K173908 and K191986 with regard to materials and processing.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and reference 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.
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| Subject Device | Indications for Use Statement | ||
|---|---|---|---|
| DESS Dental Smart Solutions | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | ||
| DESS Dental Smart Solutions | All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture. | ||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | |
| Terrats Medical SL | Astra Tech EV | 3.0 | 3.0 |
| 3.6 | 3.6 | ||
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | |
| 3.5/4.0 | 3.5/4.0 | ||
| 4.5/5.0 | 4.5/5.0 | ||
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 | |
| 3.8, 4.6 | 3.5 | ||
| 4.6, 5.8 | 4.5 | ||
| 5.8 | 5.7 | ||
| Biomet 3i Certain® | 3.25 | 3.4 | |
| 4.0 | 4.1 | ||
| 5.0 | 5.0 | ||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 | |
| 3.75, 4.0 | 4.1 | ||
| 5.0 | 5.0 | ||
| Camlog | 3.8 | 3.8 | |
| 4.3 | 4.3 | ||
| 5.0 | 5.0 | ||
| FRIADENT XIVE® | 3.8 | 3.8 | |
| 4.5 | 4.5 | ||
| 5.5 | 5.5 | ||
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | |
| NobelActive®, NobelParallel Conical | 3.0 | 3.0 | |
| 3.5 | NP | ||
| 4.3, 5.0 | RP | ||
| NobelReplace® Trilobe | 4.3 | RP | |
| 5.0 | WP | ||
| 6.0 | 6.0 | ||
| Nobel Brånemark System® | 3.3 | NP | |
| 3.75, 4.0 | RP | ||
| Osstem TS | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | |
| 5.0, 5.5, 6.5 | WB | ||
| Straumann® Bone Level | 3.3 | NC | |
| 4.1/4.8 | RC | ||
| Straumann® Tissue Level | 3.3 | NNC | |
| Zimmer Screw Vent®/ Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | |
| 4.7 | 4.5 | ||
| 6.0 | 5.7 |
Table of Substantial Equivalence – Indications for Use Statement
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| Primary PredicateDevice | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dentalimplants in the maxillary or mandibular arch to provide support for prosthetic restorations. | ||
|---|---|---|---|
| K170588,DESS Dental SmartSolutionsTerrats Medical SL | All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a TerratsMedical validated milling center for manufacture. | ||
| Compatible Implant Systems | |||
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | |
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | |
| FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | |
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP | |
| NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP | |
| Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | |
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | |
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN | |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | |
| Reference DeviceK173908 | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dentalimplants in the maxillary or mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sentto a Terrats Medical validated milling center for manufacture. | ||
| DESS Dental SmartSolutionsTerrats Medical SL | Implant System Compatibility | Implant Body | Implant Platform |
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | |
| FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | |
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP | |
| NobelReplace® Conical | 3.5, 4.3, 5.0 | NP, RP | |
| NobelReplace® Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | |
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | |
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RP, WP | |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | |
| Compatible Implant Systems | |||
| Compatible Implant System | Implant Body Diameter, | Implant Platform | |
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm | |
| Astra Tech EV | 3.6 | 2.9 mm | |
| 4.2 | 3.5 mm | ||
| 4.8 | 4.1 mm | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 mm | |
| 3.5/4.0 | 3.5/4.0 mm | ||
| 4.5/5.0 | 4.5/5.0 mm | ||
| Biomet 3i Certain® | 3.25 | 3.45 mm | |
| 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | ||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm | |
| 3.75, 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | ||
| Camlog | 3.3 | 3.3 mm | |
| 3.8 | 3.8 mm | ||
| 4.3 | 4.3 mm | ||
| 5.0 | 5.0 mm | ||
| FRIADENT XiVE® | 3.4 | 3.4 mm | |
| 3.8 | 3.8 mm | ||
| 4.5 | 4.5 mm | ||
| 5.5 | 5.5 mm | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm | |
| NobelActive®,NobelParallelConical | 3.0 | 3.0 (3.0 mm) | |
| 3.5 | NP (3.5 mm) | ||
| 4.3, 5.0 | RP (3.9 mm) | ||
| 5.5 | WP (5.1 mm) | ||
| NobelReplace® Trilobe | 3.5 | NP (3.5 mm) | |
| 4.3 | RP (4.3 mm) | ||
| 5.0 | WP (5.0 mm) | ||
| 6.0 | 6.0 (6.0 mm) | ||
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) | |
| 3.75, 4.0 | RP (4.1 mm) | ||
| 5.0 | WP (5.1 mm) | ||
| Osstem TS | 3.5 | Mini (2.8 mm) | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | ||
| Straumann® Bone Level | 3.3 | NC (3.3 mm) | |
| 4.1/4.8 | RC (4.1/4.8 mm) | ||
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) | |
| 3.3, 4.1, 4.8 | RN (4.8 mm) | ||
| 4.8 | WN (6.5 mm) | ||
| Zimmer Screw Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 mm | |
| 4.7 | 4.5 mm |
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Reference Device
K191986 DESS Dental Smart Solutions Terrats Medical SL
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with Ti Base abutments or Pre-milled (Blank)
abutments are to be sent to a Terrats Medical validated milling center for manufacture.
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| Comparison | Subject Device | PrimaryPredicate Device | Reference Devices | |
|---|---|---|---|---|
| DESS DentalSmart Solutions | K170588DESS DentalSmart Solutions | K173908DESS DentalSmart Solutions | K191986DESS Dental SmartSolutions | |
| Terrats Medical SL | Terrats MedicalSL | Terrats Medical SL | Terrats Medical SL | |
| Design | ||||
| Designs | Healing, Ti BaseInterface, DESSAurum Base,ELLIPTIBase, Pre-milled Blank, MultiUnit, DESSLoc | Healing,Temporary,Straight, Multi-unit, Locator-type,CAD/CAM Bases,CAD/CAMBlanks, | CAD/CAM Bases,CAD/CAMBlanks, | Healing, Temporary,Straight, Uniabutment,Multi-unit, DESSLoc,Ti Base (Interface), TiBase (DESS Aurum),CrCo Base, Pre-milled(Blank) |
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Restoration | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit |
| Abutment/ImplantPlatformDiameter, mm | 2.3 - 6.0 | 3.0 - 6.0 | 3.6 - 5.0 | 2.3 - 6.0 |
| Prosthetic PlatformDiameter, mm | 4.5-6.5 | 4.5 | 4.0 - 6.5 | 4.5-6.5 |
| Abutment Angle | Straight (0°) | Straight (0°) | Straight (0°) | 0°, 17°, 30° |
| Abutment/ ImplantInterface | Internal, External | Internal, External | Internal, External | Internal, External |
| Material | ||||
| Abutments | Ti-6Al-4V ELICo-Cr-Mo Alloy | Ti-6Al-4V ELICo-Cr-Mo Alloy | Ti-6Al-4V ELICo-Cr-Mo Alloy | Ti-6Al-4V ELICo-Cr-Mo Alloy |
| Screws | Ti-6Al-4V ELIDLC coating | Ti-6Al-4V ELIDLC coating | Ti-6Al-4V ELIDLC coating | Ti-6Al-4V ELIDLC coating |
Table of Substantial Equivalence – Technological Characteristics
§ 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.)