Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Graphy, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
1 daysmedian FDA review time
293 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture ( | Graphy, Inc. | 2025-11-21 | 0 | 0 |
| K240597 | TERA HARZ CLEAR | Graphy, Inc. | 2024-03-05 | 1 | 0 |
| K233502 | TERA HARZ II | Graphy, Inc. | 2023-11-01 | 1 | 0 |
| K223355 | Tera Harz Clear | Graphy, Inc. | 2022-11-03 | 1 | 0 |
| K222414 | TERA HARZ DENTURE | Graphy, Inc. | 2022-08-11 | 1 | 0 |
| K202846 | TERA HARZ | Graphy, Inc. | 2021-07-15 | 293 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda