Identity
- Trade Name
- VisCalor bulk FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- set contains Caps Sticks A1, A2, A3, uni, Caps Warmer FDA UDI
- Model / Reference
- 6063 FDA UDI
- Description
- set contains Caps Sticks A1, A2, A3, uni, Caps Warmer FDA UDI
Identifiers
- Primary DI / UDI-DI
- E22160631 FDA UDI
- FDA Product Code
- EFC FDA UDIEBZ FDA UDIEBF FDA UDIEEG FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6100 FDA UDI872.6070 FDA UDI872.3690 FDA UDI872.6475 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
Yes
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 composite resinAnaesthesia warmer
VisCalor bulk by VOCO GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia warmer.
- AdDent — Addent, Inc. · Class I
- VisCalor Dispenser — VOCO GmbH · Class I
- VisCalor Dispenser — VOCO GmbH · Class I
- VisCalor Dispenser — VOCO GmbH · Class I
- VisCalor Dispenser — VOCO GmbH · Class II
- Caps Warmer — VOCO GmbH · Class I
- VisCalor Dispenser — VOCO GmbH · Class I
- Caps Warmer — VOCO GmbH · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI b0211856-f85c-48e3-a00c-346204125615 35 fields · synced May 30, 2026