Identity
- Trade Name
- Fibrafill® FLOW EUDAMEDFDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Fibrafill® FLOW EUDAMED
- Model / Reference
- F-005 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- F-005 FDA UDI
- Primary DI / UDI-DI
- 08595652700689 EUDAMEDFDA UDI
- Basic UDI-DI
- 85956527FLOW3Q EUDAMED
- 510(k) Number
- K952353 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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 reinforcing fibre
Fibrafill® FLOW by ADM, a.s. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental reinforcing fibre.
- GlasSpan Flexible Ceramic Bonding Rope Large Refill — PRACTICON, INC. · Class II
- Infibra — BIOLOREN SRL · Class II
- everStick® — Gc America Inc. · Class II
- everStick® — Gc America Inc. · Class II
- ENFORCE FRC™ — G&H Wire Company, Inc. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- everStick® — Gc America Inc. · Class II
- GlasSpan Dental Fiber — GLASSPAN INC · Class II
Cleared under the same submission
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
- ADM, a.s.
Sources (2)
- FDA UDI d848923b-9595-427c-9915-8ce77e8f901c 34 fields · synced Jul 8, 2026
- EUDAMED 780755aa-8557-4950-ba7a-2fdb6c245a78 61 fields · synced Jun 18, 2026