(161 days)
No
The summary describes a system of dental implant abutments and their physical characteristics and compatibility, with no mention of AI or ML in the design, manufacturing process, or intended use.
No
The device is a dental implant abutment system that provides support for prosthetic restorations, which is a structural component rather than a device intended to treat or cure a disease or condition.
No
The device is a dental implant abutment system, which is used to provide support for prosthetic restorations. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a dental implant abutment system with various physical components (abutment design types, connections, surfaces, screws) and mentions manufacturing processes (milling). This indicates it is a physical medical device, not software-only.
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 for providing support for prosthetic restorations in the mouth, in conjunction with dental implants. This is a mechanical function within the body.
- Device Description: The description details the physical components, materials, and compatibility with dental implants. It describes a physical device used for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a component of a dental restoration.
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 TiBase 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 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.
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.
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, 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.
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.
K072878, K092341, K150203, K150367
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
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.
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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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 +34 93 564 60 06 | |
| Fax +34 93 564 73 17 | |
| 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: +1-858-792-1235 | |
| Fax: +1-858-792-1236 | |
| Email: LSchulz@paxmed.com | |
| KThomas@paxmed.com |
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
4
| 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 - | |
| 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 | |
| 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.
5
| Summary of Abutment Designs | DESS Abutment System | OEM Implant System | 3i Certain®
3.4 (NP), 4.1 (RP), 5.0 (WP) | 3i OSSEOTITE®
3.4 (NP), 4.1 (RP), 5.0 (WP) | OsseoSpeedTM
3.5/4.0 (RP), 4.5/5.0 (WP) | FRIADENT XIVE®
3.4 (NP), 3.8 (RP), 4.5 (WP) | NobelActive®
NP (3.5), RP (3.9) | NobelReplace® Conical
NP (3.5), RP (3.9) | NobelReplace® Trilobe
NP (3.5), RP (4.3), WP (5.0) | Brånemark System®
NP (3.5), RP (4.1), WP (5.1) | Straumann® Bone Level
NC (3.3), RC (4.1) | Straumann® Tissue Level
RN (4.8), WN (6.5) | Tapered Screw-Vent
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
Engaging | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | Ti Base
Engaging | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Ti Base
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
Engaging | | NP | NP | RP | NP | NP | NP | NP | NP | NC | RN | NP |
| | Temporary
Non-Engaging | | RP | RP | WP | RP | RP | RP | RP | RP | RC | WN | RP |
| | Healing | | NP 3.4
RP 4.1
WP 5.0 | NP 3.4
RP 4.1
WP 5.0 | RP 3.5/4.0
WP 4.5/5.0 | NP 3.4
RP 3.8
WP 4.5 | NP 3.5
RP 3.9 | NP 3.5
RP 3.9 | NP 3.5
RP 4.3
WP 5.0 | NP 3.5
RP 4.1
WP 5.1 | NC 3.3
RC 4.1 | RN 4.8
WN 6.5 | NP 3.4
RP 4.5
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 | | | | | | | | | | | | |
6
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 | |||
| Dental Smart | |||
| Solutions | |||
| Terrats Medical SL | 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. | |||
| 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 | |||
| Device | Indications for Use Statement | ||
| K120414 | |||
| OsseoSpeed™ Plus | |||
| Astra Tech AB | Implants: | ||
| 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. | |||
| Reference | |||
| Predicate Devices | |||
| K072878 | |||
| Modification to: | |||
| Locator Implant | |||
| Anchor | |||
| Zest Anchors, Inc. | Not available | ||
| 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. | ||
| K150203 | |||
| Medentika | |||
| CAD/CAM | |||
| Abutments | |||
| 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 | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9(4.3), 3.9(5.0) |
| Biomet 3i Osseotite® Certain® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Nobel Biocare Brånemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5(NNC), 4.8, 6.5 |
| Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Astra Tech OsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
| Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. | |||
| K150367 | |||
| Neodent Implant | |||
| System | |||
| JJGC Indústria e | |||
| Comércio de | |||
| Materiais Dentários | |||
| SA | Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. | ||
| PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. |
Comparison of Indications for Use Statements
7
8
| | Subject Device | Primary
Predicate | Reference Predicates | | | | |
|------------------------------------|-----------------------------------|--------------------------------------|-----------------------------------------------|---------------------------|-----------------------------------|-----------------------------------------------------------|--|
| | | K120414 | K072878 | K092341 | K150203 | K150367 | |
| | DESS
Dental Smart
Solutions | OsseoSpeed™ Plus | Modification to:
Locator Implant
Anchor | Low Profile
Abutment | Medentika
CAD/CAM
Abutments | Neodent Implant
System | |
| | Terrats Medical
SL | Astra Tech AB | Zest Anchors, Inc. | Biomet 3i, Inc. | Medentika
GmbH | JJGC Indústria e
Comércio de Materiais
Dentários SA | |
| Design | | | | | | | |
| Prosthesis Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Overdenture
attachment | Screw-retained | Cement-
retained | Cement-retained
Screw-retained | |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | Overdenture | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | |
| Abutment Platform
Diameter (mm) | 3.4 - 5.7 | 3.0 - 5.4 | 2.5 - 6.5 | 3.4 - 5.0 | 3.0 - 7.0 | 3.0 - 6.0 | |
| Abutment Angle | Straight | Straight to 30° | Straight | Straight to 30° | Straight to 30° | Straight to 30° | |
| Abutment/Implant
Interface | Internal,
External | Internal | Internal, External | Internal,
External | Internal,
External | Internal | |
| Material | | | | | | | |
| Abutment | Ti-6Al-4V | Ti-6Al-4V
Zirconia, Gold,
PEEK | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | |
| Screw | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | |
Comparison of Technological Characteristics
DESS Dental Smart Solutions abutments are substantially equivalent in design, function, material, size, and Indications for Use to OsseoSpeed Plus (K120414) and Medentika CAD/CAM Abutments (K150203). All are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. Digital files for DESS Dental Smart Solutions abutments and for Medentika CAD/CAM Abutments are to be sent to a validated milling center for manufacture. Differences in the type of restoration named or specific milling center stated in the Indications for Use statement do not affect the intended use.
Subject device abutment designs and function are substantially equivalent to design and function of abutments included in K120414, K072878, K092341, K150203 and K150367. Implant/abutment interface compatbility for the subject device is substantially equivalent 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 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.