Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- K0220 BIORACE STARTER KIT 1P BIORACE STARTER KIT FDA UDI
- Model / Reference
- 5019731U0 FDA UDI
- Description
- K0220 BIORACE STARTER KIT 1P BIORACE STARTER KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919643388 FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic obturation system
Brasseler USA by Peter Brasseler Holdings, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DUO-GUN — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- DUO-PEN — DiaDent Group International · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI ae8eaaa8-d55b-40c2-8444-2eeff3867669 33 fields · synced May 31, 2026