# K962023: Plastic Protection Healing Caps

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: Aug 15, 1996 after 84 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
Longest line of descent: 1 generation back to K912734 (1992). 2 ancestors in all.
349 later devices descend from it; 4 cite it directly.
0 of 352 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925780: Branemark System Healing Caps, Nobelpharma USA, Inc. (1993) Summary page 1.
- K912734: Interpore Hex Head Implant Restorative Components, Interpore Intl. (1992) Summary page 1.
- (no number) Calcitek's Abutment Comfort Caps: named in the summary without a submission number
- (no number) Steri-Oss' Healing Cap: named in the summary without a submission number

## Most influential descendants
- K051717: RN Synocta Temporary Meso Abutment (2005), 318 descendants of its own
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) (2007), 283 descendants of its own
- K072679: P.004 Abutments (2007), 279 descendants of its own
- K092814: Straumann Dental Abutments (2009), 223 descendants of its own
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own

## Indications for use
The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.

Source page: https://510kreport.com/device/K962023
Methodology: https://510kreport.com/methodology