DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

Device Description

The purpose of this submission is to implement a labeling change for certain Pre-milled Blanks of the DESS Dental Smart Solutions abutment system, cleared under K170588, K173908 and K191986, to permit the manufacture of custom abutments with angulation up to 30° and to add three (3) Pre-milled Blanks that also will include such labeling. Design parameters cleared in K170588. K173908 and K191986 were limited to straight abutments only. This change in labeling is for Pre-milled Blanks compatible with three (3) systems: NobelParallel Conical Connection, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent implants. Note that, because NobelActive and Nobel Parallel Conical Connection share the same implant/abutment interface, they are considered one system for purposes of this submission, as they were in K170588, K173908 and K191986. No new compatibilities are added in this submission.

Pre-milled Blanks are designed for fabrication of a custom abutment by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Nobelcompatible Pre-milled Blanks are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELL (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from cobalt chromium alloy (Co-Cr-Mo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539. Straumann-compatible and Zimmercompatible Pre-milled Blanks are made of titanium alloy (Ti-6Al-4V). They are available in engaging designs and are compatible with the implant systems shown the table below Compatible Implant Systems and Platforms. Except for the maximum angulation of the final abutment and the addition of three (3) Pre-milled Blanks of 14 mm diameter to the previously cleared Pre-milled Blanks of 10 mm and 14 mm diameter, subject device Pre-milled Blanks are identical to Pre-milled Blanks cleared (with slight variations on the name) in K170588, K173908 and K191986. Compatibility with the implant platform was demonstrated in K170588 and K191986.

The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:

Minimum wall thickness - 0.45 mm Minimum post height – 4.0 mm
Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°

Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DESS Dental Smart Solutions, formatted as requested.

The provided document is a 510(k) summary for a medical device (DESS Dental Smart Solutions). It focuses on demonstrating substantial equivalence to previously cleared devices, particularly for a labeling change allowing custom abutments with angulation up to 30 degrees.

It's important to note that this document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a detailed performance study report would. Instead, it leverages prior clearances and non-clinical testing to argue for substantial equivalence.

The acceptance criteria provided here are implied by the comparison to predicate devices and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for an existing device with a labeling change, the "acceptance criteria" are more about demonstrating equivalence and safety/performance as established by the predicate device and relevant standards. The "reported device performance" refers to the results that support this equivalence.

Acceptance Criteria (Implied)	Reported Device Performance	Comments
Mechanical Strength & Fatigue Resistance: Device withstands forces encountered during function, demonstrated by meeting ISO 14801 standards for dynamic fatigue.	Non-clinical static and dynamic testing according to ISO 14801 performed.	This testing specifically addressed the change in labeling to allow up to 30° angulation for custom abutments.
Biocompatibility: Device materials are safe for use within the human body.	Information leveraged from prior clearances (K170588 and K173908) to demonstrate substantial equivalence.	No new biocompatibility testing was performed for this specific submission as materials were unchanged.
Sterilization: Device can be effectively sterilized by the end-user.	Device is to be sterilized by the end-user, same as predicate devices.	This aspect was deemed equivalent to predicate devices.
Material Composition: Materials conform to established medical device standards.	Materials (Ti-6Al-4V ELI & Co-Cr-Mo alloy) conform to ASTM F136 and ASTM F1537 standards.	Materials were either identical to or within the scope of materials used in predicate devices.
Design Parameters: Custom abutments can be manufactured within safe and functional limits (e.g., wall thickness, post height, gingival height, angulation).	Max angulation up to 30° demonstrated by dynamic testing per ISO 14801 and comparison to reference device K183518. Other parameters (min wall thickness, min/max post/gingival height) are specified and implicitly met based on design validation (not explicitly detailed in this summary).	The key change and associated performance data here is the 30° angulation.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a "test set" in the context of a dataset of patient images or outcomes. The performance data primarily refers to non-clinical testing (e.g., mechanical tests on physical samples).
- For the ISO 14801 dynamic fatigue testing, the number of physical samples tested is not explicitly stated in this summary. It would typically be a pre-defined number per test arm as per the standard to achieve statistical significance for the specific test.
Data Provenance: The data provenance mentioned is related to:
- Prior clearances (K170588 and K173908): This refers to previously submitted and cleared devices, implying existing data on biocompatibility and other baseline characteristics. This is a form of retrospective leveraging of previously reviewed data.
- Non-clinical lab testing (ISO 14801): This testing would have been conducted in a laboratory setting, specific to the device design for this submission. The origin (country/lab) of this specific testing isn't mentioned in the summary, but it would be part of the full submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes non-clinical performance data and substantial equivalence to predicate devices, not a study involving human expert interpretation of data or images. The "ground truth" here is established by engineering standards (e.g., ISO 14801) and material specifications (e.g., ASTM standards).

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. There is no human interpretation or adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical data and substantial equivalence arguments for a physical dental device, not an AI or imaging-related device requiring human reader performance evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical dental abutment, not an algorithm or software. "Standalone performance" in this context refers to the device's mechanical and material performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device, in terms of its safety and effectiveness, is established by:

Engineering Standards: Specifically, ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) for mechanical performance.
Material Standards: ASTM F136 and ASTM F1537 for material biocompatibility and mechanical properties.
Predicate Device Performance: The underlying ground truth is based on the previously established safety and effectiveness of the legally marketed predicate devices, which this new device is deemed substantially equivalent to. This is a regulatory "ground truth" rather than a clinical or pathological one.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental abutment, not a machine learning model. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Terrats Medical SL % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K212577

Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 8, 2021 Received: November 9, 2021

Dear Melissa Burbage:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212577

Device Name

DESS Dental Smart Solutions Indications for Use (Describe)

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

Compatible Implant Systems
Compatible Implant System	Implant Body Diameter,mm	Implant Platform
NobelActive®, NobelParallelConical	3.5	NP
	4.3, 5.0	RP
	5.5	WP
Straumann® Bone Level	3.3	NC
	4.1/4.8	RC
Zimmer Screw Vent®/ TaperedScrew-Vent®	3.7, 4.1	3.5
	4.7	4.5
	6.0	5.7

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------

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510(k) Summary

Terrats Medical SL DESS® Dental Smart Solutions K212577

December 10, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	Terrats Medical SLCarrer Mogoda, 75-9908210 Barberà del VallèsBarcelona, Spain
Telephone	+34 935 646 006
Official Contact	Roger Terrats, CEO
Representative/Consultant	Melissa Burbage, BSFloyd G. Larson, MS, MBAKevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email mburbage@paxmed.com flarson@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	DESS Dental Smart Solutions
Common Name	Dental implant abutment
Regulation Number	21 CFR 872.3630
Regulation Name	Endosseous dental implant abutment
Regulatory Class	Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Division	DHT1B: Division of Dental Devices

PREDICATE DEVICE INFORMATION

Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL

Additional Predicate Devices K170588, DESS Dental Smart Solutions, Terrats Medical SL K173908, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices K193425, Pre-Milled Blank, ARUM Dentistry Co. Ltd K183518, Preat Abutments, Preat Corporation

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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 Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

Compatible Implant System	Implant BodyDiameter, mm	Implant Platform
NobelActive®, NobelParallelConical	3.5	NP
	4.3, 5.0	RP
	5.5	WP
Straumann® Bone Level	3.3	NC
	4.1/4.8	RC
Zimmer Screw-Vent®/ TaperedScrew-Vent®	3.7, 4.1	3.5
	4.7	4.5
	6.0	5.7

Compatible Implant Systems

SUBJECT DEVICE DESCRIPTION

The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:

Minimum wall thickness - 0.45 mm Minimum post height – 4.0 mm

{5}------------------------------------------------

Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°

Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.

Compatible ImplantSystem	DESS AbutmentSystem	Implant BodyDiameter, mm	Implant Platform	Connection
NobelActive®,NobelParallel Conical	Active Hex	3.5	NP	Internal
		4.3, 5.0	RP	Internal
		5.5	WP	Internal
Straumann® BoneLevel	Conical BL	3.3	NC	Internal
		4.1/4.8	RC	Internal
Zimmer Screw-Vent®/Tapered Screw-Vent®	Internal Hex USA	3.7, 4.1	3.5	Internal
		4.7	4.5	Internal
		6.0	5.7	Internal

Compatible Implant Systems and Platforms

PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included: static and dynamic testing according to ISO 14801. Information was leveraged from prior clearance (K170588 and K173908) to demonstrate substantial equivalence with regards to sterilization and biocompatibility. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the additional predicate devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, the additional predicate devices, and the reference devices.

Subject device abutments are substantially equivalent in intended use to the primary predicate device cleared in K191986, the additional predicate devices K173908 and the reference device K 193425. All are intended for use with endosseous dental implants to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K191986 and additional predicate devices K170588 and K173908.

All subject device abutments are identical in design, materials, and technological characteristics to those of the primary predicate K191986 and additional predicate devices K170588 and K173908. The only change to the subject device is a labeling change to permit custom abutments to be manufactured from the Pre-milled Blanks with an angulation up to 30°, which is substantially equivalent to that of the reference device K193425, and the addition of three new Pre-milled Blanks of 14 mm diameter to the Pre-milled Blanks of 10 mm and 14 mm diameter previously cleared for the predicate devices. No new compatibilities are included in this submission.

Substantial equivalence of the subject device with design parameters that permit angulation of the final abutment is supported by dynamic testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and by the reference device K183518.

The subject device is to be sterilized by the end-user, the same as primary predicate device K191986 and additional predicate devices K170588 and K173908.

{6}------------------------------------------------

CONCLUSION

The subject device, the primary predicate device, additional predicate devices, and the reference devices have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate, and the additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

{7}------------------------------------------------

Subject Device	DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants inthe maxillary or mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Pre-milled Blanks are to be sent to a Terrats Medicalvalidated milling center for manufacture.
DESS Dental Smart Solutions
K212577
Terrats Medical SL
Compatible Implant Systems
Compatible Implant System	Implant Body Diameter, mm	Implant Platform
NobelActive®, NobelParallel Conical	3.5	NP
	4.3, 5.0	RP
	5.5	WP
Straumann® Bone Level	3.3	NC
	4.1/4.8	RC
Zimmer Screw Vent®/ TaperedScrew-Vent®	3.7, 4.1	3.5
	4.7	4.5
	6.0	5.7
Primary Predicate Device	DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants inthe maxillary or mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Ti Base abutments or Pre-milled (Blank) abutments are to besent to a Terrats Medical validated milling center for manufacture.
K191986
DESS Dental Smart Solutions
Terrats Medical SL
Compatible Implant Systems
Compatible Implant System	Implant Body Diameter, mm	Implant Platform
Ankylos C/X	3.5, 4.5, 5.5	2.52 mm
	3.6	2.9 mm
Astra Tech EV	4.2	3.5 mm
	4.8	4.1 mm
	3.0	3.0 mm
Astra Tech OsseoSpeed™	3.5/4.0	3.5/4.0 mm
	4.5/5.0	4.5/5.0 mm
	3.25	3.45 mm
Biomet 3i Certain®	4.0	4.1 mm
	5.0	5.0 mm
	3.25	3.4 mm
Biomet 3i OSSEOTITE®	3.75, 4.0	4.1 mm
	5.0	5.0 mm
	3.3	3.3 mm
	3.8	3.8 mm
Camlog	4.3	4.3 mm
	5.0	5.0 mm
	3.4	3.4 mm
FRIADENT XiVE®	3.8	3.8 mm
	4.5	4.5 mm

Table of Substantial Equivalence – Indications for Use Statement

{8}------------------------------------------------

			5.5	5.5 mm
		MegaGen AnyRidge	3.5, 4.0, 4.5, 5.0, 5.5	3.5 mm
			3.0	3.0 (3.0 mm)
		NobelActive®,	3.5	NP (3.5 mm)
		NobelReplace/NobelParallel Conical	4.3, 5.0	RP (3.9 mm)
			5.5	WP (5.1 mm)
			3.5	NP (3.5 mm)
		NobelReplace® Trilobe	4.3	RP (4.3 mm)
			5.0	WP (5.0 mm)
			6.0	6.0 (6.0 mm)
			3.3	NP (3.5 mm)
		Nobel Brånemark System®	3.75, 4.0	RP (4.1 mm)
			5.0	WP (5.1 mm)
		Osstem TS	3.5	Mini (2.8 mm)
			4.0, 4.5, 5.0, 6.0, 7.0	Regular (3.35 mm)
		Straumann® Bone Level	3.3	NC (3.3 mm)
			4.1/4.8	RC (4.1/4.8 mm)
			3.3	NNC (3.5 mm)
		Straumann® Tissue Level	3.3, 4.1, 4.8	RN (4.8 mm)
			4.8	WN (6.5 mm)
		Zimmer Screw Vent®/ Tapered Screw-Vent®	3.3, 3.7, 4.1	3.5 mm
			4.7	4.5 mm
			6.0	5.7 mm
		DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in
Additional Predicate Device		the maxillary or mandibular arch to provide support for prosthetic restorations.

	All digitally designed custom abutments for use with Ti Base or Pre-milled (Blank) abutments are to be sent to a
K170588		Terrats Medical validated milling center for manufacture.
	Compatible Implant Systems
DESS Dental Smart Solutions
Terrats Medical SL		Implant System Compatibility	Implant Diameter (mm)	Platform Diameter (mm)
		3i Certain®	3.25, 4.0, 5.0	3.4, 4.1, 5.0
		3i OSSEOTITE®	3.25, 3.75, 4.0, 5.0	3.4, 4.1, 5.0
		OsseoSpeed™	3.5, 4.0, 5.0	3.5/4.0, 4.5/5.0
		FRIADENT XiVE	3.4, 3.8, 4.5	3.4, 3.8, 4.5
		NobelActive®	3.5, 4.3, 5.0	NP, RP
		NobelReplace Conical	3.5, 4.3, 5.0	NP, RP
		Nobel Replace Trilobe	3.5, 4.3, 5.0	NP, RP, WP
		Brånemark	3.5, 3.75/4.0, 5.0	NP, RP, WP
		Straumann® Bone Level	3.3, 4.1, 4.8	NC, RC

		Straumann® Tissue Level	3.3, 4.1, 4.8	RN, WN
		Tapered Screw-Vent®	3.7, 4.1, 4.7, 6.0	3.5, 4.5, 5.7

{9}------------------------------------------------

Additional Predicate Device	DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants inthe maxillary or mandibular arch to provide support for prosthetic restorations.All digitally designed custom abutments for use with Aurum TM Abutment or Pre-milled Blank are to be sent to aTerrats Medical validated milling center for manufacture.
K173908	Compatible Implant Systems
DESS Dental Smart SolutionsTerrats Medical SL	Implant System Compatibility	Implant Body	Implant Platform
	3i Certain®	3.25, 4.0, 5.0	3.4, 4.1, 5.0
	3i OSSEOTITE®	3.25, 3.75, 4.0, 5.0	3.4, 4.1, 5.0
	OsseoSpeedTM	3.5, 4.0, 5.0	3.5/4.0, 4.5/5.0
	FRIADENT XiVE	3.4, 3.8, 4.5	3.4, 3.8, 4.5
	NobelActive®	3.5, 4.3, 5.0	NP, RP
	NobelReplace® Conical	3.5, 4.3, 5.0	NP, RP
	NobelReplace® Trilobe	3.5, 4.3, 5.0	NP, RP, WP
	Brånemark	3.5, 3.75/4.0, 5.0	NP, RP, WP
	Straumann® Bone Level	3.3, 4.1, 4.8	NC, RC
	Straumann® Tissue Level	3.3, 4.1, 4.8	RP, WP
	Tapered Screw-Vent®	3.7, 4.1, 4.7, 6.0	3.5, 4.5, 5.7
Reference Device	ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to providesupport for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained singlerestorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment willbe attached to a dental implant using the included ARUM Dentistry prosthetic screw.
K193425
Pre-Milled BlankARUM Dentistry Co. Ltd	ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table:
	Compatibility Table
	ARUM Pre-Milled Blank		Implant Platformcompatibility	RestorativePlatformDiameter (mm)	Implant Bodydiameter (mm)	Abutment Screw
	10 mm	14 mm
	CIHE037	CIHE038	NobelActive NP	3.5	3.5	CSTO001
	CIHE039	CIHE040	NobelActive NP	3.9	4.3/5.0	CSTO002
	CIHE135	CIHE136	NobelActive WP	5.1	5.5
	All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated millingcenter for manufacture.

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



Compatible Implant System	Implant Body Diameter (mm)	Implant Platform Diameter (mm)
3i OSSEOTITE® Certain®	3.25	3.4
	4.0	4.1
	5.0	5.0
	6.0	6.0
Astra Tech OsseoSpeed™	3.0	3.0
	3.5, 4.0	3.5/4.0
	4.5, 5.0	4.5/5.0
BioHorizons Tapered Internal	3.0	3.0
	3.5	3.5
	4.0	4.5
HIOSSEN ET III	3.5	Mini
	4.0, 4.5, 5.0, 6.0, 7.0	Regular
Implant Direct Legacy	3.2	3.0
	3.7, 4.2	3.5
	4.7, 5.2	4.5
	5.7, 7.0	5.7
MegaGen AnyRidge	3.5, 4.0, 4.5, 5.0, 5.5	3.5
Neoss	3.5, 4.0, 4.5, 5.0, 5.5	4.1
NobelActive®	3.5	NP
	4.3, 5.0	RP
Nobel Replace™	3.5	NP
	4.0, 4.3, 5.0	RP
	5.0	WP
	6.0	6.0
Straumann® Bone Level	3.3	NC
	4.1, 4.8	RC
Straumann® Tissue Level	3.3, 4.1, 4.8	RN
	4.8, 6.5	WN
Zimmer Screw-Vent®/Tapered Screw-Vent®	3.3, 3.7, 4.1	3.5
	4.7	4.5
	6.0	5.7

{11}------------------------------------------------

Comparison	Subject Device	Primary PredicateDevice	Additional Predicate Devices	Reference Devices
	K212577DESS Dental SmartSolutionsTerrats Medical SL	K191986DESS Dental SmartSolutionsTerrats Medical SL	K170588DESS Dental SmartSolutionsTerrats Medical SL	K173908DESS Dental SmartSolutionsTerrats Medical SL	K193425Pre-Milled BlankARUM DentistryCo. Ltd	K183518Preat AbutmentsPreat Corporation
Reason forPredicate	n/a	Design	Design	Design	30° angle	PerformanceTesting
Design
Abutment Designs	CAD/CAM Blanks	Healing,Temporary,Straight, Multi-unit,Locator-type,CAD/CAM Bases,CAD/CAM Blanks	Healing, Temporary,Straight, Multi-unit,Locator-type,CAD/CAM Bases,CAD/CAM Blanks	CAD/CAM Bases,CAD/CAM Blanks	CAD/CAMBlanks	Healing,Temporary,Straight, Multi-unit,CAD/CAM Bases,CAD/CAM Blanks
ProsthesisAttachment	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retainedScrew-retained	Cement-retained	Cement-retainedScrew-retained
Restoration	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit	Single-unit,Multi-unit
Abutment/ImplantPlatformDiameter, mm	2.52 - 6.0	2.52 - 6.0	3.0-6.0	3.6 - 5.0	3.5 - 5.5	3.0 - 6.5
Prosthetic PlatformDiameter, mm	4.5 – 6.5	4.5-6.5	4.5	4.0 - 6.5	3.5 - 5.1	3.0 - 6.5
Blank AbutmentAngulation	0° to 30°	0°	0°	0°	0° to 30°	0° to 30°
Abutment/ ImplantInterface	Internal	Internal	Internal	Internal	Internal	Internal
Material	Ti-6Al-4V ELICo-Cr-Mo Alloy	Ti-6Al-4V ELICo-Cr-Mo Alloy	Ti-6Al-4V ELI	Ti-6Al-4V ELICo-Cr-Mo Alloy	Ti-6Al-4V ELI	Ti-6Al-4V alloy

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.)