# K073345: Certain Contoured Margin Ceramic Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Mar 7, 2008 after 100 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
No predicates in its family tree.
56 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BIOMET 3i Dental Ceramic Abutments: named in the summary without a submission number
- (no number) Zimmer Contour Ceramic Abutment: named in the summary without a submission number

## Most influential descendants
- K111421: Sirona Dental Cad/Cam System (2012), 54 descendants of its own
- K132209: Ips E.Max Cad Abutment Solutions (2013), 39 descendants of its own
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (2015), 30 descendants of its own
- K151324: Straumann Variobase for CEREC (2015), 13 descendants of its own
- K171532: TruBase S (2018), 7 descendants of its own

## Indications for use
BIOMET 3i Certain® Contoured Margin Ceramic Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or totally edentulous patient. The Certain® Contoured Margin Ceramic Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is cement-retained to the abutment.

Source page: https://510kreport.com/device/K073345
Methodology: https://510kreport.com/methodology