# K210884: 1Derful HS, 1Derful HT

- Pathway: 510(k) (Traditional)
- Applicant: 1derful, Inc.
- Decided: Jul 27, 2021 after 124 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K830955 (1983). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130991: Nexxzr (TM)T and Nexxzr (TM)S, Sagemax Bioceramics, Inc. (2014) Summary page 4.

## Indications for use
1DerfulTM Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior/ posterior applications and not used solely as an implant. lDerfulTM Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.

Source page: https://510kreport.com/device/K210884
Methodology: https://510kreport.com/methodology