Identity
- Trade Name
- ROEKO GuttaFlow®2 FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Model / Reference
- REFILL PACK CAPSULES REGULAR FDA UDI
Identifiers
- Catalog Number
- 60013704 FDA UDI
- Primary DI / UDI-DI
- E165600137040 FDA UDI
- 510(k) Number
- K032662 FDA UDI
- FDA Product Code
- EKM FDA UDIKIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 FDA UDI872.3820 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling/sealing material
ROEKO GuttaFlow®2 by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
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Cleared under the same submission
K032662 also covers:
- HYGENIC® GuttaFlow®2 — Coltène/Whaledent AG
- HYGENIC® GuttaFlow®2 — Coltène/Whaledent AG
- HYGENIC® GuttaFlow®2 — Coltène/Whaledent AG
- HYGENIC® GuttaFlow®2 — Coltène/Whaledent AG
- HYGENIC® GuttaFlow®2 — Coltène/Whaledent AG
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG
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 I | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI d2196167-ef6a-4421-9236-668c1ee79f76 36 fields · synced Jun 8, 2026