Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Prime Dental Manufacturing, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
139 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. | 2012-01-23 | 139 | 0 |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | Prime Dental Manufacturing, Inc. | 2002-11-07 | 87 | 0 |
| K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | 2002-07-19 | 70 | 0 |
| K013970 | PRIME-DENT HEMA DESENSITIZER | Prime Dental Manufacturing, Inc. | 2002-02-19 | 78 | 0 |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | 2001-11-05 | 76 | 0 |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | 2001-11-01 | 76 | 0 |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | 2001-10-24 | 71 | 0 |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | 2000-05-30 | 55 | 0 |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | 2000-01-31 | 47 | 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