# K051501: Zirace

- Pathway: 510(k) (Traditional)
- Applicant: Acucera, Inc.
- Decided: Oct 19, 2005 after 135 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: 7 generations back to K944964 (1995). 42 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004, Nobel Biocare Uas, Inc. (2004) Summary page 1.
- K031719: Esthetic Zirconia Abutment, Nobel Biocare AB (2003) Summary page 1.
- K023631: Astra Tech Dental Implants-Ceramic Abutments, Astra Tech, Inc. (2002) Summary page 1.
- K913255: Ceramic (TM) Abutment, Ceramic Core Corp. (1994)
- K974150: Procera Preparable Abutment System, Nobel Biocare Uas, Inc. (1998) Summary page 1.
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K081516: Medsource CPR Mask with & Without Oxygen Port, Medsource International, LLC (2008). Our reading of the summary gave K081516, which FDA decided on Aug 26, 2008, after this device was decided (Oct 19, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.

## Most influential descendants
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components (2007), 7 descendants of its own
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins (2007), 4 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K191740: DORO LUCENT® iXI and iMRI Headrest System (2020), 1 descendant of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own

## Indications for use
ZirAce IM abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce IM abutments hexagon connector fits the external hexagon of the following implants: Lifecore Biomedical, Sterngold Implamed.

Source page: https://510kreport.com/device/K051501
Methodology: https://510kreport.com/methodology