# K212563: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: May 23, 2022 after 283 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: 8 generations back to K990131 (1999). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152959: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes, Sybron Dental Specialties (2016) Summary page 6.
- K973667: Vitapex Pre-Loaded Dental Syringe, Neodental Chemical Products Co., Ltd. (1997) Summary page 6.
- K170175: Endoseal Mta, Maruchi (2018) Summary page 6.
- K152956: Pulp Canal Sealer, Pulp Canal Sealer EWT, Sybron Dental Specialties (2016) Summary page 6.
- K983037: Roeko Seal, Roeko Ulm, Roescheisen GmbH & Co. (1998) Summary page 6.
- K153067: Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress, Sybron Dental Specialties (2016) Summary page 6.

## Indications for use
CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification. Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling. Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points. Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.

Source page: https://510kreport.com/device/K212563
Methodology: https://510kreport.com/methodology