K Number
K173908
Device Name
DESS Dental Smart Solutions
Manufacturer
Date Cleared
2018-06-15

(175 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
Device Description
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.
More Information

No
The summary does not mention AI, ML, or related concepts, and the device description focuses on physical components and manufacturing processes.

No
The device, DESS Dental Smart Solutions abutments, is intended to provide support for prosthetic restorations in conjunction with dental implants. It is a structural component of a dental prosthetic system, not a device directly used for therapy or treatment.

No

Explanation: The device is an abutment system for dental implants used to support prosthetic restorations, not to diagnose a condition or disease.

No

The device description clearly states that the devices are physical abutments and screws, which are hardware components.

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 device is 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 to provide information for diagnosis, monitoring, or treatment.
  • Device Description: The description details physical components like abutments and screws, and their compatibility with dental implants. This aligns with a medical device used for implantation and support, not an IVD.
  • Lack of IVD Indicators: 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 samples
    • Providing diagnostic information
    • Using reagents or assays

The device described is a dental prosthetic component, which falls under the category of a medical device, but not an IVD.

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

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.

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 testing data submitted to demonstrate substantial equivalence included: sterilization to an SAL of 106 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device; biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic, and compatibility analysis by reference to K170588.

No clinical data were included in this submission.

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.

K170588

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.

K092341, K150669, K120414, K160784, K063341, K063286, K101732, K073075, K142260, K073142, K050705, K050406, K022562, K140878, K062129, K130222, 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

June 15, 2018

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

Re: K173908

Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 16, 2018 Received: May 17, 2018

Dear Linda Schulz:

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

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

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K173908

Device Name

DESS Dental Smart Solutions

Indications for Use (Describe)

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

Compatible Implant Systems
Implant System
CompatibilityImplant BodyImplant Platform
3i Certain®3.25, 4.0, 5.03.4, 4.1, 5.0
3i OSSEOTITE®3.25, 3.75, 4.0, 5.03.4, 4.1, 5.0
OsseoSpeed™3.5, 4.0, 5.03.5/4.0, 4.5/5.0
FRIADENT XiVE3.4, 3.8, 4.53.4, 3.8, 4.5
NobelActive®3.5, 4.3, 5.0NP, RP
NobelReplace® Conical3.5, 4.3, 5.0NP, RP
NobelReplace® Trilobe3.5, 4.3, 5.0NP, RP, WP
Brånemark3.5, 3.75/4.0, 5.0NP, RP, WP
Straumann® Bone Level3.3, 4.1, 4.8NC, RC
Straumann® Tissue Level3.3, 4.1, 4.8RN, WN
Tapered Screw-Vent®3.7, 4.1, 4.7, 6.03.5, 4.5, 5.7

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

510(k) Summary Terrats Medical SL DESS Dental Smart Solutions

June 15, 2018

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Terrats Medical SL
Carrer Mogoda 75-99
Barberà del Vallès 08210
Barcelona, Spain | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|
| Telephone | +34 93 564 60 06 | |
| Fax | +34 93 564 73 17 | |
| Official Contact | Roger Terrats, COO | |
| Representative/Consultant | Linda Schulz, BSDH, RDH
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 | |
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | LSchulz@paxmed.com
FLarson@paxmed.com | |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary NameDESS Dental Smart Solutions
Common NameDental implant abutment
Classification NameEndosseous dental implant abutment
Classification Regulations21 CFR 872.3630, Class II
Product CodeNHA
Classification PanelDental Products Panel
Reviewing BranchDental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL

Reference Device
K092341Low Profile AbutmentBiomet 3i, Inc.
K150669Neoss TiBase and CoCr AbutmentsNeoss Ltd.
K120414OsseoSpeed™ PlusAstra Tech AB
K160784CAM Titanium BlanksAltatec GmbH

4

K0633413i OSSEOTITE Certain® Dental ImplantsImplant Innovations, Inc.
K063286OSSEOTITE® Dental ImplantsImplant Innovations, Inc.
K101732OsseoSpeed™Astra Tech AB
K073075FRIADENT Implant SystemsDENTSPLY International, Inc.
K142260NobelActive®Nobel Biocare AB
K073142NobelReplace Hexagonal ImplantsNobel Biocare AB
K050705TiUnite® ImplantsNobel Biocare AB
K050406NOBELSPEEDY™ ImplantsNobel Biocare USA LLC
K022562Various Brånemark System Implants -
Immediate Function IndicationNobel Biocare AB
K140878Straumann® Bone Level Tapered ImplantsStraumann USA, LLC
K062129P.004 ImplantsInstitut Straumann AG
K130222Straumann® Dental Implant System SLActive and
Roxolid Product FamiliesStraumann USA, LLC
K112160Tapered Screw-Vent® X ImplantZimmer Dental, Incorporated

Compatible Implant Systems

INDICATIONS FOR USE

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

Compatible Implant Systems
Implant System CompatibilityImplant BodyImplant Platform
3i Certain®3.25, 4.0, 5.03.4, 4.1, 5.0
3i OSSEOTITE®3.25, 3.75, 4.0, 5.03.4, 4.1, 5.0
OsseoSpeed™3.5, 4.0, 5.03.5/4.0, 4.5/5.0
FRIADENT XiVE3.4, 3.8, 4.53.4, 3.8, 4.5
NobelActive®3.5, 4.3, 5.0NP, RP
NobelReplace Conical3.5, 4.3, 5.0NP, RP
Nobel Replace Trilobe3.5, 4.3, 5.0NP, RP, WP
Brånemark3.5, 3.75/4.0, 5.0NP, RP, WP
Straumann® Bone Level3.3, 4.1, 4.8NC, RC
Straumann® Tissue Level3.3, 4.1, 4.8RN, WN
Tapered Screw-Vent®3.7, 4.1, 4.7, 6.03.5, 4.5, 5.7

Compatible Implant Systems

DEVICE DESCRIPTION

DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile. The following table outlines the body and platform diameters by abutment design and corresponding compatible implant line.

5

Summary of Abutment Designs

| | CAD / CAM | | | | Cast-To | | | OEM
Implant System | Connection |
|----------------------------|------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------|------------------------------------------------|----------------------------|------------------------------------|------------|
| DESS
Abutment
System | AURUM base™
Non-Engaging
Titanium Alloy
ASTM F136 | AURUM base™
Engaging
Titanium Alloy
ASTM F136 | CoCr Pre-milled
Blank Engaging
CoCr ASTM 1537 | Ti Pre-milled
Blank Engaging
Titanium Alloy
ASTM E136 | CoCr Abutment
Non-Engaging
CoCr
ASTM 1537 | CoCr Abutment
Engaging
CoCr
ASTM 1537 | | | |
| Internal Hex
"Click" | NP
RP
WP | NP
RP
WP | NP
RP
WP | | NP
RP
WP | NP
RP
WP | 3i Certain® | 3.4 (NP)
4.1 (RP)
5.0 (WP) | Internal |
| External Hex
USA | NP
RP
WP | NP
RP
WP | NP
RP
WP | | NP
RP
WP | NP
RP
WP | 3i
OSSEOTITE® | 3.4 (NP)
4.1 (RP)
5.0 (WP) | External |
| Internal Hex
Conic | RP
WP | RP
WP | RP
WP | | RP
WP | RP
WP | OsseoSpeed™ | 3.5/4.0
(RP)
4.5/5.0
(WP) | Internal |
| Internal Hex
FD | NP
RP
WP | NP
RP
WP | NP
RP
WP | NP
RP
WP | NP
RP
WP | NP
RP
WP | FRIADENT
XiVE® | 3.4 (NP)
3.8 (RP)
4.5 (WP) | Internal |
| Active Hex | NP
RP | NP
RP | NP
RP | | NP
RP | NP
RP | NobelActive® | 3.5 (NP)
3.9 (RP) | Internal |
| | | | | | | | NobelReplace®
Conical | 3.5 (NP)
3.9 (RP) | Internal |
| Tri-Lobe | NP
RP
WP | NP
RP
WP | NP
RP
WP | | NP
RP
WP | NP
RP
WP | NobelReplace®
Trilobe | 3.5 (NP)
4.3 (RP)
5.0 (WP) | Internal |
| External Hex
Universal | NP
RP | NP
RP | NP
RP
WP | NP | NP
RP
WP | NP
RP
WP | Brånemark
System® | 3.5 (NP)
4.1 (RP)
5.1 (WP) | External |
| Conical BL | NC
RC | NC
RC | NC
RC | | NC
RC | NC
RC | Straumann®
Bone Level | 3.3 (NC)
4.1 (RC) | Internal |
| Octagon | RN
WN | RN
WN | RN
WN | | RN
WN | RN
WN | Straumann®
Tissue Level | 4.8 (RN)
6.5 (WN) | Internal |
| Internal Hex
USA | NP
RP
WP | NP
RP
WP | NP
RP
WP | | NP
RP
WP | NP
RP
WP | Tapered Screw-
Vent | 3.5 (NP)
4.5 (RP)
5.7 (WP) | Internal |

Aurum Abutment is a titanium abutment that can be used for a direct multi-unit restoration or to support a zirconia superstructure plus a single-unit or multi-unit restoration. Design parameters for the zirconia superstructure are a minimum wall thickness of 0.4 mm, a minimum post height for single-unit restorations of 4.0 mm, and a maximum gingival height of 6.0 mm. All zirconia superstructures are for straight abutments only.

Pre-milled Blank abutments are cylindrical abutments designed for custom abutment fabrication by a CAD/CAM process. All patient-specific abutment fabrication is by prescription on the order of the clinician. Pre-milled Blanks are made of cobalt-chromium alloy or titanium alloy. Design parameters for the Pre-Milled Blanks are, a minimum wall thickness of 0.45 mm, a minimum post height for single-unit restorations of 4.0 mm, a maximum gingival height of 6.0 mm, and a maximum total abutment height of 19 mm. All Pre-Milled Blanks are for straight abutments only.

6

CoCr Abutments are designed as a cast-to abutment for support of a single-unit or a multi-unit restoration. They are made of cobalt-chromium alloy. Design parameters for CoCr Abutments are, a minimum wall thickness of 0.4 mm, a minimum post height for single-unit restorations of 4.0 mm, and a maximum gingival height of 6.0 mm. All CoCr Abutments are for straight abutments only.

PERFORMANCE DATA

Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization to an SAL of 106 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device; biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic, and compatibility analysis by reference to K170588.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

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

Indications for Use Statement
Subject
Device
DESS Dental
Smart
Solutions
Terrats
Medical SLDESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the
maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Aurum Base or Pre-Milled Blank are to be sent to a Terrats Medical
validated milling center for manufacture.
Compatible Implant Systems
Implant System CompatibilityImplant Body Implant Platform 3i Certain® 3.25, 4.0, 5.0 3.4, 4.1, 5.0 3i OSSEOTITE® 3.25, 3.75, 4.0, 5.0 3.4, 4.1, 5.0 OsseoSpeed™ 3.5, 4.0, 5.0 3.5/4.0, 4.5/5.0 FRIADENT XIVE 3.4, 3.8, 4.5 3.4, 3.8, 4.5 NobelActive® 3.5, 4.3, 5.0 NP, RP NobelReplace Conical 3.5, 4.3, 5.0 NP, RP Nobel Replace Trilobe 3.5, 4.3, 5.0 NP, RP, WP Brånemark 3.5, 3.75/4.0, 5.0 NP, RP, WP Straumann® Bone Level 3.3, 4.1, 4.8 NC, RC Straumann® Tissue Level 3.3, 4.1, 4.8 RN, WN Tapered Screw-Vent® 3.7, 4.1, 4.7, 6.0 3.5, 4.5, 5.7
Primary
Predicate
Devices
K170588
DESS Dental
Smart
Solutions
Terrats
Medical SLDESS 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.
Compatible Implant Systems
Implant System CompatibilityImplant Diameter (mm) Platform Diameter (mm) 3i Certain® 3.25, 4.0, 5.0 3.4, 4.1, 5.0 3i OSSEOTITE® 3.25, 3.75, 4.0, 5.0 3.4, 4.1, 5.0 OsseoSpeed™ 3.5, 4.0, 5.0 3.5/4.0, 4.5/5.0 FRIADENT XIVE 3.4, 3.8, 4.5 3.4, 3.8, 4.5 NobelActive® 3.5, 4.3, 5.0 NP, RP NobelReplace Conical 3.5, 4.3, 5.0 NP, RP Nobel Replace Trilobe 3.5, 4.3, 5.0 NP, RP, WP Brånemark 3.5, 3.75/4.0, 5.0 NP, RP, WP Straumann® Bone Level 3.3, 4.1, 4.8 NC, RC Straumann® Tissue Level 3.3, 4.1, 4.8 RN, WN Tapered Screw-Vent® 3.7, 4.1, 4.7, 6.0 3.5, 4.5, 5.7

Comparison of Indications for Use Statements

7

| Reference

Devices
K092341
Low Profile
Abutment
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.
K150669
Neoss TiBase
and CoCr
Abutments
Neoss Ltd.Neoss TiBase:
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns
for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
K120414
OsseoSpeed™
Plus
Astra Tech
ABImplants:
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:
replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully
edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Atlantis Abutments:
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially 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.
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.
K160784
CAM
Titanium
Blanks Altatec
GmbHCAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW LINE and
CAMLOG® ROOT-LINE implants in the maxilla and mandible. Digitally designed abutments fabricated with CAD/CAM
techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants
in the maxilla and mandible. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAM Titanium
Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the
maxilla and mandible. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAM Titanium Blanks
are intended to be sent to a CAMLOG validated milling center for manufacture.

8

| Comparison | Subject
Device | Primary
Predicate
Device | Reference Devices | | | |
|------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|---------------------------------------------|
| | K170588 | K092341 | K150669 | K120414 | K160784 | |
| | DESS
Dental
Smart
Solutions
Terrats
Medical SL | DESS
Dental
Smart
Solutions
Terrats
Medical SL | Low
Profile
Abutment
Biomet 3i,
Inc. | Neoss
TiBase and
CoCr
Abutment
Neoss Ltd. | OsseoSpeed
Plus
Astra Tech
AB | CAM
Titanium
Blank
Altatec
GmbH |
| Design | | | | | | |
| Abutment Design | CAD/CAM
Blank
CAD/CAM
TiBase
Castable
Abutment
Aurum
Abutment | CAD/CAM
Blank
CAD/CAM
TiBase
Abutment | Titanium
Abutment | CAD/CAM
TiBase
Castable
Abutment | Castable
Abutment | CAD/CAM
Blank |
| Prosthesis
Attachment | Cement-
retained
Screw-
retained | Cement-
retained
Screw-
retained | Screw-
retained | Cement-
retained
Screw-
retained | Cement-
retained
Screw-
retained | Cement-
retained |
| Restoration | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-
unit, Multi-
unit |
| Abutment/Implant
Platform
Diameter* (mm) | 3.4 - 6.5 | 3.4 - 6.5 | 3.4 - 5.0 | 4.1 | 3.0 - 5.4 | 3.3 - 6.0 |
| Abutment Angle | 0° | 0° | 0°- 30° | 0°- 20° | 0°- 30° | 0°- 30° |
| Abutment/
Implant Interface | Internal
and
External | Internal
and
External | Internal
and
External | Internal | Internal | Internal |
| Material | | | | | | |
| Abutment | Titanium
Alloy
CoCr,
Zirconia | Titanium
Alloy
Zirconia | Titanium
Alloy | Titanium
Alloy,
CoCr,
Zirconia | Titanium
Alloy
Zirconia,
Gold,
PEEK | Titanium
Alloy |
| Screw | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy |

Comparison of Technological Characteristics

*See Summary of Abutment Designs (p.3) for individual OEM platform diameters

9

DESS Dental Smart Solutions subject device abutments are substantially equivalent in intended use, design, function, material, size, and Indications for Use to DESS Dental Smart Solutions abutments (K170588). The only change in the Indications for Use statement is the name of the abutment. The Aurum Abutment is substantially equivalent to the TiBase abutment in K170588. Design parameters for minimum wall thickness, maximum gingival height and no angulation correction remain the same as the primary predicate K170588. The minimum post height for single-unit restorations is now 4.0 mm. Titanium and CoCr Pre-milled Blanks are substantially equivalent to the titanium Pre-milled Blanks in K170588. Design parameters for minimum wall thickness, minimum post height for single-unit restorations, maximum gingival height and no angulation correction remain the same as the primary predicate K170588. The CoCr Abutment is substantially equivalent in design and function to OsseoSpeed Plus abutments (K120414) and in material and function to Neoss CoCr abutments (K150669). Design parameters for minimum wall thickness, minimum post height for single-unit restorations, maximum gingival height and no angulation correction remain the same as the primary predicate K170588 and reference device K160784 and are substantially equivalent in intended use, design, function, material, size and final design parameters. The Aurum Abutment has a substantially equivalent titanium post height to the titanium post height of the Low Profile Abutment in K092341. Both are used for single-unit and multi-unit restorations. When used for a single-unit restoration the Aurum Abutment and the Low Profile Abutment are to be used with an additional castable component to create a minimum post height of 4 mm). All are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. Digital files for subject device DESS Dental Smart Solutions abutments and DESS Dental Smart Solutions abutments cleared in K170588 are to be sent to a validated milling center for manufacture. Implant/abutment interface compatibility for the subject device is substantially equivalent to DESS Dental Smart Solutions abutments (K170588) and to the compatible implant system predicates listed above.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.