Identity
- Trade Name
- Fusion Core DC Flo and Fusion Bond DC FDA UDI
- Generic Name
- Dental composite resin kit FDA UDI
- Model / Reference
- Combo Pack FDA UDI
Identifiers
- Catalog Number
- 20027 FDA UDI
- Primary DI / UDI-DI
- D967200270 FDA UDI
- FDA Product Code
- EBF FDA UDIKLE FDA UDI
- GMDN Term
- Dental composite resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3200 FDA UDI
- 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
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
Yes
FDA UDI
Category: Dental composite resin kitDental acrylic resin kit
Fusion Core DC Flo and Fusion Bond DC by Prevest Denpro Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental acrylic resin kit.
- AxioBond 5 — Axiodent Inc. · Class II
- AxioBond MDP — Axiodent Inc. · Class II
- AxioBond Universal — Axiodent Inc. · Class II
- AxioBond 7 — Axiodent Inc. · Class II
- AxioBond 5 — Axiodent Inc. · Class II
- AxioBond DC — Axiodent Inc. · Class II
- AxioBond Universal — Axiodent Inc. · Class II
- The Orthodontic Store — Young Innovations, Inc. · Class II
Cleared under the same submission
K231263 also covers:
- Fusion Core DC Flo — PREVEST DENPRO LIMITED
- Fusion Flo — PREVEST DENPRO LIMITED
- Fusion Flo — PREVEST DENPRO LIMITED
- Fusion Flo — PREVEST DENPRO LIMITED
- Fusion Flo SE — PREVEST DENPRO LIMITED
- Fusion Flo SE — PREVEST DENPRO LIMITED
- Fusion Flo SE — PREVEST DENPRO LIMITED
- Fusion I Seal — PREVEST DENPRO LIMITED
- Fusion I Seal — PREVEST DENPRO LIMITED
- Fusion I Seal — PREVEST DENPRO LIMITED
- Fusion I Seal — PREVEST DENPRO LIMITED
- Fusion I Seal — PREVEST DENPRO LIMITED
K231696 also covers:
- Fusion Bond 5 — PREVEST DENPRO LIMITED
- Fusion Bond 5 — PREVEST DENPRO LIMITED
- Fusion Bond 7 — PREVEST DENPRO LIMITED
- Fusion Bond 7 — PREVEST DENPRO LIMITED
- Fusion Bond DC — PREVEST DENPRO LIMITED
- Renew MDP — PREVEST DENPRO LIMITED
- Renew Universal — PREVEST DENPRO LIMITED
- Renew Universal — PREVEST DENPRO LIMITED
- Renew Universal — PREVEST DENPRO LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (1)
- FDA UDI 26cb00ee-6f9a-4d33-9421-16a8ccdd73d9 34 fields · synced Jun 8, 2026