# K102209: Encode Patient Specific Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Dec 3, 2010 after 120 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944964 (1995). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 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.
- K052648: Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars, Implant Innovations, Inc. (2005) Summary page 2.

## Most influential descendants
- K123416: Insignia with Itero (2013), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended 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/K102209
Methodology: https://510kreport.com/methodology