(175 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 Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.
The document describes the DESS Dental Smart Solutions, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a typical tabular format with specific numerical targets. Instead, it relies on demonstrating equivalence to predicate devices through various performance tests and comparisons. The "acceptance criteria" are implied by the successful completion of these tests and the determination that the device is "substantially equivalent" to already marketed devices.
However, some design parameters are mentioned as remaining the same or being comparable to the predicate devices, which can be seen as implicit performance criteria:
| Feature / Performance Metric | Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Sterilization | SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 | "Sterilization to an SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device" (Successful) |
| Biocompatibility | Non-cytotoxic according to ISO 10993-1 and ISO 10993-5 | "Biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic" (Successful) |
| Minimum Wall Thickness | Aurum Abutment: 0.4 mm Pre-milled Blank: 0.45 mm CoCr Abutment: 0.4 mm (Same as primary predicate K170588) | Aurum Abutment: 0.4 mm Pre-milled Blank: 0.45 mm CoCr Abutment: 0.4 mm (Stated to remain the same as primary predicate K170588, implying conformity to existing successful designs) |
| Minimum Post Height (single-unit) | Aurum Abutment: 4.0 mm Pre-milled Blank: 4.0 mm CoCr Abutment: 4.0 mm (Increased from previous version, but deemed substantially equivalent to K092341 at 4mm) | Aurum Abutment: 4.0 mm (Stated as the new minimum for single-unit restorations, deemed substantially equivalent to K092341's titanium post height which also requires additional castable component to create 4mm) Pre-milled Blank: 4.0 mm CoCr Abutment: 4.0 mm (Stated to remain the same as primary predicate K170588) |
| Maximum Gingival Height | Aurum Abutment: 6.0 mm Pre-milled Blank: 6.0 mm CoCr Abutment: 6.0 mm (Same as primary predicate K170588) | Aurum Abutment: 6.0 mm Pre-milled Blank: 6.0 mm CoCr Abutment: 6.0 mm (Stated to remain the same as primary predicate K170588) |
| Maximum Total Abutment Height | Pre-milled Blank: 19 mm | Pre-milled Blank: 19 mm |
| Angulation Correction | No angulation correction (Same as primary predicate K170588) | All abutments are for straight abutments only (implies no angulation correction, same as primary predicate K170588) |
| Chemical Composition | Materials used are comparable to predicate devices (Titanium Alloy, CoCr, Zirconia) | Aurum Base (Titanium Alloy ASTM F136), CoCr Pre-milled Blank (CoCr ASTM 1537), Ti Pre-milled Blank (Titanium Alloy ASTM E136), CoCr Abutment (CoCr ASTM 1537). Screws are Titanium Alloy. (Found to be substantially equivalent to predicates) |
| Physical Dimensions | Encompasses the same range of physical dimensions including diameter and design of abutments as predicate devices. | "The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments." (Stated as a conclusion of equivalence) |
| Packaging/Sterilization Methods | Similar to predicate devices. | "The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods." (Stated as a conclusion of equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization... biological evaluation... and compatibility analysis by reference to K170588."
- The report does not specify sample sizes for the sterilization or biocompatibility tests.
- The data provenance is implied to be from the manufacturer's (Terrats Medical SL) internal testing as part of their submission for regulatory clearance. It's not explicitly stated whether the data is retrospective or prospective, or the country of origin of the raw data, beyond the manufacturer being from Spain. The "compatibility analysis by reference" means using existing data/information from the predicate device (K170588).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information – number and qualifications of experts for ground truth – is typically relevant for studies involving subjective assessments, like image interpretation in AI/ML medical devices. This document is for a physical dental implant abutment, and the tests performed are objective, non-clinical tests (sterilization, biocompatibility, mechanical properties based on design parameters). Therefore, this information is not applicable and not provided in the submission.
4. Adjudication Method for the Test Set
As the tests are objective non-clinical tests, an adjudication method for a "test set" (in the context of expert review) is not applicable and not mentioned. The results of the non-clinical tests would either meet or not meet the specified standards (e.g., SAL, non-cytotoxicity).
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
No MRMC comparative effectiveness study was done. This type of study is specifically relevant for AI/ML-driven diagnostic or interpretative devices involving human readers. The device described here is a physical dental implant abutment, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is not an AI/ML device. The "CAD/CAM process" mentioned refers to computer-aided design and manufacturing for custom abutments, which is a manufacturing process, not an analytical algorithm for diagnosis or interpretation.
7. The Type of Ground Truth Used
For the non-clinical tests conducted:
- Sterilization: The ground truth is the scientific standard for sterility, defined as a Sterility Assurance Level (SAL) of $10^{-6}$ based on ISO 17665-1 and ISO 17665-2.
- Biocompatibility: The ground truth is the absence of cytotoxicity, determined by adherence to ISO 10993-1 and ISO 10993-5.
- Design Parameters/Mechanical Equivalence: The "ground truth" for design parameters (e.g., wall thickness, post height) is derived from engineering specifications and comparison to the proven safety and effectiveness of the legally marketed predicate devices (K170588 and other reference devices). The ultimate ground truth effectively is that the device performs equivalently to previously approved devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 15, 2018
Terrats Medical SL % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K173908
Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 16, 2018 Received: May 17, 2018
Dear Linda Schulz:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173908
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 Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant Systems | ||
|---|---|---|
| Implant SystemCompatibility | 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 | RN, WN |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 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
June 15, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda 75-99Barberà del Vallès 08210Barcelona, Spain | |
|---|---|---|
| Telephone | +34 93 564 60 06 | |
| Fax | +34 93 564 73 17 | |
| Official Contact | Roger Terrats, COO | |
| Representative/Consultant | Linda Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 | |
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | LSchulz@paxmed.comFLarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL
| Reference Device | ||
|---|---|---|
| K092341 | Low Profile Abutment | Biomet 3i, Inc. |
| K150669 | Neoss TiBase and CoCr Abutments | Neoss Ltd. |
| K120414 | OsseoSpeed™ Plus | Astra Tech AB |
| K160784 | CAM Titanium Blanks | Altatec GmbH |
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| K063341 | 3i OSSEOTITE Certain® Dental Implants | Implant Innovations, Inc. |
|---|---|---|
| K063286 | OSSEOTITE® Dental Implants | Implant Innovations, Inc. |
| K101732 | OsseoSpeed™ | Astra Tech AB |
| K073075 | FRIADENT Implant Systems | DENTSPLY International, Inc. |
| K142260 | NobelActive® | Nobel Biocare AB |
| K073142 | NobelReplace Hexagonal Implants | Nobel Biocare AB |
| K050705 | TiUnite® Implants | Nobel Biocare AB |
| K050406 | NOBELSPEEDY™ Implants | Nobel Biocare USA LLC |
| K022562 | Various Brånemark System Implants -Immediate Function Indication | Nobel Biocare AB |
| K140878 | Straumann® Bone Level Tapered Implants | Straumann USA, LLC |
| K062129 | P.004 Implants | Institut Straumann AG |
| K130222 | Straumann® Dental Implant System SLActive andRoxolid Product Families | Straumann USA, LLC |
| K112160 | Tapered Screw-Vent® X Implant | Zimmer Dental, Incorporated |
Compatible Implant Systems
INDICATIONS FOR USE
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant Systems | ||
|---|---|---|
| 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 |
| 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 |
Compatible Implant Systems
DEVICE DESCRIPTION
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile. The following table outlines the body and platform diameters by abutment design and corresponding compatible implant line.
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Summary of Abutment Designs
| CAD / CAM | Cast-To | OEMImplant System | Connection | ||||||
|---|---|---|---|---|---|---|---|---|---|
| DESSAbutmentSystem | AURUM base™Non-EngagingTitanium AlloyASTM F136 | AURUM base™EngagingTitanium AlloyASTM F136 | CoCr Pre-milledBlank EngagingCoCr ASTM 1537 | Ti Pre-milledBlank EngagingTitanium AlloyASTM E136 | CoCr AbutmentNon-EngagingCoCrASTM 1537 | CoCr AbutmentEngagingCoCrASTM 1537 | |||
| Internal Hex"Click" | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | 3i Certain® | 3.4 (NP)4.1 (RP)5.0 (WP) | Internal | |
| External HexUSA | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | 3iOSSEOTITE® | 3.4 (NP)4.1 (RP)5.0 (WP) | External | |
| Internal HexConic | RPWP | RPWP | RPWP | RPWP | RPWP | OsseoSpeed™ | 3.5/4.0(RP)4.5/5.0(WP) | Internal | |
| Internal HexFD | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | FRIADENTXiVE® | 3.4 (NP)3.8 (RP)4.5 (WP) | Internal |
| Active Hex | NPRP | NPRP | NPRP | NPRP | NPRP | NobelActive® | 3.5 (NP)3.9 (RP) | Internal | |
| NobelReplace®Conical | 3.5 (NP)3.9 (RP) | Internal | |||||||
| Tri-Lobe | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NobelReplace®Trilobe | 3.5 (NP)4.3 (RP)5.0 (WP) | Internal | |
| External HexUniversal | NPRP | NPRP | NPRPWP | NP | NPRPWP | NPRPWP | BrånemarkSystem® | 3.5 (NP)4.1 (RP)5.1 (WP) | External |
| Conical BL | NCRC | NCRC | NCRC | NCRC | NCRC | Straumann®Bone Level | 3.3 (NC)4.1 (RC) | Internal | |
| Octagon | RNWN | RNWN | RNWN | RNWN | RNWN | Straumann®Tissue Level | 4.8 (RN)6.5 (WN) | Internal | |
| Internal HexUSA | NPRPWP | NPRPWP | NPRPWP | NPRPWP | NPRPWP | Tapered Screw-Vent | 3.5 (NP)4.5 (RP)5.7 (WP) | Internal |
Aurum Abutment is a titanium abutment that can be used for a direct multi-unit restoration or to support a zirconia superstructure plus a single-unit or multi-unit restoration. Design parameters for the zirconia superstructure are a minimum wall thickness of 0.4 mm, a minimum post height for single-unit restorations of 4.0 mm, and a maximum gingival height of 6.0 mm. All zirconia superstructures are for straight abutments only.
Pre-milled Blank abutments are cylindrical abutments designed for custom abutment fabrication by a CAD/CAM process. All patient-specific abutment fabrication is by prescription on the order of the clinician. Pre-milled Blanks are made of cobalt-chromium alloy or titanium alloy. Design parameters for the Pre-Milled Blanks are, a minimum wall thickness of 0.45 mm, a minimum post height for single-unit restorations of 4.0 mm, a maximum gingival height of 6.0 mm, and a maximum total abutment height of 19 mm. All Pre-Milled Blanks are for straight abutments only.
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CoCr Abutments are designed as a cast-to abutment for support of a single-unit or a multi-unit restoration. They are made of cobalt-chromium alloy. Design parameters for CoCr Abutments are, a minimum wall thickness of 0.4 mm, a minimum post height for single-unit restorations of 4.0 mm, and a maximum gingival height of 6.0 mm. All CoCr Abutments are for straight abutments only.
PERFORMANCE DATA
Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization to an SAL of 106 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device; biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic, and compatibility analysis by reference to K170588.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.
| Indications for Use Statement | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SubjectDevice | |||||||||||||||||||||||||||||||||||||
| DESS DentalSmartSolutionsTerratsMedical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in themaxillary or mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Aurum Base or Pre-Milled Blank are to be sent to a Terrats Medicalvalidated milling center for manufacture. | ||||||||||||||||||||||||||||||||||||
| Compatible Implant Systems | |||||||||||||||||||||||||||||||||||||
| 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 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 | ||||||||||||||||||||||||||||||||||||
| PrimaryPredicateDevices | |||||||||||||||||||||||||||||||||||||
| K170588DESS DentalSmartSolutionsTerratsMedical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillaryor mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validatedmilling 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 |
Comparison of Indications for Use Statements
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| ReferenceDevices | |
|---|---|
| K092341Low ProfileAbutmentBiomet 3i, Inc. | BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prostheticdevice in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple toothprosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment. |
| K150669Neoss TiBaseand CoCrAbutmentsNeoss Ltd. | Neoss TiBase:Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crownsfor use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.Neoss CoCr Abutments:Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. |
| K120414OsseoSpeed™PlusAstra TechAB | Implants:The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and withthe following clinical protocols:replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. |
| Abutments:Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fullyedentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.Atlantis Abutments: | |
| The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially orcompletely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla.The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure theabutment to the endosseous implant. | |
| The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure thatalso serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutmentscrew is intended to secure the crown abutment to the endosseous implant. | |
| K160784CAMTitaniumBlanks AltatecGmbH | CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW LINE andCAMLOG® ROOT-LINE implants in the maxilla and mandible. Digitally designed abutments fabricated with CAD/CAMtechniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture. |
| CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implantsin the maxilla and mandible. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAM TitaniumBlanks are intended to be sent to a CAMLOG validated milling center for manufacture. | |
| CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in themaxilla and mandible. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAM Titanium Blanksare intended to be sent to a CAMLOG validated milling center for manufacture. |
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| Comparison | SubjectDevice | PrimaryPredicateDevice | Reference Devices | |||
|---|---|---|---|---|---|---|
| K170588 | K092341 | K150669 | K120414 | K160784 | ||
| DESSDentalSmartSolutionsTerratsMedical SL | DESSDentalSmartSolutionsTerratsMedical SL | LowProfileAbutmentBiomet 3i,Inc. | NeossTiBase andCoCrAbutmentNeoss Ltd. | OsseoSpeedPlusAstra TechAB | CAMTitaniumBlankAltatecGmbH | |
| Design | ||||||
| Abutment Design | CAD/CAMBlankCAD/CAMTiBaseCastableAbutmentAurumAbutment | CAD/CAMBlankCAD/CAMTiBaseAbutment | TitaniumAbutment | CAD/CAMTiBaseCastableAbutment | CastableAbutment | CAD/CAMBlank |
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Screw-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retained |
| Restoration | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit, Multi-unit |
| Abutment/ImplantPlatformDiameter* (mm) | 3.4 - 6.5 | 3.4 - 6.5 | 3.4 - 5.0 | 4.1 | 3.0 - 5.4 | 3.3 - 6.0 |
| Abutment Angle | 0° | 0° | 0°- 30° | 0°- 20° | 0°- 30° | 0°- 30° |
| Abutment/Implant Interface | InternalandExternal | InternalandExternal | InternalandExternal | Internal | Internal | Internal |
| Material | ||||||
| Abutment | TitaniumAlloyCoCr,Zirconia | TitaniumAlloyZirconia | TitaniumAlloy | TitaniumAlloy,CoCr,Zirconia | TitaniumAlloyZirconia,Gold,PEEK | TitaniumAlloy |
| Screw | TitaniumAlloy | TitaniumAlloy | TitaniumAlloy | TitaniumAlloy | TitaniumAlloy | TitaniumAlloy |
Comparison of Technological Characteristics
*See Summary of Abutment Designs (p.3) for individual OEM platform diameters
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DESS Dental Smart Solutions subject device abutments are substantially equivalent in intended use, design, function, material, size, and Indications for Use to DESS Dental Smart Solutions abutments (K170588). The only change in the Indications for Use statement is the name of the abutment. The Aurum Abutment is substantially equivalent to the TiBase abutment in K170588. Design parameters for minimum wall thickness, maximum gingival height and no angulation correction remain the same as the primary predicate K170588. The minimum post height for single-unit restorations is now 4.0 mm. Titanium and CoCr Pre-milled Blanks are substantially equivalent to the titanium Pre-milled Blanks in K170588. Design parameters for minimum wall thickness, minimum post height for single-unit restorations, maximum gingival height and no angulation correction remain the same as the primary predicate K170588. The CoCr Abutment is substantially equivalent in design and function to OsseoSpeed Plus abutments (K120414) and in material and function to Neoss CoCr abutments (K150669). Design parameters for minimum wall thickness, minimum post height for single-unit restorations, maximum gingival height and no angulation correction remain the same as the primary predicate K170588 and reference device K160784 and are substantially equivalent in intended use, design, function, material, size and final design parameters. The Aurum Abutment has a substantially equivalent titanium post height to the titanium post height of the Low Profile Abutment in K092341. Both are used for single-unit and multi-unit restorations. When used for a single-unit restoration the Aurum Abutment and the Low Profile Abutment are to be used with an additional castable component to create a minimum post height of 4 mm). All are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. Digital files for subject device DESS Dental Smart Solutions abutments and DESS Dental Smart Solutions abutments cleared in K170588 are to be sent to a validated milling center for manufacture. Implant/abutment interface compatibility for the subject device is substantially equivalent to DESS Dental Smart Solutions abutments (K170588) and to the compatible implant system predicates listed above.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments. The subject and predicate devices 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.
§ 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.)