Home › Device types › EHY
Tray, Impression, Preformed
FDA product code EHY · Class 1 · Dental
1,885
Registered devices
0
Adverse events
3
Recalls
16
510(k) clearances
Devices with this code
Bright Tray — ORMCO CORPORATIONDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCOneBite Evolution — Precision Dental Products LLCMulti Tray — Kettenbach GmbH & Co. KGSupplies — AMERICAN ORTHODONTICS CORPORATION3-Way — Sultan Healthcare IncSRH3427LBlue Sky Bio, LLC — BLUE SKY BIO LLCHeatWave™ Customizable Impression Trays Refill Upper Tray Size 43 — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.Sklar® — SKLAR CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONAlgilock Solid Tray — HAGER WORLDWIDE, INC.Premium Plus — Premium Plus International LimitedBorder-Lock® Disposable Edentulous Upper Tray #34 — DEN-MAT HOLDINGS, LLCBurkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THEOrthoquest — Young Innovations, Inc.REDI-LOCK™ — ORTHO TECHNOLOGY, INC.Impression Tray — AMERICAN ORTHODONTICS CORPORATIONOneBite Evolution — Precision Dental Products LLCPresident — COLTENE/WHALEDENT INCOSUNG MND — OSUNG MND Co., Ltd.ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack — PRACTICON, INC.NA — YDM CORPORATIONNA — YDM CORPORATIONBlue Sky Bio, LLC — BLUE SKY BIO LLC
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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