(90 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 Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.
This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.
This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.
The document focuses on establishing substantial equivalence to previously cleared predicate devices through:
- Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
- Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
- Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.
Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.
However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.
Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.
The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:
- Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
- Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
- Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
- Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
- Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.
Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
- Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.
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
N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.
8. The sample size for the training set
N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.
9. How the ground truth for the training set was established
N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 24, 2024
Terrats Medical SL % Kevin Thomas VP & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130
Re: K240208
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 24, 2024 Received: January 25, 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.
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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.
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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
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Indications for Use
510(k) Number (if known)
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech EV(Internal Taper) | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Astra Tech OsseoSpeed TX(Internal Taper) | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Internal(Internal Hex) | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.2, 4.6 | 3.5 | |
| 4.6, 5.2, 5.8 | 4.5 | |
| 5.8, 7.0, 8.0 | 5.7 | |
| Biomet 3i OSSEOTITE®(External Hex) | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Dentium Superline(Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| DESS Active(Internal Conical) | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| DESS Bone Level(Internal Conical) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| PrimaConnex | 3.3, 3.5 | 3.5 |
| Prima Plus(Internal TiLobe) | 4.0, 4.1 | 4.1 |
| 5.0 | 5.0 | |
| 3.5, 3.8 | 3.5/3.8 | |
| Genesis(Internal TiLobe) | 4.5 | 4.5 |
| 5.5, 6.5 | 5.5/6.5 | |
| 7 | 5.7 | |
| Molaris Tilobemaxx(Internal TiLobe) | 8 | 6.5 |
| 9 | 7.5 | |
| 7 | 5.7 | |
| Molaris I-Hexmrt(Internal Hex) | 8 | 6.5 |
| 9 | 7.5 | |
| Paltop Advanced Classic(Internal Hex) | 3.25 | |
| Paltop Advanced Classic(Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 3.0, 3.25 | NP (3.25) | |
| Paltop Advanced Plus(Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 6.0 | WP (6.0) | |
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
| Paltop Dynamic(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop PAI | 3.25 | NP (3.25) |
| Paltop PAI TC(Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 6.0 | WP (6.0) | |
| Paltop Dynamic ConicalPaltop Conical Active (PCA)(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |
| MIS Seven | 3.3 | NP (3.1) |
| MIS M4(Internal Hex) | 3.75, 4.2 | SP (3.5) |
| 5.0, 6.0 | WP (4.5) | |
| Neodent(Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| NobelActive® | 3.0 | 3.0 |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) |
| NobelParallel Conical(Conical Connection) | 4.3, 5.0 | RP (3.9) |
| 5.5 | WP (5.1) | |
| NobelReplace | 3.5 | NP (3.5) |
| (Internal Tri-channel) | 4.3 | RP (4.3) |
| Osstem® TSHiossen® ET(Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| (TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB |
| Straumann Bone Level | 3.3 | NC |
| (CrossFit® Morse Taper) | 4.1, 4.8 | RC |
| Zimmer Screw-Vent®Tapered Screw-Vent®(Internal Hex) | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| TSX™ Implant System(Internal Hex) | 3.7, 4.1, 4.7 | 3.5 |
Compatible Implant Systems
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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 K240208 Terrats Medical SL DESS Dental Smart Solutions April 24, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda, 75-99Barberà del Vallès 08210Barcelona, Spain |
|---|---|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Email kthomas@paxmed.comflarson@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 AND REFERENCE DEVICE INFORMATION
K233316, DESS Dental Smart Solutions, Terrats Medical SL K231434, DESS Dental Smart Solutions, Terrats Medical SL K22288, DESS Dental Smart Solutions, Terrats Medical SL K222269, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K170588, DESS Dental Smart Solutions, Terrats Medical SL
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Reference Devices for OEM implant body clearances 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. K160965, SuperLine, Dentium Co., Ltd. K212538, DESS Dental Implants, Terrats Medical SL K051614, PrimaConnex™ Internal Connection Implant System, Lifecore Biomedical, Inc. K072768, Restore®, Stage-1®, Renova®, PrimaSolo® and PrimaConnex® Dental Implants, Lifecore Biomedical, Inc. K101545, Genesis Implant System, Keystone Dental, Inc. K201334, Keystone Dental XL Dental Implant System, Keystone Dental Inc. K112795, Paltop Dental Implant System, Paltop Advanced Dental Solutions Ltd. K210117, Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd K130462, Paltop Narrow Implant, Paltop Advanced Dental Solutions Limited K220200, Paltop Conical Implant System, Paltop Advanced Dental Solutions, Ltd K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. 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 K073142, NobelReplace Hexagonal Implants, 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 K 181703, 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
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 is K233316.
The reference devices K231434, K222288, K222269, K212628, K191986, and K170588 include documentation of the compatibility of the subject device abutments with the corresponding OEM implant bodies.
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 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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Compatible Implant Systems
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech EV(Internal Taper) | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Astra Tech OsseoSpeed TX(Internal Taper) | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Internal(Internal Hex) | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.2, 4.6 | 3.5 | |
| 4.6, 5.2, 5.8 | 4.5 | |
| 5.8, 7.0, 8.0 | 5.7 | |
| Biomet 3i OSSEOTITE®(External Hex) | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Dentium Superline(Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| DESS Active(Internal Conical) | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| DESS Bone Level(Internal Conical) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| PrimaConnexPrima Plus(Internal TiLobe) | 3.3, 3.5 | 3.5 |
| 4.0, 4.1 | 4.1 | |
| 5.0 | 5.0 | |
| Genesis(Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 |
| 4.5 | 4.5 | |
| 5.5, 6.5 | 5.5/6.5 | |
| Molaris Tilobemaxx(Internal TiLobe) | 7 | 5.7 |
| 8 | 6.5 | |
| 9 | 7.5 | |
| Molaris I-Hexmrt(Internal Hex) | 7 | 5.7 |
| 8 | 6.5 | |
| 9 | 7.5 | |
| Paltop Advanced Classic(Internal Hex) | 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| Paltop Advanced Plus(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop Dynamic(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop PAIPaltop PAI TC(Internal Hex) | 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop Dynamic ConicalPaltop Conical Active (PCA)(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |
| MIS Seven | 3.3 | NP (3.1) |
| MIS M4(Internal Hex) | 3.75, 4.2 | SP (3.5) |
| 5.0, 6.0 | WP (4.5) | |
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
| Neodent(Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| NobelActive® | 3.0 | 3.0 |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) |
| NobelParallel Conical | 4.3, 5.0 | RP (3.9) |
| (Conical Connection) | WP (5.1) | |
| NobelReplace | 3.5 | NP (3.5) |
| (Internal Tri-channel) | 4.3 | RP (4.3) |
| Osstem® TSHiossen® ET | 3.5 | Mini |
| (Internal Taper) | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| (TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB |
| Straumann Bone Level | 3.3 | NC |
| (CrossFit® Morse Taper) | 4.1, 4.8 | RC |
| Zimmer Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| Tapered Screw-Vent®(Internal Hex) | 4.7 | 4.5 |
| TSXTM Implant System(Internal Hex) | 3.7, 4.1, 4.7 | 3.5 |
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SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.
This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.
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Table 1 – Summary of Subject Device Abutment Designs
| Compatible Implant Systems | DESS Abutment System | Cover Screws | HealingAbutment | TemporaryAbutment | Ti BaseEngaging andNon-engaging | AURUM BaseEngaging andNon-engaging | CoCr BaseEngaging andNon-engaging | Pre-MilledBlankEngaging | Multi-UnitAbutmentStraight | Multi-UnitAbutmentAngled | DESSLocAbutment | Screws |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astra Tech EV | Conic EVO | X | X | X | ||||||||
| Astra Tech OsseoSpeed TX | Internal Hex Conic | X | X | X | X | |||||||
| BioHorizons Internal | Internal Hex BH | X | X | |||||||||
| Biomet 3i OSSEOTITE® | External Hex USA | X | ||||||||||
| Dentium SuperLine | Conic DENT | X | ||||||||||
| DESS Active | DESS Active | X | ||||||||||
| DESS Bone Level | DESS Bone Level | X | ||||||||||
| Keystone (Internal TiLobe)PrimaConnexPrima PlusGenesisMolaris Tilobemaxx | Internal TiLobe | X | X | |||||||||
| Keystone (Internal Hex)Molaris I-HexmrtPaltop Advanced ClassicPaltop Advanced PlusPaltop DynamicPaltop PAIPaltop PAI TC | Internal Hex | X | X | |||||||||
| Keystone (Internal Conical)Paltop Dynamic ConicalPaltop Conical Active (PCA) | Internal Conical | X | X | |||||||||
| MIS SevenMIS M4 | Internal Hex MI | X | X | X | X | X | X | X | X | X | ||
| Neodent Grand Morse | Neo GM | X | X | X | X | |||||||
| NobelActive®NobelReplace ConicalNobelParallel Conical | Active Hex | X | X | X | X | |||||||
| NobelReplace (Tri-channel) | Tri-lobe | X | X | |||||||||
| Osstem® TSHiossen® ET | Conic OSS | X | ||||||||||
| Straumann BLX | Conical BLX | X | X | X | ||||||||
| Straumann Bone Level | Conical BL | X | X | X | X | X | ||||||
| Zimmer Screw-Vent®Zimmer Tapered Screw-Vent® | Internal Hex USA | X | X | |||||||||
| TSX™ Implant System | Internal Hex USA | X |
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Table 2 – Summary of Subject Device Abutment Sizes
| OEM Compatible Implants | Subject Device Abutments | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Compatible Implant Lines | ImplantBody Ø | ImplantPlatform Ø | CoverScrews | Healing | Temporary | Ti Base | AURUM Base | CoCr Base | Pre-MilledBlank | Multi-UnitStraight | Multi-UnitAngled | DESSLoc | Screws |
| Astra Tech EV | 3.0 | 3.0 | X | X | |||||||||
| 3.6 | 3.6 | X | X | ||||||||||
| 4.2 | 4.2 | X | X | ||||||||||
| 4.8 | 4.8 | X | |||||||||||
| Astra Tech OsseoSpeed TX | 3.0 | 3.0 | X | X | X | ||||||||
| 3.5, 4.0 | 3.5/4.0 | X | |||||||||||
| 4.5, 5.0 | 4.5/5.0 | X | |||||||||||
| BioHorizons Internal | 3.0, 3.4, 3.8 | 3.0 | X | X | |||||||||
| 3.8, 4.2, 4.6 | 3.5 | X | |||||||||||
| 4.6, 5.2, 5.8 | 4.5 | X | |||||||||||
| 5.8, 7.0, 8.0 | 5.7 | X | |||||||||||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 | X | ||||||||||
| 3.75, 4.0 | 4.1 | X | |||||||||||
| 5.0 | 5.0 | X | |||||||||||
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | X | ||||||||||
| DESS Active | 3.0 | 3.0 | X | ||||||||||
| 3.5 | NP | X | |||||||||||
| 4.3, 5.0 | RP | X | |||||||||||
| 5.5 | WP | X | |||||||||||
| DESS Bone Level | 3.3 | NC | X | ||||||||||
| 4.1, 4.8 | RC | X | |||||||||||
| PrimaConnexPrima Plus | 3.3, 3.5 | 3.5 | X | X | |||||||||
| 4.0, 4.1 | 4.1 | X | X | ||||||||||
| 5.0 | 5.0 | X | X | ||||||||||
| Genesis | 3.5, 3.8 | 3.5/3.8 | X | X | |||||||||
| 4.5 | 4.5 | X | X | ||||||||||
| 5.5, 6.5 | 5.5/6.5 | X | X | ||||||||||
| Molaris Tilobemaxx | 7 | 5.7 | X | X | |||||||||
| 8 | 6.5 | X | X | ||||||||||
| 9 | 7.5 | X | X | ||||||||||
| Molaris I-Hexmrt | 7 | 5.7 | X | X | |||||||||
| 8 | 6.5 | X | X | ||||||||||
| 9 | 7.5 | X | X | ||||||||||
| Paltop Advanced Classic | 3.25 | NP (3.25) | X | X | |||||||||
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | ||||||||||
| OEM Compatible Implants | Subject Device Abutments | ||||||||||||
| Compatible Implant Lines | ImplantBody Ø | ImplantPlatform Ø | CoverScrews | Healing | Temporary | Ti Base | AURUM Base | CoCr Base | Pre-MilledBlank | Multi-UnitStraight | Multi-UnitAngled | DESSLoc | Screws |
| Paltop Advanced Plus | 3.0, 3.25 | NP (3.25) | X | X | |||||||||
| Paltop Advanced Plus | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop Advanced Plus | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop Dynamic | 3.0, 3.25 | NP (3.25) | X | X | |||||||||
| Paltop Dynamic | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop Dynamic | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop PAIPaltop PAI TC | 3.25 | NP (3.25) | X | X | |||||||||
| Paltop PAIPaltop PAI TC | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop PAIPaltop PAI TC | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop Dynamic ConicalPaltop Conical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | X | X | |||||||||
| MIS SevenMIS M4 | 3.3 | NP (3.1) | X | X | X | X | |||||||
| MIS SevenMIS M4 | 3.75, 4.2 | SP (3.5) | X | X | X | X | X | X | X | X | X | ||
| MIS SevenMIS M4 | 5.0, 6.0 | WP (4.5) | X | X | X | X | X | X | X | X | X | ||
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3,5.0, 6.0, 7.0 | GM | X | X | X | X | |||||||
| NobelActive® | 3.0 | 3.0 | X | X | X | X | |||||||
| NobelActive® | 3.5, 3.75 | NP (3.5) | X | X | |||||||||
| NobelReplace ConicalNobel Parallel Conical | 4.3, 5.0 | RP (3.9) | X | X | |||||||||
| NobelReplace ConicalNobel Parallel Conical | 5.5 | WP (5.1) | X | X | X | ||||||||
| NobelReplace | 3.5 | NP (3.5) | X | X | |||||||||
| NobelReplace | 4.3 | RP (4.3) | X | X | |||||||||
| Osstem® TSHiossen® ET | 3.5 | Mini | X | ||||||||||
| Osstem® TSHiossen® ET | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | X | ||||||||||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | X | X | X | ||||||||
| Straumann BLX | 5.0, 5.5, 6.5 | WB | X | X | X | ||||||||
| Straumann Bone Level | 3.3 | NC | X | X | X | ||||||||
| Straumann Bone Level | 4.1, 4.8 | RC | X | X | X | ||||||||
| Zimmer Screw-Vent®Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | X | X | |||||||||
| Zimmer Screw-Vent®Tapered Screw-Vent® | 4.7 | 4.5 | X | ||||||||||
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 | X | X |
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Table 2 – Summary of Subject Device Abutment Sizes
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SUBJECT DEVICE DESIGNS
Cover Screws are provided only for the DESS Active implants (platforms 3.0, NP, RP, and WP), and for the DESS Bone Level implants (platforms NC, RC). The coronal diameter of the Cover Screws ranges from 2.8 mm to 5.1 mm. Cover Screws are made of titanium alloy (Ti-6Al-4V).
Healing Abutments are provided for Astra Tech OsseoSpeed TX implants with a 3.0 platform, BioHorizons Internal implants with a 3.0 platform, MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms, and Nobel Biocare conical connection implants with 3.0 and WP (5.1) platforms. The Healing Abutments are provided in gingival heights from 3 mm to aid in contouring the gingiva during healing. Healing abutments are made of titanium allov (Ti-6Al-4V).
Temporary Abutments are provided for Astra Tech OsseoSpeed TX implants with a 3.0 platform. MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms, and for Nobel Biocare conical connection implants with 3.0 and WP (5.1) platforms. Temporary Abutments are available for single-unit and multiple-unit restorations, the former with engaging connections to the implants and the latter with non-engaging connections. All Temporary Abutments have a gingival height of 1.5 mm and are made of titanium alloy (Ti-6Al-4V).
Ti Base Abutments are provided in engaging and non-engaging designs. The Ti Base Abutments are for custom abutment fabrication of a CAD-CAM zirconia superstructure on which a crown may be placed. They also may be used to support a crown placed directly on the abutment. The two-pieces of the Ti Base abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The cement recommended for bonding of superstructures is Multi-Link cement by Ivoclar Vivadent. Ti Base Abutments are manufactured from titanium alloy (Ti 6Al 4V) with the Select(Gripe surface. When used for a direct crown, Ti Base Abutments may be used with a POM burn out sleve, an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis.
The design parameters for the CAD-CAM zirconia superstructure to be used on Ti Base Abutments are the same as cleared in K22288:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.2 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
Maximum angulation - refer to Table 3 Ti Base Abutments.
| Compatible ImplantSystem | Compatible BodyDiameter, mm | Compatible ImplantPlatform Name | Gingival Height,*mm | Prosthetic PlatformDiameter, mm | MaximumAngulation |
|---|---|---|---|---|---|
| Astra Tech EV | 3.0 | 3.0 | 1.5 | 3.85 | 0° |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | 1.5 | 3.85 | 0° |
| 3.25 | 3.4 | 30° | |||
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 | 0.3 - 3.0 | 4.5 – 5.2 | 30° |
| 5.0 | 5.0 | 30° | |||
| Keystone/Paltop | |||||
| 3.3, 3.5 | 3.5 | 30° | |||
| PrimaConnexPrima Plus | 4.0, 4.1 | 4.1 | 30° | ||
| 5.0 | 5.0 | 30° | |||
| 3.8, 3.5 | 3.5/3.8 | 1.0 or 2.0 | 4.1 - 7.0 | 30° | |
| Genesis | 4.5 | 4.5 | For 3 mm GH maxangle = 0° | 30° | |
| 5.5, 6.5 | 5.5/6.5 | 30° | |||
| 7 | 5.7 | 30° | |||
| Molaris Tilobemaxx | 8 | 6.5 | 30° | ||
| 9 | 7.5 | 30° |
Table 3 – Ti Base Abutments
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| Compatible ImplantSystem | Compatible BodyDiameter, mm | Compatible ImplantPlatform Name | Gingival Height,*mm | Prosthetic PlatformDiameter, mm | MaximumAngulation |
|---|---|---|---|---|---|
| Molaris I-Hexmrt | 7 | 5.7 | 1.0 or 2.0 | 6.0 - 7.0 | 30° |
| 8 | 6.5 | For 3 mm GH maxangle = 0° | 30° | ||
| 9 | 7.5 | 30° | |||
| Paltop Advanced Classic | 3.25 | NP (3.25) | 30° | ||
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | 30° | |||
| Paltop Advanced Plus | 3.0, 3.25 | NP (3.25) | 30° | ||
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | 30° | |||
| 6.0 | WP (6.0) | 1.0 or 2.0 | 30° | ||
| Paltop Dynamic | 3.0, 3.25 | NP (3.25) | For 3 mm GH maxangle = 0° | 4.25 - 5.7 | 30° |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | 30° | |||
| 6.0 | WP (6.0) | 30° | |||
| Paltop PAIPaltop PAI TC | 3.25 | NP (3.25) | 30° | ||
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | 30° | |||
| 6.0 | WP (6.0) | 30° | |||
| PaltopDynamic ConicalPaltopConical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | 1.0 - 2.0 | 4.3 | 30° |
| MIS SevenMIS M4 | 3.3 | NP (3.1) | 4.5 - 5.7 | 0° | |
| 3.75, 4.2 | SP (3.5) | 0.3 - 3.0 | 0° | ||
| 5.0, 6.0 | WP (4.5) | 0° | |||
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3,5.0, 6.0, 7.0 | GM | 1.5 | 3.85 | 0° |
| NobelActive® | 3.0 | 3.0 | 1.5 | 0° | |
| NobelReplace ConicalNobelParallel Conical | 3.5, 3.75 | NP (3.5) | 1.5 | 3.5 - 3.85 | 0° |
| Straumann® BLX | 3.5, 3.75, 4.0, 4.5,5.0, 5.5, 6.5 | RB/WB, WB | 1.5 | 3.85 | 0° |
| Straumann® Bone Level | 3.3 | NC | 0.5 - 1.5 | 3.85 - 4.95 | 0° |
| Zimmer Screw-Vent®Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | 1.5 | 3.85 | 0° |
| Zimmer TSXTM | 3.7, 4.1, 4.7 | 3.5 | 1.5 | 3.85 | 0° |
- Gingival height in the Ti Base
All patient-specific custom abutment fabrication for Ti Base Abutments and AURUM Base Abutments (described below) is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base and AURUM Base abutments will be made at a Terrats Medical validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
AURUM Base Abutments are provided in engaging and non-engaging designs for Dentium SuperLine implants with a 3.3 platform and for MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms. The two-pieces of the AURUM Base abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The design of the AURUM Base allows for easier instrument access to the abutment screw and allows for placement of the screw channel out of the esthetic region of the restoration. AURUM Base abutments are provided with a prosthetic platform diameter ranging from 4.5 mm, and a gingival height (in the base) of 0.3 mm or 0.9 mm. When used for a single-unit restoration the AURUM Base is to be used with a superstructure to create a minimum post height (length above the abutment collar/gingival height) of 4.0 mm. ARUM Base Abutments are to be used for straight abutments only, no angulation.
AURUM Base Abutments are manufactured from titanium alloy (Ti 6Al 4V) and anodized a gold color, and the SelectGrip® surface to aid in bonding retention. The AURUM Base abutments, including the titanium
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510(k) Summary Page 10 of 17
alloy, anodization treatment, and SelectGrip® surface is similar to that of DESS Aurum Abutments cleared in K222269. AURUM Base Abutments are not intended for angulation correction.
The design parameters for the CAD-CAM zirconia superstructure to be used on AURUM Base Abutments are the same as cleared in K222269:
Minimum wall thickness – 0.4 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.0 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
CoCr Base Abutments are provided for MIS Seven and MIS M4 implants with NP (3.1), SP (3.5), and WP (4.5) platforms, in engaging designs for single-unit restorations and non-engaging designs for multi-unit restorations. The two-pieces of the CoCr Base abutment which compose the final abutment consists of the pre-manufactured CoCr base component composed of CoCr alloy and the CAD-CAM patient matched superstructure composed of zirconia. CoCr Base Abutments also may be used as part of a welded multi-unit construct, intended to be used with the included exempt POM burnout sleeve for wax-up and casting of a crown or bridge from a non-precious metal alloy. CoCr Base Abutments have a gingival height of 1.5 mm, a prosthetic platform diameter of 4.5 mm, and are made from Co-Cr-Mo alloy. The design of the CoCr Base Abutments is similar to CoCr Base Abutments cleared in K222288. CoCr Base Abutments are not intended for angulation correction.
The design parameters for the CAD/CAM zirconia superstructure to be used on CoCr Base are identical to those cleared in K22288:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restorations (length above the abutment collar/gingival height) – 4.5 mm Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
Pre-Milled Blank Abutments are available in engaging designs only. All patient-specific custom abutment fabrication for Pre-Milled Blank Abutments is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm, and are provided in a solid cylindrical design and with a pre-milled angled screw-channel design. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V) and from Co-Cr-Mo alloy (for MIS Seven and MIS M4 implants). The subject device Pre-Milled Blank Abutments are similar to Pre-Milled Blank Abutments cleared in K222269
The design parameters for the CAD-CAM fabrication of custom abutments from Pre-Milled Blank Abutments are identical to those cleared in K222288 and K222269:
Minimum wall thickness - 0.45 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.0 mm Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
Maximum angulation - refer to Table 4 Pre-Milled Blank Abutments.
| Compatible Implant System | Compatible Body Diameter, mm | Compatible ImplantPlatform Name | MaximumAngulation |
|---|---|---|---|
| Astra Tech EV | 3.0 | 3.0 | 0° |
| Astra Tech EV | 3.6 | 3.6 | 0° |
| Astra Tech EV | 4.2 | 4.2 | 0° |
| Compatible Implant System | Compatible Body Diameter, mm | Compatible Implant Platform Name | Maximum Angulation |
| BioHorizons Internal | 3.0, 3.4, 3.83.8, 4.2, 4.64.6, 5.2, 5.85.8, 7.0, 8.0 | 3.03.54.55.7 | 30° |
| Keystone/PaltopPrimaConnexPrima Plus | 3.3, 3.54.0, 4.15.0 | 3.54.15.0 | 30° |
| Genesis | 3.8, 3.54.55.5, 6.5 | 3.5/3.84.55.5/6.5 | 30° |
| Molaris Tilobemaxx | 789 | 5.76.57.5 | 30° |
| Molaris I-Hexmrt | 789 | 5.76.57.5 | 30° |
| Paltop Advanced Classic | 3.253.75, 4.2, 5.0 | NP (3.25)SP (3.75/4.2/5.0) | 30° |
| Paltop Advanced Plus | 3.0, 3.253.75, 4.2, 5.06.0 | NP (3.25)SP (3.75/4.2/5.0)WP (6.0) | 30° |
| Paltop Dynamic | 3.0, 3.253.75, 4.2, 5.06.0 | NP (3.25)SP (3.75/4.2/5.0)WP (6.0) | 30° |
| Paltop PAIPaltop PAI TC | 3.253.75, 4.2, 5.06.0 | NP (3.25)SP (3.75/4.2/5.0)WP (6.0) | 30° |
| Paltop Dynamic ConicalPaltop Conical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | 30° |
| MIS Seven | 3.33.75, 4.2 | NP (3.1)SP (3.5) | 0° |
| MIS M4 | 5.0, 6.0 | WP (4.5) | 0° |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | 0° |
| NobelActive® | 3.0 | 3.0 | 0° |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) | 0° |
| NobelParallel Conical | 4.3, 5.0 | RP (3.9) | 0° |
| Osstem® TS | 3.5 | Mini | 0° |
| Hiossen® ET | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | 0° |
| Straumann® BLX | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB/WB, WB | 0° |
| Straumann® Bone Level | 3.34.1, 4.8 | NCRC | 0° |
| Zimmer Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | 0° |
| Tapered Screw-Vent® | 4.7 | 4.5 | 0° |
Table 4 - Pre-Milled Blank Abutments
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Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 17°, and angled 30°. The designs are similar to that of Multi-Unit Abutments
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cleared in K233316, K222288, and K222269. The Multi-Unit Abutments are manufactured from titanium alloy (Ti-6A1-4V).
The straight Multi-Unit Abutments are provided for MIS Seven and MIS M4 implants with SP (3.5), and WP (4.5) platforms, and for Neodent implants with the GM platform. The straight Multi-Unit Abutments have a non-engaging. threaded design that attaches directly to the implant. Straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 0.8 mm to 5.5 mm.
The angled Multi-Unit Abutments are provided for NobelReplace (Internal Tri-Channel) implants with NP (3.5) and RP (4.3) platforms. The angled Multi-Unit Abutments are provided only in a non-engaging design that requires an abutment screw. The Multi-Unit Abutments angled 17° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of either 2 mm or 3 mm. The Multi-Unit Abutments angled 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of either 4 mm or 5 mm.
DESSLoc Abutments are designed for overdenture attachment to attach directly to the implant. DESSLoc Abutments are made of titanium alloy (Ti-6Al-4V, and have a zirconium nitride (ZrN) coating, 2 um to 3 um thick, produced by a physical vapor deposition (PVD) process.
DESSLoc Abutments are provided only for MIS Seven and M4 implants with SP (3.5) and WP (4.5) platforms. Except for the implant connection, the design, material, and coating for the subject device DESSLoc Abutments are identical to those of the DESSLoc Abutments cleared in K222269.
DESS Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of eighteen (18) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K233316, K22288, and K22269. Screws are made of titanium alloy (Ti-6Al-4V) and are available with and without a DLC (Diamond-like Carbon) coating. DLC coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K233316, K222288, and K222269.
OEM IMPLANT COMPATIBILITY
To ensure that the subject abutments and screws are designed to fit the corresponding OEM implants, the dimensions and tolerances of subject abutments and screws have been established by reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) or by a contractual agreement and working relationship between Terrats Medical SL and the OEM implant manufacturer. For the subject cover screws and Multi-Unit Abutment screws for the DESS Active and Bone Level Implants, this analysis is not necessary for the Sponsor's own implant bodies. For all OEM compatibilities, except for the MIS implant lines, the reverse engineering analysis or contractual agreement information was provided in prior Terrats Medical 510(k) submissions. For the MIS implant lines, the reverse engineering analysis is provided in this submission. The confirmation of compatibility is summarized in the following Table 5 Compatible Implant Systems Confirmation of Compatibility.
| Implant Compatibility(Connection) | Implant BodyDiameter, mm | ImplantPlatform, mm | Terrats Medical 510(k)Containing Reverse Engineering orOEM Contractual Agreement |
|---|---|---|---|
| Astra Tech EV(Internal Taper) | 3.0 | 3.0 | K212628 |
| 3.6 | 3.6 | ||
| 4.2 | 4.2 | K191986 | |
| 4.8 | 4.8 | ||
| Astra Tech OsseoSpeed TX(Internal Taper) | 3.0 | 3.0 | K191986 |
| 3.5, 4.0 | 3.5/4.0 | K170588 | |
| 4.5, 5.0 | 4.5/5.0 | ||
| Implant Compatibility(Connection) | Implant BodyDiameter, mm | ImplantPlatform, mm | Terrats Medical 510(k)Containing Reverse Engineering orOEM Contractual Agreement |
| 3.0, 3.4, 3.8 | 3.0 | ||
| BioHorizons Internal | 3.8, 4.2, 4.6 | 3.5 | K212628 |
| (Internal Hex) | 4.6, 5.2, 5.8 | 4.5 | |
| 5.8, 7.0, 8.0 | 5.7 | ||
| 3.25 | 3.4 | ||
| Biomet 3i OSSEOTITE®(External Hex) | 3.75, 4.0 | 4.1 | K170588 |
| 5.0 | 5.0 | ||
| Dentium SuperLine(Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | K222288 |
| 3.0 | 3.0 | ||
| DESS Active | 3.5 | NP | |
| (Internal Conical) | 4.3, 5.0 | RP | K212538 |
| 5.5 | WP | (Sponsor's own implants) | |
| DESS Bone Level | 3.3 | NC | |
| (Internal Conical) | 4.1, 4.8 | RC | |
| PrimaConnex | 3.3, 3.5 | 3.5 | |
| Prima Plus | 4.0, 4.1 | 4.1 | K222269 |
| (Internal TiLobe) | 5.0 | 5.0 | |
| 3.5, 3.8 | 3.5/3.8 | ||
| Genesis | 4.5 | 4.5 | K222269 |
| (Internal TiLobe) | 5.5, 6.5 | 5.5/6.5 | |
| 7 | 5.7 | ||
| Molaris Tilobemaxx | 8 | 6.5 | K222269 |
| (Internal TiLobe) | 9 | 7.5 | |
| 7 | 5.7 | ||
| Molaris I-Hexmrt | 8 | 6.5 | K222269 |
| (Internal Hex) | 9 | 7.5 | |
| Paltop Advanced Classic | 3.25 | NP (3.25) | K222269 |
| (Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 3.0, 3.25 | NP (3.25) | ||
| Paltop Advanced Plus | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| 3.0, 3.25 | NP (3.25) | ||
| Paltop Dynamic | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| Paltop PAI | 3.25 | NP (3.25) | |
| Paltop PAI TC | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| Paltop Dynamic ConicalPaltop Conical Active (PCA)(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | K222269 |
| MIS Seven | 3.3 | NP (3.25) | |
| MIS M4 | 3.75, 4.2 | SP (3.5) | This Submission |
| (Internal Hex) | 5.0, 6.0 | WP (4.5) | |
| Neodent(Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | K212628 |
| Implant Compatibility(Connection) | Implant BodyDiameter, mm | ImplantPlatform, mm | Terrats Medical 510(k)Containing Reverse Engineering orOEM Contractual Agreement |
| NobelActive® | 3.0 | 3.0 | K191986 |
| NobelReplace ConicalNobelParallel Conical(Conical Connection) | 3.5, 3.75 | NP (3.5) | K170588 |
| 4.3, 5.0 | RP (3.9) | ||
| 5.5 | WP (5.1) | K191986 | |
| NobelReplace(Internal Tri-channel) | 3.5 | NP (3.5) | K170588 |
| 4.3 | RP (4.3) | ||
| Osstem® TSHiossen® ET | 3.5 | Mini | K191986 |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | ||
| Straumann BLX(TorcFit™ InternalHexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | K212628 |
| 5.0, 5.5, 6.5 | WB | ||
| Straumann Bone Level(CrossFit® Morse Taper) | 3.3 | NC | K170588 |
| 4.1, 4.8 | RC | ||
| Zimmer Screw-Vent®Tapered Screw-Vent®(Internal Hex) | 3.3, 3.7, 4.1 | 3.5 | K170588 |
| 4.7 | 4.5 | ||
| TSXTM Implant System(Internal Hex) | 3.7, 4.1, 4.7 | 3.5 | K231434 |
Table 5 - Compatible Implant Systems Confirmation of Compatibility
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MATERIALS
The subject device abutments are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 or from Co-Cr-Mo alloy conforming to ASTM F1537. The subject device screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. Abutments are colored gold by an anodization process that is identical to that used on abutments cleared in K233316, K22288, and K222269. Ti Base Abutments and AURUM Base Abutments have a SelectGrip® surface to aid in bonding retention that is identical to that used on abutments cleared in K233316, K222269, Screws are available with and without a DLC (Diamond-like Carbon) coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K233316, K22288, and K22269.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission was non-clinical analysis 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;
- provided in this submission was reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with the MIS Seven and MIS M4 implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance ● of the subject device Pre-Milled Blank Abutments compatible with BioHorizons Internal Hex connection) implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
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- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device Ti Base Abutments compatible with Biomet 3i OSSEOTITE implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance . of the subject device Multi-Unit Abutments compatible with Nobel Replace (Internal Tri-channel connection) implants:
- referenced from K233316 was moist heat sterilization for subject devices provided non-sterile to the end user, ● validated to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSVAAMI/ISO TIR 17665-2; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K233316 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 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.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device abutments are substantially equivalent in intended use to the primary predicate device K233316, and the reference devices K222288 and K222269. 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. Except for the list of compatible OEM implants and sizes, the Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of K233316, K22288, and K222269.
The lists of the specific OEM implant compatibilities in the IFUS differ between the subject device and the primary predicate and the reference devices. The other minor difference is that the IFUS for the subject device includes language regarding digital design and validated milling centers; the IFUS for the primary predicate K233316 does not include the language regarding CAD-CAM abutments or a validated milling center. The IFUS for the reference devices K222288 and K22269 include the language regarding CAD-CAM abutments and a validated milling center.
The primary predicate device K233316 and the reference devices K222289 are in support of substantial equivalence of the subject device designs, material, manufacturing, and biocompatibility.
All subject device abutments and screws are similar or identical in designs, materials, and technological characteristics to corresponding abutments of the primary predicate device K233316 and the reference devices K222288 and K222269. The subject submission, K233316, K222269 all include abutments manufactured from Ti-6A1-4V alloy conforming to ASTM F136. Abutments are anodized by a process that is identical to that used on abutments cleared in K233316. Ti Base Abutments and AURUM Base Abutments have a SelectGrip® surface to aid in bonding retention that is identical to the surface used on abutments cleared in K233316. Abutments screws manufactured from Ti-6AI-4V alloy are available with and without a DLC (Diamond-like Carbon) coating that is identical to the DLC coating on screws cleared in K233316. The subject submission and K22288 also include abutments manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
The subject device abutment screws have similar or identical ranges of abutment-implant platform diameter, prosthetic platform diameter, and angulation as the components cleared in K233316, K222288, and K22269. The subject device abutments and the reference device K212628 include abutments compatible with the
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Nobel Biocare conical connection implants (NobelActive®, NobelReplace Conical, NobelParallel Conical) with the 3.0 mm body/platform diameter.
Selected subject device components are provided sterile by gamma irradiation and are packaged in a PETG blister with a Tyvek® Id. This is the same sterilization, packaging, and 5-year shelf life that was referenced in the primary predicate K233316. For the subject devices provided non-sterile, the previously validated moist heat cycle, referenced from the primary predicate and reference devices is applicable to the non-sterile subject devices.
The risks associated with use of the subject device abutments with angulation (Ti Bases, Pre-Milled Blanks, and Angled Multi-Unit Abutments) in combination with the compatible implants are mitigated by the mechanical testing provided in the Bench Testing attachment to this submission.
CONCLUSION
Any differences in the technological characteristics between the subject device, the predicate device, and reference devices do not raise different questions of safety or effectiveness. The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.
Overall, the subject device has the following similarities to the primary predicate device and the reference devices:
- have the same intended use,
- use the same operating principles, .
- incorporate the same basic designs,
- incorporate the same or very similar materials, and
- . have similar packaging and are sterilized using the same materials and processes.
The basis for the belief of Terrats Medical SL that the substantially equivalent to the predicate devices is summarized in the following Table 6, Substantial Equivalence.
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Table 6 – Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Comparison | K240208DESS Dental Smart SolutionsTerrats Medical SL | K233316DESS Dental Smart SolutionsTerrats Medical SL | K222288DESS Dental Smart SolutionsTerrats Medical SL | K222269DESS Dental Smart SolutionsTerrats Medical SL |
| Product Code | NHA | NHA | NHA | NHA |
| Reason for predicate/reference | n/a | Abutment designs, OEM compatibilities, materials, manufacturing, biocompatibility | Abutment designs, OEM compatibilities, materials, manufacturing, biocompatibility | Abutment designs, OEM compatibilities, materials, manufacturing, biocompatibility |
| Intended Use | Functional and esthetic rehabilitation of the edentulous mandible ormaxilla | Functional and esthetic rehabilitation of the edentulous mandible ormaxilla | Functional and esthetic rehabilitation of the edentulous mandible ormaxilla | Functional and esthetic rehabilitation of the edentulous mandible ormaxilla |
| Indications for Use Statement | DESS Dental Smart Solutions abutments are intended to be used inconjunction with endosseous dental implants in the maxillary ormandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with DESS Ti Baseabutments or Pre-Milled Blank abutments are to be sent to a TerratsMedical validated milling center for manufacture.The complete Indications for Use Statement with OEM implantcompatibilities is provided in the Device Description attachment in thissubmission. | DESS Dental Smart Solutions abutments are intended to be used inconjunction with endosseous dental implants in the maxillary ormandibular arch to provide support for prosthetic restorations.The complete Indications for Use Statement with OEM implantcompatibilities is provided in the 510(k) Summary for K233316. | DESS Dental Smart Solutions abutments are intended to be used inconjunction with endosseous dental implants in the maxillary ormandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Ti Base abutmentsor Pre-Milled Blank abutments are to be sent to a Terrats Medicalvalidated milling center for manufacture.The complete Indications for Use Statement with OEM implantcompatibilities is provided in the 510(k) Summary for K222288. | DESS Dental Smart Solutions abutments are intended to be used inconjunction with endosseous dental implants in the maxillary ormandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with DESS Bases orBlanks are to be sent to a Terrats Medical validated milling center formanufacture.The complete Indications for Use Statement with OEM implantcompatibilities is provided in the 510(k) Summary for K222269. |
| Designs | Healing AbutmentsTemporary AbutmentsTi Base AbutmentsAURUM Base AbutmentsCoCr Base AbutmentsPre-Milled Blank AbutmentsMulti-unit Abutments, StraightMulti-unit Abutments, Angled 17° and 30°DESSLoc AbutmentsScrews | Healing AbutmentsTemporary AbutmentsMulti-unit Abutments, StraightMulti-unit Abutments, Angled 17° and 30°Screws | Healing AbutmentsTemporary AbutmentsTi Base AbutmentsCoCr Base AbutmentsPre-Milled Blank AbutmentsMulti-unit Abutments, StraightMulti-unit Abutments, Angled 17° and 30°DESSLoc AbutmentsScrews | Ti Base AbutmentsAURUM Base AbutmentsPre-Milled Blank AbutmentsMulti-unit Abutments, StraightMulti-unit Abutments, Angled 17° and 30°DESSLoc AbutmentsScrews |
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit |
| Abutment/Implant Platform Ø, mm | 3.0 - 7.5 | 2.52 - 5.7 | 2.52 - 6.5 | 3.25 - 7.5 |
| Prosthetic Platform Ø, mm | 3.5 - 7.0 | 4.5 – 6.8 | 4.5 – 6.5 | 4.1 - 7.0 |
| Abutment Angle | 0° - 30° | 0°, 17°, 30° | 0°, 17°, 30° | 0°, 17°, 30° |
| Materials | ||||
| Abutment Material | Ti-6Al-4V (ASTM F136)Co-Cr-Mo (ASTM F1537) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V alloy (ASTM F136)Co-Cr-Mo (ASTM F1537) | Ti-6Al-4V (ASTM F136) |
| Abutment Surface | AnodizationSelectGrip® surfaceZirconium nitride (ZrN) | AnodizationSelectGrip® surface | AnodizationSelectGrip® surfaceZirconium nitride (ZrN) | AnodizationSelectGrip® surfaceZirconium nitride (ZrN) |
| Superstructure Material | Zirconia (Y-TZP) | Zirconia (Y-TZP) | Zirconia (Y-TZP) | |
| Screw Material | Ti-6Al-4V alloyDLC coating | Ti-6Al-4V alloyDLC coating | Ti-6Al-4V alloyDLC coating | Ti-6Al-4V alloyDLC coating |
| How Provided | ||||
| Sterilization | Sterile by gamma irradiation, andNon-sterile | Sterile by gamma irradiation, andNon-sterile | Non-sterile | Non-sterile |
| Usage - All Components | Single patient, single use | Single patient, single use | Single patient, single use | Single patient, single use |
§ 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.)