Identity
- Trade Name
- Harmony Anterior Disposable Dual Arch Tray FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box FDA UDI
- Model / Reference
- Anterior FDA UDI
- Description
- Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850211006083 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression tray, single-use
Harmony Anterior Disposable Dual Arch Tray by Ho Dental Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ho Dental Co., Inc.
Sources (1)
- FDA UDI 91196e11-3021-4f49-84ca-3a90097bee79 33 fields · synced May 29, 2026