Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Glen Whitten, Dds · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864655 | DZIDRA GLASS FOR USE IN DENTISTRY | Glen Whitten, Dds | 1987-02-25 | 89 | 0 |
| K864656 | DZIDRA GLASS FOR USE IN OPHTHALMOLOGY | Glen Whitten, Dds | 1987-02-25 | 89 | 0 |
| K864678 | DZIDRA GLASS FOR USE IN NEUROLOGY | Glen Whitten, Dds | 1987-02-25 | 85 | 0 |
| K864679 | DZIDRA GLASS FOR USE IN GENERAL MEDICAL | Glen Whitten, Dds | 1987-02-25 | 85 | 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