(90 days)
K120414, K111287, K101732, K042429, K071638, K093321, K063341, K160965, K212538, K051614, K072768, K101545, K201334, K112795, K210117, K130462, K220200, K180282, K163194, K180536, K201225, K142260, K073142, K173418, K050705, K050406, K050258, K023113, K161604, K173961, K181703, K191256, K210855, K212533, K140878, K013227, K072589, K220978
No
The document describes dental abutments and related components, focusing on mechanical properties, compatibility, and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as dental abutments and components used to support prosthetic restorations, not to treat a disease or condition.
No
Explanation: The device, DESS Dental Smart Solutions abutments, is intended to provide support for prosthetic restorations in conjunction with dental implants. Its description focuses on components like abutments and prosthetic parts. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly lists various physical components such as dental implants, abutments (including different types like Cover Screws, Healing Abutments, Ti Base Abutments, etc.), and abutment screws. The performance studies also detail mechanical testing and sterilization validation of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are used in conjunction with dental implants to provide support for prosthetic restorations in the mouth (maxillary or mandibular arch). This is a mechanical function within the body.
- Device Description: The description details the physical components (abutments, screws) and their purpose in supporting dental prosthetics.
- 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) to provide information for diagnosis, monitoring, or screening. The device itself is implanted and functions mechanically.
- Performance Studies: The performance studies focus on mechanical testing (ISO 14801), MR compatibility, sterilization, and shelf life, which are relevant to an implantable medical device, not an IVD.
Therefore, the DESS Dental Smart Solutions abutments described are classified as a medical device, specifically a dental prosthetic component, and not an In Vitro Diagnostic device.
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 DESS Ti Base abutments or Pre-Milled Blank abutments 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 add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants. This submission adds various abutments to the DESS and OEM implant lines. The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.
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 or referenced to demonstrate substantial equivalence included:
- provided in this submission was non-clinical analysis to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
- provided in this submission was reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with the MIS Seven and MIS M4 implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device Pre-Milled Blank Abutments compatible with BioHorizons Internal Hex connection) implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device Ti Base Abutments compatible with Biomet 3i OSSEOTITE implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device Multi-Unit Abutments compatible with Nobel Replace (Internal Tri-channel connection) implants:
- referenced from K233316 was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10^-6 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSVAAMI/ISO TIR 17665-2; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K233316 was gamma irradiation validation to a sterility assurance level of 10^-6 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 24, 2024
Terrats Medical SL % Kevin Thomas VP & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130
Re: K240208
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: January 24, 2024 Received: January 25, 2024
Dear Kevin Thomas:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 -S
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
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 DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
| Compatible Implant System
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech EV | ||
| (Internal Taper) | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Astra Tech OsseoSpeed TX | ||
| (Internal Taper) | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Internal | ||
| (Internal Hex) | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.2, 4.6 | 3.5 | |
| 4.6, 5.2, 5.8 | 4.5 | |
| 5.8, 7.0, 8.0 | 5.7 | |
| Biomet 3i OSSEOTITE® | ||
| (External Hex) | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Dentium Superline | ||
| (Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| DESS Active | ||
| (Internal Conical) | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| DESS Bone Level | ||
| (Internal Conical) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| PrimaConnex | 3.3, 3.5 | 3.5 |
| Prima Plus | ||
| (Internal TiLobe) | 4.0, 4.1 | 4.1 |
| 5.0 | 5.0 | |
| 3.5, 3.8 | 3.5/3.8 | |
| Genesis | ||
| (Internal TiLobe) | 4.5 | 4.5 |
| 5.5, 6.5 | 5.5/6.5 | |
| 7 | 5.7 | |
| Molaris Tilobemaxx | ||
| (Internal TiLobe) | 8 | 6.5 |
| 9 | 7.5 | |
| 7 | 5.7 | |
| Molaris I-Hexmrt | ||
| (Internal Hex) | 8 | 6.5 |
| 9 | 7.5 | |
| Paltop Advanced Classic | ||
| (Internal Hex) | 3.25 | |
| Paltop Advanced Classic | ||
| (Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 3.0, 3.25 | NP (3.25) | |
| Paltop Advanced Plus | ||
| (Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 6.0 | WP (6.0) | |
| Compatible Implant System | ||
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
| Paltop Dynamic | ||
| (Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop PAI | 3.25 | NP (3.25) |
| Paltop PAI TC | ||
| (Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| 6.0 | WP (6.0) | |
| Paltop Dynamic Conical | ||
| Paltop Conical Active (PCA) | ||
| (Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |
| MIS Seven | 3.3 | NP (3.1) |
| MIS M4 | ||
| (Internal Hex) | 3.75, 4.2 | SP (3.5) |
| 5.0, 6.0 | WP (4.5) | |
| Neodent | ||
| (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| NobelActive® | 3.0 | 3.0 |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) |
| NobelParallel Conical | ||
| (Conical Connection) | 4.3, 5.0 | RP (3.9) |
| 5.5 | WP (5.1) | |
| NobelReplace | 3.5 | NP (3.5) |
| (Internal Tri-channel) | 4.3 | RP (4.3) |
| Osstem® TS | ||
| Hiossen® ET | ||
| (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| (TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB |
| Straumann Bone Level | 3.3 | NC |
| (CrossFit® Morse Taper) | 4.1, 4.8 | RC |
| Zimmer Screw-Vent® | ||
| Tapered Screw-Vent® | ||
| (Internal Hex) | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| TSX™ Implant System | ||
| (Internal Hex) | 3.7, 4.1, 4.7 | 3.5 |
Compatible Implant Systems
4
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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5
510(k) Summary K240208 Terrats Medical SL DESS Dental Smart Solutions April 24, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
Barberà del Vallès 08210
Barcelona, Spain |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Email kthomas@paxmed.com
flarson@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 |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, |
| ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE AND REFERENCE DEVICE INFORMATION
K233316, DESS Dental Smart Solutions, Terrats Medical SL K231434, DESS Dental Smart Solutions, Terrats Medical SL K22288, DESS Dental Smart Solutions, Terrats Medical SL K222269, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K170588, DESS Dental Smart Solutions, Terrats Medical SL
6
Reference Devices for OEM implant body clearances K120414, OsseoSpeed™ Plus, Astra Tech AB K111287, Astra Tech Implant System Plus, Astra Tech AB K101732, Astra Tech Implant System, Astra Tech AB K042429, BioHorizons The Prodigy System™ Endosseous Implants, BioHorizons Implant Systems, Inc. K071638. BioHorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. K093321, BioHorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. K160965, SuperLine, Dentium Co., Ltd. K212538, DESS Dental Implants, Terrats Medical SL K051614, PrimaConnex™ Internal Connection Implant System, Lifecore Biomedical, Inc. K072768, Restore®, Stage-1®, Renova®, PrimaSolo® and PrimaConnex® Dental Implants, Lifecore Biomedical, Inc. K101545, Genesis Implant System, Keystone Dental, Inc. K201334, Keystone Dental XL Dental Implant System, Keystone Dental Inc. K112795, Paltop Dental Implant System, Paltop Advanced Dental Solutions Ltd. K210117, Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd K130462, Paltop Narrow Implant, Paltop Advanced Dental Solutions Limited K220200, Paltop Conical Implant System, Paltop Advanced Dental Solutions, Ltd K180282, MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K180536, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K201225, Neodent Implant System - GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A. K142260, NobelActive®, Nobel Biocare AB K073142, NobelReplace Hexagonal Implants, Nobel Biocare AB K173418, NobelParallel™ Conical Connection, Nobel Biocare AB K050705, TiUnite Implants®, Nobel Biocare AB K050406, NOBELSPEEDY™ Implants, Nobel Biocare USA LLC K050258, Groovy Implants, Nobel Biocare AB K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA, Inc. K161604, OSSTEM Implant System, Osstem Implant Co., Ltd K173961, Straumann® BLX Implant System, Institut Straumann AG K 181703, Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments, Institut Straumann AG K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG K210855, Straumann BLX Implant System, Institut Straumann AG K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC
K013227, Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc.
K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.
K220978, TSXTM Implants, Biomet 3i LLC
The primary predicate device is K233316.
The reference devices K231434, K222288, K222269, K212628, K191986, and K170588 include documentation of the compatibility of the subject device abutments with the corresponding OEM implant bodies.
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 DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
7
Compatible Implant Systems
| Compatible Implant System
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech EV | ||
| (Internal Taper) | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Astra Tech OsseoSpeed TX | ||
| (Internal Taper) | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Internal | ||
| (Internal Hex) | 3.0, 3.4, 3.8 | 3.0 |
| 3.8, 4.2, 4.6 | 3.5 | |
| 4.6, 5.2, 5.8 | 4.5 | |
| 5.8, 7.0, 8.0 | 5.7 | |
| Biomet 3i OSSEOTITE® | ||
| (External Hex) | 3.25 | 3.4 |
| 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Dentium Superline | ||
| (Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 |
| DESS Active | ||
| (Internal Conical) | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| DESS Bone Level | ||
| (Internal Conical) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| PrimaConnex | ||
| Prima Plus | ||
| (Internal TiLobe) | 3.3, 3.5 | 3.5 |
| 4.0, 4.1 | 4.1 | |
| 5.0 | 5.0 | |
| Genesis | ||
| (Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 |
| 4.5 | 4.5 | |
| 5.5, 6.5 | 5.5/6.5 | |
| Molaris Tilobemaxx | ||
| (Internal TiLobe) | 7 | 5.7 |
| 8 | 6.5 | |
| 9 | 7.5 | |
| Molaris I-Hexmrt | ||
| (Internal Hex) | 7 | 5.7 |
| 8 | 6.5 | |
| 9 | 7.5 | |
| Paltop Advanced Classic | ||
| (Internal Hex) | 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| Paltop Advanced Plus | ||
| (Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop Dynamic | ||
| (Internal Hex) | 3.0, 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop PAI | ||
| Paltop PAI TC | ||
| (Internal Hex) | 3.25 | NP (3.25) |
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| 6.0 | WP (6.0) | |
| Paltop Dynamic Conical | ||
| Paltop Conical Active (PCA) | ||
| (Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |
| MIS Seven | 3.3 | NP (3.1) |
| MIS M4 | ||
| (Internal Hex) | 3.75, 4.2 | SP (3.5) |
| 5.0, 6.0 | WP (4.5) | |
| Compatible Implant System | ||
| (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
| Neodent | ||
| (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| NobelActive® | 3.0 | 3.0 |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) |
| NobelParallel Conical | 4.3, 5.0 | RP (3.9) |
| (Conical Connection) | WP (5.1) | |
| NobelReplace | 3.5 | NP (3.5) |
| (Internal Tri-channel) | 4.3 | RP (4.3) |
| Osstem® TS | ||
| Hiossen® ET | 3.5 | Mini |
| (Internal Taper) | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular |
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB |
| (TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB |
| Straumann Bone Level | 3.3 | NC |
| (CrossFit® Morse Taper) | 4.1, 4.8 | RC |
| Zimmer Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| Tapered Screw-Vent® | ||
| (Internal Hex) | 4.7 | 4.5 |
| TSXTM Implant System | ||
| (Internal Hex) | 3.7, 4.1, 4.7 | 3.5 |
8
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.
This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.
The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.
9
Table 1 – Summary of Subject Device Abutment Designs
| Compatible Implant Systems | DESS Abutment System | Cover Screws | Healing
Abutment | Temporary
Abutment | Ti Base
Engaging and
Non-engaging | AURUM Base
Engaging and
Non-engaging | CoCr Base
Engaging and
Non-engaging | Pre-Milled
Blank
Engaging | Multi-Unit
Abutment
Straight | Multi-Unit
Abutment
Angled | DESSLoc
Abutment | Screws |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------|---------------------|-----------------------|-----------------------------------------|--------------------------------------------|-------------------------------------------|---------------------------------|------------------------------------|----------------------------------|---------------------|--------|
| Astra Tech EV | Conic EVO | | | | X | | | X | | | | X |
| Astra Tech OsseoSpeed TX | Internal Hex Conic | | X | X | X | | | | | | | X |
| BioHorizons Internal | Internal Hex BH | | X | | | | | X | | | | |
| Biomet 3i OSSEOTITE® | External Hex USA | | | | X | | | | | | | |
| Dentium SuperLine | Conic DENT | | | | | X | | | | | | |
| DESS Active | DESS Active | X | | | | | | | | | | |
| DESS Bone Level | DESS Bone Level | X | | | | | | | | | | |
| Keystone (Internal TiLobe)
PrimaConnex
Prima Plus
Genesis
Molaris Tilobemaxx | Internal TiLobe | | | | X | | | X | | | | |
| Keystone (Internal Hex)
Molaris I-Hexmrt
Paltop Advanced Classic
Paltop Advanced Plus
Paltop Dynamic
Paltop PAI
Paltop PAI TC | Internal Hex | | | | X | | | X | | | | |
| Keystone (Internal Conical)
Paltop Dynamic Conical
Paltop Conical Active (PCA) | Internal Conical | | | | X | | | X | | | | |
| MIS Seven
MIS M4 | Internal Hex MI | | X | X | X | X | X | X | X | | X | X |
| Neodent Grand Morse | Neo GM | | | | X | | | X | X | | | X |
| NobelActive®
NobelReplace Conical
NobelParallel Conical | Active Hex | | X | X | X | | | X | | | | |
| NobelReplace (Tri-channel) | Tri-lobe | | | | | | | | | X | | X |
| Osstem® TS
Hiossen® ET | Conic OSS | | | | | | | X | | | | |
| Straumann BLX | Conical BLX | | | | X | | | X | | | | X |
| Straumann Bone Level | Conical BL | | | X | X | | X | X | | | | X |
| Zimmer Screw-Vent®
Zimmer Tapered Screw-Vent® | Internal Hex USA | | | | X | | | X | | | | |
| TSX™ Implant System | Internal Hex USA | | | | X | | | | | | | |
10
Table 2 – Summary of Subject Device Abutment Sizes
| OEM Compatible Implants | Subject Device Abutments | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Compatible Implant Lines | Implant | ||||||||||||
| Body Ø | Implant | ||||||||||||
| Platform Ø | Cover | ||||||||||||
| Screws | Healing | Temporary | Ti Base | AURUM Base | CoCr Base | Pre-Milled | |||||||
| Blank | Multi-Unit | ||||||||||||
| Straight | Multi-Unit | ||||||||||||
| Angled | DESSLoc | Screws | |||||||||||
| Astra Tech EV | 3.0 | 3.0 | X | X | |||||||||
| 3.6 | 3.6 | X | X | ||||||||||
| 4.2 | 4.2 | X | X | ||||||||||
| 4.8 | 4.8 | X | |||||||||||
| Astra Tech OsseoSpeed TX | 3.0 | 3.0 | X | X | X | ||||||||
| 3.5, 4.0 | 3.5/4.0 | X | |||||||||||
| 4.5, 5.0 | 4.5/5.0 | X | |||||||||||
| BioHorizons Internal | 3.0, 3.4, 3.8 | 3.0 | X | X | |||||||||
| 3.8, 4.2, 4.6 | 3.5 | X | |||||||||||
| 4.6, 5.2, 5.8 | 4.5 | X | |||||||||||
| 5.8, 7.0, 8.0 | 5.7 | X | |||||||||||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 | X | ||||||||||
| 3.75, 4.0 | 4.1 | X | |||||||||||
| 5.0 | 5.0 | X | |||||||||||
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | X | ||||||||||
| DESS Active | 3.0 | 3.0 | X | ||||||||||
| 3.5 | NP | X | |||||||||||
| 4.3, 5.0 | RP | X | |||||||||||
| 5.5 | WP | X | |||||||||||
| DESS Bone Level | 3.3 | NC | X | ||||||||||
| 4.1, 4.8 | RC | X | |||||||||||
| PrimaConnex | |||||||||||||
| Prima Plus | 3.3, 3.5 | 3.5 | X | X | |||||||||
| 4.0, 4.1 | 4.1 | X | X | ||||||||||
| 5.0 | 5.0 | X | X | ||||||||||
| Genesis | 3.5, 3.8 | 3.5/3.8 | X | X | |||||||||
| 4.5 | 4.5 | X | X | ||||||||||
| 5.5, 6.5 | 5.5/6.5 | X | X | ||||||||||
| Molaris Tilobemaxx | 7 | 5.7 | X | X | |||||||||
| 8 | 6.5 | X | X | ||||||||||
| 9 | 7.5 | X | X | ||||||||||
| Molaris I-Hexmrt | 7 | 5.7 | X | X | |||||||||
| 8 | 6.5 | X | X | ||||||||||
| 9 | 7.5 | X | X | ||||||||||
| Paltop Advanced Classic | 3.25 | NP (3.25) | X | X | |||||||||
| 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | ||||||||||
| OEM Compatible Implants | Subject Device Abutments | ||||||||||||
| Compatible Implant Lines | Implant | ||||||||||||
| Body Ø | Implant | ||||||||||||
| Platform Ø | Cover | ||||||||||||
| Screws | Healing | Temporary | Ti Base | AURUM Base | CoCr Base | Pre-Milled | |||||||
| Blank | Multi-Unit | ||||||||||||
| Straight | Multi-Unit | ||||||||||||
| Angled | DESSLoc | Screws | |||||||||||
| Paltop Advanced Plus | 3.0, 3.25 | NP (3.25) | X | X | |||||||||
| Paltop Advanced Plus | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop Advanced Plus | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop Dynamic | 3.0, 3.25 | NP (3.25) | X | X | |||||||||
| Paltop Dynamic | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop Dynamic | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop PAI | |||||||||||||
| Paltop PAI TC | 3.25 | NP (3.25) | X | X | |||||||||
| Paltop PAI | |||||||||||||
| Paltop PAI TC | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | |||||||||
| Paltop PAI | |||||||||||||
| Paltop PAI TC | 6.0 | WP (6.0) | X | X | |||||||||
| Paltop Dynamic Conical | |||||||||||||
| Paltop Conical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | X | X | |||||||||
| MIS Seven | |||||||||||||
| MIS M4 | 3.3 | NP (3.1) | X | X | X | X | |||||||
| MIS Seven | |||||||||||||
| MIS M4 | 3.75, 4.2 | SP (3.5) | X | X | X | X | X | X | X | X | X | ||
| MIS Seven | |||||||||||||
| MIS M4 | 5.0, 6.0 | WP (4.5) | X | X | X | X | X | X | X | X | X | ||
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, | ||||||||||||
| 5.0, 6.0, 7.0 | GM | X | X | X | X | ||||||||
| NobelActive® | 3.0 | 3.0 | X | X | X | X | |||||||
| NobelActive® | 3.5, 3.75 | NP (3.5) | X | X | |||||||||
| NobelReplace Conical | |||||||||||||
| Nobel Parallel Conical | 4.3, 5.0 | RP (3.9) | X | X | |||||||||
| NobelReplace Conical | |||||||||||||
| Nobel Parallel Conical | 5.5 | WP (5.1) | X | X | X | ||||||||
| NobelReplace | 3.5 | NP (3.5) | X | X | |||||||||
| NobelReplace | 4.3 | RP (4.3) | X | X | |||||||||
| Osstem® TS | |||||||||||||
| Hiossen® ET | 3.5 | Mini | X | ||||||||||
| Osstem® TS | |||||||||||||
| Hiossen® ET | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | X | ||||||||||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | X | X | X | ||||||||
| Straumann BLX | 5.0, 5.5, 6.5 | WB | X | X | X | ||||||||
| Straumann Bone Level | 3.3 | NC | X | X | X | ||||||||
| Straumann Bone Level | 4.1, 4.8 | RC | X | X | X | ||||||||
| Zimmer Screw-Vent® | |||||||||||||
| Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | X | X | |||||||||
| Zimmer Screw-Vent® | |||||||||||||
| Tapered Screw-Vent® | 4.7 | 4.5 | X | ||||||||||
| TSX™ Implant System | 3.7, 4.1, 4.7 | 3.5 | X | X |
11
Table 2 – Summary of Subject Device Abutment Sizes
12
SUBJECT DEVICE DESIGNS
Cover Screws are provided only for the DESS Active implants (platforms 3.0, NP, RP, and WP), and for the DESS Bone Level implants (platforms NC, RC). The coronal diameter of the Cover Screws ranges from 2.8 mm to 5.1 mm. Cover Screws are made of titanium alloy (Ti-6Al-4V).
Healing Abutments are provided for Astra Tech OsseoSpeed TX implants with a 3.0 platform, BioHorizons Internal implants with a 3.0 platform, MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms, and Nobel Biocare conical connection implants with 3.0 and WP (5.1) platforms. The Healing Abutments are provided in gingival heights from 3 mm to aid in contouring the gingiva during healing. Healing abutments are made of titanium allov (Ti-6Al-4V).
Temporary Abutments are provided for Astra Tech OsseoSpeed TX implants with a 3.0 platform. MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms, and for Nobel Biocare conical connection implants with 3.0 and WP (5.1) platforms. Temporary Abutments are available for single-unit and multiple-unit restorations, the former with engaging connections to the implants and the latter with non-engaging connections. All Temporary Abutments have a gingival height of 1.5 mm and are made of titanium alloy (Ti-6Al-4V).
Ti Base Abutments are provided in engaging and non-engaging designs. The Ti Base Abutments are for custom abutment fabrication of a CAD-CAM zirconia superstructure on which a crown may be placed. They also may be used to support a crown placed directly on the abutment. The two-pieces of the Ti Base abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The cement recommended for bonding of superstructures is Multi-Link cement by Ivoclar Vivadent. Ti Base Abutments are manufactured from titanium alloy (Ti 6Al 4V) with the Select(Gripe surface. When used for a direct crown, Ti Base Abutments may be used with a POM burn out sleve, an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis.
The design parameters for the CAD-CAM zirconia superstructure to be used on Ti Base Abutments are the same as cleared in K22288:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.2 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
Maximum angulation - refer to Table 3 Ti Base Abutments.
| Compatible Implant
System | Compatible Body
Diameter, mm | Compatible Implant
Platform Name | Gingival Height,*
mm | Prosthetic Platform
Diameter, mm | Maximum
Angulation |
|------------------------------|---------------------------------|-------------------------------------|-------------------------------|-------------------------------------|-----------------------|
| Astra Tech EV | 3.0 | 3.0 | 1.5 | 3.85 | 0° |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 | 1.5 | 3.85 | 0° |
| | 3.25 | 3.4 | | | 30° |
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 | 0.3 - 3.0 | 4.5 – 5.2 | 30° |
| | 5.0 | 5.0 | | | 30° |
| Keystone/Paltop | | | | | |
| | 3.3, 3.5 | 3.5 | | | 30° |
| PrimaConnex
Prima Plus | 4.0, 4.1 | 4.1 | | | 30° |
| | 5.0 | 5.0 | | | 30° |
| | 3.8, 3.5 | 3.5/3.8 | 1.0 or 2.0 | 4.1 - 7.0 | 30° |
| Genesis | 4.5 | 4.5 | For 3 mm GH max
angle = 0° | | 30° |
| | 5.5, 6.5 | 5.5/6.5 | | | 30° |
| | 7 | 5.7 | | | 30° |
| Molaris Tilobemaxx | 8 | 6.5 | | | 30° |
| | 9 | 7.5 | | | 30° |
Table 3 – Ti Base Abutments
13
| Compatible Implant
System | Compatible Body
Diameter, mm | Compatible Implant
Platform Name | Gingival Height,*
mm | Prosthetic Platform
Diameter, mm | Maximum
Angulation |
|-----------------------------------------------------------|---------------------------------------|-------------------------------------|-------------------------------|-------------------------------------|-----------------------|
| Molaris I-Hexmrt | 7 | 5.7 | 1.0 or 2.0 | 6.0 - 7.0 | 30° |
| | 8 | 6.5 | For 3 mm GH max
angle = 0° | | 30° |
| | 9 | 7.5 | | | 30° |
| Paltop Advanced Classic | 3.25 | NP (3.25) | | | 30° |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | | | 30° |
| Paltop Advanced Plus | 3.0, 3.25 | NP (3.25) | | | 30° |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | | | 30° |
| | 6.0 | WP (6.0) | 1.0 or 2.0 | | 30° |
| Paltop Dynamic | 3.0, 3.25 | NP (3.25) | For 3 mm GH max
angle = 0° | 4.25 - 5.7 | 30° |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | | | 30° |
| | 6.0 | WP (6.0) | | | 30° |
| Paltop PAI
Paltop PAI TC | 3.25 | NP (3.25) | | | 30° |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | | | 30° |
| | 6.0 | WP (6.0) | | | 30° |
| Paltop
Dynamic Conical
Paltop
Conical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | 1.0 - 2.0 | 4.3 | 30° |
| MIS Seven
MIS M4 | 3.3 | NP (3.1) | | 4.5 - 5.7 | 0° |
| | 3.75, 4.2 | SP (3.5) | 0.3 - 3.0 | | 0° |
| | 5.0, 6.0 | WP (4.5) | | | 0° |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3,
5.0, 6.0, 7.0 | GM | 1.5 | 3.85 | 0° |
| NobelActive® | 3.0 | 3.0 | 1.5 | | 0° |
| NobelReplace Conical
NobelParallel Conical | 3.5, 3.75 | NP (3.5) | 1.5 | 3.5 - 3.85 | 0° |
| Straumann® BLX | 3.5, 3.75, 4.0, 4.5,
5.0, 5.5, 6.5 | RB/WB, WB | 1.5 | 3.85 | 0° |
| Straumann® Bone Level | 3.3 | NC | 0.5 - 1.5 | 3.85 - 4.95 | 0° |
| Zimmer Screw-Vent®
Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | 1.5 | 3.85 | 0° |
| Zimmer TSXTM | 3.7, 4.1, 4.7 | 3.5 | 1.5 | 3.85 | 0° |
- Gingival height in the Ti Base
All patient-specific custom abutment fabrication for Ti Base Abutments and AURUM Base Abutments (described below) is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base and AURUM Base abutments will be made at a Terrats Medical validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
AURUM Base Abutments are provided in engaging and non-engaging designs for Dentium SuperLine implants with a 3.3 platform and for MIS Seven and MIS M4 implants with SP (3.5) and WP (4.5) platforms. The two-pieces of the AURUM Base abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD-CAM patient matched superstructure composed of zirconia. The design of the AURUM Base allows for easier instrument access to the abutment screw and allows for placement of the screw channel out of the esthetic region of the restoration. AURUM Base abutments are provided with a prosthetic platform diameter ranging from 4.5 mm, and a gingival height (in the base) of 0.3 mm or 0.9 mm. When used for a single-unit restoration the AURUM Base is to be used with a superstructure to create a minimum post height (length above the abutment collar/gingival height) of 4.0 mm. ARUM Base Abutments are to be used for straight abutments only, no angulation.
AURUM Base Abutments are manufactured from titanium alloy (Ti 6Al 4V) and anodized a gold color, and the SelectGrip® surface to aid in bonding retention. The AURUM Base abutments, including the titanium
14
510(k) Summary Page 10 of 17
alloy, anodization treatment, and SelectGrip® surface is similar to that of DESS Aurum Abutments cleared in K222269. AURUM Base Abutments are not intended for angulation correction.
The design parameters for the CAD-CAM zirconia superstructure to be used on AURUM Base Abutments are the same as cleared in K222269:
Minimum wall thickness – 0.4 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.0 mm
Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
CoCr Base Abutments are provided for MIS Seven and MIS M4 implants with NP (3.1), SP (3.5), and WP (4.5) platforms, in engaging designs for single-unit restorations and non-engaging designs for multi-unit restorations. The two-pieces of the CoCr Base abutment which compose the final abutment consists of the pre-manufactured CoCr base component composed of CoCr alloy and the CAD-CAM patient matched superstructure composed of zirconia. CoCr Base Abutments also may be used as part of a welded multi-unit construct, intended to be used with the included exempt POM burnout sleeve for wax-up and casting of a crown or bridge from a non-precious metal alloy. CoCr Base Abutments have a gingival height of 1.5 mm, a prosthetic platform diameter of 4.5 mm, and are made from Co-Cr-Mo alloy. The design of the CoCr Base Abutments is similar to CoCr Base Abutments cleared in K222288. CoCr Base Abutments are not intended for angulation correction.
The design parameters for the CAD/CAM zirconia superstructure to be used on CoCr Base are identical to those cleared in K22288:
Minimum wall thickness - 0.4 mm
Minimum post height for single-unit restorations (length above the abutment collar/gingival height) – 4.5 mm Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
All zirconia superstructures are for straight abutments only.
Pre-Milled Blank Abutments are available in engaging designs only. All patient-specific custom abutment fabrication for Pre-Milled Blank Abutments is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm, and are provided in a solid cylindrical design and with a pre-milled angled screw-channel design. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V) and from Co-Cr-Mo alloy (for MIS Seven and MIS M4 implants). The subject device Pre-Milled Blank Abutments are similar to Pre-Milled Blank Abutments cleared in K222269
The design parameters for the CAD-CAM fabrication of custom abutments from Pre-Milled Blank Abutments are identical to those cleared in K222288 and K222269:
Minimum wall thickness - 0.45 mm
Minimum post height for single-unit restoration (length above the abutment collar/gingival height) – 4.0 mm Minimum gingival height - 0.5 mm
Maximum gingival height - 6.0 mm
Maximum angulation - refer to Table 4 Pre-Milled Blank Abutments.
| Compatible Implant System | Compatible Body Diameter, mm | Compatible Implant
Platform Name | Maximum
Angulation |
|-----------------------------------------------------|------------------------------------------------------------------|--------------------------------------------|-----------------------|
| Astra Tech EV | 3.0 | 3.0 | 0° |
| Astra Tech EV | 3.6 | 3.6 | 0° |
| Astra Tech EV | 4.2 | 4.2 | 0° |
| Compatible Implant System | Compatible Body Diameter, mm | Compatible Implant Platform Name | Maximum Angulation |
| BioHorizons Internal | 3.0, 3.4, 3.8
3.8, 4.2, 4.6
4.6, 5.2, 5.8
5.8, 7.0, 8.0 | 3.0
3.5
4.5
5.7 | 30° |
| Keystone/Paltop
PrimaConnex
Prima Plus | 3.3, 3.5
4.0, 4.1
5.0 | 3.5
4.1
5.0 | 30° |
| Genesis | 3.8, 3.5
4.5
5.5, 6.5 | 3.5/3.8
4.5
5.5/6.5 | 30° |
| Molaris Tilobemaxx | 7
8
9 | 5.7
6.5
7.5 | 30° |
| Molaris I-Hexmrt | 7
8
9 | 5.7
6.5
7.5 | 30° |
| Paltop Advanced Classic | 3.25
3.75, 4.2, 5.0 | NP (3.25)
SP (3.75/4.2/5.0) | 30° |
| Paltop Advanced Plus | 3.0, 3.25
3.75, 4.2, 5.0
6.0 | NP (3.25)
SP (3.75/4.2/5.0)
WP (6.0) | 30° |
| Paltop Dynamic | 3.0, 3.25
3.75, 4.2, 5.0
6.0 | NP (3.25)
SP (3.75/4.2/5.0)
WP (6.0) | 30° |
| Paltop PAI
Paltop PAI TC | 3.25
3.75, 4.2, 5.0
6.0 | NP (3.25)
SP (3.75/4.2/5.0)
WP (6.0) | 30° |
| Paltop Dynamic Conical
Paltop Conical Active PCA | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | 30° |
| MIS Seven | 3.3
3.75, 4.2 | NP (3.1)
SP (3.5) | 0° |
| MIS M4 | 5.0, 6.0 | WP (4.5) | 0° |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | 0° |
| NobelActive® | 3.0 | 3.0 | 0° |
| NobelReplace Conical | 3.5, 3.75 | NP (3.5) | 0° |
| NobelParallel Conical | 4.3, 5.0 | RP (3.9) | 0° |
| Osstem® TS | 3.5 | Mini | 0° |
| Hiossen® ET | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | 0° |
| Straumann® BLX | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB/WB, WB | 0° |
| Straumann® Bone Level | 3.3
4.1, 4.8 | NC
RC | 0° |
| Zimmer Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | 0° |
| Tapered Screw-Vent® | 4.7 | 4.5 | 0° |
Table 4 - Pre-Milled Blank Abutments
15
Multi-Unit Abutments are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight, angled 17°, and angled 30°. The designs are similar to that of Multi-Unit Abutments
16
cleared in K233316, K222288, and K222269. The Multi-Unit Abutments are manufactured from titanium alloy (Ti-6A1-4V).
The straight Multi-Unit Abutments are provided for MIS Seven and MIS M4 implants with SP (3.5), and WP (4.5) platforms, and for Neodent implants with the GM platform. The straight Multi-Unit Abutments have a non-engaging. threaded design that attaches directly to the implant. Straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 0.8 mm to 5.5 mm.
The angled Multi-Unit Abutments are provided for NobelReplace (Internal Tri-Channel) implants with NP (3.5) and RP (4.3) platforms. The angled Multi-Unit Abutments are provided only in a non-engaging design that requires an abutment screw. The Multi-Unit Abutments angled 17° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of either 2 mm or 3 mm. The Multi-Unit Abutments angled 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height of either 4 mm or 5 mm.
DESSLoc Abutments are designed for overdenture attachment to attach directly to the implant. DESSLoc Abutments are made of titanium alloy (Ti-6Al-4V, and have a zirconium nitride (ZrN) coating, 2 um to 3 um thick, produced by a physical vapor deposition (PVD) process.
DESSLoc Abutments are provided only for MIS Seven and M4 implants with SP (3.5) and WP (4.5) platforms. Except for the implant connection, the design, material, and coating for the subject device DESSLoc Abutments are identical to those of the DESSLoc Abutments cleared in K222269.
DESS Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of eighteen (18) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K233316, K22288, and K22269. Screws are made of titanium alloy (Ti-6Al-4V) and are available with and without a DLC (Diamond-like Carbon) coating. DLC coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K233316, K222288, and K222269.
OEM IMPLANT COMPATIBILITY
To ensure that the subject abutments and screws are designed to fit the corresponding OEM implants, the dimensions and tolerances of subject abutments and screws have been established by reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) or by a contractual agreement and working relationship between Terrats Medical SL and the OEM implant manufacturer. For the subject cover screws and Multi-Unit Abutment screws for the DESS Active and Bone Level Implants, this analysis is not necessary for the Sponsor's own implant bodies. For all OEM compatibilities, except for the MIS implant lines, the reverse engineering analysis or contractual agreement information was provided in prior Terrats Medical 510(k) submissions. For the MIS implant lines, the reverse engineering analysis is provided in this submission. The confirmation of compatibility is summarized in the following Table 5 Compatible Implant Systems Confirmation of Compatibility.
| Implant Compatibility
(Connection) | Implant Body
Diameter, mm | Implant
Platform, mm | Terrats Medical 510(k)
Containing Reverse Engineering or
OEM Contractual Agreement |
|-----------------------------------------------------------------------------|------------------------------------|-------------------------|------------------------------------------------------------------------------------------|
| Astra Tech EV
(Internal Taper) | 3.0 | 3.0 | K212628 |
| | 3.6 | 3.6 | |
| | 4.2 | 4.2 | K191986 |
| | 4.8 | 4.8 | |
| Astra Tech OsseoSpeed TX
(Internal Taper) | 3.0 | 3.0 | K191986 |
| | 3.5, 4.0 | 3.5/4.0 | K170588 |
| | 4.5, 5.0 | 4.5/5.0 | |
| Implant Compatibility
(Connection) | Implant Body
Diameter, mm | Implant
Platform, mm | Terrats Medical 510(k)
Containing Reverse Engineering or
OEM Contractual Agreement |
| | 3.0, 3.4, 3.8 | 3.0 | |
| BioHorizons Internal | 3.8, 4.2, 4.6 | 3.5 | K212628 |
| (Internal Hex) | 4.6, 5.2, 5.8 | 4.5 | |
| | 5.8, 7.0, 8.0 | 5.7 | |
| | 3.25 | 3.4 | |
| Biomet 3i OSSEOTITE®
(External Hex) | 3.75, 4.0 | 4.1 | K170588 |
| | 5.0 | 5.0 | |
| Dentium SuperLine
(Internal Taper) | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | K222288 |
| | 3.0 | 3.0 | |
| DESS Active | 3.5 | NP | |
| (Internal Conical) | 4.3, 5.0 | RP | K212538 |
| | 5.5 | WP | (Sponsor's own implants) |
| DESS Bone Level | 3.3 | NC | |
| (Internal Conical) | 4.1, 4.8 | RC | |
| PrimaConnex | 3.3, 3.5 | 3.5 | |
| Prima Plus | 4.0, 4.1 | 4.1 | K222269 |
| (Internal TiLobe) | 5.0 | 5.0 | |
| | 3.5, 3.8 | 3.5/3.8 | |
| Genesis | 4.5 | 4.5 | K222269 |
| (Internal TiLobe) | 5.5, 6.5 | 5.5/6.5 | |
| | 7 | 5.7 | |
| Molaris Tilobemaxx | 8 | 6.5 | K222269 |
| (Internal TiLobe) | 9 | 7.5 | |
| | 7 | 5.7 | |
| Molaris I-Hexmrt | 8 | 6.5 | K222269 |
| (Internal Hex) | 9 | 7.5 | |
| Paltop Advanced Classic | 3.25 | NP (3.25) | K222269 |
| (Internal Hex) | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| | 3.0, 3.25 | NP (3.25) | |
| Paltop Advanced Plus | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| | 3.0, 3.25 | NP (3.25) | |
| Paltop Dynamic | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| Paltop PAI | 3.25 | NP (3.25) | |
| Paltop PAI TC | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | K222269 |
| (Internal Hex) | 6.0 | WP (6.0) | |
| Paltop Dynamic Conical
Paltop Conical Active (PCA)
(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | K222269 |
| MIS Seven | 3.3 | NP (3.25) | |
| MIS M4 | 3.75, 4.2 | SP (3.5) | This Submission |
| (Internal Hex) | 5.0, 6.0 | WP (4.5) | |
| Neodent
(Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | K212628 |
| Implant Compatibility
(Connection) | Implant Body
Diameter, mm | Implant
Platform, mm | Terrats Medical 510(k)
Containing Reverse Engineering or
OEM Contractual Agreement |
| NobelActive® | 3.0 | 3.0 | K191986 |
| NobelReplace Conical
NobelParallel Conical
(Conical Connection) | 3.5, 3.75 | NP (3.5) | K170588 |
| | 4.3, 5.0 | RP (3.9) | |
| | 5.5 | WP (5.1) | K191986 |
| NobelReplace
(Internal Tri-channel) | 3.5 | NP (3.5) | K170588 |
| | 4.3 | RP (4.3) | |
| Osstem® TS
Hiossen® ET | 3.5 | Mini | K191986 |
| | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Straumann BLX
(TorcFit™ Internal
Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | K212628 |
| | 5.0, 5.5, 6.5 | WB | |
| Straumann Bone Level
(CrossFit® Morse Taper) | 3.3 | NC | K170588 |
| | 4.1, 4.8 | RC | |
| Zimmer Screw-Vent®
Tapered Screw-Vent®
(Internal Hex) | 3.3, 3.7, 4.1 | 3.5 | K170588 |
| | 4.7 | 4.5 | |
| TSXTM Implant System
(Internal Hex) | 3.7, 4.1, 4.7 | 3.5 | K231434 |
Table 5 - Compatible Implant Systems Confirmation of Compatibility
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MATERIALS
The subject device abutments are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 or from Co-Cr-Mo alloy conforming to ASTM F1537. The subject device screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. Abutments are colored gold by an anodization process that is identical to that used on abutments cleared in K233316, K22288, and K222269. Ti Base Abutments and AURUM Base Abutments have a SelectGrip® surface to aid in bonding retention that is identical to that used on abutments cleared in K233316, K222269, Screws are available with and without a DLC (Diamond-like Carbon) coating is a polycrystalline tungsten carbide/carbon and chromium coating that is identical to the DLC coating on screws cleared in K233316, K22288, and K22269.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- provided in this submission was non-clinical analysis to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
- provided in this submission was reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with the MIS Seven and MIS M4 implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance ● of the subject device Pre-Milled Blank Abutments compatible with BioHorizons Internal Hex connection) implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
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- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device Ti Base Abutments compatible with Biomet 3i OSSEOTITE implants, the PrimaConnex (Internal TiLobe connection) implants, Paltop Dynamic (Internal Hex connection) implants, and Paltop Dynamic Conical (Internal Conical connection) implants;
- provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance . of the subject device Multi-Unit Abutments compatible with Nobel Replace (Internal Tri-channel connection) implants:
- referenced from K233316 was moist heat sterilization for subject devices provided non-sterile to the end user, ● validated to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSVAAMI/ISO TIR 17665-2; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K233316 was gamma irradiation validation to a sterility assurance level of 10° by ● selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of