# K223355: Tera Harz Clear

- Pathway: 510(k) (Traditional)
- Applicant: Graphy, Inc.
- Decided: Nov 3, 2022 after 1 day
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- 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 K780619 (1978). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180107: Blue Sky Bio Aligner, Blue Sky Bio, LLC (2018) Summary page 4.

## Most influential descendants
- K251616: Clear Miracle (2025), 0 descendants of its own
- K233935: DigiLine Direct Print Aligner System (2024), 0 descendants of its own

## Indications for use
TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following: Brand Design: Scanner 3Shape A/S Design software 3Shape A/S Printing;: 3D Printer UNIZ SprintRay Inc. Post-Curing: Post-cure unit CureM Type TRIOS 3 Basic 3Shape Ortho System™ SLASH 2 SprintRay Pro 95 U102H

Source page: https://510kreport.com/device/K223355
Methodology: https://510kreport.com/methodology