Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Austenal Dental, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
175 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890713 | OVERDENTURE - STUD ATTACHMENT | Austenal Dental, Inc. | 1989-07-14 | 151 | 0 |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | Austenal Dental, Inc. | 1988-10-20 | 43 | 0 |
| K880875 | VITALLIUM EQUIPOISE ALLOY | Austenal Dental, Inc. | 1988-04-07 | 37 | 0 |
| K871849 | LIGHT CURE DENTURE GLAZE | Austenal Dental, Inc. | 1987-08-10 | 90 | 0 |
| K872746 | VITALLIUM WIRE | Austenal Dental, Inc. | 1987-07-21 | 8 | 0 |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | Austenal Dental, Inc. | 1987-03-11 | 175 | 0 |
| K862557 | AUSTENAL ACUSOFT SOFT LINER | Austenal Dental, Inc. | 1987-02-19 | 231 | 0 |
| K865025 | AUSTENAL CONDENSING INSTRUMENT | Austenal Dental, Inc. | 1987-02-19 | 58 | 0 |
| K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | Austenal Dental, Inc. | 1987-02-10 | 63 | 0 |
| K862856 | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR | Austenal Dental, Inc. | 1986-08-26 | 28 | 0 |
| K862667 | COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY | Austenal Dental, Inc. | 1986-07-31 | 17 | 0 |
| K862558 | AUSTENAL ACUPAC HI DENTURE BASE MATERIAL | Austenal Dental, Inc. | 1986-07-18 | 15 | 0 |
| K862417 | NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY | Austenal Dental, Inc. | 1986-07-03 | 8 | 0 |
| K860964 | WHITE SILVER SOLDER AND YELLOW SILVER SOLDER | Austenal Dental, Inc. | 1986-03-26 | 13 | 0 |
| K860911 | AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL | Austenal Dental, Inc. | 1986-03-26 | 15 | 0 |
| K860217 | NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY) | Austenal Dental, Inc. | 1986-03-17 | 54 | 0 |
| K854957 | AUSTENAL DENTAL COMPOSITE RESIN | Austenal Dental, Inc. | 1986-01-30 | 50 | 0 |
| K853160 | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN | Austenal Dental, Inc. | 1985-10-31 | 93 | 0 |
| K844497 | AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY | Austenal Dental, Inc. | 1985-02-27 | 99 | 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