# K030951: Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jun 6, 2003 after 72 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NTL-Flow: named in the summary without a submission number

## Most influential descendants
- K083051: Flowtain & Flowtain LV (2009), 5 descendants of its own
- K234043: 3M™ Transbond™ Orthodontic Adhesive (2023), 0 descendants of its own
- K130237: Pontic Paint (2013), 0 descendants of its own
- K123348: Clear Aligner Adhesive (2013), 0 descendants of its own
- K101951: Light Cure Retainer (2010), 0 descendants of its own

## Indications for use
1. Esthetic restorative material for Class 111, IV, and V. 2. Conservative Class I and Class I1 not involving opposing occlusal contact for direct or indirect use. 3. Direct Esthetic veneer restorative for masking stains and developmental anomalies. 4. Pit and fissure sealant. 5. Core buildup material to replace missing tooth structure. 6. Direct cementing agent and dental liner. 7. Indirect cement for use with reinforcement materials to fabricate crowns and bridges. 6. Composite/porcelain repair material.

Source page: https://510kreport.com/device/K030951
Methodology: https://510kreport.com/methodology