# K213201: DeltaFil, DeltaFil Conditioner

- Pathway: 510(k) (Traditional)
- Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH
- Decided: Jun 1, 2022 after 245 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K872984 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961448: Fuji IX GP, GC America, Inc. (1996) Summary page 4.
- K872984: Ketac-Conditioner, Espe GmbH (Us) (1988) Summary page 4.

## Indications for use
DeltaFil (in capsule) is used for geriatric and pediatric restorative filling procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material. DeltaFil Conditioner: • Treatment of the smear layer • Conditioning of the cavity

Source page: https://510kreport.com/device/K213201
Methodology: https://510kreport.com/methodology