DESS Dental Smart Solutions abutments are in conjunction with endosseus dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "DESS Dental Smart Solutions" (K203464), which are endosseous dental implant abutments. The submission aims to expand the existing product line by adding new titanium base components (C-Base engaging and C-Base non-engaging abutments) compatible with previously cleared OEM implant platforms.

The core of the submission argues for substantial equivalence to predicate devices (K191986 and K170588). This means the device does not require a new approval process if it's shown to be as safe and effective as a legally marketed device. In this context, comprehensive studies with specific acceptance criteria are usually not required in the same way they would be for a novel device. Instead, the focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text for your requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in terms of performance statistics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor are there reported device performance metrics in that sense. Instead, the acceptance criteria are implicit in demonstrating that the new device meets the same safety and effectiveness standards as the predicate devices, which is achieved through a comparison of technological characteristics and non-clinical data.

The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, rather than a standalone clinical efficacy study.

Here's a table summarizing the relevant points:

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance / Justification
Material Equivalence	Subject device abutments and screws are made of Ti-6Al-4V ELI (ASTM F136), and zirconia superstructures are made of Y-TZP (ISO 13356). Performance: These materials are identical to those used in the predicate devices (K191986 and K170588), establishing material equivalence and safety.
Biocompatibility	References biocompatibility according to ISO 10993-5 and ISO 10993-12 from the primary and additional predicate devices. Performance: No new biocompatibility testing was performed as the subject device is substantially equivalent to predicate devices regarding materials and processing, indicating safety based on previously established standards.
Sterilization Validation	References sterilization validation according to ISO 17665-1 and ISO 17665-2 from the primary and additional predicate devices.Performance: The device is to be sterilized by the end-user using the same methods as the predicate devices, indicating validated sterilization procedures.
Design Principles & Intended Use Equivalence	The subject device shares similar design principles and identical intended use with the predicate devices: "intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations." Performance: Minor dimensional differences (e.g., slightly greater post height of 4.7 mm vs. 4.2 mm, addition of retention grooves, slight taper) do not affect worst-case design parameters or substantial equivalence. Limited new screws were added with minor design changes unrelated to implant compatibility.
Manufacturing Process & Facilities Equivalence	All subject device components are manufactured from the same materials, treated with the same surface treatments, and manufactured in the same facilities using the same processes as previously cleared predicate devices. Performance: Ensures consistent quality and safety standards as established for predicate devices.
CAD/CAM Zirconia Superstructure Design Parameters	Minimum wall thickness – 0.4 mmMinimum post height for single-unit loading - 4.7 mmMinimum gingival height - 0.5 mmMaximum gingival height - 6.0 mm (These parameters are largely consistent with predicates, with slight adjustment to minimum post height to accommodate the new C-Base design without affecting worst-case scenarios). Performance: These parameters, combined with manufacturing at a Terrats Medical validated milling center, ensure satisfactory design and structural integrity of the final restoration.
Implant System Compatibility (No new compatibilities)	The subject device is compatible with 33 implant platforms from 13 implant compatibilities already cleared in previous Terrats Medical submissions. Performance: Compatibility has been demonstrated in these predicate submissions, and no new compatibility analysis was needed. This confirms the device functions as intended with established implant systems.
Surface Treatments Equivalence	Gold anodized surface treatment (identical to K191986) and SelectGrip® surface treatment (identical to K191986 and K170588). Performance: Ensures the same surface properties, adhesion, and biocompatibility as previously cleared and proven treatments.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document explicitly states, "No clinical data were included in this submission." The evaluation for substantial equivalence relied on non-clinical data (sterilization validation, biocompatibility, reverse engineering analysis). Therefore, there is no "test set" in the sense of patient data for performance evaluation in this submission.
Data Provenance: The biocompatibility and sterilization validation data referenced are from the predicate devices (K191986 and K170588), which were previously submitted. The reverse engineering analysis was performed on OEM implant bodies, OEM abutments, and OEM abutment screws. The manufacturer, Terrats Medical SL, is located in Barcelona, Spain. The specific country of origin for the referenced predicate data is not detailed, but it would have been part of their previous FDA submissions. The data is retrospective in the sense that it relies on previously generated and accepted data for the predicate devices and existing OEM components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical data or clinical test set was used, there was no need for experts to establish ground truth from patient data. The evaluation was based on engineering and materials science principles, and reference to previously cleared devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental implant abutment, a physical component, and does not involve AI or "human readers" in its intended use or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical data, the "ground truth" essentially refers to established engineering standards, material specifications (e.g., ASTM F136, ISO 13356), and regulatory requirements (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). The substantial equivalence argument relies on the device meeting these established standards, which serve as the implicit "ground truth" for material properties, biocompatibility, and manufacturing quality. The "ground truth" for compatibility was established through reverse engineering analysis of OEM implant bodies and comparison to previously cleared predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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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.

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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

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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)

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

K203464

August 4, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	Terrats Medical SLCarrer Mogoda, 75-99Barberà del VallèsBarcelona, 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

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

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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).

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.

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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 SmartSolutionsTerrats Medical SL	DESS Dental Smart Solutions abutments are intended to be used in conjunction withendosseous dental implants in the maxillary or mandibular arch to provide support forprosthetic restorations.
	All digitally designed custom abutments for use with C-Base abutments are to be sent toa Terrats Medical validated milling center for manufacture.
	Compatible Implant Systems
	Compatible Implant System	Implant BodyDiameter, 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/NobelParallelConical	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 PredicateDevice	Indications for Use Statement
191986,DESS Dental SmartSolutionsTerrats Medical SL	DESS Dental Smart Solutions abutments are intended to be used in conjunction withendosseous dental implants in the maxillary or mandibular arch to provide support forprosthetic 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 formanufacture.
Compatible Implant Systems
Compatible Implant System	Implant Body Diameter, mm	ImplantPlatform
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®/ TaperedScrew-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

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{10}------------------------------------------------

AdditionalPredicateDevice	Indications for Use Statement
K170588,DESSDentalSmartSolutionsTerratsMedical SL	DESS Dental Smart Solutions abutments are intended to be used in conjunction withendosseous dental implants in the maxillary or mandibular arch to provide support forprosthetic restorations.All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to besent 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

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Table of Substantial Equivalence – Technological Characteristics
Comparison	Subject Device	Primary PredicateDevice	Additional PredicateDevice
	DESS DentalSmart SolutionsTerrats MedicalSL	K191986DESS Dental SmartSolutionsTerrats Medical SL	K170588DESS Dental SmartSolutionsTerrats Medical SL
Design
Abutment Design(s)	CAD/CAMBases	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-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retainedScrew-retained
Restoration	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit
Abutment/Implant PlatformDiameter, 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 (SingleUnit), 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 (DESSAurum), SelectGrip (TiBase - Interface)	SelectGrip
Screws	Ti-6Al-4V ELIWithout coating	Ti-6Al-4V ELIWith or without DLCcoating	Ti-6Al-4V ELIWith or without DLCcoating

Table of Substantial Equivalence – Technological Characteristics

Regulation Number and Section

§ 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.)