# K033585: Diapex

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jan 16, 2004 after 64 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- 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 K973667 (1997). 1 ancestor in all.
38 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973667: Vitapex Pre-Loaded Dental Syringe, Neodental Chemical Products Co., Ltd. (1997) Summary page 1.

## Most influential descendants
- K080917: Iroot SP (2008), 37 descendants of its own
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K212983: Injectable Root Canal Bioceramic Sealer (2021), 4 descendants of its own

## Indications for use
1. For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. 2. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. 3. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. 4. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: 1. Intracanal Medicament 2. Apexification 3. Periapical Lesions 4. Root Resorption 5. Temporary Root Filling 6. Perforations 7. Underdeveloped pulpless teeth

Source page: https://510kreport.com/device/K033585
Methodology: https://510kreport.com/methodology