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ACCU BITE Tray Ext Half Arch – Box of 40
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100000023
Identity
- Trade Name
- ACCU BITE Tray Ext Half Arch – Box of 40 EUDAMEDACCU BITE FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- ACCU BITE EUDAMEDACCU BITE Tray Ext Half Arch – Box of 40 FDA UDI
- Model / Reference
- 100000023 EUDAMEDFDA UDI
- Description
- ACCU BITE Tray Ext Half Arch – Box of 40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783005783 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783AccuBiteVX EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Category: Dental impression tray, single-use
ACCU BITE Tray Ext Half Arch – Box of 40 by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental impression tray, single-use.
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- 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00348783AccuBiteVX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
- EUDAMED SRN
- US-MF-000015778
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 755a3e38-e58f-4085-8497-c0f77a9d329e 61 fields · synced Jun 19, 2026
- FDA UDI 5d83b9f3-00f3-4e61-8e8f-d1bb33f0f826 33 fields · synced May 29, 2026
- EUDAMED 8364ea29-5342-41bb-b541-0b87a5ba4227 61 fields · synced Jun 14, 2026