# K993783: Tetric Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Dec 13, 1999 after 35 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 7 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063593: Clearfil Majesty Flow (2007), 17 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own
- K111980: Clearfil Tri-S Bond Plus (2011), 4 descendants of its own
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own

## Indications for use
Class V restorations (cervical caries, root erosion, wedge shaped defects) Anterior restorations (Class III and IV) Small posterior restorations Restorative therapy for mini-cavities of all types (preparation with Sonic-Sys Micro Instruments from KaVo) Adhesive cementation of Sonic-Sys Inlays Extended fissures sealings in molars and pre-molars Repair of composite/ceramic veneers Blocking out of undercuts Adhesive cementation of ceramic and composite restorations

Source page: https://510kreport.com/device/K993783
Methodology: https://510kreport.com/methodology