# K052648: Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Oct 20, 2005 after 24 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944964 (1995). 35 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 1.

## Most influential descendants
- K141544: Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System (2014), 12 descendants of its own
- K143505: Zimmer Patient-Specific Abutment, Internal Hex, Titanium (2015), 8 descendants of its own
- K181037: DIO CAD/CAM Abutment (2018), 7 descendants of its own
- K160850: Nucleoss Tpure Implant System (2017), 2 descendants of its own
- K222913: s-Clean Link Abutment (2023), 1 descendant of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0074-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0077-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0079-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0073-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0075-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0076-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Aug 31, 2020 · Class II · Z-0078-2021: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutmen
- Feb 26, 2019 · Class II · Z-2141-2019: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Feb 26, 2019 · Class II · Z-2142-2019: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Feb 26, 2019 · Class II · Z-2143-2019: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Feb 26, 2019 · Class II · Z-2140-2019: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Feb 26, 2019 · Class II · Z-2144-2019: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Aug 26, 2013 · Class II · Z-1215-2014: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

## Indications for use
The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Source page: https://510kreport.com/device/K052648
Methodology: https://510kreport.com/methodology