ACCU BITE Tray Anterior – Box of 30
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ACCU BITE Tray Anterior – Box of 30 EUDAMEDACCU BITE FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- ACCU BITE EUDAMEDACCU BITE Tray Anterior – Box of 30 FDA UDI
- Model / Reference
- 100000016 EUDAMEDFDA UDI
- Description
- ACCU BITE Tray Anterior – Box of 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783005769 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental impression tray, single-use
ACCU BITE Tray Anterior – Box of 30 by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 00b2fd7a-fe81-4ab6-a727-0ca1eb40f22e 61 fields · synced Jun 18, 2026
- FDA UDI 880ad682-41d2-49eb-93cd-7f221c03ca37 33 fields · synced May 30, 2026
- EUDAMED 46074f97-b537-4042-8519-3129705ae6cf 61 fields · synced Jun 18, 2026