# K962647: Angled Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Oct 7, 1996 after 91 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 K905434 (1992). 2 ancestors in all.
176 later devices descend from it; 1 cites it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941393: Iti Angled Abutment, The Straumann Co. (1995) Summary page 1.
- K905434: Angulated Abutment, Complete,Titanium Sdca 102, Nobelpharma USA, Inc. (1992) Summary page 1.
- (no number) Calcitek Angled Abutment: named in the summary without a submission number
- (no number) 3i Angled Abutment: named in the summary without a submission number

## Most influential descendants
- K994119: Synocta Angled Abutments (2000), 175 descendants of its own
- K080239: P.004 Abutments,  P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings (2008), 164 descendants of its own
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw (2014), 115 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Indications for use
The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.

Source page: https://510kreport.com/device/K962647
Methodology: https://510kreport.com/methodology