# K994119: Synocta Angled Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Mar 17, 2000 after 102 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: 2 generations back to K905434 (1992). 6 ancestors in all.
175 later devices descend from it; 5 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K962647: Angled Abutment, Straumann USA (1996) 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) Implant Innovations Angled Abutment: named in the summary without a submission number

## Most influential descendants
- 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
- K111935: TI-Base Abutment, 1 Connect Abutment (2012), 64 descendants of its own

## Indications for use
The synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

Source page: https://510kreport.com/device/K994119
Methodology: https://510kreport.com/methodology