Identity
- Trade Name
- HYGENIC® GuttaFlow®2 FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Model / Reference
- REFILL PACK CAPSULES FAST FDA UDI
Identifiers
- Catalog Number
- 60013713 FDA UDI
- Primary DI / UDI-DI
- E165600137130 FDA UDI
- 510(k) Number
- K032662 FDA UDI
- FDA Product Code
- KIF FDA UDIEKM FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI872.3850 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
HYGENIC® GuttaFlow®2 by Coltène/Whaledent AG — Class II — 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
- 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
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 7082da59-27f8-42b2-9430-eef5a272d184 36 fields · synced May 30, 2026