Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lang Dental Mfg. Co., Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
219 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112397 | ORTHO-JET CRYSTAL | Lang Dental Mfg. Co., Inc. | 2011-11-04 | 77 | 0 |
| K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADI | Lang Dental Mfg. Co., Inc. | 2010-10-08 | 214 | 0 |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC R | Lang Dental Mfg. Co., Inc. | 2009-06-05 | 219 | 0 |
| K081981 | LANG DENTAL ACRYLIC PRIMER | Lang Dental Mfg. Co., Inc. | 2008-11-17 | 129 | 0 |
| K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, | Lang Dental Mfg. Co., Inc. | 2008-09-22 | 115 | 0 |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | 2008-09-17 | 92 | 0 |
| K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE | Lang Dental Mfg. Co., Inc. | 2007-11-05 | 53 | 0 |
| K972553 | LANG DENTAL RESIN A97 FIBRED PINK | Lang Dental Mfg. Co., Inc. | 1997-11-13 | 128 | 0 |
| K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | Lang Dental Mfg. Co., Inc. | 1994-05-27 | 37 | 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