Who is the manufacturer of Straumann Bone Level Tapered Implants?

Institut Straumann AG filed the 510(k) submission for Straumann Bone Level Tapered Implants (K153758).

What is the FDA product code for Straumann Bone Level Tapered 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 Bone Level Tapered Implants?

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

Who can help prepare an FDA 510(k) submission like Straumann Bone Level Tapered 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 Bone Level Tapered Implants

Q: What are the predicate devices for Straumann Bone Level Tapered Implants?

Straumann Bone Level Tapered Implants (K140878).

K153758 · Institut Straumann AG · DZE · Mar 23, 2016 · Dental

Device Facts

Record ID	K153758
Device Name	Straumann Bone Level Tapered Implants
Applicant	Institut Straumann AG
Product Code	DZE · Dental
Decision Date	Mar 23, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® Bone Level Tapered 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 Bone Level Tapered 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).

Device Story

Straumann Bone Level Tapered Implants are endosseous dental implants designed for oral rehabilitation. This device is a line extension of previously cleared implants (K140878), introducing an 18 mm length option. The implants are surgically placed into the jawbone by dental professionals to support prosthetic restorations, including single crowns, bridges, and dentures. The device is manufactured from a titanium-13zirconium alloy (Roxolid) with SLA or SLActive surface finishes. The system utilizes Narrow CrossFit (NC) or Regular CrossFit (RC) implant-to-abutment interfaces. The primary clinical benefit is the restoration of chewing function and esthetics for patients with missing teeth. The device is used in a clinical setting; the surgeon performs the implantation, and the restorative dentist manages the prosthetic connection. The 18 mm length provides an additional option for specific anatomical requirements, with performance validated through bench testing, including dynamic fatigue and insertion torque analysis in simulated bone material.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, biological compatibility per ISO 10993, sterilization validation per ISO 11137, and shelf-life stability per ASTM F1980. Additional bench testing measured peak insertion torque in simulated bone material (polyurethane foam, 10-40 pcf) to validate the 18 mm length and 3.3 mm diameter design.

Technological Characteristics

Material: Titanium-13zirconium alloy (Roxolid) for implants; Titanium-6aluminum-7niobium alloy (TAN) for transfer pieces. Surface: SLA or SLActive. Dimensions: 3.3, 4.1, 4.8 mm diameters; 18 mm length. Connection: Narrow CrossFit (NC) or Regular CrossFit (RC). Sterilization: ISO 11137 series. Mechanical: Constant major/minor thread diameter (parallel wall), 0.8 mm pitch.

Indications for Use

Indicated for edentulous and partially dentate patients requiring oral endosteal implantation in the upper or lower jaw for functional and esthetic rehabilitation. Suitable for immediate or early implantation post-extraction/tooth loss and immediate function in single or multiple tooth applications, provided primary stability and appropriate occlusal loading are achieved.

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 Bone Level Tapered Implants (K140878)

Reference Devices

Straumann Roxolid SLA Implants (K150938)
Neodent CM Drive Line Extension (K150182)

Related Devices

K140878 — STRAUMANN BONE LEVEL TAPERED IMPLANT · Straumann USA, LLC · Aug 20, 2014
K150938 — Straumann® Dental Implant System ¿ Roxolid® SLA Implants · Straumann USA, LLC · Jul 24, 2015
K234049 — Straumann® BLC and TLC Implants - Line extension · Institut Straumann AG · Mar 20, 2024
K230108 — Straumann® BLC and TLC Implants · Institut Straumann AG · Sep 14, 2023
K202942 — Straumann 4 mm Short Implants · Straumann USA, LLC · Feb 8, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 23, 2016 Institut Straumann AG c/o Ms. Jennifer Jackson. M.S. Head of Regulatory Affairs and Quality Straumann USA. Inc. 60 Minuteman Road Andover, Massachusetts 01810 Re: K153758 Trade/Device Name: Straumann® Bone Level Tapered Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 29, 2015 Received: December 30, 2015 Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K153758 Device Name Straumann® Bone Level Tapered Implants Indications for Use (Describe) Straumann® Bone Level Tapered 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 Bone Level Tapered 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). Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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}------------------------------------------------ | 5. | 510(k) Summary | K153758 | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | | | Contact Person: | Jennifer Jackson, MS Head of Regulatory Affairs and Quality (978) 747-2509 | | | Prepared By: | Christopher Klaczyk Head of North American Regulatory Affairs +41 79 915 8367 | | | Date Prepared: | March 7, 2016 | | | Product Code(s): | DZE (21 CFR 872.3640) | | | Device Class: | II (21 CFR 872.3640) | | | Classification Panel: | Dental | | | Classification Name: | Endosseous dental implant (21 CFR 872.3640) | | | Proprietary Name: | Straumann® Bone Level Tapered Implant | | | Predicate Device:: | Straumann Bone Level Tapered Implants (K140878) | | | Reference Device(s): | Straumann Roxolid SLA Implants (K150938) Neodent CM Drive Line Extension (K150182) | | | Device Description: | The subject devices represent a line extension of the previously cleared Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm. | | Intended Use: Bone Level Tapered Implants | Straumann® Bone Level Tapered 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 Bone Level Tapered 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). | | | Materials: | Versions of the subject devices will be produced from a titanium-13zirconium alloy, trade named Roxolid®, as previously reviewed and cleared to market per premarket notification submission K140878. The transfer piece is produced from titanium-6aluminum- 7niobium alloy (TAN). This is the same material as for the predicate transfer pieces cleared to market per premarket notification submission K140878. | | | Technological Characteristics: | The subject devices are identical in every respect to the identified Bone Level Tapered predicate devices with the exception of overall length; the subject device is 18 mm in length where the longest previously cleared Bone Level Tapered devices previously cleared to market per K140878 and K150938 is 16 mm in length. The 18 mm length subject devices have the same length as the Neodent CM Drive device cleared to market per K150182, however the Neodent CM Drive devices have a minimum diameter of Ø3.5 mm where the subject device has a minimum diameter of Ø3.3 mm. | | {4}------------------------------------------------ {5}------------------------------------------------ | Feature | Primary Predicate Device Bone Level Tapered Implants (K140878) | Subject Devices Bone Level Tapered Implants | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | 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® Bone Level Tapered 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 Bone Level Tapered 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-to-Abutment Connection | Narrow CrossFit® (NC) Regular CrossFit® (RC) | Narrow CrossFit® (NC) Regular CrossFit® (RC) | | Implant Diameter | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm | | Implant Length | 8, 10, 12, 14, 16 mm | 18 mm | | Coronal Thread Form | Constant major and minor thread diameters (i.e., parallel wall) 0.8mm thread pitch | Constant major and minor thread diameters (i.e., parallel wall) 0.8mm thread pitch | | Material | Titanium Grade 4 Titanium zirconium alloy Ti-13Zr | Titanium zirconium alloy Ti-13Zr | | Surface Finish | SLA SLActive | SLA SLActive | {6}------------------------------------------------ | Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. The following studies are incorporated into this submission by reference to the submission for the primary predicate (K140878): Dynamic fatigue test data consistent with FDA guidance and ISO 14801Biological compatibility per the ISO 10993 series standardsSterilization validation per the ISO 11137 series standardsShelf life (stability) per ASTM F1980 | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | In order to confirm that the reduced minimum implant diameter between the subject device (Ø3.3 mm) and the Neodent CM Drive reference device (Ø3.5 mm) does not result in a new failure mode, the following additional bench study was performed on all three diameters of the subject device: Peak insertion torque was measured while driving the implants to a clinically appropriate position relative to the surface of simulated bone material (polyurethane foam) having densities of between 10 and 40 pounds per cubic foot that had been prepared per the instructions for use. | | Conclusions: | Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices. |