Identity
- Trade Name
- Prisma® Gloss™ Composite Polishing Paste System FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- Prisma® Gloss™ Polishing Cups Refill FDA UDI
- Model / Reference
- 624020 FDA UDI
- Description
- Prisma® Gloss™ Polishing Cups Refill FDA UDI
Identifiers
- Catalog Number
- 624020 FDA UDI
- Primary DI / UDI-DI
- D0026240201 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
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: Dental unfilled resin sealant/coatingDental mandrel
Prisma® Gloss™ Composite Polishing Paste System by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental mandrel.
- Preat — PREAT Corporation · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- Johnson-Promident — Young Innovations, Inc. · Class I
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
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
- Dentsply International
Sources (1)
- FDA UDI 0647a67e-ff50-4611-9640-355c610a330f 37 fields · synced May 31, 2026