(90 days)
No
The summary describes physical dental abutments and related components, focusing on material, design variations, and compatibility with existing implant systems. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device, DESS Dental Smart Solutions abutments, is used with dental implants to support prosthetic restorations in the maxilla or mandible, which is a therapeutic purpose.
No
The device description indicates that DESS Dental Smart Solutions abutments are "intended to be used in conjunction with endosseous dental implants...to provide support for prosthetic restorations." This describes a supportive, restorative function, not a diagnostic one.
No
The device description explicitly lists physical components such as abutments, bases, blanks, attachments, and screws, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the abutments are used "in conjunction with endosseous dental implants... to provide support for prosthetic restorations." This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the human body for diagnostic purposes.
- Device Description: The description details components like abutments, bases, blanks, and screws, all of which are physical parts intended for implantation and connection within the mouth. There is no mention of reagents, test kits, or analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or test procedures
The device is a dental prosthetic component used in the restoration of dental implants, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
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 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 Name |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 |
| 3.0 | 3.0 | |
| Astra Tech EV | 3.6 | 3.6 |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| 5.4 | 5.4 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | |
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.6 | 3.5 | |
| 4.6, 5.8 | 4.5 | |
| 5.8 | 5.7 | |
| Biomet 3i Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Camlog | 3.8 | 3.8 |
| 4.3 | 4.3 | |
| 5.0 | 5.0 | |
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| 3.4 | 3.4 | |
| FRIADENT XiVE® | 3.8 | 3.8 |
| 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) |
| NobelActive®, NobelParallel Conical | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| NobelReplace® Trilobe | 3.5 | NP |
| 4.3 | RP | |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Nobel Brånemark System® | 3.3 | NP |
| 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 | |
| Straumann® Tissue Level | 3.3 | NNC, RN |
| 4.1 | RN | |
| 4.8 | RN, WN | |
| Zimmer Screw Vent®/ Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| Zimmer Spline | 3.25 | 3.25 |
| 3.75, 4.0 | 3.75/4.0 | |
| 5.0 | 5.0 | |
| Zimmer SwissPlus | 3.7 | 3.8 |
| 4.8 | 4.8 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908, K191986, K203464, K212577, and K212628 to:
- include new OEM platform compatibilities (that have not been previously cleared) for previously ● cleared DESS designs,
- include previously-cleared OEM platform compatibilities for previously-cleared DESS abutment ● designs for which the specific combinations of compatibility and design were not cleared previously,
- add angulation to previously cleared Ti Base Abutments, Pre-Milled Blank, Ti, and Multi Unit Abutment,
- include a new abutment design, ZRN Multi Unit Abutment,
- include additional gingival height variations for the Ti Base Interface and DESSLoc Abutment, ●
- include two attachments: Interface Attachment for UniAbutment and Bar Attachment. ●
This submission includes five (5) abutment designs [Healing Abutments, Temporary Abutments, Multi Unit Abutments (straight and angled), ZRN Multi Unit Abutments (straight and angled), and DESSLoc Abutments], one (1) abutment blank (Pre-Milled Blank, Ti), three (3) base designs (Ti Base, C-Base, CrCo Base), two (2) attachments, and twenty (20) screws.
This submission includes one (1) new abutment design (ZRN Multi Unit abutment), based on the previously cleared Multi Unit abutment, but with an added zirconium nitride (Zr\V) coating. The identical coating is used on the DESSLoc Abutments that have been cleared in K170588, and K212628.
This submission includes two attachments. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in K170588. The subject device DESSLoc for Bar is designed to attached directly to the bar. The top portion of this attachment has the same design and material as the DESSLoc abutment cleared in K170588. K191986, and K212628.
The subject device includes the addition of new and previously cleared OEM compatibilities to previously cleared abutment design (Healing Abutments, Temporary Abutments, Ti Base, C-Base, Pre-Milled Blank Ti, Multi Unit abutments, and DESSLoc abutment). New compatibility is introduced for four (4) implant systems for which Terrats Medical has no prior clearance, for a total of eleven (11) new platforms. The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems.
The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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: sterilization validation according to ISO 17665-1 and ISO 14937, and biocompatibility according to ISO 10993-5 and ISO 10993-12, leveraged from K170588, K173908, K191986, K203464, K212577, and K212628; and reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility for new OEM connections. 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.
K173908, K191986, K203464, K212577, K212628, K160965, K082639, K013494, K012055, K142082
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 contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
10/27/2022
Terrats Medical SL % Melissa Burbage Senior Regulatory Specialist PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K222288
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: July 29, 2022 Received: July 29, 2022
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 (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.
for Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22288
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 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 Name |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 |
| 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 | 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 | |
| 3.8 | 3.8 | |
| Camlog | 4.3 | 4.3 |
| 5.0 | 5.0 | |
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| 3.4 | 3.4 | |
| FRIADENT XiVE® | 3.8 | 3.8 |
| 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®, NobelParallel Conical | 3.5 | NP |
| 4.3, 5.0 | RP | |
| 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, RN | |
| Straumann® Tissue Level | 4.1 | RN |
| 4.8 | RN, WN | |
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
| Zimmer Screw Vent®/ Tapered Screw- | ||
| Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 | |
| Zimmer Spline | 3.25, | 3.25 |
| 3.75, 4.0 | 3.75/4.0 | |
| 5.0 | 5.0 | |
| Zimmer SwissPlus | 3.7 | 3.8 |
| 4.8 | 4.8 |
Compatible Implant Systems
3
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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FORM FDA 3881 (8/14)
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PSC Publishing Services (301) 443-6740 EF
4
510(k) Summary
K22288
Terrats Medical SL DESS® Dental Smart Solutions
October 27, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
08210 Barberà del Vallès
Barcelona, Spain |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Melissa Burbage, BS
Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 |
| Telephone | +1 858-792-1235 |
| Fax | +1 858-792-1236 |
| Email | mburbage@paxmed.com
flarson@paxmed.com
kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | DESS Dental Smart Solutions |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices
K173908, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K203464, DESS Dental Smart Solutions, Terrats Medical SL K212577, DESS Dental Smart Solutions, Terrats Medical SL
5
K212628, DESS Dental Smart Solutions, Terrats Medical SL
K160965, SuperLine, Dentium Co., LTD.
K082639, Dental Tapered SwissPlus Implant, Zimmer Dental, Inc.
K013494, Spline Twist Implant, Sulzer Dental, Inc.
K012055, Spline Twist Implant, Sulzer Dental, Inc.
K142082, Zimmer 3.1mmD Dental Implant System, Zimmer Dental, Inc.
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 Name |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 |
| Ankylos C/X | 3.0 | 3.0 |
| Astra Tech EV | 3.6 | 3.6 |
| Astra Tech EV | 4.2 | 4.2 |
| Astra Tech EV | 4.8 | 4.8 |
| Astra Tech EV | 5.4 | 5.4 |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 |
| Astra Tech OsseoSpeed™ | 4.5/5.0 | 4.5/5.0 |
| BioHorizons | 3.0, 3.4, 3.8 | 3.0 |
| BioHorizons | 3.8, 4.6 | 3.5 |
| BioHorizons | 4.6, 5.8 | 4.5 |
| BioHorizons | 5.8 | 5.7 |
| Biomet 3i Certain® | 3.25 | 3.4 |
| Biomet 3i Certain® | 4.0 | 4.1 |
| Biomet 3i Certain® | 5.0 | 5.0 |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 |
| Biomet 3i OSSEOTITE® | 5.0 | 5.0 |
| Camlog | 3.8 | 3.8 |
| Camlog | 4.3 | 4.3 |
| Camlog | 5.0 | 5.0 |
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| Dentium SuperLine | 3.4 | 3.4 |
| FRIADENT XiVE® | 3.8 | 3.8 |
| FRIADENT XiVE® | 4.5 | 4.5 |
| FRIADENT XiVE® | 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) |
| NobelActive®, NobelParallel Conical | 3.0 | 3.0 |
| NobelActive®, NobelParallel Conical | 3.5 | NP |
| NobelActive®, NobelParallel Conical | 4.3, 5.0 | RP |
| NobelReplace® Trilobe | 3.5 | NP |
| NobelReplace® Trilobe | 4.3 | RP |
Compatible Implant Systems
6
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Nobel Brånemark System® | 3.3 | NP |
| Nobel Brånemark System® | 3.75, 4.0 | RP |
| 5.0 | WP | |
| Osstem TS | 3.5 | Mini |
| Osstem TS | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| Straumann BLX | 5.0, 5.5, 6.5 | WB |
| Straumann® Bone Level | 3.3 | NC |
| Straumann® Bone Level | 4.1/4.8 | RC |
| Straumann® Tissue Level | 3.3 | NNC, RN |
| Straumann® Tissue Level | 4.1 | RN |
| Straumann® Tissue Level | 4.8 | RN, WN |
| Zimmer Eztetic | 3.1 | 2.9 |
| Zimmer Screw Vent®/ Tapered | ||
| Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| Zimmer Screw Vent®/ Tapered | ||
| Screw-Vent® | 4.7 | 4.5 |
| Zimmer Screw Vent®/ Tapered | ||
| Screw-Vent® | 6.0 | 5.7 |
| Zimmer Spline | 3.25, | 3.25 |
| Zimmer Spline | 3.75, 4.0 | 3.75/4.0 |
| Zimmer Spline | 5.0 | 5.0 |
| Zimmer SwissPlus | 3.7 | 3.8 |
| Zimmer SwissPlus | 4.8 | 4.8 |
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908, K191986, K203464, K212577, and K212628 to:
- include new OEM platform compatibilities (that have not been previously cleared) for previously ● cleared DESS designs,
- include previously-cleared OEM platform compatibilities for previously-cleared DESS abutment ● designs for which the specific combinations of compatibility and design were not cleared previously,
- add angulation to previously cleared Ti Base Abutments, Pre-Milled Blank, Ti, and Multi Unit Abutment,
- include a new abutment design, ZRN Multi Unit Abutment,
- include additional gingival height variations for the Ti Base Interface and DESSLoc Abutment, ●
- include two attachments: Interface Attachment for UniAbutment and Bar Attachment. ●
This submission includes five (5) abutment designs [Healing Abutments, Temporary Abutments, Multi Unit Abutments (straight and angled), ZRN Multi Unit Abutments (straight and angled), and DESSLoc Abutments], one (1) abutment blank (Pre-Milled Blank, Ti), three (3) base designs (Ti Base, C-Base, CrCo Base), two (2) attachments, and twenty (20) screws.
This submission includes one (1) new abutment design (ZRN Multi Unit abutment), based on the previously cleared Multi Unit abutment, but with an added zirconium nitride (Zr\V) coating. The identical coating is used on the DESSLoc Abutments that have been cleared in K170588, and K212628.
This submission includes two attachments. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in
7
K170588. The subject device DESSLoc for Bar is designed to attached directly to the bar. The top portion of this attachment has the same design and material as the DESSLoc abutment cleared in K170588. K191986, and K212628.
The subject device includes the addition of new and previously cleared OEM compatibilities to previously cleared abutment design (Healing Abutments, Temporary Abutments, Ti Base, C-Base, Pre-Milled Blank Ti, Multi Unit abutments, and DESSLoc abutment). New compatibility is introduced for four (4) implant systems for which Terrats Medical has no prior clearance, for a total of eleven (11) new platforms. The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems.
The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.
Healing Abutment
Healing Abutments are designed to cover the implant connection during the period between implant placement and final abutment placement. Healing Abutments are provided in multiple gingival heights to aid in contouring the gingiva during healing. All healing abutments are marked to identify their gingival height and compatible implant platform. Healing abutments are made of titanium alloy (Ti-6Al-4V). Healing abutments that are the subject of this submission are identical to those cleared under K 170588. K191986, and K212628 but are provided for one (1) additional platform compatibility.
Temporary Abutment
Temporary Abutments are designed with horizontal grooves and a vertical flat portion to aid in the fabrication of temporary restorations. They can be reduced in height to adapt to individual patient occlusion. Temporary Abutments are not intended for angle correction. In addition, Temporary Abutments have a SelectGrip® surface to aid in bonding retention. SelectGrip is a sandblasted surface treatment process that significantly improves bonding strength between the treated abutment surface and the cemented prosthesis. Temporary Abutments are available for single-unit and multiple-unit restorations, the former with engaging connections to the implants and the latter with non-engaging connections. Temporary abutments are made of titanium alloy (Ti-6Al-4V). Healing abutments that are the subject of this submission are identical to those cleared under K170588 and K191986 but are provided for one (1) additional platform compatibility.
Base Abutments
Subject device Bases, including Ti Base Interface, C-Base, are designed for custom abutment fabrication of a CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Bases is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Bases 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).
8
510(k) Summary Page 5 of 11
The design parameters for the CAD/CAM zirconia superstructure to be used on Ti Base Interface compatible with all implants except those listed in the next paragraph are identical to those previously cleared in K170588, K191986, and K212628. They are:
Minimum wall thickness – 0.4 mm Minimum post height - 4.2 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All zirconia superstructures are for straight abutments only.
For the CAD/CAM zirconia superstructure to be used on Ti Base Interface compatible with Biomet 3i Certain, NobelReplace Trilobe, and Zimmer Screw-Vent/Tapered Screw-Vent (except for 3.3 mm implants), the following design parameters may be used:
Minimum wall thickness - 0.4 mm Minimum post height - 4.2 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Maximum angulation of the final abutment - 30°
The design parameters for the CAD/CAM zirconia superstructure to be used on C-Base are identical to those cleared in K203464. They are:
Minimum wall thickness – 0.4 mm Minimum post height - 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 zirconia superstructure to be used on CrCo Base are identical to those cleared in K173908 and K191986. They are:
Minimum wall thickness - 0.4 mm Minimum post height for single-unit restorations - 4.5 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.0 mm All zirconia superstructures are for straight abutments only.
Pre-Milled Blank, Ti
Pre-milled Blank Abutments are available in engaging designs. They are made of titanium alloy (Ti-6Al-4V). Subject device Pre-milled (Blank) Abutments are identical to Pre-milled Blank Abutments cleared in K170588, K191986, K212628, and K212577.
The design parameters for the CAD/CAM fabrication of custom abutments from Pre-milled Blank Ti compatible with all implants except those listed in the next paragraph are identical to those cleared in K170588, K191986, and K212628. They are:
Minimum wall thickness – 0.45 mm Minimum post height - 4.0 mm Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Pre-Milled Blanks are for straight abutments only
9
The design parameters for the CAD/CAM Pre-milled Blanks that are compatible with Astra Tech EV (except for 3.0 mm implants), Astra Tech OssesSpeed, Biomet 3i Certain. Nobel Active/Nobel Parallel Conical (except for 3.0 mm implants), NobelReplace Trilobe, Nobel Branemark, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent (except 3.3 mm implants) are identical to those cleared in K212577. They are:
Minimum wall thickness - 0.45 mm Minimum post height - 4.0 mm Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°
Multi Unit Abutment
Multi Unit Abutment is designed for attachment of multi-unit screw-retained restorations and is provided in straight and angled designs. The design is the same as that of the Multi Unit Abutments cleared in K170588, K191986, and K212628 and the abutment is made from the same titanium alloy (Ti-6Al-4V). A new abutment line. Multi Unit Abutment ZRN, is being introduced. This subject device abutment has exactly the same design as the Multi Unit Abutment with an added coating of zirconium nitride (ZrN) to the top portion of the abutment. This coating is identical to the ZrN coating used on the DESSLoc Abutments that have been cleared in K170588. K191986, and K212628. Dedicated titanium alloy screws coated with Diamond-like carbon (DLC) are available to attach the abutment to the implant and a dedicated titanium alloy prosthetic screw is available to attach the abutment. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in K170588.
DESSLoc® Abutment
DESSLoc Abutment is designed for overdenture attachment. It is identical to the DESS LOC Abutment cleared in K170588, K191986, and K212628, except that additional gingival heights and new OEM Combabilities are provided. DESSLoc Abutments are made of titanium alloy (Ti-6Al-4V) and have a zirconium nitride (ZrN) coating.
Screws
DESS Dental Smart Solutions screws are designed to attach the implant or the prosthesis to the abutment. There are twenty (20) new screws for the subject device components with similar designs to those of screws cleared in K170588, K173908, K191986, K203464, K212577, and K212628. Two (2) of these new screws are variations that are being used with the already cleared components. The subject device screw 19.349 has same connection and thread mating as screws cleared in K191986, and 19.102 has the same connection and thread mating as screws cleared in K170588. Screws are available with and without a DLC (Diamond-like Carbon) coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K170588.
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510(k) Summary Page 7 of 11
| Compatible Implant
Systems | DESS
Abutment
System | Healing Abutment | Temporary Abutment | Ti Base Interface,
Engaging and
non-engaging | C-Base, Engaging and
non-engaging | CrCo Base, Engaging and
non-engaging | Pre-milled Blank Ti,
Engaging | Multi Unit Abutment | Multi Unit ZRN | DESSLoc
Abutment | Screws |
|-------------------------------------------|----------------------------|----------------------------|-----------------------|----------------------------------------------------|-----------------------------------------|--------------------------------------------|------------------------------------------|------------------------------------------------------|------------------------------------------------------|-----------------------------|--------|
| Ankylos C/X | Internal
ANK | 2.52 | 2.52 | 2.52
(0°) | 2.52
(0°) | 2.52
(0°) | 2.52
(0°) | | | 2.52 | 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, 5.4
(0°) | 3.6, 4.2, 4.8
(0°) | 3.6, 4.2, 4.8
(0°) | 3.0 (0°),
3.6, 4.2, 4.8,
5.4 (30°) | 3.0 (0°), 3.6,
4.2, 4.8, 5.4
(0°, 17°,
30°) | 3.0 (0°), 3.6,
4.2, 4.8, 5.4
(0°, 17°,
30°) | 3.6, 4.2,
4.8 | X |
| Astra Tech
OsseoSpeed | Internal Hex
Conic | 3.5/4.0,
4.5/5.0 | 3.5/4.0,
4.5/5.0 | 3.5/4.0,
4.5/5.0
(0°) | 3.5/4.0,
4.5/5.0
(0°) | 3.5/4.0,
4.5/5.0
(0°) | 3.0 (0°),
3.5/4.0,
4.5/5.0 (30°) | 3.5/4.0,
4.5/5.0
(0°, 17°,
30°) | 3.5/4.0,
4.5/5.0
(0°, 17°,
30°) | 3.0,
3.5/4.0,
4.5/5.0 | X |
| BioHorizons Internal | Internal Hex
BH | 3.5, 4.5, 5.7 | | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5
(0°) | 3.5, 4.5
(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
(30°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(30°) | | | 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
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1, 5.0
(0°) | 3.4, 4.1,
5.0 | |
| Camlog | Internal
CAM | 3.8. 4.3. 5.0 | 3.8. 4.3. 5.0 | 3.8, 4.3, 5.0
(0°) | | 3.8, 4.3, 5.0
(0°) | 3.8, 4.3, 5.0
(0°) | | | 3.8, 4.3,
5.0 | |
| Dentium SuperLine | DENT | | | | | | | 3.3
(0°) | 3.3
(0°) | | |
| FRIADENT XiVE | Internal Hex
FD | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | 3.4. 3.8,
4.5, 5.5
(0°) | 3.4. 3.8. 4.5
(0°) | 3.4, 3.8, 4.5
(0°) | 3.4, 3.8, 4.5
(0°) | | | 3.4, 3.8,
4.5 | |
| Megagen AnyRidge | Conic Anyr | | | 3.5
(0°) | 3.5
(0°) | | | | | | X |
| Neodent Grand
Morse | Neo GM | | | Grand
Morse
(0°) | Grand
Morse
(0°) | | | Grand Morse
(0°, 17°,
30°) | Grand
Morse
(0°, 17°,
30°) | | X |
| NobelActive®,
NobelParallel
Conical | Active Hex | NP, RP | NP, RP | 3.0, NP,
RP, WP
(0°) | NP, RP,
WP
(0°) | NP, RP
(0°) | 3.0 (0°), NP,
RP, WP
(30°) | NP, RP
(0°, 17°,
30°) | NP, RP
(0°, 17°,
30°) | NP, RP | X |
| NobelReplace
Trilobe | Tri-lobe | NP, RP,
WP | NP, RP, WP | NP, RP,
WP, 6.0
(30°) | NP, RP,
WP, 6.0
(0°) | NP, RP,
WP (0°) | NP, RP, WP,
6.0 (30°) | NP, RP, WP
(0°) | NP, RP, WP
(0°) | NP, RP | X |
| Nobel Branemark
System | External Hex
Universal | NP, RP,
WP | NP, RP, WP | NP, RP,
WP (0°) | NP, RP,
WP (0°) | NP, RP,
WP (0°) | NP, RP, WP,
6.0 (30°) | NP, RP, WP
(0°) | NP, RP, WP
(0°) | NP, RP,
WP | |
| Compatible Implant
Systems | DESS
Abutment
System | Healing
Abutment | Temporary
Abutment | Ti Base
Interface, Engaging and
non-engaging | C-Base,
Engaging and
non-engaging | CrCo Base,
Engaging and
non-engaging | Pre-milled
Blank Ti,
Engaging | Multi Unit
Abutment | Multi Unit ZRN | DESSLoc
Abutment | Screws |
| Osstem TS | Conic OSS | | Mini,
Regular | Mini,
Regular
(0°) | Mini,
Regular
(0°) | Mini,
Regular
(0°) | Mini,
Regular
(0°) | Mini,
Regular
(0°) | Mini,
Regular
(0°) | | |
| Straumann BLX | Conical
BLX | RB/WB,
WB | | RB/WB,
WB (0°) | | | RB/WB, WB
(0°) | RB/WB
(0°, 17°,
30°) | RB/WB
(0°, 17°,
30°) | | X |
| Straumann Bone
Level | Conical BL | NC, RC | NC, RC | NC, RC
(0°) | NC, RC
(0°) | NC, RC
(0°) | NC, RC
(30°) | NC, RC
(0°, 17°,
30°) | NC, RC
(0°, 17°,
30°) | NC, RC | X |
| Straumann Tissue
Level | Octagon | RN, WN | RN, WN | NNC, RN,
WN (0°) | NNC, RN,
WN (0°) | RN, WN
(0°) | NNC, RN,
WN (0°) | | | RN, WN | X |
| Zimmer Eztetic | Internal EZ | | | | | | | | | 2.9 | |
| Zimmer Screw Vent /
Tapered Screw Vent | Internal Hex
USA | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7
(30°) | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5, 5.7
(0°) | 3.5, 4.5, 5.7
(30°) | 3.5
(0°, 17°,
30°)
4.5
(0°, 17°,
30°) | 3.5, 4.5
(0°, 17°,
30°) | 3.5, 4.5,
5.7 | X |
| Zimmer Spline | External
SPL | | | | | | | | | 3.25,
3.75/4.0,
5.0 | |
| Zimmer SwissPlus | Internal
Swiss | | | | | | | | | 2.5, 3.0 | |
Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems
11
Bold indicates new components
12
COMPATIBLITIES
All compatibilities are identical to those of the primary predicate K170588 and additional predicate K173908, K191986, K203464, K212577, K212628, except for the addition of compatibilities with four (4) new systems, eleven (11) platforms, for Dentium SuperLine, Zimmer Eztetic, Zimmer Spline, and Zimmer SwissPlus.
| Compatible Implant
System | Implant
510(k) | Implant 510(k) Name | Manufacturer |
|-------------------------------------------|-------------------|---------------------------------------------------------------------------|--------------------------------------------------------|
| Ankylos C/X | K140347 | Ankylos C/X Implant System | DENTSPLY International, Inc. |
| Astra Tech EV | K111287 | Astra Tech Implant System | Astra Tech AB |
| | K120414 | OsseoSpeed Plus | |
| Astra Tech OsseoSpeed | K101732 | OsseoSpeed™ | Astra Tech AB |
| BioHorizons Internal | K042429 | The Prodigy System Dental Implants | BioHorizons Implants System, Inc. |
| | K071638 | BioHorizons Tapered Internal Implant System | |
| Biomet 3i Certain® | K063341 | 3i OSSEOTITE Certain® Dental Implants | Implant Innovations, Inc. |
| Biomet 3i OSSEOTITE | K063286 | OSSEOTITE® Dental Implants | Implant Innovations, Inc. |
| Camlog | K083496 | Camlog Implant System | Altatech GmbH |
| Dentium SuperLine | K160965 | SuperLine | Dentium Co., Ltd |
| Friadent XiVE | K073075 | Friadent Implant Systems | DENTSPLY International, Inc. |
| MegaGen AnyRidge | K110955 | AnyRidge Internal Implant System | Megagen Co., Ltd. |
| Neodent Grand Morse | K163194 | Neodent Implant System - GM Line | JJGC Industria E Comercio De
Materials Dentarios SA |
| NobelActive,
NobelParallel Conical | K142260 | NobelActive® | Nobel Biocare AB |
| | K102436 | NobelActive 3.0 | |
| | K073142 | NobelReplace Hexagonal Implants | |
| Nobel-Replace Tri-Lobe | K050705 | TiUnite Implants | Nobel Biocare AB |
| | K050406 | NobelSpeedy Implants | |
| Nobel Brånemark | K022562 | Various Brånemark System Implants-
Immediate Function Indication | |
| OSSTEM TS | K161604 | Osstem Implant System | OSSTEM IMPLANT Co., Ltd |
| Straumann BLX | K173961 | Straumann BLX Implant System | Institut Straumann AG |
| Straumann Bone Level | K140878 | Straumann® Bone Level Tapered Implants | Straumann USA, LLC |
| Straumann Tissue Level | K130222 | Straumann® Dental Implant System SLActive and
Roxolid Product Families | Straumann USA, LLC |
| Zimmer Eztetic | K142082 | Zimmer 3.1mm Dental Implant | Zimmer Dental, Inc. |
| Zimmer Screw-Vent /
Tapered Screw-Vent | K011028 | Screw-Vent Dental Implant System | Sulzer Dental, Inc. |
| | K112160 | Tapered Screw-Vent® X Implant | Zimmer Dental, Inc. |
| Zimmer Spline | K012055 | 3.25mm Spline Twist Implant | Sulzer Dental, Inc. |
| | K013494 | 3.75mm and 5.0mm Spline Twist Implant | |
| Zimmer SwissPlus | K082639 | Zimmer Tapered SwissPlus Implants | Zimmer Dental, Inc. |
| 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-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or from Co-Cr-Mo alloy (CrCo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
13
Zirconia superstructures for Ti Base, C-Base, and CrCo Base are made of Y-TZP conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The cement recommended in labeling for bonding of superstructures is Multi Link Hybrid Abutment Cement from Ivoclar Vivadent AG, cleared under K130436. All of these materials are equivalent to those cleared in K170588, K173908, K191986, and K203464.
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 as corresponding devices cleared in K170588, K173908. K191986. K203464. K212577. and K212628.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 14937, and biocompatibility according to ISO 10993-5 and ISO 10993-12, leveraged from K170588, K173908, K191986, K203464, K212577, and K212628; and reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility for new OEM connections. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
All subject device abutments are identical in design, materials and technological characteristics to corresponding abutments of the primary predicate K170588 and additional predicates K173908, K191986. K203464. K212577. K212628. The subject device Multi Unit Abutment ZRN are substantially equivalent to Multi Unit abutments cleared in primary predicate K170588 and additional predicates K 191986, and K212628, except that it has a zirconium nitride (ZrN) coating added to the top portion of the abutment. This coating is used on the DESSLoc Abutments that have been cleared in primary predicate K170588 and additional predicates K191986 and K212628.
The SelectGrip® surface on Ti Base Interface is identical to the SelectGrip surface on equivalent abutments cleared in primary predicate K170588. The ZrN coating on DESSLoc and Multi Unit ZRN Abutment is identical to that on DESS LOC Abutments cleared in primary predicate K170588 and additional predicate K191986 and K212628.
The cement recommended in labeling for bonding of superstructures is Multi-Link cement from Ivoclar Vivadent, cleared under K130436. This is the same cement recommended in labeling for the primary predicate K170588 and the additional predicates K173908, K191986, and K212628.
All screws are identical in design, materials and technological characteristics to those cleared in primary predicate K170588 and additional predicates K173908, K203464, K212577, K212628 except for threads that accommodate the new compatibilities. Diamond-like carbon (DLC) coatings that are available on certain screws are identical to those on screws cleared in primary predicate K170588 and additional predicates K173908, K191986, K203464, K212577, K212628.
CONCLUSION
The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate, and additional predicate 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.
14
| Comparison | Subject Device | Primary Predicate Device | Additional Predicate Devices |
|---|---|---|---|
| DESS Dental Smart Solutions | |||
| Terrats Medical SL | K170588 | ||
| DESS Dental Smart Solutions | |||
| Terrats Medical SL | K173908, K191986, K203464, | ||
| K212577, K212628 | |||
| DESS Dental Smart Solutions | |||
| Terrats Medical SL | |||
| 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 Blanks are to be sent to a Terrats
Medical validated milling center for
manufacture.
For complete Indications for Use
statement on OEM Compatibility
see Section 4. | DESS Dental Smart Solutions
abutments are intended to be used
in conjunction with endosseous
dental implants in the maxillary or
mandibular arch to provide
support for prosthetic restorations.
All digitally designed custom
abutments for use with DESS
Bases or Blanks are to be sent to a
Terrats Medical validated milling
center for manufacture.
For complete Indications for Use
statement on OEM Compatibility
see 510(k) Summary for K170588
in Section 12. | DESS Dental Smart Solutions
abutments are intended to be used
in conjunction with endosseous
dental implants in the maxillary or
mandibular arch to provide
support for prosthetic restorations.
All digitally designed custom
abutments for use with DESS
Bases or Blanks are to be sent to a
Terrats Medical validated milling
center for manufacture.
For complete Indications for Use
statement on OEM Compatibility
see 510(k) Summaries for
K173908, K191986, K203464,
K212577, K212628 in Section 12. |
| Design | | | |
| Designs | Healing, Temporary Abutment, Ti
Base, C-base, CrCo Base, Pre-
milled Blank, Multi Unit Abutment,
Multi Unit ZRN Abutment,
DESSLoc | Healing, Temporary, Straight,
Multi-unit, Locator-type,
CAD/CAM Bases, CAD/CAM
Blanks | Healing, Temporary, Straight,
Uniabutment, Multi-unit,
DESSLoc, CAD/CAM Bases,
CAD/CAM Blanks,Ti Bases,
CrCo Base, Pre-milled (Blank) |
| Prosthesis Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained |
| Restoration | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit |
| Abutment/Implant
Platform
Diameter, mm | 2.52 - 6.5 | 2.52 - 6.5 | 2.3 - 6.0 |
| Prosthetic Platform
Diameter, mm | 4.5-6.5 | 4.5 | 4.0 - 6.5 |
| Abutment Angle | 0°, 17°, 30° | Straight (0°) | 0°, 17°, 30° |
| Abutment/ Implant
Interface | Internal, External | Internal, External | Internal, External |
| Material | | | |
| Abutments | Ti-6Al-4V ELI
Co-Cr-Mo Alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI
Co-Cr-Mo Alloy |
| Screws | Ti-6Al-4V ELI
DLC coating | Ti-6Al-4V ELI
DLC coating | Ti-6Al-4V ELI
DLC coating |