Who is the manufacturer of Straumann® BLC and TLC Implants?

Institut Straumann AG filed the 510(k) submission for Straumann® BLC and TLC Implants (K230108).

What is the FDA product code for Straumann® BLC and TLC Implants?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann® BLC and TLC Implants?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Straumann® BLC and TLC Implants?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann® BLC and TLC Implants

K230108 · Institut Straumann AG · DZE · Sep 14, 2023 · Dental

Device Facts

Record ID	K230108
Device Name	Straumann® BLC and TLC Implants
Applicant	Institut Straumann AG
Product Code	DZE · Dental
Decision Date	Sep 14, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Device Story

Straumann® BLC and TLC Implants are endosseous dental implants designed for oral rehabilitation. The system consists of solid screw implants, abutments, and healing components. Implants are manufactured from Titanium-13 Zirconium alloy (Roxolid®) with either SLA® (sand-blasted, large-grit, acid-etched) or SLActive® (chemically activated, hydrophilic) surface treatments. The BLC implants feature a TorcFit connection, while TLC implants offer NT, RT, and WT prosthetic platforms. Used in dental clinics by trained professionals, the implants are surgically placed into the jawbone to support single crowns, bridges, or dentures. The device provides a stable foundation for prosthetic restorations, restoring chewing function and esthetics for patients. Clinical benefit is derived from the osseointegration of the implant surface with the jawbone, providing a durable anchor for dental prosthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including dynamic fatigue testing (ISO 14801) at 2 million cycles, insertion torque testing, and comparative analysis of bone-to-implant contact (BIC) and pull-out force against previously cleared devices. Biocompatibility was assessed per ISO 10993-1.

Technological Characteristics

Materials: Titanium-13 Zirconium alloy (Roxolid®). Surface: SLA® (sand-blasted, large-grit, acid-etched) or SLActive® (hydrophilic). Connection: TorcFit (conical). Sterilization: Gamma irradiation (25 kGy, SAL 10^-6). Dimensions: Diameters 3.3mm to 6.5mm; lengths 6mm to 18mm. MR Conditional per K180540.

Indications for Use

Indicated for functional and esthetic oral rehabilitation of upper or lower jaw of edentulous or partially edentulous patients. Used for immediate, early, or late implantation following tooth extraction or loss. Can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Straumann® Dental Implant System Roxolid® SLA Implants (K150938)

Reference Devices

Straumann BLX Implant System (K173961)
Straumann BLX Implant System (K210855)
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants (K212533)
Straumann TLX Implant System (K200586)
Straumann Bone Level Tapered Implants (K153758)

Related Devices

K234049 — Straumann® BLC and TLC Implants - Line extension · Institut Straumann AG · Mar 20, 2024
K150938 — Straumann® Dental Implant System ¿ Roxolid® SLA Implants · Straumann USA, LLC · Jul 24, 2015
K191256 — Straumann BLX Ø3.5 mm Implants · Institut Straumann AG · Dec 27, 2019
K171784 — Straumann Dental Implant System · Straumann USA, LLC · Jan 19, 2018
K212533 — BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants · Institut Straumann AG · Jan 28, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and 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. 9/14/23 Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality StraumannUSA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K230108 Trade/Device Name: Straumann® BLC and TLC Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 10, 2023 Received: August 11, 2023 Dear Jennifer Jackson: 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. Sherrill Lathrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number: K230108 Device Name Straumann® BLC and TLC Implants #### Indications for Use (Describe) Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Straumann® BLC and TLC Implants 510(k) Summary #### 510(k) Summary – K230108 5 #### 5.1 Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: Institut Straumann AG Peter Merian-Weg 12 4052 Basel, Switzerland | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS, RAC Sr. Director, Regulatory Affairs and Quality Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | Prepared By & Alternate Contact: | Corinne Arimatea Regulatory Affairs and Compliance Manager Institut Straumann AG Phone number: +41 61 965 1217 | | Date of Submission: | September 14, 2023 | #### 5.2 Name of the Device | Trade Names: | Straumann® BLC and TLC Implants | |------------------------|---------------------------------| | Common Name: | Endosseous Dental Implant | | Classification Name: | Endosseous Dental Implant | | Regulation Number: | §872.3640 | | Device Classification: | II | | Product Code(s): | DZE | | Classification Panel: | Dental | {4}------------------------------------------------ ### Straumann® BLC and TLC Implants 510(k) Summary #### Predicate Device(s) 5.3 Primary Predicate: - K150938 Straumann® Dental Implant System Roxolid® SLA Implants . Reference Devices: - K173961 Straumann BLX Implant System . - K210855 Straumann BLX Implant System . - K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants . - K200586 Straumann TLX Implant System . - K153758 Straumann Bone Level Tapered Implants . #### Device Description 5.4 The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments. The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm. The BLC implants are available with the following length options: - L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm. - L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm - L 6 mm to L 16 mm for diameter Ø 5.5 mm - L 6 mm to 14 mm for diameter Ø 6.5 mm. The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform. A summary of the diameter/length implant body combinations is given in Table 1. {5}------------------------------------------------ ## Straumann® BLC and TLC Implants | Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm | |----------------------|---------|----------|---------|---------|---------| | Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm | | | | 8 mm | 8 mm | 8 mm | 8 mm | | | | 10 mm | 10 mm | 10 mm | 10 mm | | | | 12 mm | 12 mm | 12 mm | 12 mm | | | | 14 mm | 14 mm | 14 mm | 14 mm | | | | 16 mm | 16 mm | 16 mm | 16 mm | | | | 18 mm | 18 mm | 18 mm | - | | Prosthetic platforms | RB | RB | WB | WB | WB | 510(k) Summary Table 1 – Overview of diameter/length implant body combinations for BLC implants The TLC implants are available with the following length options: - L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm, - L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm - L 6 mm to L 12 mm for diameter Ø 5.5 mm - L 6 mm to 10 mm for diameter Ø 6.5 mm. The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option. A summary of the diameter/length implant body combinations is given in Table 2. | Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm | |----------------------|---------|----------|---------|---------|---------| | Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm | | | 8 mm | 8 mm | 8 mm | 8 mm | 8 mm | | | 10 mm | 10 mm | 10 mm | 10 mm | 10 mm | | | 12 mm | 12 mm | 12 mm | 12 mm | - | | | 14 mm | 14 mm | 14 mm | - | - | | | 16 mm | 16 mm | 16 mm | - | - | | | 18 mm | 18 mm | 18 mm | - | - | | Prosthetic platforms | NT / RT | NT / RT | RT / WT | WT | WT | Table 2 – Overview of diameter/length implant body combinations for TLC implants {6}------------------------------------------------ ### Straumann® BLC and TLC Implants 510(k) Summary #### Intended Use 5.5 Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices. #### 5.6 Indications for Use Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. #### Technological Characteristics 5.7 - The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables: {7}------------------------------------------------ ## Straumann® BLC and TLC Implants 510(k) Summary | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | K Number | K230108 | K150938 | K200586 | K153758 | | Indications for Use | Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple- tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. | 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). | Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. | Straumann BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX implants can be placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components. | Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple- tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. | 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 primary predicate 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). | Indications for Use | Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. | 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). | Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi- unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. | 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 primary predicate 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). | | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | Material | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | | K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | Surface Treatment | Hydrophilic SLActive® and SLA® | Hydrophilic SLA® | Hydrophilic SLActive® | Hydrophilic SLActive® | | Material | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Implant to Abutment Connection | TorcFit (with conical fitting) | Narrow CrossFit (NC) Regular CrossFit (RC) Narrow Neck CrossFit (NNC) Regular Neck (RN) Wide Neck (WN) | TorcFit (with conical fitting) | Narrow CrossFit® (NC) Regular CrossFit® (RC) | | Surface Treatment | Hydrophilic SLActive® and SLA® | Hydrophilic SLA® | Hydrophilic SLActive® | Hydrophilic SLActive® and SLA® | Hydrophilic SLActive® and SLA® | Hydrophilic SLActive® | Implant Diameter | $Ø 3.3, 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ | $Ø 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ | | Implant to Abutment Connection | TorcFit (with conical fitting) | Narrow CrossFit (NC) Regular CrossFit (RC) Narrow Neck CrossFit (NNC) Regular Neck (RN) Wide Neck (WN) | TorcFit (with conical fitting) | TorcFit (with conical fitting) | TorcFit (with conical fitting) | Narrow CrossFit® (NC) Regular CrossFit® (RC) | Implant Length | $Ø 3.3: 8, 10, 12, 14, 16,18 mm$ $Ø 3.75 and 4.5:6, 8, 10, 12, 14, 16,18 mm$ $Ø 5.5: 6, 8, 10, 12 mm$ $Ø 6.5: 6, 8, 10 mm$ | $6, 8, 10, 12, 14, 16 mm$ | $Ø 3.75, 4.0, 4.5, 5.0 mm:6, 8, 10, 12, 14, 16,18 mm$ $Ø 5.5 and 6.5 mm:6, 8, 10, 12 mm$ | $18 mm$ | | Implant Diameter | Ø 3.3, 3.75, 4.5, 5.5, 6.5 mm | Ø 3.3, 4.1, 4.8 mm | Ø 4.5, 5.5, 6.5 mm | Ø 3.75 and 4.0 mm…