Identity
- Trade Name
- FLOW LINE SYR 2 X 1 ML - A2 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Dental Composite resin FDA UDI
- Model / Reference
- 66000343 FDA UDI
- Description
- Dental Composite resin FDA UDI
Identifiers
- Catalog Number
- 66000343 FDA UDI
- Primary DI / UDI-DI
- J014660003430 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Flow Line Syr 2 X 1 Ml - A2 by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI ecec157b-7333-4e7b-974b-812f244e4f5e 36 fields · synced Jun 6, 2026