(138 days)
No
The summary describes a digital dentistry workflow involving scanning, CAD software, CAM software, and milling. While this is a digital process, there is no mention of AI or ML being used for tasks like design automation, image analysis, or predictive modeling. The software mentioned (Abutment Designer Software and AbutmentCAD) are standard CAD tools for dental prosthetics.
No
The device, DESS Dental Smart Solutions abutments, provides support for prosthetic restorations in conjunction with dental implants. Its purpose is structural and restorative, not to cure, mitigate, treat, or prevent disease.
No
The device, DESS Dental Smart Solutions abutments, is an implant accessory intended to provide support for prosthetic restorations. It is a manufacturing component in a prosthetic workflow, not a device used to diagnose a medical condition.
No
The device description clearly states that the submission is for "DESS Dental Smart Solutions abutments" which are physical dental implants. While the submission discusses the software used in the digital dentistry workflow for designing these abutments, the subject device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations in the maxillary or mandibular arch, used in conjunction with dental implants. This is a mechanical and structural function within the body.
- Device Description: The device is described as abutments, which are components used in dental implant systems to connect the implant to the prosthetic restoration (like a crown). The description focuses on materials (titanium, ceramic), manufacturing processes (milling), and compatibility with dental implants.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the DESS Dental Smart Solutions abutments does not involve any testing of biological samples or providing diagnostic information.
The device is clearly a component of a dental implant system, which is a type of medical device, but not an in vitro diagnostic device.
N/A
Intended Use / 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 DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, ceramic material, milling machine, and associated tooling and accessories. Compatible Implant System:
Ankylos C/X (3.5, 4.5, 5.5 mm diameter, 3.5, 4.5, 5.5 platform; 3.0 mm diameter, 3.0 platform; 3.6 mm diameter, 3.6 platform)
Astra Tech EV (4.2 mm diameter, 4.2 platform; 4.8 mm diameter, 4.8 platform; 5.4 mm diameter, 5.4 platform; 3.0 mm diameter, 3.0 platform)
Astra Tech OsseoSpeed™ (3.5/4.0 mm diameter, 3.5/4.0 platform; 4.5/5.0 mm diameter, 4.5/5.0 platform)
BioHorizons Internal (3.0, 3.4, 3.8 mm diameter, 3.0 platform; 3.8, 4.6 mm diameter, 3.5 platform; 4.6, 5.8 mm diameter, 4.5 platform; 5.8 mm diameter, 5.7 platform)
Biomet 3i Certain® (3.25 mm diameter, 3.4 platform; 4.0 mm diameter, 4.1 platform; 5.0 mm diameter, 5.0 platform)
Biomet 3i OSSEOTITE® (3.25 mm diameter, 3.4 platform; 3.75, 4.0 mm diameter, 4.1 platform; 5.0 mm diameter, 5.0 platform)
Camlog (3.3 mm diameter, 3.3 platform; 3.8 mm diameter, 3.8 platform; 4.3 mm diameter, 4.3 platform; 5.0 mm diameter, 5.0 platform)
Friadent XiVE® (3.4 mm diameter, 3.4 platform; 3.8 mm diameter, 3.8 platform; 4.5 mm diameter, 4.5 platform; 5.5 mm diameter, 5.5 platform)
MegaGen AnyRidge (3.5, 4.0, 4.5, 5.0, 5.5 mm diameter, 3.5 platform)
Neodent Grand Morse (3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 mm diameter, Grand Morse (GM) platform)
NobelActive® (3.0 mm diameter, 3.0 platform; 3.5 mm diameter, NP platform; 4.3, 5.0 mm diameter, RP platform; 5.5 mm diameter, WP platform)
NobelReplace/ NobelParallel Conical (3.5 mm diameter, NP platform; 4.3 mm diameter, RP platform; 5.0 mm diameter, WP platform; 6.0 mm diameter, 6.0 platform)
Nobel Brånemark System® (3.3 mm diameter, NP platform; 3.75, 4.0 mm diameter, RP platform; 5.0 mm diameter, WP platform; 3.5 mm diameter, Mini platform)
Osstem TS (4.0, 4.5, 5.0, 6.0, 7.0 mm diameter, Regular platform; 3.5, 3.75, 4.0, 4.5 mm diameter, RB platform; 5.0, 5.5, 6.5 mm diameter, WB platform)
Straumann® BLX (3.3 mm diameter, NC platform; 4.1, 4.8 mm diameter, RC platform)
Straumann® Bone Level (3.3 mm diameter, NNC platform; 3.3, 4.1, 4.8 mm diameter, RN platform; 4.8 mm diameter, WN platform)
Zimmer Screw-Vent® / Tapered Screw-Vent® (3.3, 3.7, 4.1 mm diameter, 3.5 platform; 4.7 platform; 6.0 platform)
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.
The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):
- Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
- Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
- Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
- Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD (K193352)
- Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software
The design parameters for the CAD/CAM zirconia superstructure to be used on Base Abutments:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit loading
Ti Base Interface - 4.2 mm
DESS Aurum Base - 4.0 mm
ELLIPTIBase - 4.0 mm
C-Base - 4.7 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
The design parameters for the CAD/CAM Pre-Milled Blank custom abutments:
Minimum wall thickness - 0.4 mm
Minimum post height - 4.0 mm
Maximum gingival height - 6.0 mm
Minimum gingival height - 0.5 mm
All Pre-Milled Blank are for straight abutments only.
For the CAD/CAM Pre-milled Blanks that are compatible with Astra Tech EV (except for 3.0 mm implants), Astra Tech OsseoSpeed (except for 3.0), Biomet 3i Certain, Neodent Grand Morse, Nobel Active/NobelParallel Conical (except for 3.0 mm implants), NobelReplace Trilobe, Nobel Brånemark, Straumann Bone Level, Straumann BLX, and Zimmer Screw-Vent/Tapered Screw-Vent, the following design parameters may be used:
Minimum wall thickness - 0.45 mm
Minimum post height - 4.0 mm
Maximum gingival height - 6.0 mm
Minimum gingival height - 0.5 mm
Maximum angulation of the final abutment - 30°
For the CAD/CAM Pre-milled Blanks that are compatible NobelParallel Conical 3.0 mm implants, the following design parameters may be used:
Minimum wall thickness - 0.45 mm
Minimum post height - 4.0 mm
Maximum gingival height - 3.0 mm
Minimum gingival height - 0.5 mm
Maximum angulation of the final abutment - 30°
Screws
DESS Dental Smart Solutions screws are designed to attach the abutment to the implant or the prosthesis to the abutment. The screws were cleared in K170588, K173908, K191986, K203464, K212577, and K212628. There have been no changes to the screws and there are no new subject device screws. Screws are available with and without a DLC (Diamond-like Carbon) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan files from intra-oral and lab (desktop) scanners
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted to demonstrate substantial equivalence included the following: Sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937; biocompatibility testing according to ISO 10993-5 and ISO 10993-12; fatigue testing and reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; MR Conditional labeling; and validation testing of the CAM restriction zones were leveraged from K221301. Fatigue testing of OEM implant bodies with patient specific abutments made at worst-case angled conditions. Software verification included testing of restrictions that prevent design of components outside of the stated design parameters. In addition, the abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified by the user. To address the potential risk of damage to the implant-abutment connection geometry during the milling of the patientmatched portions of the abutment blanks, validation testing of the CAM restriction zones was conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software. No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221301, K180703, K130436, K151455, K193352, K140347, K111287, K120414, K101732, K042429, K071638, K063341, K063286, K083496, K073075, K110955, K163194, K142260, K102436, K073142, K050705, K050406, K022562, K161604, K173961, K140878, K130222, K011028, K112160
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 2024
Terrats Medical SL % Melissa Burbage QA/RA Consultant Enerxen Consulting, Inc. 1155 Metcalfe Street Suite 1572 Montreal, QC H3B2V6 CANADA
Re: K240982
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, PNP Dated: April 9, 2024 Received: August 2, 2024
Dear Melissa Burbage:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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.
2
For comprehensive regulatory information about mediation-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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
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 Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAM software, ceramic material, milling machine, and associated tooling and accessories. atible Imnlant Syste
| Implant System Compatibility | Compatible Implant Systems
Implant Diameter (mm) | Implant Platform Name |
|------------------------------------------|-----------------------------------------------------|-----------------------|
| Ankylos C/X | 3.5, 4.5, 5.5 | 3.5, 4.5, 5.5 |
| | 3.0 | 3.0 |
| | 3.6 | 3.6 |
| Astra Tech EV | 4.2 | 4.2 |
| | 4.8 | 4.8 |
| | 5.4 | 5.4 |
| | 3.0 | 3.0 |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 |
| | 4.5/5.0 | 4.5/5.0 |
| | 3.0, 3.4, 3.8 | 3.0 |
| | 3.8, 4.6 | 3.5 |
| BioHorizons Internal | 4.6, 5.8 | 4.5 |
| | 5.8 | 5.7 |
| | 3.25 | 3.4 |
| Biomet 3i Certain® | 4.0 | 4.1 |
| | 5.0 | 5.0 |
| | 3.25 | 3.4 |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 |
| | 5.0 | 5.0 |
| | 3.3 | 3.3 |
| | 3.8 | 3.8 |
| Camlog | 4.3 | 4.3 |
| | 5.0 | 5.0 |
| | 3.4 | 3.4 |
| | 3.8 | 3.8 |
| Friadent XiVE® | 4.5 | 4.5 |
| | 5.5 | 5.5 |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
| | 3.0 | 3.0 |
| NobelActive® | 3.5 | NP |
| NobelReplace/ NobelParallel Conical | 4.3, 5.0 | RP |
| | 5.5 | WP |
| | 3.5 | NP |
| | 4.3 | RP |
| NobelReplace® Trilobe | 5.0 | WP |
| | 6.0 | 6.0 |
| | 3.3 | NP |
| Nobel Brånemark System® | 3.75, 4.0 | RP |
| | 5.0 | WP |
| | 3.5 | Mini |
| Osstem TS | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular |
| | 3.5, 3.75, 4.0, 4.5 | RB |
| Straumann® BLX | 5.0, 5.5, 6.5 | WB |
| | 3.3 | NC |
| Straumann® Bone Level | 4.1, 4.8 | RC |
| | 3.3 | NNC |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN |
| | 4.8 | WN |
| Zimmer Screw-Vent¹ / Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| | | 4.7 |
| | | 6.0 |
4
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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5
510(k) Summary Terrats Medical SL
DESS® Dental Smart Solutions
August 26, 2024
melissa.burbage(@enerxen.com
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL | |||
|---|---|---|---|---|
| Carrer Mogoda 75-99 | ||||
| Barberà del Vallès | ||||
| 08210 Barcelona, Spain | ||||
| Telephone: | +34 935 646 006 | |||
| Fax: | +34 935 647 317 | |||
| Official Contact | Roger Terrats, CEO | |||
| Representative/Consultant | Melissa Burbage | |||
| Enerxen Consulting, Inc. | ||||
| 1155 Metcalfe Street, Suite 1572 | ||||
| Montreal, Quebec H3B 2V6 | ||||
| Telephone: | +1 619-480-7733 |
Email:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Primary Product Code | NHA |
| Secondary Product Code | PNP |
| Classification Panel | Dental Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K222288, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices
K221301, DESS Dental Smart Solutions, Terrats Medical SL
K180703, VITA YZ ST and VITA YZ XT, VITA Zahnfabrik H.Rauter GmbH. Co.
K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG
K151455, 3Shape Abutment Designer Software, 3Shape A/S
K193352, AbutmentCAD, exocad GmbH
K140347, Ankylos C/X Implant System, DENTSPLY International, Inc.
K111287, Astra Tech Implant System, Astra Tech AB
K120414, OsseoSpeed Plus, Astra Tech AB
K101732, OsseoSpeed™ Astra Tech AB
K042429, The Prodigy System Dental Implants, BioHorizons Implants System, Inc.
K071638, BioHorizons Tapered Internal Implant System, BioHorizons Implants System, Inc.
6
Traditional 510(k) Premarket Notification 510(k) Summary
K063341, 3i OSSEOTITE Certain® Dental Implants, Implant Innovations, Inc.
K063286, OSSEOTITE® Dental Implants, Implant Innovations, Inc.
K083496, Camlog Implant System, Altatech GmbH
K073075, Friadent Implant Systems, DENTSPLY International, Inc.
K110955, AnyRidge Internal Implant System, Megagen Co., Ltd.
K163194, Neodent Implant System - GM Line, JJGC Industria E Comercio De Materials Dentarios SA
K142260, NobelActive®, Nobel Biocare AB
K102436, NobelActive 3.0, Nobel Biocare AB
K073142, NobelReplace Hexagonal Implants, Nobel Biocare AB
K050705, TiUnite Implants, Nobel Biocare AB
K050406 NobelSpeedy Implants, Nobel Biocare AB
K022562, Various Brånemark System Implants-Immediate Function Indication, Nobel Biocare AB
K161604, Osstem Implant System, OSSTEM IMPLANT Co., Ltd
K173961, Straumann BLX Implant System, Institut Straumann AG
K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC
K 130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC
K011028, Screw-Vent Dental Implant System, Sulzer Dental, Inc.
K112160, Tapered Screw-Vent® X Implant, Zimmer Dental, Inc.
7
INDICATIONS FOR USE STATEMENT
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, ceramic material, milling machine, and associated tooling and accessories.
| Implant System Compatibility | Implant Diameter (mm) | Implant Platform Name |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 3.5, 4.5, 5.5 |
| 3.0 | 3.0 | |
| 3.6 | 3.6 | |
| Astra Tech EV | 4.2 | 4.2 |
| 4.8 | 4.8 | |
| 5.4 | 5.4 | |
| 3.0 | 3.0 | |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 |
| 4.5/5.0 | 4.5/5.0 | |
| 3.0, 3.4, 3.8 | 3.0 | |
| 3.8, 4.6 | 3.5 | |
| BioHorizons Internal | 4.6, 5.8 | 4.5 |
| 5.8 | 5.7 | |
| 3.25 | 3.4 | |
| Biomet 3i Certain® | 4.0 | 4.1 |
| 5.0 | 5.0 | |
| 3.25 | 3.4 | |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 |
| 5.0 | 5.0 | |
| 3.3 | 3.3 | |
| 3.8 | 3.8 | |
| Camlog | 4.3 | 4.3 |
| 5.0 | 5.0 | |
| 3.4 | 3.4 | |
| 3.8 | 3.8 | |
| Friadent XiVE® | 4.5 | 4.5 |
| 5.5 | 5.5 | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
| 3.0 | 3.0 | |
| NobelActive® | 3.5 | NP |
| NobelReplace/ NobelParallel Conical | 4.3, 5.0 | RP |
| 5.5 | WP | |
| 3.5 | NP | |
| NobelReplace® Trilobe | 4.3 | RP |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| 3.3 | NP | |
| Nobel Brånemark System® | 3.75, 4.0 | RP |
| 5.0 | WP | |
| Osstem TS | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Straumann® BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1, 4.8 | RC | |
| 3.3 | NNC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Zimmer Screw-Vent® / Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
Compatible Implant Systems
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SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.
The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):
- Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
- . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
- Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
- Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
- . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software
9
The design parameters for the CAD/CAM zirconia superstructure to be used on Base Abutments: Minimum wall thickness - 0.4 mm Minimum post height for single-unit loading Ti Base Interface - 4.2 mm DESS Aurum Base - 4.0 mm ELLIPTIBase - 4.0 mm C-Base - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Pre-Milled Blank custom abutments: Minimum wall thickness - 0.4 mm Minimum post height - 4.0 mm Maximum gingival height - 6.0 mm Minimum gingival height - 0.5 mm All Pre-Milled Blank are for straight abutments only.
For the CAD/CAM Pre-milled Blanks that are compatible with Astra Tech EV (except for 3.0 mm implants), Astra Tech OsseoSpeed (except for 3.0), Biomet 3i Certain, Neodent Grand Morse, Nobel Active/NobelParallel Conical (except for 3.0 mm implants), NobelReplace Trilobe, Nobel Brânemark, Straumann Bone Level, Straumann BLX, and Zimmer Screw-Vent/Tapered Screw-Vent, the following design parameters may be used:
Minimum wall thickness - 0.45 mm Minimum post height - 4.0 mm Maximum gingival height - 6.0 mm Minimum gingival height - 0.5 mm Maximum angulation of the final abutment - 30°
For the CAD/CAM Pre-milled Blanks that are compatible NobelParallel Conical 3.0 mm implants, the following design parameters may be used:
Minimum wall thickness - 0.45 mm Minimum post height - 4.0 mm Maximum gingival height - 3.0 mm Minimum gingival height - 0.5 mm Maximum angulation of the final abutment - 30°
Screws
DESS Dental Smart Solutions screws are designed to attach the abutment to the implant or the prosthesis to the abutment. The screws were cleared in K170588. K173908. K191986. K203464. K212577, and K212628. There have been no changes to the screws and there are no new subject device screws. Screws are available with and without a DLC (Diamond-like Carbon) coating.
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| Compatible Implant
Systems | DESS
Abutment System | Ti Base
Interface | DESS Aurum
Base | ELLIPTI-Base | DESS C-Base | Pre-milled
Blank Ti | Screws |
|-------------------------------------------|---------------------------|----------------------------|--------------------|--------------|--------------------|----------------------------|--------|
| Ankylos C/X | Internal Ank | 3.5, 4.5,5.5 | | | 3.5, 4.5, 5.5 | 3.5, 4.5, 5.5 | X |
| Astra Tech EV | Conic EVO | 3.0, 3.6, 4.2,
4.8, 5.4 | 3.6, 4.2, 4.8 | 3.0 | 3.6, 4.2, 4.8 | 3.0, 3.6, 4.2,
4.8, 5.4 | X |
| Astra Tech OsseoSpeed | Internal Hex Conic | 3.0, 3.5/4.0,
4.5/5.0 | 3.5/4.0, 4.5/5.0 | | 3.5/4.0, 4.5/5.0 | 3.0, 3.5/4.0,
4.5/5.0 | X |
| BioHorizons Internal | BH Internal | 3.0, 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | 3.0 | | 3.5, 4.5, 5.7 | X |
| Biomet 3i Certain | Internal Hex Click | 3.4, 4.1, 5.0 | 3.4, 4.1, 5.0 | | 3.4, 4.1, 5.0 | 3.4, 4.1, 5.0 | X |
| Biomet 3i OSSEOTITE | External Hex USA | 3.4, 4.1, 5.0 | 3.4, 4.1, 5.0 | | 3.4, 4.1, 5.0 | 3.4, 4.1, 5.0 | X |
| Camlog | Internal CAM | 3.3, 3.8,4.3, 5.0 | 3.8, 4.3 | | | 3.3, 3.8,
4.3, 5.0 | X |
| Frident XiVE | Internal Hex FD | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5 | | 3.4, 3.8, 4.5, 5.5 | 3.8, 4.5, 5.5 | X |
| Neodent Grand Morse | Neo GM | Grand Morse | Grand Morse | | | Grand Morse | X |
| NobelActive,
NobelParallel Conical | Active Hex | 3.0, NP, RP,
WP | NP, RP | 3.0 | NP, RP, WP | 3.0, NP, RP,
WP | X |
| NobelReplace Trilobe | Tri-lobe | NP, RP, WP,
6.0 | NP, RP, WP | | NP, RP, WP,
6.0 | NP, RP, WP,
6.0 | X |
| Nobel Brånemark
System | External Hex
Universal | NP,RP, WP | NP, RP | | NP, RP | NP, RP, WP | X |
| Osstem TS | Conic OSS | Mini, Regular | Mini, Regular | | Mini, Regular | Mini, Regular | X |
| Straumann BLX | Conical BLX | RB/WB, WB | RB/WB, WB | | | RB/WB, WB | X |
| Straumann Bone Level | Conical BL | NC, RC | NC, RC | NC | NC, RC | NC, RC | X |
| Straumann Tissue Level | Octagon | NNC, RN, WN | RN, WN | NNC | RN, WN | NNC, RN,
WN | X |
| Zimmer Screw Vent /
Tapered Screw Vent | Internal Hex USA | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | 3.5 | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | X |
Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems
MATERIAL COMPOSITION
All subject device abutments and screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). These materials are the same as those used for devices cleared in K221301.
The new material recommended for zirconia superstructures on Ti Base Interface, DESS Aurum Base and ELLIPTIBase, and C-Base is VITA YZ ST and VITA YZ XT, conforming to ISO 6872 Dentistry -Ceramic Materials and cleared in K180703. This material is the same as that used for devices cleared in K221301.
The cement recommended in labeling for bonding of superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG, cleared under K130436. This material is the same as that used for devices cleared in K2213018.
All subject device components are manufactured from the same materials, are treated with the same surface treatments (SelectGrip® surface, DLC coating and anodization), and are manufactured in the same facilities using the same manufacturing processes cleared in K221301.
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PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included the following: Sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937; biocompatibility testing according to ISO 10993-5 and ISO 10993-12; fatigue testing and reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; MR Conditional labeling; and validation testing of the CAM restriction zones were leveraged from K221301. Fatigue testing of OEM implant bodies with patient specific abutments made at worst-case angled conditions. Software verification included testing of restrictions that prevent design of components outside of the stated design parameters. In addition, the abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified by the user. To address the potential risk of damage to the implant-abutment connection geometry during the milling of the patientmatched portions of the abutment blanks, validation testing of the CAM restriction zones was conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
Subject device abutments are identical to the predicate device K221301. Both are intended for use with endosseous dental implants to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Both have the same compatible OEM implants. Both indicate manufacturing using a validated milling center or to be designed and manufactured using a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.
All subject device abutments (base and blanks) and screws are equivalent in design, materials and technological characteristics to those of the predicate device K221301. There are no changes to the abutment designs or implant compatibilities. The material of the abutment and superstructure is the same as predicate device K221301. All part numbers and design parameters have been cleared within previous submissions cleared for manufacturing via a validated milling center and digital dentistry workflow. The purpose of this submission is to allow using an additional software for design, AbumentCAD.
CONCLUSION
The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, 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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| Comparison | Subject Device | Predicate Devices |
|---|---|---|
| DESS Dental Smart Solutions | ||
| Terrats Medical SL | K221301 | |
| DESS Dental Smart Solutions | ||
| Terrats Medical SL | ||
| Product Code | NHA, PNP | NHA, PNP |
| Reason for predicate/reference | n/a | n/a |
| Intended Use | Support of a prosthesis to restore chewing function | Support of a prosthesis to restore chewing function |
| Indications | DESS Dental Smart Solutions abutments are | |
| intended to be used in conjunction with | ||
| endosseous dental implants in the maxillary or | ||
| mandibular arch to provide support for prosthetic | ||
| restorations. | ||
| All digitally designed custom abutments for | ||
| use with DESS Bases or Pre-milled Blanks are | ||
| to be sent to a Terrats Medical validated milling | ||
| center for manufacture, or to be designed and | ||
| manufactured according to the digital dentistry | ||
| workflow. The digital dentistry workflow | ||
| integrates multiple components: scan files from | ||
| intra-oral and lab (desktop) scanners, CAD | ||
| software, CAM software, ceramic material, | ||
| milling machine, and associated tooling and | ||
| accessories. | ||
| For complete Indications for Use statement on | ||
| OEM Compatibility see form FDA 3881. | DESS Dental Smart Solutions abutments are | |
| intended to be used in conjunction with endosseous | ||
| dental implants in the maxillary or mandibular arch | ||
| to provide support for prosthetic restorations. | ||
| All digitally designed custom abutments for use | ||
| with DESS Bases or Pre-milled Blanks are to be | ||
| sent to a Terrats Medical validated milling center | ||
| for manufacture, or to be designed and | ||
| manufactured according to the digital dentistry | ||
| workflow. The digital dentistry workflow integrates | ||
| multiple components: scan files from intra-oral and | ||
| lab (desktop) scanners, CAD software, CAM | ||
| software, ceramic material, milling machine, and | ||
| associated tooling and accessories. | ||
| For complete Indications for Use statement on OEM | ||
| Compatibility see 510(k) Summary for K221301 | ||
| Design | ||
| Abutment Designs | CAD/CAM Bases, CAD/CAM Blanks | CAD/CAM Bases, CAD/CAM Blanks |
| Prosthesis Attachment | Cement-retained Screw-retained | Cement-retained Screw-retained |
| Restoration | Single-unit, Multi-unit | Single-unit, Multi-unit |
| Abutment/Implant | ||
| Platform Ø, mm | 2.52 - 6.5 | 2.52 - 6.5 |
| Abutment Angle | 30° max* for Blanks 0° for TiBases | 30° max* for Blanks 0° for TiBases |
| Material | ||
| Abutment Material (Blanks) | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Abutment Material (Bases) | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Screw Material | Ti-6Al-4V ELI | |
| DLC coating | Ti-6Al-4V ELI | |
| DLC coating | ||
| Superstructure Material (Bases) | Zirconium Oxide (Y-TZP), K180703 | Zirconium Oxide (Y-TZP), K180703 |
| Surface | Anodization and a SelectGrip® surface | Anodization and a SelectGrip® surface |
| Manufacturing | Digital Dentistry Workflow & Validated Milling | |
| Center | Digital Dentistry Workflow & Validated Milling | |
| Center | ||
| Digital Design Workflow | 3Shape Intraoral scanner Trios series, 3Shape E- | |
| series and D/R2000 Lab Scanner, 3Shape Abutment | ||
| Designer Software (3Shape A/S) K151455, | ||
| AbutmentCAD (exocad GmbH) K193352 | 3Shape Intraoral scanner Trios series, 3Shape E- | |
| series and D/R2000 Lab Scanner, 3 Shape | ||
| Abutment Designer Software (3Shape A/S) | ||
| K151455 | ||
| Digital Manufacturing | ||
| Workflow | VHF R5 By vhf camfacture AG with DentalCAM & | |
| DentalCNC | VHF R5 By vhf camfacture AG with DentalCAM & | |
| DentalCNC |
Device Comparison Table
*30° for select OEM Connections as listed above in the Subject