# K960634: Titanium Healing Caps

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: Jun 18, 1996 after 125 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
224 later devices descend from it; 3 cite it directly.
0 of 225 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) ITI Large Closure Screw: named in the summary without a submission number
- (no number) Branemark Healing Abutments: named in the summary without a submission number
- (no number) Steri-Oss Healing Abutments: named in the summary without a submission number
- (no number) Implant Innovations’ Healing Abutments: named in the summary without a submission number

## Most influential descendants
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 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
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K123784: Straumann Dental Implant System (2013), 122 descendants of its own

## Recalls of this device
- Mar 30, 2006 · Not classified · Z-0840-06: The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top

## Indications for use
The esthetic healing caps are intended to protect the inner configuration of the ITI implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft tissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

Source page: https://510kreport.com/device/K960634
Methodology: https://510kreport.com/methodology