# 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

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 6, 2026 after 234 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894595 (1990). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200040: Universal Base Conical Connection (CC), Nobel Biocare AG (2020) Summary page 8.
- K211109: N1 TiUltra TCC Implant System, Nobel Biocare Services AG (2021) Summary page 9.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 9.
- K133731: Nobelactive Wide Platform (WP), Nobel Biocare AB (2014) Summary page 9.
- K233208: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium, Nobel Biocare AB (2024) Summary page 9.
- K220048: NobelProcera Zirconia N1 Base, Nobel Biocare Services AG (2022) Summary page 9.
- K202452: NobelProcera Zirconia Implant Bridge, Nobel Biocare AB (2020) Summary page 9.

## Indications for use
Universal Bases ASC Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured 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 and ceramic-dominant material, milling machine and associated tooling and accessories. Universal Bases ASC Non-Engaging are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base Non-Engaging consists of multiple parts. Specifically, the titanium base and multi-unit 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 and ceramic-dominant material, milling machine and associated tooling and accessories. Universal Bases MUA ASC: Universal Base MUA ASC are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base MUA consists of three major parts, specifically the Multi-unit abutment, the Universal Base MUA 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 and ceramic-dominant material, milling machine and associated tooling and accessories. Temporary Abutment Engaging and Non-Engaging: Temporary Abutments Engaging CC 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. Temporary Abutment Non-Engaging CC are indicated for use with multiple unit screw-retained temporary dental prosthesis placed on endosseous dental implant in the maxilla and mandible, for up to 180 days, for implants with less than 14 ° overall divergences to allow path of insertion. Omnigrip Clinical Screw Titanium: Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. Omnigrip Prosthetic Screw: Prosthetic screws are indicated for use to secure a dental abutment or framework to a dental abutment or base in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. Healing Abutment Conical Connection: The Healing Abutments Conical Connection are premanufactured prosthetic components to be directly connected to the endosseous dental implants or abutments and are indicated as temporary components for one single tooth to full arch denture procedures.

Source page: https://510kreport.com/device/K253999
Methodology: https://510kreport.com/methodology