Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOJ — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
141 daysmedian FDA review time
683 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251425 | turbodent touch | Mectron S.P.A. | 2025-05-09 | 1 | 0 |
| K063236 | BETA-POWDER | Brainbase Corporation | 2007-02-16 | 114 | 0 |
| K042872 | RONDOFLEX PLUS 360 | Kavo America Corporation | 2004-11-23 | 36 | 0 |
| K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | Sirona Dental Systems GmbH | 2004-01-15 | 52 | 0 |
| K033215 | PREPAIR | Danville Materials, Inc. | 2004-01-09 | 98 | 0 |
| K024105 | VELOPEX AQUACUT FLUID ABRASION UNIT | Velopex International, Inc. | 2003-10-09 | 300 | 0 |
| K030292 | GROMAN PREPMASTER | Groman, Inc. | 2003-04-15 | 77 | 0 |
| K021450 | CLINPRO PROPHY POWDER | 3M Espe AG Dental Products | 2002-08-01 | 87 | 0 |
| K014188 | NEW PROPHY POWDER | Dentsply Intl. | 2002-03-15 | 84 | 0 |
| K014249 | JETPOLISHER | Deldent , Ltd. | 2002-02-19 | 55 | 0 |
| K014252 | JETSTREAM | Deldent , Ltd. | 2002-02-19 | 55 | 0 |
| K014245 | JETSONIC 2000 | Deldent , Ltd. | 2002-01-29 | 34 | 0 |
| K013969 | MINIBLASTER | Deldent , Ltd. | 2002-01-10 | 38 | 0 |
| K984380 | DISPO ETCH | Kis Products | 2001-08-06 | 972 | 0 |
| K993182 | DISPOPROPHY | Kis Products | 2001-08-06 | 683 | 0 |
| K993124 | DISPODRILL | Kis Products | 2001-08-06 | 686 | 0 |
| K010816 | DENTO-PREP PARTICLE MICROBLASTER | Ronvig A/S | 2001-05-10 | 52 | 0 |
| K002708 | KAVO CORUND HANDPIECE 2013 | Kavo America | 2000-11-28 | 90 | 0 |
| K990060 | MACH 7 | Kreativ, Inc. | 2000-06-15 | 524 | 0 |
| K001313 | AIRDENT II CS | Air Technologies, Inc. | 2000-06-08 | 43 | 0 |
| K980672 | SIMPLEX AIRBRATOR (SAB-7) | Irt Management Corp. | 2000-05-04 | 804 | 0 |
| K984415 | S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F | S.S. White Technologies, Inc. | 1999-09-29 | 293 | 0 |
| K990545 | JETSONIC 2000 | Sds Dental, Inc. | 1999-08-11 | 170 | 0 |
| K981564 | AIR TECHNIQUES' AIRDENT II | Air Techniques, Inc. | 1998-09-24 | 146 | 0 |
| K974655 | PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM | Prep Technology Corp. | 1998-07-09 | 206 | 0 |
| K980216 | KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 | Kreativ, Inc. | 1998-06-16 | 146 | 0 |
| K974488 | AIRPREP SYSTEM - MODEL 9001 | Asi Medical, Inc. | 1998-05-26 | 181 | 0 |
| K980726 | ULTRA-BLASTER | Ultradent Products, Inc. | 1998-05-12 | 77 | 0 |
| K973679 | AEROETCHER | Parkell, Inc. | 1998-03-10 | 165 | 0 |
| K970589 | MICROETCHER AP | Danville Engineering, Inc. | 1997-09-17 | 211 | 0 |
| K964755 | MICROJET CAVITY PREPARATION SYSTEM | Midwest Dental Products Corp. | 1997-09-11 | 288 | 0 |
| K970484 | ACCU-PREP | Bisco, Inc. | 1997-07-01 | 141 | 0 |
| K970249 | SIMPLEX AIRBRATOR | Simplex Medical Systems, Inc. | 1997-05-07 | 105 | 0 |
| K964145 | ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 | Crystal Mark, Inc. | 1996-12-31 | 75 | 0 |
| K964059 | MICADENT | Hampton Research | 1996-12-19 | 71 | 0 |
| K955573 | OPTIBLAST INTRAORAL SANDBLASTER | Buffalo Dental Mfg. Co., Inc. | 1996-05-03 | 148 | 0 |
| K955050 | JETSTREAM CAVITY PREPARATION SYSTEM | Dove Systems, Inc. | 1996-03-07 | 125 | 0 |
| K931845 | SANDBLASTER | Mirage Dental Systems | 1995-03-01 | 687 | 0 |
| K940776 | KREATIV MODEL KV-1 | Kreativ, Inc. | 1994-12-21 | 302 | 0 |
| K932997 | MICROPREP CAVITY PREPERATION SYSTEM | Sunrise Technologies, Inc. | 1994-04-25 | 311 | 0 |
| K921748 | MODEL 2000 DENTAL AIR ABRASIVE SYSTEM | Texas Airsonics, Inc. | 1992-11-25 | 226 | 0 |
| K903284 | YOUNG PROPHY SYSTEM, PS UNIT | Young Dental Manufacturing Co. 1, LLC | 1990-12-17 | 148 | 0 |
| K902836 | MICROETCHER | Danville Engineering, Inc. | 1990-11-20 | 145 | 0 |
| K875340 | JETPOLISHER(TM) | Young Dental Manufacturing Co. 1, LLC | 1988-06-10 | 163 | 0 |
| K871980 | D-23 DENTURE ADHESIVE | Solar Dental Co., Inc. | 1987-06-05 | 14 | 0 |
| K862384 | SCHEIN AP-1 AIR POLISHING UNIT | Henry Schein, Inc. | 1986-11-07 | 136 | 0 |
| K852521 | SATLEC PROPHY UNIT PU 3055 | Spelna, Inc. | 1985-07-31 | 47 | 0 |
| K840720 | FIBER HEMOFILTERS FH55-FH77 & 88 | Gambro, Inc. | 1984-04-24 | 67 | 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