Home › Device types › EHY
Tray, Impression, Preformed
FDA product code EHY · Class 1 · Dental
2,160
Registered devices
0
Adverse events
3
Recalls
16
510(k) clearances
Devices with this code
Rapid Arch Small Tapered Upper 1PK, Shade A2 — SMART DENTURE CONVERSIONS, LLCCOMPLETE DENTAL SUPPLIES — Complete Dental Supplies LLCImpression Tray — AMERICAN ORTHODONTICS CORPORATIONPremium Plus — Premium Plus (Dongguan) LimitedRemi Impression Kit — GrindGuard Inc.STOMA® — Storz am Mark GmbHNA — YDM CORPORATIONNA — YDM CORPORATIONTough Conversion Tray Medium Round Upper 1PK, BL — SMART DENTURE CONVERSIONS, LLCGood Fit Immediate Denture Trays — GOOD FIT TECHNOLOGIES, LLCBorder-Lock® Green Mouldable Lower Dentulous Tray #52 — DEN-MAT HOLDINGS, LLCCandid Redo Impression Kit — CANDID CARE CO.Algilock Solid Tray — HAGER WORLDWIDE, INC.Rapid Arch DCL Arch Large Square Lower 1PK, B1 — SMART DENTURE CONVERSIONS, LLCHeatWave™ Customizable Impression Trays Refill Lower Tray Size 52 — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.Morelli — Dental Morelli LtdaReicodent — devemed GmbHDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCBorder-Lock® Green Mouldable Lower Dentulous Tray #57 — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.Premium Plus — Premium Plus International LimitedRapid Arch Impression Tray Small Square Lower 1PK, B1 — SMART DENTURE CONVERSIONS, LLCThe Orthodontic Store — Young Innovations, Inc.Rapid Arch DCL Arch Large Round Lower 1PK, A2 — SMART DENTURE CONVERSIONS, LLCAstek — Young Innovations, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-05-19 | Implant Direct Sybron Manufacturing, LLC | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6 |
| 2005-09-21 | Rite-Dent Manufacturing Corp. | At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula f |
| 2004-10-13 | Harry J Bosworth Company | The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth. |
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