# K152175: Upcera Dental Zirconia Blank for Aesthetic Restoration

- Pathway: 510(k) (Traditional)
- Applicant: Liaoning Upcera Co., Ltd.
- Decided: Dec 4, 2015 after 122 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: 8 generations back to K830955 (1983). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093560: Upcera Zirconia Blanks, Shenyang Upcera Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K231687: Gradual Dental Zirconia Blank (2023), 2 descendants of its own
- K253973: Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP Series (2026), 0 descendants of its own
- K251593: DenMat Multilayered Zirconia Disc (2025), 0 descendants of its own
- K240912: Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) (2024), 0 descendants of its own

## Indications for use
“Dental Zirconia Blank for Aesthetic Restoration” is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering, inlay, single crown, and substructure ceramic for three-unit prostheses not involving molar restoration; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.”

Source page: https://510kreport.com/device/K152175
Methodology: https://510kreport.com/methodology
