DESS Dental Smart Solutions

K170588 · Terrats Medical SL · NHA · Aug 8, 2017 · Dental

Device Facts

• Record ID: K170588
• Device Name: DESS Dental Smart Solutions
• Applicant: Terrats Medical SL
• Product Code: NHA · Dental
• Decision Date: Aug 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended 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 TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

Device Story

DESS Dental Smart Solutions is a dental implant abutment system comprising seven design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit) compatible with eleven major OEM implant systems. The system facilitates prosthetic restoration support in the maxilla or mandible. Clinicians use these abutments to connect prosthetic restorations to endosseous implants. For custom abutments (TiBase/Pre-milled Blank), digital design files are transmitted to a Terrats Medical validated milling center for manufacturing. The device provides a mechanical interface between the implant and the final restoration (crown, bridge, or overdenture). Benefits include compatibility with a wide range of existing implant platforms, enabling restorative flexibility for dental professionals.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 17665-2), biological evaluation (ISO 10993-1), cytotoxicity testing (ISO 10993-5), SEM surface evaluation, and engineering/dimensional analysis to confirm compatibility with OEM implant systems.

Technological Characteristics

Materials: Ti-6Al-4V alloy. Surface treatments: SelectGrip® and ZrN coating. DLC coating on selected screws. Dimensions: Platform diameters 3.3 mm to 5.7 mm. Interface: Internal and external hex/conical connections. Sterilization: Non-sterile, validated for steam sterilization. Connectivity: Digital workflow for custom abutments via validated milling centers.

Indications for Use

Indicated for use with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations in partially or fully edentulous patients.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• OsseoSpeed™ Plus (K120414)

Reference Devices

• Locator Implant Anchor (K072878)
• Low Profile Abutment (K092341)
• Medentika CAD/CAM Abutments (K150203)
• Neodent Implant System (K150367)
• 3i OSSEOTITE Certain® Dental Implants (K063341)
• OSSEOTITE® Dental Implants (K063286)
• OsseoSpeed™ (K101732)
• FRIADENT Implant Systems (K073075)
• NobelActive® (K142260)
• NobelReplace Hexagonal Implants (K073142)
• TiUnite® Implants (K050705)
• NOBELSPEEDY™ Implants (K050406)
• Various Brånemark System Implants (K022562)
• Straumann® Bone Level Tapered Implants (K140878)
• P.004 Implants (K062129)
• Straumann® Dental Implant System SLActive and Roxolid (K130222)
• Tapered Screw-Vent® X Implant (K112160)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2017

Terrats Medical SL % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K170588

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: June 6, 2017 Received: July 7, 2017

Dear Linda Schulz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -S

for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K170588

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 TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|------------------------------|-----------------------|------------------------|
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP |
| Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |

Compatible Implant Systems

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary Terrats Medical SL

# DESS Dental Smart Solutions

#### K170588 August 8, 2017

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Terrats Medical SL |
|---------------------------|----------------------------------------------|
| | Avenida La Ferrería (Pol Ind La Ferrería) 62 |
| | Montcada i Reixac, 08110 |
| | Spain |
| | Telephone [phone] |
| | Fax [phone] |
| Official Contact | Roger Terrats, COO |
| Representative/Consultant | Linda Schulz, BSDH, RDH |
| | Kevin Thomas, PhD |
| | PaxMed International, LLC |
| | 12264 El Camino Real, Suite 400 |
| | San Diego, CA 92130 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | DESS Dental Smart Solutions |
|----------------------------|------------------------------------|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

## PREDICATE DEVICE INFORMATION

Primary Predicate K120414, OsseoSpeed™ Plus, Astra Tech AB

Reference Predicates K072878, Modification to: Locator Implant Anchor, Zest Anchors, Inc. K092341, Low Profile Abutment, Biomet 3i K 150203, Medentika CAD/CAM Abutments, Medentika GmbH K150367, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA

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| K063341 | 3i OSSEOTITE Certain® Dental Implants | Implant Innovations, Inc. |
|---------|---------------------------------------------------------------------------|------------------------------|
| K063286 | OSSEOTITE® Dental Implants | Implant Innovations, Inc. |
| K101732 | OsseoSpeed™ | Astra Tech AB |
| K073075 | FRIADENT Implant Systems | DENTSPLY International, Inc. |
| K142260 | NobelActive® | Nobel Biocare AB |
| K073142 | NobelReplace Hexagonal Implants | Nobel Biocare AB |
| K050705 | TiUnite® Implants | Nobel Biocare AB |
| K050406 | NOBELSPEEDY™ Implants | Nobel Biocare USA LLC |
| K022562 | Various Brånemark System Implants -<br>Immediate Function Indication | Nobel Biocare AB |
| K140878 | Straumann® Bone Level Tapered Implants | Straumann USA, LLC |
| K062129 | P.004 Implants | Institut Straumann AG |
| K130222 | Straumann® Dental Implant System SLActive and<br>Roxolid Product Families | Straumann USA, LLC |
| K112160 | Tapered Screw-Vent® X Implant | Zimmer Dental, Incorporated |

Compatible Implant System Predicates

#### 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 TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|------------------------------|-----------------------|------------------------|
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP |
| Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |

Compatible Implant Systems

#### DEVICE DESCRIPTION

DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. The following table outlines the body and platform diameters by abutment design and corresponding implant line.

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| Summary of Abutment Designs | DESS Abutment System | OEM Implant System | 3i Certain®<br>3.4 (NP), 4.1 (RP), 5.0 (WP) | 3i OSSEOTITE®<br>3.4 (NP), 4.1 (RP), 5.0 (WP) | OsseoSpeedTM<br>3.5/4.0 (RP), 4.5/5.0 (WP) | FRIADENT XIVE®<br>3.4 (NP), 3.8 (RP), 4.5 (WP) | NobelActive®<br>NP (3.5), RP (3.9) | NobelReplace® Conical<br>NP (3.5), RP (3.9) | NobelReplace® Trilobe<br>NP (3.5), RP (4.3), WP (5.0) | Brånemark System®<br>NP (3.5), RP (4.1), WP (5.1) | Straumann® Bone Level<br>NC (3.3), RC (4.1) | Straumann® Tissue Level<br>RN (4.8), WN (6.5) | Tapered Screw-Vent<br>3.4 (NP), 4.5 (RP), 5.7 (WP) |
|-----------------------------|------------------------------|--------------------|---------------------------------------------|-----------------------------------------------|--------------------------------------------|------------------------------------------------|------------------------------------|---------------------------------------------|-------------------------------------------------------|---------------------------------------------------|---------------------------------------------|-----------------------------------------------|----------------------------------------------------|
| | Multi-Unit | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | DESS LOC | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Pre-milled Blank<br>Engaging | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | Ti Base<br>Engaging | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Ti Base<br>Non-Engaging | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | Straight | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Temporary<br>Engaging | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | Temporary<br>Non-Engaging | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Healing | | NP 3.4<br>RP 4.1<br>WP 5.0 | NP 3.4<br>RP 4.1<br>WP 5.0 | RP 3.5/4.0<br>WP 4.5/5.0 | NP 3.4<br>RP 3.8<br>WP 4.5 | NP 3.5<br>RP 3.9 | NP 3.5<br>RP 3.9 | NP 3.5<br>RP 4.3<br>WP 5.0 | NP 3.5<br>RP 4.1<br>WP 5.1 | NC 3.3<br>RC 4.1 | RN 4.8<br>WN 6.5 | NP 3.4<br>RP 4.5<br>WP 5.7 |
| | Internal Hex “Click” | | | | | | | | | | | | |
| | External Hex USA | | | | | | | | | | | | |
| | Internal Hex Conic | | | | | | | | | | | | |
| | Internal Hex FD | | | | | | | | | | | | |
| | Active Hex | | | | | | | | | | | | |
| | Tri-Lobe | | | | | | | | | | | | |
| | External Hex Universal | | | | | | | | | | | | |
| | Conical BL | | | | | | | | | | | | |
| | Octagon | | | | | | | | | | | | |
| | Internal Hex USA | | | | | | | | | | | | |

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Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile.

## PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation to an SAL of 10° according to ISO 17665-2 to ensure sterilization of the final finished device; biological evaluation according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 for all surfaces to demonstrate that all devices are non-cytotoxic; SEM evaluation and measurement of the ZrN and SelectGrip surfaces to demonstrate suitability of the surface; and engineering and dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment fixation screws to confirm compatibility.

No clinical data were included in this submission.

## EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.

| Subject Device | Indications for Use Statement | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------|
| DESS<br>Dental Smart<br>Solutions<br>Terrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the<br>maxillary or mandibular arch to provide support for prosthetic restorations.<br>All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical<br>validated milling center for manufacture. | | |
| | Compatible Implant Systems | | |
| | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
| | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| | FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| | NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP |
| | Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| | Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| | Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Primary Predicate<br>Device | Indications for Use Statement | | |
| K120414<br>OsseoSpeed™ Plus<br>Astra Tech AB | Implants:<br>The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:<br>• replacing single and multiple missing teeth in the mandible and maxilla,<br>• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,<br>• especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective,<br>• immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.<br>The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.<br>Abutments:<br>Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.<br>Atlantis Abutments:<br>The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.<br>The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. | | |
| Reference<br>Predicate Devices | | | |
| K072878<br>Modification to:<br>Locator Implant<br>Anchor<br>Zest Anchors, Inc. | Not available | | |
| K092341<br>Low Profile<br>Abutment<br>Biomet 3i, Inc. | Biomet 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment. | | |
| K150203<br>Medentika<br>CAD/CAM<br>Abutments<br>Medentika GmbH | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | |
| Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
| Nobel Biocare Replace™ Select | E…