Who is the manufacturer of Straumann TLX Variobase C?

Institut Straumann AG filed the 510(k) submission for Straumann TLX Variobase C (K220878).

What is the FDA product code for Straumann TLX Variobase C?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann TLX Variobase C?

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

What are the predicate devices for Straumann TLX Variobase C?

Straumann Variobase C (K192742).

Who can help prepare an FDA 510(k) submission like Straumann TLX Variobase C?

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 TLX Variobase C

K220878 · Institut Straumann AG · NHA · Jun 16, 2022 · Dental

Device Facts

Record ID	K220878
Device Name	Straumann TLX Variobase C
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Jun 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® TLX Variobase® C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns.

Device Story

Two-piece dental abutment system consisting of titanium alloy (Ti-6Al-7Nb) base and patient-specific coping/crown; used with Straumann TLX dental implants. Clinician uses Sirona CEREC software to design prosthetic restoration; milling performed by Sirona CEREC, inLab MC X, or MC XL units. Final assembly involves cementing IPS e.max CAD restoration to Ti-base using PANAVIA F2.0 dental cement. Device provides interface between implant and restoration; supports single tooth or bridge restorations. Used in dental clinics; operated by dentists/dental technicians. Output is a customized prosthetic abutment; aids in restoring chewing function and aesthetics. Benefits patient through stable, implant-supported tooth replacement.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing performed per FDA guidance for endosseous dental abutments. Biocompatibility confirmed via material identity to predicate. Sterilization validated per FDA guidance. Software verification/validation confirmed design library constraints and locking mechanisms.

Technological Characteristics

Material: Titanium-aluminum-niobium (TAN) alloy. Two-piece design: stock Ti-base and CAD/CAM-milled coping/crown. Compatible with Straumann TLX (NT, RT, WT) implant platforms. Max angulation 20°. Non-sterile; requires autoclave sterilization. Connectivity: Digital workflow via Sirona CEREC software/milling units. Software library is encrypted and locked.

Indications for Use

Indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations in patients requiring dental implant-supported prosthetic restorations.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Straumann Variobase C (K192742)

Reference Devices

Sirona Dental CAD/CAM System (K181520)
Variobase for CEREC (K151324)
Straumann TLX Implant System (K200586)
Straumann Variobase (K142890)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Related Devices

K192742 — Straumann Variobase C · Institut Straumann AG · Feb 12, 2021
K223535 — SMARTbase Abutment System · Implant Direct Sybron Manufacturing, LLC · Jun 20, 2023
K170022 — Klockner Vega TiBase for CEREC · SOADCO, S.L. · Nov 16, 2017
K222913 — s-Clean Link Abutment · Dentis Co., Ltd. · Jan 13, 2023
K211225 — MIS Ti-base abutment · Dentsply Sirona · Jul 28, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K220878 Trade/Device Name: Straumann® TLX Variobase® C Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: March 24, 2022 Received: March 25, 2022 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. 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K220878 Device Name Straumann® TLX Variobase® C Indications for Use (Describe) The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. 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." FORM FDA 3881 (6/20) {3}------------------------------------------------ ## Straumann® TLX Variobase® C ## 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: Institut Straumann AG Peter MerianWeg 12 CH-4002 Basel, Switzerland | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality Phone Number: +1 978 747-2509 Fax Number: +1 978 747-0023 | | Prepared By & Alternate Contact: | Gordon Dodds Manager Design Control QM Institut Straumann AG Phone number: +49 89 30 90 75 291 | | Date of Submission: | June 16, 2022 | ### Name of the Device | Trade Names: | Straumann® TLX Variobase® C | |-------------------------|------------------------------------------------------| | Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) | | Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | | Regulation Number: | §872.3630 | | Device Classification: | II | | Primary Product Code: | NHA | | Secondary Product Code: | PNP | | Classification Panel: | Dental | {4}------------------------------------------------ ## Straumann® TLX Variobase® C #### 510(k) Summary #### Predicate Device(s) Primary Predicate: - K192742 Straumann Variobase C . Reference Devices: - K181520 Sirona Dental CAD/CAM System (Sirona Dental) . - K151324 Variobase for CEREC (Institut Straumann AG) ● - . K200586 - Straumann TLX Implant System (Institut Straumann AG) - K142890- Straumann Variobase (Institut Straumann AG) . - K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut . Straumann AG) #### Device Description The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components: - . Straumann® TLX Variobase® C (Ti-base) - Prosthetic Restoration (patient specific coping or crown) . - . Basal Screw The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD. The design parameters are provided in Table 1. {5}------------------------------------------------ ## Straumann® TLX Variobase® C #### 510(k) Summary | Abutment | lvoclar IPS e.max CAD | |---------------------------------|-----------------------| | Material minimum wall-thickness | 0.8 mm | | Maximum angle of restoration | 20° | | Minimum post height of crown | 5.2 mm | | Material duration of use | Permanent | #### Table 1 – Design parameters PANAVIA F2.0 dental cement (K032455) is to be used for cementing the prosthetic restoration to the Straumann® TLX Variobase® C to complete the finished, two-piece CAD/CAM dental abutment. #### Intended Use Straumann® TLX Variobase® C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns. #### Indications for Use The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. ### Technological Characteristics As outlined in Table 1, the subject system includes a combination of previously cleared technologies that are now being implemented into one system. The Variobase C technology has received prior clearance for each Straumann implant body compatibility. The IPS e.max CAD material has received prior clearance for use as the second piece of a two-piece abutment under product code NHA and for use with the Sirona CAD/CAM digital workflow. Performance testing has addressed any differences resultant from new combinations of technologies. The technological characteristics of the subject devices are compared to the primary predicate device in Table 2. The reference device K190662 is included for reference to MRI compatibility. {6}------------------------------------------------ # Straumann® TLX Variobase® C 510(k) Summary | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | 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| K Number | | K192742 | K151324 | K181520 | K142890 | K200586 | | Indications for Use | The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit | The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple- unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructured. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: | The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | TLX Dental Implant: 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. TLX Closure Caps and Healing Caps: Straumann Closure Caps and Healing Caps are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months. TLX Temporary Abutment: TLX Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. TLX Temporary Abutments have a maximum duration of usage of 180 days. TLX Variobase for Crown: Straumann Variobase prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann Variobase prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. TLX CARES Abutment TAN: The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. TLX Screw-retained Bridges and Bars: CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | K Number | | K192742 | K151324 | K181520 | K142890 | K200586 | | | | | | | | implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw- retained Bridges and Bars are indicated for Screw- retained restorations. Straumann CARES Screw- retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants and TLX implants of the Straumann Dental Implant System (SDIS). | | Compatible Implants | Straumann TLX implants having the NT, RT and WT implant-to-abutment interface geometries. | Straumann Bone Level implants having the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implants having the NNC implant-to-abutment interface geometries. Straumann BLX implants having the RB/WB and WB implant-to-abutment interface geometries. | Straumann Bone Level implants having the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implants having the RN and WN implant-to- abutment interface geometries. | Nobel Biocare - Replace, Active, and Branemark Straumann - Synocta and Bone Level Dentsply Sirona Implants - Osseospeed, Xive, Osseospeed EV, and Ankylos Biomet 3i - Osseotite and Certain Zimmer - Tapered Screw- Vent Thommen Medical - SPI Element, SPI Element Inicell, SPI Contact Inicell Osstem/Hiossen - Osstem TS Implant System and Hiossen Implant System Biohorizons (Internal Connection | Straumann Bone Level implants having the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implants having the NNC, RN, and WN implant-to-abutment interface geometries. | Straumann TLX implants having the NT, RT and WT implant-to-abutment interface geometries. | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | K Number | | K192742 | K151324 | K181520 | K142890 | K200586 | | Compatible Restoration Materials | Ivoclar IPS e.max CAD (S and L) - K132209 | Sirona inCoris Zi meso (S and L) - K181520 Ivoclar IPS e.max CAD (S and L) - K132209 Straumann n!ce Glass Ceramic A14 Blocks (L) - K171773 | Sirona inCoris Zi (L) - K062509 and K123664 Ivoclar IPS e.max CAD (S and L) - K132209 Ivoclar TelioCAD (S and L) - K093708 | Sirona inCoris Zi (S and L) | Traditional Workflow: Type 4 Metals (ISO 22674) IPS e.max® Press Ceramic Digital Workflow: polycon® ae (temporary) zerion® (permanent) IPS e.max® CAD Ceramic (permanent) coron® (permanent) | Digital Workflow: polycon® ae (temporary) zerion LT (permanent)…