# K240597: Tera Harz Clear

- Pathway: 510(k) (Special)
- Applicant: Graphy, Inc.
- Decided: Mar 5, 2024 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.
No later device cites it as a predicate yet.
0 of 11 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.

## 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 Type Design: Scanner 3Shape A/S TRIOS 3 Basic Design software 3Shape A/S 3Shape Ortho System™ Printing: 3D Printer UNIZ SLASH 2 UNIZ Nbee SprintRay Inc. SprintRay Pro 95 Post-Curing: Post-cure unit ~ CureM U102H Tera Harz Cure THC

Source page: https://510kreport.com/device/K240597
Methodology: https://510kreport.com/methodology