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Novacryl
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0010473 CEModel Self-curing polymer A2 color Novacryl CE 500gRef 0010472 CEModel Self-curing polymer A3 color Novacryl CE 500gRef 0010538 CEModel Self-curing monomer Novacryl CE 110mlRef 82236 CEModel Self-curing polymer B3 color Novacryl CE 40gRef 82310 CEModel Self-curing monomer Novacryl CE 55mlRef 82215 CEModel Self-curing polymer A3 color 40g Novacryl CE
by Productora Y Comercializadora Odontologica New Stetic S.a
Identity
- Trade Name
- Novacryl EUDAMEDNovacryl Self Curing Acrylic D4 X 125g FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- SELF-CURING ACRYLIC RESINS EUDAMEDNovacryl Self Curing Acrylic D4 X 125g FDA UDI
- Model / Reference
- Self-curing polymer A2 color Novacryl CE 500g EUDAMED0010473 CE EUDAMEDSelf-curing polymer A3 color Novacryl CE 500g EUDAMED0010472 CE EUDAMEDSelf-curing monomer Novacryl CE 110ml EUDAMED0010538 CE EUDAMEDSelf-curing polymer B3 color Novacryl CE 40g EUDAMED82236 CE EUDAMEDSelf-curing monomer Novacryl CE 55ml EUDAMED82310 CE EUDAMEDSelf-curing polymer A3 color 40g Novacryl CE EUDAMED82215 CE EUDAMED0017889 FDA UDI
- Description
- Novacryl Self Curing Acrylic D4 X 125g FDA UDI
Identifiers
- Catalog Number
- 0017889 FDA UDI
- Primary DI / UDI-DI
- 07701126633617 EUDAMED07701126633600 EUDAMED07701126633945 EUDAMED07701126633563 EUDAMED07701126633822 EUDAMED07701126633594 EUDAMED07701126607861 FDA UDI
- Basic UDI-DI
- 7701126633617XN EUDAMED7701126633600X5 EUDAMED7701126633945YA EUDAMED7701126633563XQ EUDAMED7701126633822XR EUDAMED7701126633594Y3 EUDAMED
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Novacryl by Productora Y Comercializadora Odontologica New Stetic S A — Class IIa — 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 | 7701126633617XN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (7)
- EUDAMED 6983c641-e4fd-4405-9135-dc1aaeaab0df 61 fields · synced Oct 6, 2026
- EUDAMED b37e7fef-84c4-433a-b840-cfae3f9f01af 61 fields · synced May 17, 2026
- EUDAMED 9fffc257-1710-45bb-b381-4da40144e6b6 61 fields · synced May 17, 2026
- EUDAMED 1a96924a-4b40-43e7-b8f3-b3c4e61e7571 61 fields · synced May 18, 2026
- EUDAMED ee23a195-1a48-49ac-8ccd-4f24a0e0116e 61 fields · synced May 19, 2026
- EUDAMED ba4c4e5c-d0a7-4278-bdc2-4ca96b4625ae 61 fields · synced May 19, 2026
- FDA UDI 54ed0a5f-0c7d-42fb-93a9-80c59c8ee866 34 fields · synced May 24, 2026