(108 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Ti Base abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K173908 to add additional components for previously cleared OEM platform compatibilities and to add additional OEM platform compatibilities for previously cleared DESS abutment designs. In total, this submission includes abutments compatible with 43 implant platforms from 16 OEM implant systems. Note that, because Nobel Active and NobelParallel Conical Connection implants share conical connection platforms, we have shown them as one system for purposes of this submission.
This submission includes abutments compatible with five (5) additional OEM implant systems (11 platforms) and abutments compatible with six (6) additional platforms for OEM implant system compatibilities that were cleared in K170588.
Additional subject device components for previously cleared compatibilities include addition of gingival heights of 1.5 mm and 3.0 mm for titanium bases and addition of 17° and 30° angled multi-unit abutments to the previously cleared straight multi-unit abutments.
Abutment designs and the correlation between each subject device abutment design and the corresponding compatible implant platforms are shown in Table 1 Summary of DESS Components and Abutment Platforms for Compatible Implant Systems.
All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
All subject device abutments are made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). All ceramic components of the Ti Base abutments are composed of zirconia conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
This document is a 510(k) premarket notification for DESS Dental Smart Solutions, specifically for endosseous dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with acceptance criteria and performance data like a typical medical device AI/ML submission would.
Therefore, the requested information regarding acceptance criteria and performance data in the context of an AI/ML study (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC study, standalone performance) is not applicable to this type of regulatory submission.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical testing performed to demonstrate the device's functional equivalence and safety compared to predicates.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or performance metrics in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons.
The "acceptance criteria" here are implied to be that the new abutment designs and expanded compatibilities perform equivalently to the predicate devices and meet established standards for dental implants.
The "reported device performance" is described qualitatively as:
- Sterilization validation: According to ISO 17665-1 and ISO 14937.
- Biocompatibility: According to ISO 10993-12. (No new testing performed as materials are identical to cleared predicates).
- Reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
- Static compression and compression fatigue testing: According to ISO 14801.
- Dynamic testing: For Multi-unit Abutments Angled according to ISO 14801.
The conclusion states that minor differences in design, dimensions, sizes, or compatible OEM implant lines do not affect substantial equivalence because these differences are either related to compatible OEM implant designs or are mitigated by mechanical performance testing.
2. Sample sizes used for the test set and the data provenance
- Sample Size: The document does not specify exact sample sizes for the mechanical tests (static compression, fatigue, dynamic testing). For instance, ISO 14801 typically requires a minimum of 5 samples for fatigue testing and 3 for static testing, but the document does not provide the exact numbers used for this submission.
- Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Terrats Medical SL) or outsourced labs. The country of origin of this test data is not explicitly stated but would presumably align with the manufacturer's location (Barcelona, Spain) or the testing facilities they contracted. The data is "prospective" in the sense that it was generated for this specific submission, but it's not "clinical" data from patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For this type of mechanical device clearance, "ground truth" is established by engineering specifications, material standards (e.g., ASTM, ISO), and established testing methodologies, not by expert consensus on clinical data. No human experts are used to "read" or "interpret" test results in the same way they would for medical images.
4. Adjudication method for the test set
This is not applicable. "Adjudication" typically refers to resolving discrepancies in expert interpretations of clinical data (e.g., for ground truth establishment). Since this submission involves non-clinical mechanical testing, there is no need for such an adjudication method. Test results are compared against predetermined engineering specifications and standards.
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
This is not applicable. This submission is for dental implant abutments, a physical medical device, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a hardware device, not a software algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence for this device is based on:
- Engineering specifications and design parameters: For abutment dimensions, materials, and connections.
- International standards: Such as ISO 14801 (dynamic fatigue test), ISO 17665-1 (sterilization), ISO 14937 (sterilization), and ISO 10993-12 (biocompatibility).
- Material specifications: Conforming to ASTM F136 (titanium alloy), ASTM F1537 (Co-Cr-Mo alloy), and ISO 13356 (zirconia).
- Compatibility analysis: Through reverse engineering of OEM implant bodies and abutment screws.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI/ML model for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 25, 2019
Terrats Medical SL % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K191986
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: October 9, 2019 Received: October 11, 2019
Dear Floyd Larson:
This letter corrects our substantially equivalent letter of November 10, 2019.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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 mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Ti Base abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| Astra Tech EV | 3.6 | 2.9 mm |
| 4.2 | 3.5 mm | |
| 4.8 | 4.1 mm | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 mm |
| 3.5/4.0 | 3.5/4.0 mm | |
| 4.5/5.0 | 4.5/5.0 mm | |
| Biomet 3i Certain® | 3.25 | 3.45 mm |
| 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm |
| 3.75, 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Camlog | 3.3 | 3.3 mm |
| 3.8 | 3.8 mm | |
| 4.3 | 4.3 mm | |
| 5.0 | 5.0 mm | |
| FRIADENT XIVE® | 3.4 | 3.4 mm |
| 3.8 | 3.8 mm | |
| 4.5 | 4.5 mm | |
| 5.5 | 5.5 mm | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm |
| NobelActive®,NobelParallel Conical | 3.0 | 3.0 (3.0 mm) |
| 3.5 | NP (3.5 mm) | |
| 4.3, 5.0 | RP (3.9 mm) | |
| 5.5 | WP (5.1 mm) | |
| NobelReplace® Trilobe | 3.5 | NP (3.5 mm) |
| 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | |
| 6.0 | 6.0 (6.0 mm) | |
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) |
| 3.75, 4.0 | RP (4.1 mm) | |
| 5.0 | WP (5.1 mm) | |
| Osstem TS | 3.5 | Mini (2.8 mm) |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | |
| Straumann® Bone Level | 3.3 | NC (3.3 mm) |
| 4.1/4.8 | RC (4.1/4.8 mm) | |
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) |
| 3.3, 4.1, 4.8 | RN (4.8 mm) | |
| 4.8 | WN (6.5 mm) | |
| Zimmer Screw Vent®/ TaperedScrew-Vent® | 3.3, 3.7, 4.1 | 3.5 mm |
| 4.7 | 4.5 mm | |
| 6.0 | 5.7 mm |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Terrats Medical SL DESS Dental Smart Solutions
November 9, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SLCarrer Mogoda, 75-99Barberà del Vallès 08210Barcelona, Spain |
|---|---|
| Telephone +34 935 646 006Fax +34 935 647 317 | |
| Official Contact | Roger Terrats, COO |
| Representative/Consultant | Floyd G. Larson, MS, MBAKevin Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 |
| Telephone: +1-858-792-1235Fax: +1-858-792-1236Email: FLarson@paxmed.comKThomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
Classification Panel Reviewing Division Dental Products Panel DHT1B: Division of Dental Devices
PREDICATE DEVICE INFORMATION
Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical ST
Reference Devices K173908, DESS Dental Smart Solutions, Terrats Medical SL K161416, Multi-Unit Abutment Plus, Nobel Biocare AB
{4}------------------------------------------------
| Compatible Implant Systems | ||
|---|---|---|
| K140347 | Ankylos C/X | Dentsply Sirona |
| K111287, K120414 | Astra Tech EV (Cleared as OsseoSpeed Plus) | Dentsply Sirona |
| K101732 | Astra Tech OsseoSpeed™ | Dentsply Sirona |
| K063341 | Biomet 3i Certain® | Zimmer Biomet Dental |
| K063286 | Biomet 3i OSSEOTITE® Implant System | Zimmer Biomet Dental |
| K083496 | Camlog | CAMLOG Biotechnologies AG |
| K073075 | FRIADENT XIVE® | Dentsply Sirona |
| K110955 | MegaGen AnyRidge | MegaGen Implant Co., Ltd. |
| K142260, K102436 | NobelActive®, NobelParallel Conical | Nobel Biocare |
| K050705, K050406 | NobelReplace® Trilobe | Nobel Biocare |
| K022562 | Nobel Brånemark System® | Nobel Biocare |
| K161604 | Osstem TS | Osstem Implant |
| K140878 | Straumann® Bone Level | Institut Straumann AG |
| K130222 | Straumann® Tissue Level | Institut Straumann AG |
| K011028, K112160 | Zimmer Screw-Vent®/Tapered Screw-Vent® | Zimmer Biomet Dental |
{5}------------------------------------------------
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 Ti Base abutments or Pre-milled (Blank) abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| Astra Tech EV | 3.6 | 2.9 mm |
| 4.2 | 3.5 mm | |
| 4.8 | 4.1 mm | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 mm |
| 3.5/4.0 | 3.5/4.0 mm | |
| 4.5/5.0 | 4.5/5.0 mm | |
| Biomet 3i Certain® | 3.25 | 3.45 mm |
| 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm |
| 3.75, 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Camlog | 3.3 | 3.3 mm |
| 3.8 | 3.8 mm | |
| 4.3 | 4.3 mm | |
| 5.0 | 5.0 mm | |
| FRIADENT XIVE® | 3.4 | 3.4 mm |
| 3.8 | 3.8 mm | |
| 4.5 | 4.5 mm | |
| 5.5 | 5.5 mm | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm |
| NobelActive®,NobelParallel Conical | 3.0 | 3.0 (3.0 mm) |
| 3.5 | NP (3.5 mm) | |
| 4.3, 5.0 | RP (3.9 mm) | |
| 5.5 | WP (5.1 mm) | |
| NobelReplace® Trilobe | 3.5 | NP (3.5 mm) |
| 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | |
| 6.0 | 6.0 (6.0 mm) | |
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) |
| 3.75, 4.0 | RP (4.1 mm) | |
| 5.0 | WP (5.1 mm) | |
| Osstem TS | 3.5 | Mini (2.8 mm) |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | |
| Straumann® Bone Level | 3.3 | NC (3.3 mm) |
| 4.1/4.8 | RC (4.1/4.8 mm) | |
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) |
| 3.3, 4.1, 4.8 | RN (4.8 mm) | |
| 4.8 | WN (6.5 mm) | |
| Zimmer Screw Vent®/ TaperedScrew-Vent® | 3.3, 3.7, 4.1 | 3.5 mm |
| 4.7 | 4.5 mm |
atible Implant Syste ﻖ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
{6}------------------------------------------------
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K173908 to add additional components for previously cleared OEM platform compatibilities and to add additional OEM platform compatibilities for previously cleared DESS abutment designs. In total, this submission includes abutments compatible with 43 implant platforms from 16 OEM implant systems. Note that, because Nobel Active and NobelParallel Conical Connection implants share conical connection platforms, we have shown them as one system for purposes of this submission.
This submission includes abutments compatible with five (5) additional OEM implant systems (11 platforms) and abutments compatible with six (6) additional platforms for OEM implant system compatibilities that were cleared in K170588.
Additional subject device components for previously cleared compatibilities include addition of gingival heights of 1.5 mm and 3.0 mm for titanium bases and addition of 17° and 30° angled multi-unit abutments to the previously cleared straight multi-unit abutments.
Abutment designs and the correlation between each subject device abutment design and the corresponding compatible implant platforms are shown in Table 1 Summary of DESS Components and Abutment Platforms for Compatible Implant Systems.
All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
All subject device abutments are made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). All ceramic components of the Ti Base abutments are composed of zirconia conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
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| CompatibleImplantSystems | DESSAbutmentSystem | Healing Abutment (TitaniumAlloy ASTM F136) | Temporary Abutment, Engaging(Titanium Alloy ASTM F136) | Temporary Abutment,Non-engaging (Titanium AlloyASTM F136) | Straight Abutment (TitaniumAlloy ASTM F136) | Uniabutment (Titanium AlloyASTM F136) | Multi-unit Abutment, Angled(Titanium Alloy ASTM F136) | DESSLOC®(Titanium Alloy ASTM F136) | Ti Base (Interface), Engaging(Titanium Alloy ASTM F136) | Ti Base (Interface),Non-engaging (Titanium AlloyASTM F136) | Ti Base (DESS Aurum),Engaging (Titanium Alloy ASTMF136) | Ti Base (DESS Aurum),Non-engaging (Titanium AlloyASTM F136) | CrCo Base, Engaging(Co-Cr-Mo Alloy ASTM F1537) | CrCo Base, Non-engaging (Co-Cr-Mo Alloy ASTM F1537) | Pre-milled (Blank) Abutment Ti,Engaging (Titanium Alloy ASTMF136) | Pre-milled (Blank) AbutmentCrCo, Engaging (Co-Cr-MoAlloy ASTM F1537) | Connection |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ankylos C/X | InternalAnk | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | 2.52 | Internal | ||||
| Astra Tech EV | ConicEvo | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9, 3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | 2.9,3.5,4.1 | Internal | ||
| Astra TechOsseoSpeed™ | InternalHexConic | 3.0,3.5/4.0,4.5/5.0 | 3.0,3.5/4.0,4.5/5.0 | Internal | |||||||||||||
| Biomet 3iCertain® | InternalHex Click | 3.45,4.1,5.0 | 3.45,4.1,5.0 | Internal | |||||||||||||
| Biomet 3iOSSEOTITE® | ExternalHex USA | 3.4,4.1,5.0 | 3.4,4.1,5.0 | External | |||||||||||||
| Camlog | InternalCam | 3.8,4.3 | 3.8,4.3 | 3.8,4.3 | 3.8,4.3 | 3.3,3.8,4.3,5.0 | 3.3,3.8,4.3,5.0 | 3.8,4.3 | 3.8,4.3 | 3.8,4.3 | 3.8,4.3 | 3.3,3.8,4.3,5.0 | 3.3,3.8,4.3,5.0 | Internal | |||
| FRIADENTXiVE® | InternalHex FD | 3.4,3.8,4.5,5.5 | 3.4,3.8,4.5,5.5 | Internal | |||||||||||||
| MegaGenAnyRidge | ConicAnyr | 3.5 | 3.5 | 3.5 | 3.5 | 3.5 | 3.5 | Internal | |||||||||
| NobelActive®NobelParallelConical | ActiveHex | NP,RP | 3.0,NP,RP,WP | 3.0,NP,RP,WP | 3.0,NP,RP,WP | WP | Internal | ||||||||||
| NobelReplace®Trilobe | Tri-Lobe | NP,RP,WP,6.0 | NP,RP,WP,6.0 | 6.0 | 6.0 | Internal | |||||||||||
| NobelBrånemarkSystem® | ExternalHexUniversal | NP,RP,WP | NP,RP,WP | External |
Table 1 Summary of DESS Components and Abutment Platforms for Compatible Implant Systems
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| Zimmer Screw-Vent®Tapered Screw-Vent® Hex USA | Zimmer® Tissue Level | Straumann® Bone Level | Osstem TS Osstem OSS | Conic System Systems | DESS Abutment Compatible Implant System |
|---|---|---|---|---|---|
| Internal | Octagon | BL Conical | Healing Abutment (Titanium Alloy ASTM F136) | ||
| Temporary Abutment, Engaging (Titanium Alloy ASTM F136) | |||||
| Temporary Abutment, Non-engaging (Titanium Alloy ASTM F136) | |||||
| Straight Abutment (Titanium Alloy ASTM F136) | |||||
| Uniabutment (Titanium Alloy ASTM F136) | |||||
| NC, RC | Multi-unit Abutment, Angled (Titanium Alloy ASTM F136) | ||||
| DESSLoc® (Titanium Alloy ASTM F136) | |||||
| 3.5, 4.5 | NNC | Mini, Regular | Ti Base (Interface), Engaging (Titanium Alloy ASTM F136) | ||
| 3.5, 4.5, 5.7 | NC, RC | Mini, Regular | Ti Base (Interface), Non-engaging (Titanium Alloy ASTM F136) | ||
| Mini, Regular | Ti Base (DESS Aurum), Engaging (Titanium Alloy ASTM F136) | ||||
| Mini, Regular | Ti Base (DESS Aurum), Non-engaging (Titanium Alloy ASTM F136) | ||||
| CrCo Base, Engaging (Co-Cr-Mo Alloy ASTM F1537) | |||||
| CrCo Base, Non-engaging (Co-Cr-Mo Alloy ASTM F1537) | |||||
| 3.5 | NNC, RN, WN | Mini, Regular | Pre-milled (Blank) Abutment Ti, Engaging (Titanium Alloy ASTM F136) | ||
| NC, RC | Mini, Regular | Pre-milled (Blank) Abutment CrCo, Engaging (Co-Cr-Mo Alloy ASTM F1537) | |||
| Internal | Internal | Internal | Internal | Connection |
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Ti Base (Interface) is a two-piece abutment designed for custom abutment fabrication with a CAD/CAM zirconia superstructure on which a crown may be placed. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. The Ti Base may also support a ceramic Hybrid abutment in which the crown is included in the design of the abutment ceramic superstructure. The prosthetic post height is 4.2 mm. It is available in an engaging design and a non-engaging design. TiBase (Interface) is made of titanium allov (Ti-6A1-4V) with a Select(Grip® surface. When used for a direct crown, TiBase (Interface) may be used with a POM burn out sleeve, which is available for laboratory fabrication of the prosthesis.
Designs of Ti Base (Interface) that are the subject of this submission are identical, including the SelectGrip surface, to those cleared under K170588, but are provided in gingival heights of 1.5 mm and 3.0 mm for implant connections cleared in K170588 and are provided for three (3) additional implant compatibilities (four systems) and additional platforms for systems cleared in K170855.
The design parameters for the CAD/CAM zirconia superstructure to be used on Ti Base (Interface) are identical to those cleared in K170588. They are:
Minimum wall thickness – 0.4 mm Minimum post height - 4.2 mm Maximum gingival height - 6.0 mm All zirconia superstructures are for straight abutments only.
Ti Base (DESS Aurum) is a two-piece abutment used as a base that can be used for a direct multi-unit restoration or to support a CAD/CAM zirconia superstructure plus a single-unit or multi-unit restoration. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. It is available in an engaging design and a non-engaging design. Before attachment of the zirconia superstructure or crown, the Ti Base (DESS Aurum) post height is 3.0 mm. When used for a single-unit restoration the Ti Base (DESS Aurum) is to be used with a superstructure to create a minimum post height of 4 mm. Ti Base (Aurum) is made of titanium alloy (Ti-6A1-4V) with a gold anodized surface. Abutments are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color.
Design of Ti Base (DESS Aurum), including the titanium alloy and the anodization treatment, is identical to that cleared as DESS Aurum Abutment in K173908, except that the subject device is provided in four additional implant system compatibilities as shown in Table 11.12 Ti Base (DESS Aurum), Engaging and Non-engaging.
When the Ti Base (DESS Aurum) is used with a zirconia superstructure, design parameters for the zirconia superstructure are identical to those cleared in K173908. They are:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restorations – 4.0 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
All patient-specific custom abutment fabrication for TiBase (Interface) and Ti Base (DESS Aurum is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base (Interface) and Ti Base (Aurum) will be made at a Terrats Medical validated milling center under FDA quality system regulations, and the material will conform to ISO 13356 Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
DESS Dental Smart Solutions screws are designed to attach the abutment to the implant or the prosthesis to the abutment. Abutment screws for the DESS Abutment Systems Tri-Lobe and External Hex Universal, and prosthetic screws for Multi-unit Abutments are available with the DLC (Diamond-like
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Carbon) coating to provide a low friction surface finish, designed to improve the preload of the screw and to produce a high clamping force between the abutment and the implant. This allows the clinician to apply less torque while achieving the same clamping force with the screw. DLC coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K170588.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 14937; biocompatibility according to ISO 10993-12; reverse engineering analysis of OEM implant bodies, OEM abutment, and OEM abutment screws to confirm compatibility; and static compression and compression fatigue testing according to ISO 14801. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
Subject device abutments are substantially equivalent in intended use to the primary predicate device cleared in K170588 and the reference devices cleared in K173908 and K161416. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K170588, except for the list of compatible OEM implants.
All subject device abutments are identical in design, materials and technological characteristics to those of the primary predicate K170588, with the exception of Multi-unit Abutments Angled, Ti Base (Interface) with gingival heights 1.5 mm and 3.0 mm and Ti Base (DESS Aurum). Subject device Multiunit Abutments Angled are substantially equivalent in design, materials and technological characteristics to Multi-Unit Abutment Plus, cleared in reference device K161416. Abutments with gingival heights of 1.5 mm, 3.0 mm and greater are in common use in dental implant systems such as compatible system Astra Tech EV, cleared in K111287. Subject device Ti Base (DESS Aurum) is identical in design, materials and technological characteristics to Aurum Abutments cleared in reference device K173908. The SelectGrip® surface on Temporary Abutments. Straight Abutments and Ti Base (Interface) is identical to the SelectGrip surface on equivalent abutments cleared in primary predicate K170588. The gold anodized surface on Ti Base (DESS Aurum) is identical to the anodized surface on Aurum Abutments of the reference device K173908. The ZrN coating on DESSLoc is identical to that on DESS LOC Abutments cleared in primary predicate K170588.
All screws are identical in design, materials and technological characteristics to those cleared in primary predicate K170588 except for threads that accommodate the new compatibilities. Diamond-like carbon (DLC) coatings on screws are identical to those on screws cleared in primary predicate K170588.
Substantial equivalence of new compatibilities is supported by compatibility analysis.
Substantial equivalence of Multi-unit Abutments Angled is supported by dynamic testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
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Digital files for all CAD/CAM superstructures or abutments from blanks must be sent to a validated milling center for manufacture. DESS Ti Base (Interface), Ti Base (DESS Aurum), CrCo Base, and Premilled Blank abutments are for fabrication of straight custom abutments only.
The subject device is to be sterilized by the end-user, the same as primary predicate device K170588 and reference device K173908.
All of the subject device components are manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Terrats Medical components previously cleared in K170588 and K173908. Therefore, no new biocompatibility testing has been performed, as the subject device is substantially equivalent to the predicate devices in K170588 and K173908 with regards to materials and processing.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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| Subject Device | Indications for Use Statement | |
|---|---|---|
| DESS Dental Smart SolutionsTerrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular restorations.All digitally designed custom abutments for use with Ti Base abutments or Pre-milled (Blank) abutments are to be sent to a Terrats Medical via | |
| Compatible Implant Systems | ||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| Astra Tech EV | 3.6 | 2.9 mm |
| 4.2 | 3.5 mm | |
| 4.8 | 4.1 mm | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 mm |
| 3.5/4.0 | 3.5/4.0 mm | |
| 4.5/5.0 | 4.5/5.0 mm | |
| 3.25 | 3.45 mm | |
| Biomet 3i Certain® | 4.0 | 4.1 mm |
| 5.0 | 5.0 mm | |
| 3.25 | 3.4 mm | |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 mm |
| 5.0 | 5.0 mm | |
| 3.3 | 3.3 mm | |
| Camlog | 3.8 | 3.8 mm |
| 4.3 | 4.3 mm | |
| 5.0 | 5.0 mm | |
| 3.4 | 3.4 mm | |
| FRIADENT XIVE® | 3.8 | 3.8 mm |
| 4.5 | 4.5 mm | |
| 5.5 | 5.5 mm | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm |
| NobelActive®,NobelParallel Conical | 3.0 | 3.0 (3.0 mm) |
| 3.5 | NP (3.5 mm) | |
| 4.3, 5.0 | RP (3.9 mm) | |
| 5.5 | WP (5.1 mm) | |
| NobelReplace® Trilobe | 3.5 | NP (3.5 mm) |
| 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | |
| 6.0 | 6.0 (6.0 mm) | |
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) |
| 3.75, 4.0 | RP (4.1 mm) | |
| 5.0 | WP (5.1 mm) | |
| Osstem TS | 3.5 | Mini (2.8 mm) |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | |
| Straumann® Bone Level | 3.3 | NC (3.3 mm) |
| 4.1/4.8 | RC (4.1/4.8 mm) | |
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) |
| 3.3, 4.1, 4.8 | RN (4.8 mm) | |
| 4.8 | WN (6.5 mm) | |
| Zimmer Screw Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 mm |
| 4.7 | 4.5 mm | |
| 6.0 | 5.7 mm |
r arch to provide support for prosthetic
lidated milling center for manufacture.
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| 510(k) Summary | |
|---|---|
| ---------------- | -- |
| Primary Predicate Devices | ||||
|---|---|---|---|---|
| K170588,DESS Dental Smart SolutionsTerrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or rAll digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling | |||
| Compatible Implant Systems | ||||
| Implant SystemCompatibility | Implant Diameter(mm) | Platform Diameter(mm) | ||
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | ||
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | ||
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | ||
| FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | ||
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP | ||
| NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP | ||
| Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | ||
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | ||
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | ||
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN | ||
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | ||
| Reference Devices | ||||
| K173908DESS Dental Smart SolutionsTerrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or rAll digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical vali | |||
| 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 | RP, WP |
lar arch to provide support for prosthetic restorations.
for manufacture.
lar arch to provide support for prosthetic restorations.
illing center for manufacture.
| Item |
|---|
d for use as an aid in prosthetic rehabilitation.
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Table 3 Table of Substantial Equivalence – Technological Characteristics
| Comparison | Subject Device | Primary Predicate Device | Reference Devices | |
|---|---|---|---|---|
| DESS Dental Smart Solutions | K170588DESS Dental Smart Solutions | K173908DESS Dental Smart Solutions | K161416Multi-Unit Abutment Plus | |
| Terrats Medical SL | K170588Terrats Medical SL | Terrats Medical SL | Nobel Biocare AB | |
| Design | ||||
| Abutment Designs | Healing, Temporary, Straight, Multi-unit, Locator-type, CAD/CAMBases, CAD/CAM Blanks, | Healing, Temporary, Straight,Multi-unit, Locator-type,CAD/CAM Bases, CAD/CAMBlanks, | CAD/CAM Bases, CAD/CAMBlanks, | Multi-unit |
| Prosthesis Attachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Screw-retained |
| Restoration | Single-unit,Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit | Multi-unit |
| Abutment/ImplantPlatformDiameter, mm | 2.52 - 6.0 | 3.0 - 6.0 | 3.6 - 5.0 | NP, RP, WP |
| Prosthetic PlatformDiameter, mm | 4.5-6.5 | 4.5 | 4.0 – 6.5 | 4.8 |
| Multi-unit Abutment Angle | 0°, 17°, 30° | Straight (0°) | Straight (0°) | 0°, 17°, 30° |
| All other abutment angles | Straight (0°) | Straight (0°) | Straight (0°) | |
| Abutment/ ImplantInterface | Internal | Internal | Internal | Internal |
| Material | ||||
| Abutments | Ti-6Al-4V ELICo-Cr-Mo AlloyZirconia (Y-TZP) | Ti-6Al-4V ELICo-Cr-Mo AlloyZirconia (Y-TZP) | Ti-6Al-4V ELICo-Cr-Mo AlloyZirconia (Y-TZP) | Titanium vanadium alloy |
| Screws | Ti-6Al-4V ELIDLC coating | Ti-6Al-4V ELIDLC coating | Ti-6Al-4V ELIDLC coating | Titanium vanadium alloy |
§ 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.)