Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulpdent Corp. — Predicate Candidate Screening
78 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
105 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CE | Pulpdent Corp. | 2002-03-14 | 87 | 0 |
| K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corp. | 2002-03-14 | 87 | 0 |
| K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | Pulpdent Corp. | 2002-02-28 | 48 | 0 |
| K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE | Pulpdent Corp. | 2002-02-27 | 79 | 0 |
| K013411 | PULPDENT CAVITY PREPARATION IV | Pulpdent Corp. | 2001-12-12 | 58 | 0 |
| K994180 | PULPDENT CAVITY PREPARATION III | Pulpdent Corp. | 2000-03-02 | 83 | 0 |
| K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION | Pulpdent Corp. | 2000-02-29 | 81 | 0 |
| K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 | Pulpdent Corp. | 2000-02-23 | 75 | 0 |
| K993683 | PULPDENT UNO-DUO | Pulpdent Corp. | 1999-12-13 | 42 | 0 |
| K974202 | PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS | Pulpdent Corp. | 1998-03-19 | 129 | 0 |
| K974398 | PULPDENT CAVITY VARNISH | Pulpdent Corp. | 1998-02-18 | 89 | 0 |
| K974014 | PULPDENT DENTASTIC UNO | Pulpdent Corp. | 1997-12-17 | 56 | 0 |
| K972445 | PULPDENT OX-OUT | Pulpdent Corp. | 1997-10-02 | 94 | 0 |
| K971594 | FLOW-RITE | Pulpdent Corp. | 1997-09-12 | 134 | 0 |
| K964430 | PULPDENT SNOOP | Pulpdent Corp. | 1997-01-17 | 73 | 0 |
| K963921 | PULPDENT SEAL-RITE UDMA | Pulpdent Corp. | 1996-11-12 | 43 | 0 |
| K963652 | PULPDENT DESENSITIZER | Pulpdent Corp. | 1996-10-11 | 29 | 0 |
| K962747 | PULPDENT ENDODONTIC POST CEMENT KIT | Pulpdent Corp. | 1996-09-30 | 77 | 0 |
| K962383 | PULPDENT RESILUTE II | Pulpdent Corp. | 1996-09-03 | 75 | 0 |
| K962743 | PULPDENT SODIUM HYPOCHLORITE SOLUTION | Pulpdent Corp. | 1996-08-06 | 22 | 0 |
| K961089 | PULPDENT ENDOPREP II | Pulpdent Corp. | 1996-04-23 | 35 | 0 |
| K955017 | PULPDENT RESILUTE | Pulpdent Corp. | 1995-12-01 | 29 | 0 |
| K953272 | PULPDENT DENTASTIC II | Pulpdent Corp. | 1995-08-25 | 43 | 0 |
| K953301 | DENTASTIC ONE-STEP | Pulpdent Corp. | 1995-08-25 | 42 | 0 |
| K953217 | PULPDENT TOUCHDOWN | Pulpdent Corp. | 1995-08-25 | 46 | 0 |
| K953079 | LIMELIGHT | Pulpdent Corp. | 1995-08-07 | 35 | 0 |
| K952960 | PULPDENT POST CEMENT | Pulpdent Corp. | 1995-07-19 | 23 | 0 |
| K952854 | PULPDENT GLASS IONOMER CEMENTS | Pulpdent Corp. | 1995-07-14 | 23 | 0 |
| K951270 | PULPDENT GLASS IONOMER CEMENTS | Pulpdent Corp. | 1995-05-31 | 71 | 0 |
| K946137 | PULPDENT PERIODONTAL DRESSINGS | Pulpdent Corp. | 1995-01-26 | 41 | 0 |
| K946138 | PULPDENT ROOT CANAL SEALER | Pulpdent Corp. | 1995-01-20 | 35 | 0 |
| K945811 | PULPDENT CANAL FINDER | Pulpdent Corp. | 1995-01-20 | 53 | 0 |
| K940368 | CANAL KING (THIN) CANAL KING (THICK) | Pulpdent Corp. | 1995-01-20 | 359 | 0 |
| K945378 | PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT | Pulpdent Corp. | 1995-01-17 | 76 | 0 |
| K945173 | PULPDENT HARDSHELL | Pulpdent Corp. | 1994-12-15 | 55 | 0 |
| K945057 | PULPDENT HYBRID ANTERIOR COMPOSITE | Pulpdent Corp. | 1994-12-14 | 61 | 0 |
| K945113 | PULPDENT CERVICAL RESTORATIVE | Pulpdent Corp. | 1994-12-14 | 57 | 0 |
| K945056 | PULPDENT RESIN CEMENT | Pulpdent Corp. | 1994-12-14 | 61 | 0 |
| K945112 | PULPDENT DUAL CURE UNFILLED BONDING RESIN | Pulpdent Corp. | 1994-12-14 | 57 | 0 |
| K945058 | PULPDENT MICROFILLED ANTERIOR COMPOSITE | Pulpdent Corp. | 1994-12-14 | 61 | 0 |
| K945018 | PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL | Pulpdent Corp. | 1994-12-14 | 62 | 0 |
| K944945 | PULPDENT CALCIUM HYDROXIDE PREPARATIONS | Pulpdent Corp. | 1994-11-30 | 54 | 0 |
| K932794 | PULPDENT SEAL-RITE LOW VISCOSITY | Pulpdent Corp. | 1993-09-20 | 103 | 0 |
| K932791 | PULPDENT EDTA PREPARATIONS | Pulpdent Corp. | 1993-09-20 | 103 | 0 |
| K932793 | PULPDENT 2.5% NITRIC ACID ETCHANT | Pulpdent Corp. | 1993-09-13 | 96 | 0 |
| K932792 | PULPDENT MALEIC ACID ETCHANTS | Pulpdent Corp. | 1993-09-09 | 92 | 0 |
| K931710 | PULPDENT DENTAL BOND ENHANCER 2-B | Pulpdent Corp. | 1993-08-24 | 140 | 0 |
| K930989 | PULPDENT UNFILLED DUAL CURE BONDING RESIN | Pulpdent Corp. | 1993-04-20 | 54 | 0 |
| K926074 | PULPDENT DENTAL BOND ENCHANCER | Pulpdent Corp. | 1993-03-16 | 105 | 0 |
| K922755 | PULPDENT HARD CORE | Pulpdent Corp. | 1992-08-20 | 72 | 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