Identity
- Trade Name
- Premium Plus FDA UDI
- Generic Name
- Dental material mixing surface, chairside, reusable FDA UDI
- Device Name
- MIXING BOWLS FDA UDI
- Model / Reference
- 7460-L FDA UDI
- Description
- MIXING BOWLS FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8387460L4 FDA UDI
- FDA Product Code
- JDZ FDA UDI
- GMDN Term
- Dental material mixing surface, chairside, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4210 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material mixing surface, chairside, reusable
Premium Plus by Premium Plus International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material mixing surface, chairside, reusable.
- ACUWELL — PLASDENT CORP. · Class I
- ACUWELL — PLASDENT CORP. · Class I
- ACUWELL — PLASDENT CORP. · Class I
- Mini-Bowls — Pulpdent Corporation · Class I
- SPECTRUM FLOWBOWL — PLASDENT CORP. · Class I
- Salvin Stainless Steel Weighted Graft Material Dish — SALVIN DENTAL SPECIALTIES, LLC · Class I
- ACUWELL — PLASDENT CORP. · Class I
- FLOWBOWL — PLASDENT CORP. · 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
- Premium Plus International Limited
Sources (1)
- FDA UDI e0fd2c6e-fb9a-4b6a-9bd9-5dad975fbdec 33 fields · synced May 29, 2026