# K973353: Bonding Base

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Dec 2, 1997 after 88 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 K894844 (1990). 2 ancestors in all.
67 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943720: Iti Transversal Screwing System, The Straumann Co. (1995) Summary page 2.
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 2.
- (no number) 3M Unitek orthodontic bands: named in the summary without a submission number
- (no number) ITI Transverse Screw Gold Coping: named in the summary without a submission number

## Most influential descendants
- K982509: Ortho Implant and Accessories (1998), 66 descendants of its own
- K031936: Osteomed Orthodontic Screw System (2004), 63 descendants of its own
- K033767: Dual Top Anchor System Screws (2004), 54 descendants of its own
- K042965: Tomas Pin (2005), 26 descendants of its own
- K060126: Absoanchor Microimplant (2006), 19 descendants of its own

## Indications for use
The bonding base is indicated for use with a standard 1Tl implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

Source page: https://510kreport.com/device/K973353
Methodology: https://510kreport.com/methodology