Identity
- Trade Name
- Regennex-Etchant / Cleanser FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Model / Reference
- 90719-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020557 FDA UDI
- 510(k) Number
- K061981 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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: Dentine bonding agent/set
Regennex-Etchant / Cleanser by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Cleared under the same submission
K061981 also covers:
- RE-GEN Self Etch Adhesive Kit — Vista Dental
- Self-Etch Bottle 1 — Vista Dental
- Self-Etch Bottle 2 — Vista Dental
- Self-Etch Refill — Vista Dental
- Self-etch Bottle 3 — Vista Dental
- Surpass 1 Refill Bottle — Vista Dental
- Surpass 2 Refill Bottle — Vista Dental
- Surpass 3 Refill Bottle — Vista Dental
- Surpass Refill Kit — Vista Dental
- Surpass Self Etch Adhesive Kit — Vista Dental
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
- Vista Dental
Sources (1)
- FDA UDI 99ff8d1d-33cf-43c7-b9ed-272b7a1e90b2 35 fields · synced Jun 8, 2026