DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

Device Description

The purpose of this submission is to obtain marketing clearance for two designs of DESS Dental Implants. The implants are compatible with DESS Dental Smart Solutions abutments manufactured by the sponsor of this submission, Terrats Medical SL and cleared under K170588, K173908 and K191986. The new dental implants are parallel-walled root-form threaded endosseous dental implants made from unalloyed titanium, ranging in diameter from 3.0 mm to 5.5 mm and in length from 7 mm to 18 mm, as described more fully below.

This submission includes two designs of DESS Dental Implants, designated Active and Bone Level. The external portion of each design is threaded, with a uniform major diameter and a slightly decreasing minor diameter along the length of the apical portion of each is tapered and includes cutting flutes to facilitate the insertion of the implant into the alveolar bone. Both designs have an internal connection, an internal anti-rotation feature (used for engaging abutment designs) that also serves to facilitate insertion into bone, and an internal screw channel to secure an abutment. Differences between the designs include the type of antirotational feature which, in the Active implant is an internal hex and in the Bone Level implant is an internal 4-lobed design. The external thread of the Active implant ends below the crest of the implant and a machined collar with shallow grooves is located between the end of the external thread and the crest of the implant. The external thread of the Bone Level implant ends below the crest of the implant, and the collar is included in the surface treatment. The endosseous surface of each implant is treated with a grit blasting and acid etching process to provide a rough surface for attachment of bone.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the DESS Dental Implants. This is a regulatory submission for a medical device seeking substantial equivalence to already legally marketed devices, not a study proving the device meets acceptance criteria derived from a clinical trial or algorithm performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly applicable to this type of regulatory submission. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and non-clinical performance data, rather than establishing efficacy or accuracy through human reader studies or similar clinical investigations.

However, I can extract the relevant information from the document as it pertains to the device's characteristics and the non-clinical performance data provided to support its safety and effectiveness relative to predicate devices.

Here's a breakdown of what can be extracted based on your request, with an explanation of why some fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical data, there are no specific "acceptance criteria" in the sense of performance metrics from a diagnostic study, nor is there "reported device performance" in terms of clinical accuracy or reader improvement. Instead, the device's characteristics are compared to predicate devices, and testing ensures it meets established engineering and safety standards.

Characteristic / Test	Acceptance Criterion (Implicitly, Substantial Equivalence to Predicate)	Reported Device Performance (Compliance)
Material	Unalloyed titanium conforming to ISO 5832-2	Unalloyed titanium conforming to ISO 5832-2
Sterilization	Sterility Assurance Level (SAL) of 10^-6 via gamma irradiation	Achieved SAL of 10^-6 with 25 kGy dose (ISO 11137-1 and 11137-2 VDmax 3 method)
Bacterial Endotoxin	Limit of < 20 EU/device	< 20 EU/device (ANSI/AAMI ST72 LAL test)
Cytotoxicity	Non-cytotoxic	Non-cytotoxic (ISO 10993-5 and 10993-12 MEM elution)
Shelf Life	Maintain sterile barrier and product sterility for specified duration	Demonstrated 5 years (accelerated aging per ASTM F1980)
Surface Characterization	Rough surface for bone attachment, verified chemistry	Surface roughness measured (ISO 25178), surface chemistry analyzed (XPS)
Static and Dynamic Mechanical Testing	Meet performance standards for dental implants (ISO 14801)	Performed according to ISO 14801 on worst-case configurations (smallest diameter implant with specific abutment configuration)
Design Principles	Similar to predicate devices	Similar design, thread form, dimensions, anti-rotational features to NobelActive and Straumann implants
Physical Dimensions	Within range or same as predicate devices	Within range or same as predicate devices (diameters, lengths, platform sizes)
Intended Use	Substantially equivalent to predicate device Indications for Use	Substantially equivalent, with minor linguistic differences that do not affect intended use. Specific limitations for small diameter implants mentioned.

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

This information is not provided in the document as it refers to non-clinical bench testing, not a clinical test set from human data. The tests performed (sterilization, endotoxin, cytotoxicity, shelf-life, surface characterization, mechanical testing) would have involved a specific number of manufactured devices or material samples. The provenance is internal to the manufacturer's testing or contract labs.

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

Not applicable. There is no "test set" in the context of human data requiring expert ground truth in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human data requiring adjudication in this 510(k) submission.

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 is a medical device for surgical placement (dental implant), not an AI-powered diagnostic tool. No MRMC studies were performed or are relevant to this submission.

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

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

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" would be established by:

Standards Compliance: Meeting the specifications of international standards (ISO 11137, ANSI/AAMI ST72, ISO 10993, ASTM F1980, ISO 25178, ISO 14801).
Material Specifications: Conforming to recognized material standards (ISO 5832-2).
Engineering Specifications: The design and functional requirements of the implant itself (e.g., thread form, dimensions, anti-rotational features).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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 & 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 blue square is the text "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: K212538

Trade/Device Name: DESS Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 9, 2021 Received: November 10, 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 andENT 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)

K212538

Device Name

DESS Dental Implants

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
X 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 Implants

December 13, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	Terrats Medical SL
	Carrer Mogoda, 75-99 Barberà del Vallès
	08210 Barcelona, Spain
Telephone	+34 935 646 006
Official Contact	Roger Terrats, CEO
Representative/Consultant	Floyd G. Larson, MS, MBA
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone	+1 858-792-1235
	Fax	+1 858-792-1236
	Email	flarson@paxmed.com
		kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	DESS® Dental Implants
Common Name	Dental implant
Regulation Number	21 CFR 872.3640
Regulation Name	Endosseous dental implant
Regulatory Class	Class II
Product Code	DZE
Classification Panel	Dental Products Panel
Reviewing Division	DHT1B: Division of Dental Devices

PREDICATE DEVICE INFORMATION

Primary Predicate Device K142260, NobelActive®, Nobel Biocare AB

Additional Predicate Devices K140878, Straumann® Bone Level Tapered Implants Titanium SLA, Straumann USA, LLC K171784, Straumann® Dental Implant System, Straumann USA, LLC K212125, Nobel Biocare Dental Implant Systems Portfolio - MR Conditional. Nobel Biocare AG K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA Inc.

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INDICATIONS FOR USE STATEMENT

DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to obtain marketing clearance for two designs of DESS Dental Implants. The implants are compatible with DESS Dental Smart Solutions abutments manufactured by the sponsor of this submission. Terrats Medical SL and cleared under K170588. K173908 and K191986. The new dental implants are parallel-walled root-form threaded endosseous dental implants made from unalloyed titanium, ranging in diameter from 3.0 mm to 5.5 mm and in length from 7 mm to 18 mm, as described more fully below.

ImplantLine	Body Ø, mm	PlatformName	Lengths, mm
Active	3.0	3.0	10	11.5	13	15
	3.5	NP	8.5	10	11.5	13	15	18
	4.3	RP	8.5	10	11.5	13	15	18
	5.0	RP	8.5	10	11.5	13	15	18
	5.5	WP	7	8.5	10	11.5	13	15
BoneLevel	3.3	NC	8	10	12	14	16	18
	4.1	RC	8	10	12	14	16	18
	4.8	RC	8	10	12	14	16	18

The subject device dental implants are summarized in the following table.

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All subject device implants are made of unalloyed titanium conforming to ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium.

The subject device dental implants are compatible with abutments and prosthetic components cleared previously in K170588, K173908 and K191986.

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:

. gamma irradiation sterilization validation to a sterility assurance level of 106 by selecting and substantiating a 25 kGy dose using method VDmax 3, according to ISO 11137-1 and ISO 11137-2;
bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to . ANSI/AAMI ST72 on all batches of finished devices to demonstrate that all sterile product meets a limit of < 20 EU/device;
cytotoxicity testing (MEM elution), performed on the final finished subject device ● according to ISO 10993-5 and ISO 10993-12;
shelf life testing, including testing of samples after accelerated aging equivalent to five (5) years of real time aging according to ASTM F1980, with testing of the packaging sterile barrier and sterility testing of product;
. surface characterization, including determination of surface roughness by measuring microscopic surface area according to ISO 25178 Geometrical product specifications (GPS) - Surface texture: Areal and analysis of surface chemistry by XPS (X-ray Photoelectron Spectroscopy);
static and dynamic testing performed according to ISO 14801. All test constructs ● included the DESS dental implant with the smallest body diameter that is compatible with a DESS Angled Multi Unit Abutment, the corresponding compatible DESS Angled Multi Unit Abutment 30° 4.5 mm RP, the abutment screw, the prosthetic coping (interface CoCr) and the prosthetic screw.

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 predicate device and the additional predicate devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the additional predicate devices.

The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device K142260 and additional predicate devices. The differences between the IFUS for the subject device and that of the primary predicate implant (K142260) include the omission in the latter of reference to edentulous or partially edentulous patients. However, the primary predicate IFUS includes no exclusion for either edentulous or partially edentulous patients and the additional predicates include the same explicit statement as the subject device. Likewise, the

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IFUS for K142260 includes no mention of immediate or early placement. However, the IFUS for the additional predicates include such a statement.

A difference between the IFUS for the subject device and those for the Straumann additional predicates K140878 and K171784 is that the latter include no special limitations for small diameter implants, while the subject device IFUS includes limitations on the use of diameter 3.0 mm. 3.3 mm and 3.5 mm. These limitations for the subject device are similar to those for the primary predicate K 142260. Slight differences in the language of the IFUS do not affect the intended use as an endosseous dental implant for support of abutments and a prosthesis to restore chewing function.

All subject device DESS Dental Implants are similar in design to the predicate implants listed above. DESS Active implants are similar in design, including thread form, dimensions and antirotational features to those of NobelActive implants cleared in K142260. The machined collar of the DESS Active implant is similar to those of the additional predicate devices K212125 and K023113. DESS Bone Level implants are similar in design to Straumann Bone Level implants cleared in K140878 and K171784. The ranges of implant diameters, platform diameters and lengths are the same as or within the range of those of the predicate devices.

All subject device implants components are provided sterile by gamma irradiation, the same sterilization method used in K170588, K173908 and K191986.

CONCLUSION

The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of identical 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 sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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Table of Substantial Equivalence – Indications for Use Statement

Subject Device	DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to retain overdentures. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth..	Comparison	Subject Device	Primary Predicate Device	Additional Predicate Devices
K212538			K212538	K142260	K140878	K171784	K212125	K023113
DESS Dental Implants			DESS Dental Implants	NobelActive®	Straumann® Bone LevelTapered Implants	Straumann® DentalImplant System	Nobel Biocare DentalImplant SystemsPortfolio - MRConditional(Brånemark Implant)	Replace TiUniteEndosseous Implant
Terrats Medical SL			Terrats Medical SL	Nobel Biocare AB	Titanium SLAStraumann USA, LLC	Straumann USA, LLC	Nobel Biocare AG	Nobel Biocare USA
Primary Predicate Device	NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® implants are indicated for single or multiple unit restorations in splinted or non- splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive® 3.0 implants are indicated for single unit restorations only.	Design
K142260		Implant Design	Root-form, threaded	Root-form, threaded	Root-form, threaded	Root-form, threaded	Root-form, threaded	Root-form, threaded
NobelActive®		Placement	Bone-level	Bone-level	Bone-level	Bone-level	Bone-level	Bone-level
Nobel Biocare AB		Implant diameters, mm	3.0, 3.3, 3.5, 4.1, 4.3, 4.8,5.0, 5.5	3.0, 3.5, 4.3, 5.0, 5.5	3.3, 4.1, 4.8	3.3, 4.1, 4.8	4.0, 5.0	3.5, 4.3, 5.0, 6.0
Additional Predicate Device	Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).	Implant lengths, mm	7, 8, 8.5, 10, 11.5, 12, 13,14, 15, 16, 18	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0	8, 10, 12, 14, 16	8, 10, 12, 14	7, 8.5, 10, 11.5, 13, 15,18	8, 10, 11.5, 13, 16
K140878		Abutment/ImplantPlatformDiameter, mm	2.5, 2.75, 3.0, 3.3, 4.4	2.5, 3.0, 3.3, 4.4	2.75 (NC), 3.3 (RC)	2.75 (NC), 3.3 (RC)	4.1, 5.1	3.5, 4.3, 5.0, 6.0
Straumann® Bone Level TaperedImplants Titanium SLA		Machined collar, mm	0.77, 0.92, 0.97, 1.36	Not stated - Anodized	NA	NA	0.8, 0.2(Brånemark Mk IIITiUnite)	0.75 (Replace SelectTapered), 1.5 (ReplaceSelect Tapered PMC)
Straumann USA, LLC		Connection Type	Internal conical with hex(Active)Internal conical with anti-rotation (Bone Level)	Internal (conical with) hex	CrossFit® (Internalconical with anti-rotation)	CrossFit® (Internalconical with anti-rotation)	External Hex(Brånemark)	Internal Tri-channel
Additional Predicate Device	Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple- tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).	Material	Titanium Grade 4	Titanium Grade 4	Titanium Grade 4or TiZr alloy	Titanium Grade 4or TiZr alloy	Titanium Grade 4	Titanium Grade 4
K171784		Surface	SLA	TiUnite	SLA or SLActive	SLA or SLActive	TiUniteor fully machined	TiUnite
Straumann® Dental Implant System
Straumann USA, LLC

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Table of Substantial Equivalence – Technological Characteristics

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.