Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JES — Predicate Candidate Screening
62 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
145 days90th percentile
62clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | 2009-09-24 | 85 | 0 |
| K964976 | FLOSSBRUSH WITH FLUORIDE | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 | 145 | 0 |
| K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS | Whitehill Oral Technologies, Inc. | 1996-12-12 | 86 | 0 |
| K944034 | PERIO-MED DENTAL FLOSS | Whitehill Oral Technologies, Inc. | 1995-07-25 | 357 | 0 |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | John O. Butler Co. | 1995-06-28 | 56 | 0 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 | 16 | 0 |
| K942689 | RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 | 324 | 0 |
| K944886 | COLGATE PRECISION MINT WZXED DENTAL FLOSS | Colgate-Palmolive Co. | 1995-04-27 | 206 | 0 |
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 | 300 | 0 |
| K942690 | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE | Ranir/Dcp Corp. | 1995-04-27 | 324 | 0 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 | 83 | 0 |
| K935522 | RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE | Ranir/Dcp Corp. | 1994-01-26 | 71 | 0 |
| K931353 | FLOSS PLUS | Floss Plus, Inc. | 1993-07-27 | 132 | 0 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 | 94 | 0 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 | 94 | 0 |
| K921601 | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE | Ultradent Products, Inc. | 1992-06-16 | 74 | 0 |
| K914962 | FUN FLOSS | Fun Floss Co. | 1991-12-30 | 55 | 0 |
| K913087 | DENTAL FLOSS | Westone Products , Ltd. | 1991-09-30 | 80 | 0 |
| K912430 | DENTAL FLOSS | Westone Products , Ltd. | 1991-09-30 | 122 | 0 |
| K911701 | G-FLOSS & G-FLOSS II | Implant Innovations International, Inc. | 1991-05-15 | 29 | 0 |
| K911470 | BUFFING FLOSS | Lamar Industries | 1991-05-15 | 42 | 0 |
| K905382 | SCRIBBON | Varnum Corp. | 1990-12-17 | 18 | 0 |
| K902325 | DENTAL CLEANING RINGS | H. Bernath & Assoc. | 1990-11-13 | 173 | 0 |
| K903712 | FLOSSIE TOOTHFLOSS | Flossie, Inc. | 1990-09-05 | 22 | 0 |
| K885056 | TWIXEL(TM) | Fouts Development, Inc. | 1989-01-04 | 28 | 0 |
| K884145 | FLOSER PLUS | Pacific Lin Intl., Co. | 1988-10-19 | 16 | 0 |
| K882571 | KOLYNOS DENTAL FLOSS | Whitehall Laboratories, Inc. | 1988-10-12 | 112 | 0 |
| K883024 | ORAL-B FLOSSERS | Oral-B Laboratories | 1988-08-26 | 38 | 0 |
| K883335 | COLGATE DENTAL FLOSS | Colgate-Palmolive Co. | 1988-08-26 | 17 | 0 |
| K882828 | DENTAL FLOSS PICK | Bik Pik | 1988-08-12 | 35 | 0 |
| K882164 | FLOSS CARD | Arthur Blank & Co., Inc. | 1988-06-10 | 17 | 0 |
| K874471 | SUPER FLOSSER | U.S. Pacific Corp. | 1988-01-28 | 87 | 0 |
| K871736 | CARERITE BIOPACK GINGIVAL RETRACTION CORD | Cost Rite Health Products, Inc. | 1987-05-27 | 22 | 0 |
| K871393 | DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE | Flossrite Corp. | 1987-04-15 | 8 | 0 |
| K871392 | DR FLOSSER REFILL | Flossrite Corp. | 1987-04-15 | 8 | 0 |
| K870996 | SEWON DENTAL FLOSSER | Sewon Industry | 1987-03-19 | 8 | 0 |
| K864832 | DENTAL FLOSS | Westone Products , Ltd. | 1987-02-10 | 63 | 0 |
| K862694 | FLOSS CARD | Floss Card Co. | 1986-08-06 | 22 | 0 |
| K860963 | 'E-Z FLOSS' AND 'LAZY FLOSS' | Login Industries , Ltd. | 1986-03-26 | 13 | 0 |
| K860324 | DENTAL FLOSS CARD | Washburn Laboratories | 1986-03-26 | 56 | 0 |
| K860769 | DENTAL FLOSS HOLDER | Sewon Industry | 1986-03-26 | 23 | 0 |
| K855113 | FLOSS HOLDER (PLASTIC) | Pacific Union Dental, Inc. | 1986-03-06 | 73 | 0 |
| K854701 | RETRACT-A-CORD | Almore Intl., Inc. | 1986-03-06 | 105 | 0 |
| K853767 | FLOSPIK | Medelco , Ltd. | 1985-12-02 | 84 | 0 |
| K844626 | MINI FLOW- DENTAL FLOSS | Mini Floss | 1985-01-09 | 43 | 0 |
| K844438 | SIMPLIFLOS DENTAL FLOSSER | Valiant Steel & Equipment, Inc. | 1985-01-04 | 49 | 0 |
| K842846 | SEWON DENTAL FLOSS FOLDER | Sewon Industry | 1984-08-17 | 28 | 0 |
| K841675 | FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE | Leonard Lorch | 1984-06-27 | 65 | 0 |
| K840093 | DENTAL FLOSSING INSTRUMENT | Leverette Corp. | 1984-04-05 | 86 | 0 |
| K831254 | DENTAL FLOSS HOLDER | Sewon Industry | 1983-05-09 | 21 | 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