(116 days)
No
The summary describes a labeling change for pre-milled blanks used in a CAD/CAM process for dental abutments. It focuses on material specifications, design parameters (like angulation and dimensions), and mechanical testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device, DESS Dental Smart Solutions abutments, are prosthetic components that support dental restorations, not devices used to treat or prevent a disease.
No
Explanation: The device is an abutment system intended to provide support for prosthetic restorations in dental implants. Its function is descriptive rather than diagnostic.
No
The device described is a physical dental abutment system, including pre-milled blanks made of titanium or cobalt chromium alloy, intended for use with dental implants. While a CAD/CAM process is mentioned for custom abutment fabrication, the core device being regulated is the physical hardware (the pre-milled blanks and the resulting abutments).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide support for prosthetic restorations" in the mouth. This is a structural and mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical component (abutment) made of materials like titanium or cobalt chromium, designed to be implanted and support a dental prosthesis. This aligns with a medical device, not an IVD.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies mentioned are related to mechanical testing (static and dynamic fatigue) and biocompatibility, which are typical for implantable medical devices, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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 Pre-milled Blanks 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
The purpose of this submission is to implement a labeling change for certain Pre-milled Blanks of the DESS Dental Smart Solutions abutment system, cleared under K170588, K173908 and K191986, to permit the manufacture of custom abutments with angulation up to 30° and to add three (3) Pre-milled Blanks that also will include such labeling. Design parameters cleared in K170588. K173908 and K191986 were limited to straight abutments only. This change in labeling is for Pre-milled Blanks compatible with three (3) systems: NobelParallel Conical Connection, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent implants. Note that, because NobelActive and Nobel Parallel Conical Connection share the same implant/abutment interface, they are considered one system for purposes of this submission, as they were in K170588, K173908 and K191986. No new compatibilities are added in this submission.
Pre-milled Blanks are designed for fabrication of a custom abutment by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Nobelcompatible Pre-milled Blanks are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELL (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from cobalt chromium alloy (Co-Cr-Mo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539. Straumann-compatible and Zimmercompatible Pre-milled Blanks are made of titanium alloy (Ti-6Al-4V). They are available in engaging designs and are compatible with the implant systems shown the table below Compatible Implant Systems and Platforms. Except for the maximum angulation of the final abutment and the addition of three (3) Pre-milled Blanks of 14 mm diameter to the previously cleared Pre-milled Blanks of 10 mm and 14 mm diameter, subject device Pre-milled Blanks are identical to Pre-milled Blanks cleared (with slight variations on the name) in K170588, K173908 and K191986. Compatibility with the implant platform was demonstrated in K170588 and K191986.
The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:
Minimum wall thickness - 0.45 mm Maximum gingival height - 6.0 mm
Minimum post height – 4.0 mm Minimum gingival height - 0.3 mm
Maximum angulation of the final abutment - 30°
Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.
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: static and dynamic testing according to ISO 14801. Information was leveraged from prior clearance (K170588 and K173908) to demonstrate substantial equivalence with regards to sterilization and biocompatibility. No clinical data were included in this submission.
Substantial equivalence of the subject device with design parameters that permit angulation of the final abutment is supported by dynamic testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
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.
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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Terrats Medical SL % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K212577
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: November 8, 2021 Received: November 9, 2021
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.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212577
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 Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant Systems | ||
|---|---|---|
| Compatible Implant System | Implant Body Diameter, | |
| mm | Implant Platform | |
| NobelActive®, NobelParallel | ||
| Conical | 3.5 | NP |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1/4.8 | RC | |
| Zimmer Screw Vent®/ Tapered | ||
| Screw-Vent® | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 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 K212577
December 10, 2021
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 K191986, DESS Dental Smart Solutions, Terrats Medical SL
Additional Predicate Devices K170588, DESS Dental Smart Solutions, Terrats Medical SL K173908, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K193425, Pre-Milled Blank, ARUM Dentistry Co. Ltd K183518, Preat Abutments, Preat Corporation
4
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 Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System | Implant Body
Diameter, mm | Implant Platform |
|--------------------------------------------|------------------------------|------------------|
| NobelActive®, NobelParallel
Conical | 3.5 | NP |
| | 4.3, 5.0 | RP |
| | 5.5 | WP |
| Straumann® Bone Level | 3.3 | NC |
| | 4.1/4.8 | RC |
| Zimmer Screw-Vent®/ Tapered
Screw-Vent® | 3.7, 4.1 | 3.5 |
| | 4.7 | 4.5 |
| | 6.0 | 5.7 |
Compatible Implant Systems
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to implement a labeling change for certain Pre-milled Blanks of the DESS Dental Smart Solutions abutment system, cleared under K170588, K173908 and K191986, to permit the manufacture of custom abutments with angulation up to 30° and to add three (3) Pre-milled Blanks that also will include such labeling. Design parameters cleared in K170588. K173908 and K191986 were limited to straight abutments only. This change in labeling is for Pre-milled Blanks compatible with three (3) systems: NobelParallel Conical Connection, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent implants. Note that, because NobelActive and Nobel Parallel Conical Connection share the same implant/abutment interface, they are considered one system for purposes of this submission, as they were in K170588, K173908 and K191986. No new compatibilities are added in this submission.
Pre-milled Blanks are designed for fabrication of a custom abutment by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Nobelcompatible Pre-milled Blanks are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELL (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from cobalt chromium alloy (Co-Cr-Mo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539. Straumann-compatible and Zimmercompatible Pre-milled Blanks are made of titanium alloy (Ti-6Al-4V). They are available in engaging designs and are compatible with the implant systems shown the table below Compatible Implant Systems and Platforms. Except for the maximum angulation of the final abutment and the addition of three (3) Pre-milled Blanks of 14 mm diameter to the previously cleared Pre-milled Blanks of 10 mm and 14 mm diameter, subject device Pre-milled Blanks are identical to Pre-milled Blanks cleared (with slight variations on the name) in K170588, K173908 and K191986. Compatibility with the implant platform was demonstrated in K170588 and K191986.
The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:
Minimum wall thickness - 0.45 mm Minimum post height – 4.0 mm
5
Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°
Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.
| Compatible Implant
System | DESS Abutment
System | Implant Body
Diameter, mm | Implant Platform | Connection |
|--------------------------------------------|-------------------------|------------------------------|------------------|------------|
| NobelActive®,
NobelParallel Conical | Active Hex | 3.5 | NP | Internal |
| | | 4.3, 5.0 | RP | Internal |
| | | 5.5 | WP | Internal |
| Straumann® Bone
Level | Conical BL | 3.3 | NC | Internal |
| | | 4.1/4.8 | RC | Internal |
| Zimmer Screw-Vent®/
Tapered Screw-Vent® | Internal Hex USA | 3.7, 4.1 | 3.5 | Internal |
| | | 4.7 | 4.5 | Internal |
| | | 6.0 | 5.7 | Internal |
Compatible Implant Systems and Platforms
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: static and dynamic testing according to ISO 14801. Information was leveraged from prior clearance (K170588 and K173908) to demonstrate substantial equivalence with regards to sterilization and biocompatibility. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the additional predicate devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, the additional predicate devices, and the reference devices.
Subject device abutments are substantially equivalent in intended use to the primary predicate device cleared in K191986, the additional predicate devices K173908 and the reference device K 193425. All are intended for use with endosseous dental implants to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K191986 and additional predicate devices K170588 and K173908.
All subject device abutments are identical in design, materials, and technological characteristics to those of the primary predicate K191986 and additional predicate devices K170588 and K173908. The only change to the subject device is a labeling change to permit custom abutments to be manufactured from the Pre-milled Blanks with an angulation up to 30°, which is substantially equivalent to that of the reference device K193425, and the addition of three new Pre-milled Blanks of 14 mm diameter to the Pre-milled Blanks of 10 mm and 14 mm diameter previously cleared for the predicate devices. No new compatibilities are included in this submission.
Substantial equivalence of the subject device with design parameters that permit angulation of the final abutment is supported by dynamic testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and by the reference device K183518.
The subject device is to be sterilized by the end-user, the same as primary predicate device K191986 and additional predicate devices K170588 and K173908.
6
CONCLUSION
The subject device, the primary predicate device, additional predicate devices, and the reference devices have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate, and the 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.
7
| Subject Device | 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 Pre-milled Blanks are to be sent to a Terrats Medical
validated milling center for manufacture. | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| DESS Dental Smart Solutions | | |
| K212577 | | |
| Terrats Medical SL | | |
| Compatible Implant Systems | | |
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
| NobelActive®, NobelParallel Conical | 3.5 | NP |
| | 4.3, 5.0 | RP |
| | 5.5 | WP |
| Straumann® Bone Level | 3.3 | NC |
| | 4.1/4.8 | RC |
| Zimmer Screw Vent®/ Tapered
Screw-Vent® | 3.7, 4.1 | 3.5 |
| | 4.7 | 4.5 |
| | 6.0 | 5.7 |
| Primary Predicate Device | 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. | |
| K191986 | | |
| DESS Dental Smart Solutions | | |
| Terrats Medical SL | | |
| Compatible Implant Systems | | |
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| | 3.6 | 2.9 mm |
| Astra Tech EV | 4.2 | 3.5 mm |
| | 4.8 | 4.1 mm |
| | 3.0 | 3.0 mm |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 mm |
| | 4.5/5.0 | 4.5/5.0 mm |
| | 3.25 | 3.45 mm |
| Biomet 3i Certain® | 4.0 | 4.1 mm |
| | 5.0 | 5.0 mm |
| | 3.25 | 3.4 mm |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 mm |
| | 5.0 | 5.0 mm |
| | 3.3 | 3.3 mm |
| | 3.8 | 3.8 mm |
| Camlog | 4.3 | 4.3 mm |
| | 5.0 | 5.0 mm |
| | 3.4 | 3.4 mm |
| FRIADENT XiVE® | 3.8 | 3.8 mm |
| | 4.5 | 4.5 mm |
Table of Substantial Equivalence – Indications for Use Statement
8
| 5.5 | 5.5 mm | |||||
|---|---|---|---|---|---|---|
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm | ||||
| 3.0 | 3.0 (3.0 mm) | |||||
| NobelActive®, | 3.5 | NP (3.5 mm) | ||||
| NobelReplace/NobelParallel Conical | 4.3, 5.0 | RP (3.9 mm) | ||||
| 5.5 | WP (5.1 mm) | |||||
| 3.5 | NP (3.5 mm) | |||||
| NobelReplace® Trilobe | 4.3 | RP (4.3 mm) | ||||
| 5.0 | WP (5.0 mm) | |||||
| 6.0 | 6.0 (6.0 mm) | |||||
| 3.3 | NP (3.5 mm) | |||||
| Nobel Brånemark System® | 3.75, 4.0 | RP (4.1 mm) | ||||
| 5.0 | WP (5.1 mm) | |||||
| Osstem TS | 3.5 | Mini (2.8 mm) | ||||
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | |||||
| Straumann® Bone Level | 3.3 | NC (3.3 mm) | ||||
| 4.1/4.8 | RC (4.1/4.8 mm) | |||||
| 3.3 | NNC (3.5 mm) | |||||
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN (4.8 mm) | ||||
| 4.8 | WN (6.5 mm) | |||||
| Zimmer Screw Vent®/ Tapered Screw- | ||||||
| Vent® | 3.3, 3.7, 4.1 | 3.5 mm | ||||
| 4.7 | 4.5 mm | |||||
| 6.0 | 5.7 mm | |||||
| DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in | ||||||
| Additional Predicate Device | the maxillary or mandibular arch to provide support for prosthetic restorations. | |||||
| All digitally designed custom abutments for use with Ti Base or Pre-milled (Blank) abutments are to be sent to a | ||||||
| K170588 | Terrats Medical validated milling center for manufacture. | |||||
| Compatible Implant Systems | ||||||
| DESS Dental Smart Solutions | ||||||
| Terrats Medical SL | 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 |
9
| Additional Predicate Device | 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 TM Abutment or Pre-milled Blank are to be sent to a
Terrats Medical validated milling center for manufacture. | | | | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------|------------------------------------------|-------------------------------|----------------|
| K173908 | Compatible Implant Systems | | | | | |
| DESS Dental Smart Solutions
Terrats Medical SL | Implant System Compatibility | Implant 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 | | | |
| | OsseoSpeedTM | 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 | | | |
| | NobelReplace® 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 | RP, WP | | | |
| | Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | | | |
| Reference Device | ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide
support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single
restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will
be attached to a dental implant using the included ARUM Dentistry prosthetic screw. | | | | | |
| K193425 | | | | | | |
| Pre-Milled Blank
ARUM Dentistry Co. Ltd | ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table: | | | | | |
| | Compatibility Table | | | | | |
| | ARUM Pre-Milled Blank | | Implant Platform
compatibility | Restorative
Platform
Diameter (mm) | Implant Body
diameter (mm) | Abutment Screw |
| | 10 mm | 14 mm | | | | |
| | CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 |
| | CIHE039 | CIHE040 | NobelActive NP | 3.9 | 4.3/5.0 | CSTO002 |
| | CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | |
| | All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling
center for manufacture. | | | | | |
10
| Compatible Implant Systems | |||
|---|---|---|---|
| Compatible Implant System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |
| 3i OSSEOTITE® Certain® | 3.25 | 3.4 | |
| 4.0 | 4.1 | ||
| 5.0 | 5.0 | ||
| 6.0 | 6.0 | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | |
| 3.5, 4.0 | 3.5/4.0 | ||
| 4.5, 5.0 | 4.5/5.0 | ||
| BioHorizons Tapered Internal | 3.0 | 3.0 | |
| 3.5 | 3.5 | ||
| 4.0 | 4.5 | ||
| HIOSSEN ET III | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Implant Direct Legacy | 3.2 | 3.0 | |
| 3.7, 4.2 | 3.5 | ||
| 4.7, 5.2 | 4.5 | ||
| 5.7, 7.0 | 5.7 | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 | |
| NobelActive® | 3.5 | NP | |
| 4.3, 5.0 | RP | ||
| Nobel Replace™ | 3.5 | NP | |
| 4.0, 4.3, 5.0 | RP | ||
| 5.0 | WP | ||
| 6.0 | 6.0 | ||
| Straumann® Bone Level | 3.3 | NC | |
| 4.1, 4.8 | RC | ||
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN | |
| 4.8, 6.5 | WN | ||
| Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | |
| 4.7 | 4.5 | ||
| 6.0 | 5.7 |
11
| Comparison | Subject Device | Primary Predicate
Device | Additional Predicate Devices | Reference Devices | | |
|----------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------|
| | K212577
DESS Dental Smart
Solutions
Terrats Medical SL | K191986
DESS Dental Smart
Solutions
Terrats Medical SL | K170588
DESS Dental Smart
Solutions
Terrats Medical SL | K173908
DESS Dental Smart
Solutions
Terrats Medical SL | K193425
Pre-Milled Blank
ARUM Dentistry
Co. Ltd | K183518
Preat Abutments
Preat Corporation |
| Reason for
Predicate | n/a | Design | Design | Design | 30° angle | Performance
Testing |
| Design | | | | | | |
| Abutment Designs | CAD/CAM Blanks | Healing,
Temporary,
Straight, Multi-unit,
Locator-type,
CAD/CAM Bases,
CAD/CAM Blanks | Healing, Temporary,
Straight, Multi-unit,
Locator-type,
CAD/CAM Bases,
CAD/CAM Blanks | CAD/CAM Bases,
CAD/CAM Blanks | CAD/CAM
Blanks | Healing,
Temporary,
Straight, Multi-unit,
CAD/CAM Bases,
CAD/CAM Blanks |
| Prosthesis
Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained | Cement-retained
Screw-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 | 2.52 - 6.0 | 2.52 - 6.0 | 3.0-6.0 | 3.6 - 5.0 | 3.5 - 5.5 | 3.0 - 6.5 |
| Prosthetic Platform
Diameter, mm | 4.5 – 6.5 | 4.5-6.5 | 4.5 | 4.0 - 6.5 | 3.5 - 5.1 | 3.0 - 6.5 |
| Blank Abutment
Angulation | 0° to 30° | 0° | 0° | 0° | 0° to 30° | 0° to 30° |
| Abutment/ Implant
Interface | Internal | Internal | Internal | Internal | Internal | Internal |
| Material | Ti-6Al-4V ELI
Co-Cr-Mo Alloy | Ti-6Al-4V ELI
Co-Cr-Mo Alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI
Co-Cr-Mo Alloy | Ti-6Al-4V ELI | Ti-6Al-4V alloy |