(253 days)
No
The summary describes a dental abutment system and its components, focusing on materials, manufacturing processes, and compatibility with existing implant platforms. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, DESS Dental Smart Solutions abutments, is intended to provide support for prosthetic restorations in conjunction with dental implants. It serves a structural and supportive role for dental prostheses rather than actively treating or curing a disease or condition.
No
This device, DESS Dental Smart Solutions abutments, is intended to provide support for prosthetic restorations in conjunction with dental implants. It is a restorative component, not a device used to diagnose a medical condition.
No
The device description explicitly states that the device consists of physical components made of titanium alloy, including abutments and screws. It also mentions surface treatments and manufacturing processes for these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with endosseus dental implants... to provide support for prosthetic restorations." This describes a surgical and restorative dental procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the physical components of the abutment system (titanium bases, screws, materials, surface treatments) and their function in supporting dental prosthetics. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is a component of a dental implant system used for structural support in dental restorations.
N/A
Intended Use / Indications for Use
DESS Dental Smart Solutions abutments are in conjunction with endosseus dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with C-Base abutments are to be sent to a Terrats Medical validature. Compatible Implant Systems
Product codes
NHA
Device Description
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K191986 to add an additional series of titanium base components for previously cleared OEM implant platform compatibilities. The new components, referred to as C-Base engaging and C-Base non-engaging abutments, are available in a range of abutment gingival heights and abutment platform diameters. This submission includes abutments compatible with 33 implant platforms from 13 implant compatibilities have been cleared in previous Terrats Medical submissions. No new implant compatibilities are added in this submission. Screws used with the subject device C-Base abutments were cleared previously, with the exception of two screws added in this submission. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
The subject device DESS Dental Smart Solutions C-Base abutments are similar to TiBase Abutments cleared in K170588 and K191986. C-Base abutments are two-piece abutments designed to support a custom CAD/CAM zirconia superstructure on which a single-unit or multiunit restoration may be placed. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. The C-Base also may support a ceramic hybrid abutment (direct restoration) in which the crown is included in the design of the zirconia superstructure. They are available either in designs that engage with the anti-rotational feature of the implant or in non-engaging designs for multi-unit restorations. The C-Base post is 4.7 mm high. The gingival height of the abutment (distance from implant platform to abutment platform) ranges from 0.3 mm to 3.0 mm. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. C-Base abutments are made of titanium alloy (Ti-6Al-4V) with anodization and a SelectGrip® surface, described below. When used for a direct crown, a POM burn-out sleeve, an exempt laboratory component that is not a subject of this submission, is available for laboratory fabrication of the prosthesis.
When the C-Base abutment is used with a CAD/CAM zirconia superstructure, or for a direct restoration, design parameters are identical to those cleared in K191986 and in K170588, except that the minimum post height for the subject device is 4.7 mm. The superstructure or direct restoration design parameters are:
Minimum wall thickness – 0.4 mm Minimum post height for single-unit loading - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Zirconia superstructures and direct restorations are not intended for angulation correction.
Manufacture of the CAD/CAM zirconia superstructure is to be performed at a Terrats Medical validated milling center, defined as a facility that is registered with FDA as a manufacturer or contract manufacturer.
Each abutment is supplied with the appropriate abutment screw for attachment to the corresponding implant. DESS Dental Smart Solutions screws are designed to attach the abutment or restoration to the implant. With the exception of two new subject device screws, all screws were cleared in previous Terrats Medical submissions. As discussed above, the two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
All subject device abutments and subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Zirconia superstructures for C-Base abutments are made of Y-TZP conforming to ISO 13356 Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
Abutments are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color. They also are treated with the SelectGrip® surface to improve adhesion of the cement that is used to attach the superstructure or restoration to the C-Base abutment. The gold anodized surface treatment is identical to that cleared in K191986 and the SelectGrip surface treatment is identical to that cleared in K191986 and K170588. All the subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K191986 and K170588.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandbular 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: sterilization validation according to ISO 17665-1 and ISO 17665-2 referenced from the primary predicate device and the sponsor's additional predicate device; biocompatibility according to ISO 10993-5 and ISO 10993-12 referenced from the primary predicate device and the sponsor's additional predicate device; and reverse engineering analysis of OEM implant bodies, OEM abutment, and OEM abutment screws to confirm compatibility, referenced from the primary predicate device and the additional predicate device. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants. Because the minor differences between the designs of these two subject device screws and corresponding screws cleared in K170588 and K191986 are not related to implant compatibility, no new OEM analysis was needed. No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Terrats Medical SL % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K203464
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: July 16, 2021 Received: July 19, 2021
Dear Floyd Larson:
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
Indications for Use
510(k) Number (if known) K203464
Device Name
DESS Dental Smart Solutions
Indications for Use (Describe)
DESS Dental Smart Solutions abutments are in conjunction with endosseus dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with C-Base abutments are to be sent to a Terrats Medical validature. Compatible Implant Systems
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform |
|---|---|---|
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| Astra Tech EV | 3.6 | 2.9 mm |
| 4.2 | 3.5 mm | |
| 4.8 | 4.1 mm | |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 mm | |
| Biomet 3i Certain® | 3.25 | 3.45 mm |
| 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm |
| 3.75, 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| FRIADENT XIVE® | 3.4 | 3.4 mm |
| 3.8 | 3.8 mm | |
| 4.5 | 4.5 mm | |
| 5.5 | 5.5 mm | |
| NobelActive®, | ||
| NobelReplace/NobelParallel Conical | 3.5 | NP (3.5 mm) |
| 4.3, 5.0 | RP (3.9 mm) | |
| 5.5 | WP (5.1 mm) | |
| NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm) |
| 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | |
| 6.0 | 6.0 (6.0 mm) | |
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) |
| 3.75, 4.0 | RP (4.1 mm) | |
| Osstem TS | 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) | |
| 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 |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person it to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Terrats Medical SL DESS Dental Smart Solutions
K203464
August 4, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
Barberà del Vallès
Barcelona, Spain | |
|---------------------------|--------------------------------------------------------------------------------------|--------------------|
| | Telephone | +34 935 646 006 |
| | Fax | +34 935 646 006 |
| Official Contact | Roger Terrats, COO | |
| Representative/Consultant | Floyd G. Larson, MS, MBA | |
| | 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: | FLarson@paxmed.com |
| | | KThomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name Common Name Regulation Number Regulation Name Regulatory Class Product Code
Classification Panel Reviewing Division
DESS Dental Smart Solutions Dental implant abutment 21 CFR 872.3630 Endosseous dental implant abutment Class II NHA
Dental Products Panel DHT1B: Division of Dental Devices
PREDICATE DEVICE INFORMATION
Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL
Additional Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL
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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 C-Base abutments 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 |
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm |
| Astra Tech EV | 3.6 | 2.9 mm |
| 4.2 | 3.5 mm | |
| 4.8 | 4.1 mm | |
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 mm |
| 4.5/5.0 | 4.5/5.0 mm | |
| Biomet 3i Certain® | 3.25 | 3.45 mm |
| 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm |
| 3.75, 4.0 | 4.1 mm | |
| 5.0 | 5.0 mm | |
| FRIADENT XIVE® | 3.4 | 3.4 mm |
| 3.8 | 3.8 mm | |
| 4.5 | 4.5 mm | |
| 5.5 | 5.5 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) | |
| NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm) |
| 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | |
| 6.0 | 6.0 (6.0 mm) | |
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) |
| 3.75, 4.0 | RP (4.1 mm) | |
| Osstem TS | 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) | |
| 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 |
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SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K191986 to add an additional series of titanium base components for previously cleared OEM implant platform compatibilities. The new components, referred to as C-Base engaging and C-Base non-engaging abutments, are available in a range of abutment gingival heights and abutment platform diameters. This submission includes abutments compatible with 33 implant platforms from 13 implant compatibilities have been cleared in previous Terrats Medical submissions. No new implant compatibilities are added in this submission. Screws used with the subject device C-Base abutments were cleared previously, with the exception of two screws added in this submission. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
The subject device DESS Dental Smart Solutions C-Base abutments are similar to TiBase Abutments cleared in K170588 and K191986. C-Base abutments are two-piece abutments designed to support a custom CAD/CAM zirconia superstructure on which a single-unit or multiunit restoration may be placed. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. The C-Base also may support a ceramic hybrid abutment (direct restoration) in which the crown is included in the design of the zirconia superstructure. They are available either in designs that engage with the anti-rotational feature of the implant or in non-engaging designs for multi-unit restorations. The C-Base post is 4.7 mm high. The gingival height of the abutment (distance from implant platform to abutment platform) ranges from 0.3 mm to 3.0 mm. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. C-Base abutments are made of titanium alloy (Ti-6Al-4V) with anodization and a SelectGrip® surface, described below. When used for a direct crown, a POM burn-out sleeve, an exempt laboratory component that is not a subject of this submission, is available for laboratory fabrication of the prosthesis.
When the C-Base abutment is used with a CAD/CAM zirconia superstructure, or for a direct restoration, design parameters are identical to those cleared in K191986 and in K170588, except that the minimum post height for the subject device is 4.7 mm. The superstructure or direct restoration design parameters are:
Minimum wall thickness – 0.4 mm Minimum post height for single-unit loading - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Zirconia superstructures and direct restorations are not intended for angulation correction.
Manufacture of the CAD/CAM zirconia superstructure is to be performed at a Terrats Medical validated milling center, defined as a facility that is registered with FDA as a manufacturer or contract manufacturer.
Each abutment is supplied with the appropriate abutment screw for attachment to the corresponding implant. DESS Dental Smart Solutions screws are designed to attach the abutment or restoration to the implant. With the exception of two new subject device screws, all screws were cleared in previous Terrats Medical submissions. As discussed above, the two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
All subject device abutments and subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra
6
Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Zirconia superstructures for C-Base abutments are made of Y-TZP conforming to ISO 13356 Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
Abutments are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color. They also are treated with the SelectGrip® surface to improve adhesion of the cement that is used to attach the superstructure or restoration to the C-Base abutment. The gold anodized surface treatment is identical to that cleared in K191986 and the SelectGrip surface treatment is identical to that cleared in K191986 and K170588. All the subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K191986 and K170588.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 17665-2 referenced from the primary predicate device and the sponsor's additional predicate device; biocompatibility according to ISO 10993-5 and ISO 10993-12 referenced from the primary predicate device and the sponsor's additional predicate device; and reverse engineering analysis of OEM implant bodies, OEM abutment, and OEM abutment screws to confirm compatibility, referenced from the primary predicate device and the additional predicate device. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants. Because the minor differences between the designs of these two subject device screws and corresponding screws cleared in K170588 and K191986 are not related to implant compatibility, no new OEM analysis was needed. 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 TiBase abutments of the primary predicate device and the sponsor's additional predicate device 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, and the additional predicate device.
Subject device abutments are substantially equivalent in intended use to the TiBase abutments of the primary predicate device cleared in K191968 and the additional predicate device cleared in K170588. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation. The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate K191986 and the additional predicate K170588, except for the specific name of the subject device and the list of compatible OEM implants.
All subject device abutments are similar in design and are identical in materials and technological characteristics to the TiBase abutments of the primary predicate K191986. All are titanium base abutments intended to be completed by attaching a zirconia superstructure fabricated from Y -TZP conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) that is manufactured at a validated milling center - a facility that is registered with FDA as a manufacturer and is approved by Terrats Medical as a contract manufacturer.
7
The only differences between the subject devices and the TiBase abutments of the primary predicate device are slight dimensional differences in the abutment to which the zirconia superstructure is cemented. These differences include a slightly greater post height for the subject devices (4.7 mm vs. 4.2 mm), the addition of retention grooves to the post of the subject device and a slight taper in the coronal portion of the subject device. These differences are accommodated by corresponding differences in the design of the zirconia superstructure. These differences do not affect the worst-case design parameters of the corresponding superstructures and do not have any effect on substantial equivalence.
All implant compatibilities for subject devices are included among those for primary predicate devices in K191986 and for additional predicate devices in K170588. Because compatibility has been demonstrated in these predicate submissions, this submission does not include compatibility analysis.
The SelectGrip® surface on subject C-Base abutments is identical to the SelectGrip surface on equivalent abutments cleared in the primary predicate K191986 and in the additional predicate K170588.
The gold anodized surface on subject C-Base abutments is identical to the anodized surface on Aurum Abutments of the primary predicate K191986.
The two subject device screws are substantially equivalent in design, materials, and technological characteristics to those cleared in the primary predicate K191986 and additional predicate K170588. The new screw designs incorporate only changes related to the new geometries of the subject abutments and are not related to any mating features with the OEM devices.
Digital files for all CAD/CAM superstructures must be sent to a validated milling center for manufacture. DESS C-Base abutments are for fabrication of straight custom abutments only.
The subject device is to be sterilized by the end-user, the same as primary predicate device K191986 and additional predicate device K170588.
All the subject device components are manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Terrats Medical components previously cleared in K191986 and K170588. Therefore, no new biocompatibility testing has been performed, as the subject device is substantially equivalent to the predicate devices in K191986 and K170588 with regard to materials and processing.
Minor differences in the designs, dimensions or sizes among the subject device, the primary predicate device, and the additional predicate device do not affect substantial equivalence. These minor differences do not impact substantial equivalence because the only differences are in the portion of the abutment to which the CAD/CAM zirconia superstructure is attached.
CONCLUSION
The subject device, the primary predicate device, and the sponsor's additional predicate device have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device and the primary predicate device encompass the same range of physical dimensions, are packaged in the same materials, and are to be sterilized using the same methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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| 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 C-Base abutments 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 | ||
| 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 | ||
| 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 | ||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm | |
| 3.75, 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | ||
| FRIADENT XIVE® | 3.4 | 3.4 mm | |
| 3.8 | 3.8 mm | ||
| 4.5 | 4.5 mm | ||
| 5.5 | 5.5 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® | |||
| (Internal tri-channel) | 4.3 | RP (4.3 mm) | |
| 5.0 | WP (5.0 mm) | ||
| 6.0 | 6.0 (6.0 mm) | ||
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) | |
| 3.75, 4.0 | RP (4.1 mm) | ||
| Osstem TS | 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) | ||
| 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 | ||
| Primary Predicate | |||
| Device | Indications for Use Statement | ||
| 191986, | |||
| 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 abutments or Pre-milled | |||
| (Blank) abutments 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 | |||
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm | |
| Astra Tech EV | 3.6 | 2.9 mm | |
| 4.2 | 3.5 mm | ||
| 4.8 | 4.1 mm | ||
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 mm | |
| 3.5/4.0 | 3.5/4.0 mm | ||
| 4.5/5.0 | 4.5/5.0 mm | ||
| Biomet 3i Certain® | 3.25 | 3.45 mm | |
| 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | ||
| Biomet 3i OSSEOTITE® | 3.25 | 3.4 mm | |
| 3.75, 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | ||
| Camlog | 3.3 | 3.3 mm | |
| 3.8 | 3.8 mm | ||
| 4.3 | 4.3 mm | ||
| 5.0 | 5.0 mm | ||
| FRIADENT XIVE® | 3.4 | 3.4 mm | |
| 3.8 | 3.8 mm | ||
| 4.5 | 4.5 mm | ||
| 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®, | |||
| NobelParallel Conical | 3.5 | NP (3.5 mm) | |
| 4.3, 5.0 | RP (3.9 mm) | ||
| 5.5 | WP (5.1 mm) | ||
| NobelReplace® Trilobe | 3.5 | NP (3.5 mm) | |
| 4.3 | RP (4.3 mm) | ||
| 5.0 | WP (5.0 mm) | ||
| 6.0 | 6.0 (6.0 mm) | ||
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) | |
| 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) | ||
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) | |
| 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 |
Table of Substantial Equivalence – Indications for Use Statement
9
10
| Additional
Predicate
| Device | Indications for Use Statement | ||
|---|---|---|---|
| K170588, | |||
| 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 | Implant Diameter | Platform Diameter | |
| Compatibility | (mm) | (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 |
11
| Table of Substantial Equivalence – Technological Characteristics | |||
|---|---|---|---|
| Comparison | Subject Device | Primary Predicate | |
| Device | Additional Predicate | ||
| Device | |||
| DESS Dental | |||
| Smart Solutions | |||
| Terrats Medical | |||
| SL | K191986 | ||
| DESS Dental Smart | |||
| Solutions | |||
| Terrats Medical SL | K170588 | ||
| DESS Dental Smart | |||
| Solutions | |||
| Terrats Medical SL | |||
| Design | |||
| Abutment Design(s) | CAD/CAM | ||
| Bases | 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, | |||
| Prosthesis Attachment | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | |||
| Restoration | Single-unit, | ||
| Multi-unit | Single-unit, | ||
| Multi-unit | Single-unit, | ||
| Multi-unit | |||
| Abutment/Implant Platform | |||
| Diameter, mm | 2.52 - 6.5 | 2.52 - 6.5 | 3.3 - 6.5 |
| TiBase Post Height, mm | 4.7 | 4.2 | 4.2 |
| TiBase Post Diameter | 3.0 | 3.5 | 3.5 |
| Abutment/ Implant Interface | Internal, External | Internal, External | Internal, External |
| Final TiBase Abutment Design | |||
| Minimum Wall thickness, mm | 0.4 | 0.4 | 0.4 |
| Minimum Post Height (Single | |||
| Unit), mm | 4.7 | 4.0 | 4.2 |
| Minimum Gingival Height, mm | 0.5 | ||
| Maximum Gingival Height, mm | 6.0 | 6.0 | 6.0 |
| TiBase Abutment Angles | Straight (0°) | Straight (0°) | Straight (0°) |
| Material | |||
| Abutments | Ti-6Al-4V ELI, | ||
| Zirconia (Y-TZP) | Ti-6Al-4V ELI, | ||
| Co-Cr-Mo Alloy, | |||
| Zirconia (Y-TZP) | Ti-6Al-4V ELI, | ||
| Zirconia (Y-TZP) | |||
| Abutment Surface Treatment | Gold anodized, | ||
| SelectGrip | Gold anodized (DESS | ||
| Aurum), SelectGrip (Ti | |||
| Base - Interface) | SelectGrip | ||
| Screws | Ti-6Al-4V ELI | ||
| Without coating | Ti-6Al-4V ELI | ||
| With or without DLC | |||
| coating | Ti-6Al-4V ELI | ||
| With or without DLC | |||
| coating |