# K014050: Hex-Lock Temporary Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Nov 13, 2002 after 338 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
219 later devices descend from it; 1 cites it directly.
0 of 220 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) ProTect abutment from Friadent: named in the summary without a submission number

## Most influential descendants
- K041070: Straumann Temporary Coping (2004), 218 descendants of its own
- K072071: Straumann P.004 Cementable Abutments, Temporary Copings  and Protective Caps (2007), 205 descendants of its own
- K080286: Cementable Abuntments; Temporary Copings; Protective Caps (2008), 179 descendants of its own
- K113283: NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC Basal Screw  Cementable Abutments (2011), 166 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own

## Indications for use
The plastic temporary abutment can be used to create esthetic, screw-retained or cemented provisional restorations at second stage uncovering. Once the restoration has been applied to the temporary abutment, it can be used to develop a more esthetic emergence profile. Temporary abutment is not to be used as a permanent abutment. Not to exceed 28-days of placement.

Source page: https://510kreport.com/device/K014050
Methodology: https://510kreport.com/methodology