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Enigma Anterior Denture Teeth
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EA:C3:D66Model Enigma Anterior Denture Teeth
Identity
- Trade Name
- Enigma EUDAMEDEnigma Anterior Denture Teeth FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- EA:C3:D66 EUDAMED
- Model / Reference
- EA:C3:D66 EUDAMEDFDA UDIEnigma Anterior Denture Teeth EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052674033094 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05052674033094 EUDAMED
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Over-the-Counter
Yes
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 — 0.006 Kilogram FDA UDI
Category: Resin artificial teeth
Enigma Anterior Denture Teeth by Davis Schottlander & Davis Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Davis Schottlander & Davis Limited
Sources (2)
- FDA UDI c985e50f-778f-4281-8b14-2b988f3d5229 34 fields · synced Jul 13, 2026
- EUDAMED f39b01f7-fa68-4154-bef8-b56dc069cfde 61 fields · synced Jul 13, 2026