Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKJ · Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
233 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961714 | ASEPTYLUM, UNI-CARRIER | Distriflor S.A. | 1996-06-10 | 39 | 0 |
| K953707 | MEDTROL DENTAL KIT | Medtrol, Inc. | 1996-01-04 | 149 | 0 |
| K945815 | DENTAL KIT | Constancy Ent., Inc. | 1995-07-19 | 233 | 0 |
| K951607 | SUREFLEX FILES | Dentsply Intl. | 1995-06-22 | 98 | 0 |
| K945077 | INSTRUMENT,FILLING,PLASTIC,DENTAL | Worldwide Dental, Inc. | 1994-11-30 | 44 | 0 |
| K943820 | STAT PAK | Magnum Instruments, Inc. | 1994-11-02 | 89 | 0 |
| K943351 | MAUNAL DISPOSABLE DENTAL INSTRUMENTS | Magnum Instruments, Inc. | 1994-10-07 | 87 | 0 |
| K943584 | PRESTERILIZED ENDODONTIC FILES | Dentsply Intl. | 1994-09-21 | 61 | 0 |
| K935127 | SOUTHLAND STERILE DENTAL SYSTEM | Southland, Ltd. | 1994-07-28 | 273 | 0 |
| K941954 | NON-FOGGING DENTAL MIRROR | Buffalo Dental Mfg. Co., Inc. | 1994-07-08 | 77 | 0 |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Advance Medical Designs, Inc. | 1994-07-05 | 634 | 0 |
| K925889 | FORCEPS, DRESSING, DENTAL | Protector, Inc. | 1994-02-15 | 456 | 0 |
| K925888 | EXPLORER, OPERATIVE | Protector, Inc. | 1994-02-15 | 456 | 0 |
| K925890 | MIRROR, MOUTH | Protector, Inc. | 1994-02-15 | 456 | 0 |
| K935217 | LC DENTAL HAND INSTRUMENT | L.C. Dental | 1994-01-05 | 71 | 0 |
| K932511 | SILICONE MIRROR | Moyco Industries, Inc. | 1993-11-05 | 164 | 0 |
| K926368 | APPLICATOR NOZZLE | Centrix, Inc. | 1993-09-15 | 267 | 0 |
| K923902 | STERILE DENTAL KITS | Professional Sterile Systems, Inc. | 1993-06-29 | 329 | 0 |
| K922988 | ECO/DENTAL GENERAL DENTAL PACK | Dyna-Pace Systems, Inc. | 1992-11-04 | 135 | 0 |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Innovators, Inc. | 1992-09-25 | 189 | 0 |
| K914368 | PART 872 DEGUFILL H & DEGUFILL M DA | Degussa AG | 1991-11-13 | 43 | 0 |
| K911655 | IMPLARETTE | Implant Innovations International, Inc. | 1991-10-21 | 192 | 0 |
| K912473 | ACCU-PLACER TM KIT | Hu-Friedy Mfg. Co., Inc. | 1991-07-24 | 50 | 0 |
| K911214 | NUTIP (TM) SYRINGE SHIELD | Western M/D, Inc. | 1991-07-17 | 120 | 0 |
| K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | Premier Dental Products Co. | 1991-06-24 | 40 | 0 |
| K911281 | PULPDENT PIC N STIC | Pulpdent Corp. | 1991-05-15 | 57 | 0 |
| K901053 | MIRROR SHIELD | Pulpdent Corp. | 1990-05-07 | 63 | 0 |
| K901178 | AMALGAM CONDENSER | American Medical Ceramics, Inc. | 1990-04-27 | 45 | 0 |
| K901175 | HAND MIRROR | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901171 | U-15 SINGLE END SCALER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901176 | #23 EXPLORER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901174 | ELEVATOR #11 | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901170 | PERIODONTAL KNIFE | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901177 | DISCOID/CLEOID DOUBLE END AMALGAM CARVER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901172 | GRACEY CURETTE #13-14 | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901173 | DISCOID SPOON EXCAVATOR | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901169 | 5 STRAIGHT SCISSORS | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K896843 | EXPLORER 24 DENTAL HAND INSTRUMENT | American Medical Ceramics, Inc. | 1990-03-06 | 90 | 0 |
| K896565 | DMV(R) VENEER SUCTION GRIPPER | Dmv Corp. | 1990-02-02 | 77 | 0 |
| K895985 | SANI-PIKS DENTAL HAND INSTRUMENT | Bison-Lee Co. | 1990-01-10 | 89 | 0 |
| K895958 | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) | Brevet, Inc. | 1989-12-04 | 54 | 0 |
| K895959 | BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) | Brevet, Inc. | 1989-11-29 | 49 | 0 |
| K894896 | ANSWER DENTAL IMPLEMENT, EXPLORER | Tern Chien Ent. Co., Ltd. | 1989-10-30 | 90 | 0 |
| K894895 | ANSWER DENTAL IMPLEMENTS, MIRROR | Tern Chien Ent. Co., Ltd. | 1989-10-30 | 90 | 0 |
| K894897 | ANSWER DENTAL IMPLEMENT, FORCEPS | Tern Chien Ent. Co., Ltd. | 1989-10-30 | 90 | 0 |
| K892239 | DENTAL HAND INSTRUMENTS | Implant Support Systems, Inc. | 1989-05-18 | 84 | 0 |
| K892261 | RUBBER DAM CLAMPS/FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-05-10 | 36 | 0 |
| K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 | Zinnanti Surgical Instruments, Inc. | 1989-05-02 | 28 | 0 |
| K884308 | MANDIBLE MANIPULATOR | Leonard Medical, Inc. | 1989-03-31 | 169 | 0 |
| K890357 | DENTAL IMPRESSION SYINGE | Innotek Dental Corp. | 1989-02-13 | 20 | 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