# K211109: N1 TiUltra TCC Implant System - Pathway: 510(k) (Traditional) - Applicant: Nobel Biocare Services AG - Decided: Dec 21, 2021 after 251 days - Product code: DZE (Implant, Endosseous, Root-Form) - Device class: 2 - Regulation: 21 CFR 872.3640 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 13 generations back to K894595 (1990). 98 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 101 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K142260: NobelActive, Nobel Biocare AB (2015) Summary page 7. - K202344: TiUltra Implants and Xeal Abutments, Nobel Biocare AB (2020) Summary page 7. - K200040: Universal Base Conical Connection (CC), Nobel Biocare AG (2020) Summary page 7. - K133731: Nobelactive Wide Platform (WP), Nobel Biocare AB (2014) Summary page 7. - K181869: On1 Universal Abutment, Nobel Biocare AB (2018) Summary page 7. - K161655: On1 Concept, Nobel Biocare AB (2017) Summary page 7. - K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 7. ## Most influential descendants - K220048: NobelProcera Zirconia N1 Base (2022), 1 descendant of its own - K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (2026), 0 descendants of its own ## Recalls of this device - Jan 10, 2025 · Class II · Z-1101-2025: Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product. - Jul 25, 2022 · Class II · Z-1565-2022: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. ## Indications for use N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved. The N1™ system Implant Site Preparation Tools are indicated to be used in the maxilla or mandible to prepare an osteotomy prior to placement of a Nobel Biocare N1™ TiUltra™ TCC implant. To be used when applicable together with the implant during healing in order to protect the implant platform and internal threads from overgrowth of bone. Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Universal abutments are indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible. The Universal Abutment consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion. The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible. The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screw-retained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion. Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N1™ TCC are indicated for use for up to 180 days. Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days. The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days. The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion. The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM. The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation. Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation. Source page: https://510kreport.com/device/K211109 Methodology: https://510kreport.com/methodology