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Simplicity Self Etch Dental Adhesive System
FDA UDIClass II (US FDA UDI)
by Vista Dental
Identity
- Trade Name
- Simplicity Self Etch Dental Adhesive System FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Simplicity Kit Self Etch Dental Adhesive System FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Simplicity Kit Self Etch Dental Adhesive System FDA UDI
Identifiers
- Catalog Number
- 100-51 FDA UDI
- Primary DI / UDI-DI
- 00850194007053 FDA UDI
- 510(k) Number
- K020570 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
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
No
FDA UDI
Category: Dentine bonding agent/set
Simplicity Self Etch Dental Adhesive System 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
K020570 also covers:
- Simplicity 1 Refill Bottle — Vista Dental
- Simplicity 2 Refill Bottle — Vista Dental
- Simplicity Kit: Original — Vista Dental
- Simplicity Refill Bottle Set — Vista Dental
- V-Force Twin Kit Self Etch Dental Adhesive System — Vista Dental
- V-Force Twin Refill Bottle 1 — Vista Dental
- V-Force Twin Refill Bottle 2 — Vista Dental
- V-Force Twin Refill Bottle Set — 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 124d57e7-c542-4531-80a9-f9bd43fa24d5 35 fields · synced May 30, 2026