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Enigma
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ET:C1:K21KModel Enigma Denture Teeth - Pairs
Identity
- Trade Name
- Enigma EUDAMEDEnigma Denture Teeth - Pairs FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- ET:C1:K21K EUDAMED
- Model / Reference
- Enigma Denture Teeth - Pairs EUDAMEDET:C1:K21K EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05052674043833 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05052674043833 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 — 0.003 Kilogram FDA UDI
Enigma by Davis Schottlander & Davis Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05052674043833 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Davis Schottlander & Davis Ltd
- EUDAMED SRN
- GB-MF-000035008
- Authorised Representative
- Schottlander (IRL) Ltd IE-AR-000029625
Sources (2)
- EUDAMED 71bbd843-0b18-4f86-a69c-77e58e5058c9 61 fields · synced May 30, 2026
- FDA UDI eb469391-dc7f-41f3-bd95-b909e822ee39 34 fields · synced May 30, 2026