Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBH — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
174 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933745 | PERMAGEN UNIVERSAL BONDING RESIN | Bio-Systems Research | 1994-01-26 | 176 | 0 |
| K930487 | PALATRAY LC MINT | Heraeus Kulzer, Inc. | 1993-06-18 | 140 | 0 |
| K923979 | LC TRAY MATERIAL | Dentsply Intl. | 1992-11-17 | 103 | 0 |
| K923549 | PALADISC LC | Heraeus Kulzer, Inc. | 1992-09-29 | 75 | 0 |
| K912820 | POLYESTER RESIN HAND MOLDED TRAY | E&D Dental Products, Inc. | 1991-08-21 | 57 | 0 |
| K905058 | PALAVIT L | Kulzer, Inc. | 1991-06-06 | 210 | 0 |
| K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Kulzer, Inc. | 1990-07-26 | 62 | 0 |
| K901782 | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM | Productivity Training Corp. | 1990-06-29 | 73 | 0 |
| K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS | Advantage Dental Products, Inc. | 1989-04-25 | 71 | 0 |
| K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) | 1988-07-27 | 86 | 0 |
| K875257 | IMPREGUM F ADHESIVE | Espe GmbH (Us) | 1988-03-09 | 78 | 0 |
| K875228 | PERMADYNE ADHESIVE | Espe GmbH (Us) | 1988-03-09 | 78 | 0 |
| K873739 | ACRYLIC IMPRESSION TRAY MATERIALS | E&D Dental Manufacturing Co. | 1988-03-07 | 174 | 0 |
| K872210 | IMPRESSION TRAY | Dentsply Intl. | 1987-06-22 | 13 | 0 |
| K863421 | SR-IVOLEN TRAY MATERIAL | Ivoclar USA, Inc. | 1986-11-03 | 60 | 0 |
| K854042 | RESIN TRAY IMPRESSION MATERIAL | Dentsply Intl. | 1985-11-07 | 36 | 0 |
| K853093 | PSP TEMP - TRAY | Psp Dental Co., Ltd. | 1985-09-06 | 45 | 0 |
| K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | The S. S. White Co. | 1985-07-02 | 43 | 0 |
| K844471 | VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE | Dentsply Intl. | 1985-02-08 | 81 | 0 |
| K850014 | HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE | Medi-Dent American, Inc. | 1985-01-23 | 21 | 0 |
| K831293 | SOLARCRYL CUSTOM TRAY MATERIAL | Solar Dental Co., Inc. | 1983-07-26 | 97 | 0 |
| K820998 | DENTRON-DIRECT-TRAY | Dentron, Inc. | 1982-06-10 | 62 | 0 |
| K820997 | DENTRON-EXACT - TRAY | Dentron, Inc. | 1982-06-10 | 62 | 0 |
| K813550 | HYBRID DENTAL PRODUCT | Dentsply Intl. | 1982-02-24 | 65 | 0 |
| K810686 | SR-IVOLEN | J. Aderer, Inc. | 1981-04-14 | 32 | 0 |
| K802751 | P-10 POSTERIOR FILLING MATERIAL | 3M Company | 1980-11-12 | 9 | 0 |
| K801780 | OXY CUSTOM TRAY RESIN | Oxy Dental Products, Inc. | 1980-08-07 | 10 | 0 |
| K790897 | QUAD IV CUSTOM IMPRESSION TRAY | Sted, Inc. | 1979-06-15 | 37 | 0 |
| K782153 | IMPRESSION TRAY, MDDS CUSTOM | Chayet and Sonnenrich, P.C. | 1979-02-26 | 62 | 0 |
| K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS | Cutter Laboratories, Inc. | 1976-10-15 | 14 | 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