Identity
- Trade Name
- SURFACE COAT™ FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Model / Reference
- #263-KA FDA UDI
Identifiers
- Primary DI / UDI-DI
- EKUR000263KA1 FDA UDI
- 510(k) Number
- K063228 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 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
Surface Coat™ by Kuraray Noritake Dental Inc. — 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
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
- Kuraray Noritake Dental Inc.
Sources (1)
- FDA UDI cb6039d4-4515-4205-8439-5a333e8d5e3f 33 fields · synced Jun 8, 2026