Identity
- Trade Name
- HotShotElite Single Shot Assortment EUDAMEDHot Shot Elite Single Shot Assortment FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Thermoplastic denture base EUDAMEDVariety pack (30 Single Shots) All three brands in one (Visiclear x2, Duracetal A1x1,A2x1,A3x1,A3.5x1,A4x1,B1x1,B2x1,B3x1,B4x1,C1x1,C2x1,C3x1,C4x1,D2x1,D3x1,D4x1,G1x1,G2x1,G3x1,P1x1,P2x1,P3x1, Duraflex DPx2,MPx2,Px2) FDA UDI
- Model / Reference
- VP-0100 EUDAMEDFDA UDI
- Description
- Variety pack (30 Single Shots) All three brands in one (Visiclear x2, Duracetal A1x1,A2x1,A3x1,A3.5x1,A4x1,B1x1,B2x1,B3x1,B4x1,C1x1,C2x1,C3x1,C4x1,D2x1,D3x1,D4x1,G1x1,G2x1,G3x1,P1x1,P2x1,P3x1, Duraflex DPx2,MPx2,Px2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326104143 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423261HSESSAGM EUDAMED
- FDA Product Code
- EHP FDA UDIEBI FDA UDI
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3285 FDA UDI872.3760 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 7 Gram FDA UDIWeight — 8 Gram FDA UDI
HotShotElite Single Shot Assortment by The Myerson Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08423261HSESSAGM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
- EUDAMED SRN
- TT-MF-000045141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1ab5cf4a-4bd3-4498-8da9-d8f65920f91d 61 fields · synced Aug 2, 2026
- FDA UDI 3b032cbe-8ec0-408c-aa22-457537cd0078 35 fields · synced May 30, 2026