Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vivadent (Usa), Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
67 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. | 1986-10-14 | 14 | 0 |
| K823409 | HELIOSIT-ORTHODONTIC | Vivadent (Usa), Inc. | 1983-01-21 | 67 | 0 |
| K813015 | HELIOSEAL | Vivadent (Usa), Inc. | 1981-12-02 | 36 | 1 |
| K802679 | SILANIT | Vivadent (Usa), Inc. | 1980-12-17 | 50 | 0 |
| K802684 | HELIOMAT | Vivadent (Usa), Inc. | 1980-11-24 | 27 | 0 |
| K802682 | CONTACT SEAL | Vivadent (Usa), Inc. | 1980-11-24 | 27 | 0 |
| K802683 | HELIOSIT | Vivadent (Usa), Inc. | 1980-11-24 | 27 | 0 |
| K802681 | HELIOBOND | Vivadent (Usa), Inc. | 1980-11-24 | 27 | 0 |
| K802685 | REOLIT | Vivadent (Usa), Inc. | 1980-11-12 | 15 | 0 |
| K802680 | ISOPAST-DS | Vivadent (Usa), Inc. | 1980-11-12 | 15 | 0 |
| K801227 | SILICAP | Vivadent (Usa), Inc. | 1980-08-12 | 81 | 0 |
| K801228 | BONDALCAP (SILICO-PHOSPHATE) | Vivadent (Usa), Inc. | 1980-06-04 | 12 | 0 |
| K801229 | BONDALCAP (CARBOXYLATE) | Vivadent (Usa), Inc. | 1980-06-04 | 12 | 0 |
| K790874 | AMALCAP-NON-GAMMA-2 | Vivadent (Usa), Inc. | 1979-06-05 | 29 | 0 |
| K790438 | COLORANT | Vivadent (Usa), Inc. | 1979-04-10 | 34 | 0 |
| K790439 | CONTACT RESIN | Vivadent (Usa), Inc. | 1979-04-10 | 34 | 0 |
| K781787 | ISOPLAST | Vivadent (Usa), Inc. | 1978-12-20 | 62 | 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