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Seamless Kit - Wetting Resin 3ml Bottle
FDA UDIClass II (US FDA UDI)
by Vista Dental
Identity
- Trade Name
- Seamless Kit - Wetting Resin 3ml Bottle FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- Seamless Kit - Wetting Resin 3ml Bottle FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Seamless Kit - Wetting Resin 3ml Bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850194007886 FDA UDI
- 510(k) Number
- K092539 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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: Dental unfilled resin sealant/coating
Seamless Kit - Wetting Resin 3ml Bottle by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental unfilled resin sealant/coating.
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
- ResinBlend LV Composite Blending Resin — Den-Mat Holdings, LLC · Class II
- Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- Champ — CENTRIX, INC. · Class II
- OptiGuard — KERR CORPORATION · Class II
- OPTIGLAZE™ — Gc America Inc. · Class II
Cleared under the same submission
K092539 also covers:
- ResinBlend LV Composite Blending Resin — Den-Mat Holdings, LLC
- ResinBlend LV Composite Blending Resin Unit Dose — Den-Mat Holdings, LLC
- Seamfree Kit - Wetting Resin (3ml Bottle) — Vista Dental
- Seamfree Single Syringe with Tips — Vista Dental
- Seamfree Syringe 5 Pack with Tips — Vista Dental
- Seamless Single Syringe Pack with Tips — Vista Dental
- Seamless Syringe 5 Pack with Tips — 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 603ee57f-ef6b-44f9-a521-0b81207444e6 34 fields · synced Jun 6, 2026