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ProFil
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 18U0BWRef 180023Ref 184C03Ref 182A01Ref 182B02Ref 18400PRef 182OA2Ref 184A04Ref 184A03Ref 184B02Ref 182A35Ref 182A03Ref 184OA3
by Silmet Ltd
Identity
- Trade Name
- ProFil EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Composites EUDAMEDDental Composite Restorative FDA UDI
- Model / Reference
- 184A03 EUDAMEDFDA UDI18400P EUDAMEDFDA UDI182OA2 EUDAMEDFDA UDI18U0BW EUDAMEDFDA UDI182A03 EUDAMEDFDA UDI182A01 EUDAMEDFDA UDI184A04 EUDAMEDFDA UDI182A35 EUDAMEDFDA UDI180023 EUDAMEDFDA UDI184C03 EUDAMEDFDA UDI184B02 EUDAMEDFDA UDI184OA3 EUDAMEDFDA UDI182B02 EUDAMED182BO2 FDA UDI
- Description
- Dental Composite Restorative FDA UDI
Identifiers
- Catalog Number
- 184A03 FDA UDI18400P FDA UDI182OA2 FDA UDI18U0BW FDA UDI182A03 FDA UDI182A01 FDA UDI184A04 FDA UDI182BO2 FDA UDI182A35 FDA UDI180023 FDA UDI184C03 FDA UDI184B02 FDA UDI184OA3 FDA UDI
- Primary DI / UDI-DI
- 07290015358095 EUDAMEDFDA UDI07290015358262 EUDAMEDFDA UDI07290015358217 EUDAMEDFDA UDI07290015358705 EUDAMEDFDA UDI07290015358088 EUDAMEDFDA UDI07290015358040 EUDAMEDFDA UDI07290015358125 EUDAMEDFDA UDI07290015358149 EUDAMEDFDA UDI07290015358101 EUDAMEDFDA UDI07290015358422 EUDAMEDFDA UDI07290015358194 EUDAMEDFDA UDI07290015358156 EUDAMEDFDA UDI07290015358231 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290012DMR2X5 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Italy EUDAMEDMalta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Category: Dental composite resin
ProFil by Silmet Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Silmet Ltd
Sources (26)
- FDA UDI 71bfcf65-7222-4bb6-99d5-6ba31aa84421 34 fields · synced Aug 2, 2026
- FDA UDI d2250ab8-e4c7-4593-baff-d3ff4ab81a89 34 fields · synced May 29, 2026
- FDA UDI d2737a3b-8b7c-4083-a5a2-55b7f66a3339 34 fields · synced May 29, 2026
- FDA UDI c1e691ae-1ddc-47f5-b2c3-d57e9ae059fe 34 fields · synced May 30, 2026
- FDA UDI 0bb89669-97a5-4f00-a34d-aefa26ec3dc0 34 fields · synced May 30, 2026
- FDA UDI 8dc9401e-ab92-4d44-a74c-83cda2e23c9c 34 fields · synced May 30, 2026
- FDA UDI 7c559c75-b221-4267-ac7d-876cea67f701 34 fields · synced May 30, 2026
- FDA UDI e8f65273-2cd0-4512-b1d4-220c335ca371 34 fields · synced May 30, 2026
- FDA UDI 9b5dbd43-b59b-42f4-86d5-896b17c3d1b9 34 fields · synced May 30, 2026
- FDA UDI 23e36b50-7dd5-462c-8aeb-1be34bbcaa22 34 fields · synced May 30, 2026
- FDA UDI 6764e52d-21b3-4517-8dc4-5334b1c9f0fe 34 fields · synced May 30, 2026
- FDA UDI 1160db25-5943-459f-93ed-c89f6070899d 34 fields · synced May 30, 2026
- FDA UDI 77cd218c-7a39-4c0c-a2a5-33e4e553d3a6 34 fields · synced May 30, 2026
- EUDAMED e5588c4c-7a12-48b1-aee3-f2ffdeee2bbd 61 fields · synced Jul 8, 2026
- EUDAMED c3ac6a06-9832-48bf-9fe1-ffe98876ca1a 61 fields · synced Jul 8, 2026
- EUDAMED ec4a046a-bac3-4575-9b3a-2655bcbf6b4e 61 fields · synced Jul 11, 2026
- EUDAMED db92c386-0cdb-4e66-a301-1b21fb2ec851 61 fields · synced Jul 11, 2026
- EUDAMED f3753358-7eef-4ffe-8efb-59441a47470f 61 fields · synced Jul 11, 2026
- EUDAMED 3e23f324-7b9b-4571-b1a6-8c2e85d3919f 61 fields · synced Jul 11, 2026
- EUDAMED a801bc34-64dd-46c0-b433-8183187d3925 61 fields · synced Jul 12, 2026
- EUDAMED eb0073a6-e35b-4d35-96e5-9c35eba6470c 61 fields · synced Jul 12, 2026
- EUDAMED db33fd06-e2dd-41fc-bc13-a962a56e2663 61 fields · synced Jul 15, 2026
- EUDAMED 94907d30-8d94-46e5-af37-dc4acdebe770 61 fields · synced Jul 24, 2026
- EUDAMED 3d369d7e-104b-47cc-83f3-51a883de53d7 61 fields · synced Jul 25, 2026
- EUDAMED fad5a1dc-37d9-4efe-8135-73948e6b0fcf 61 fields · synced Jul 29, 2026
- EUDAMED f3a6563f-2000-4514-92b2-f233ca2dbbc9 61 fields · synced Aug 2, 2026