Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
- Device Name
- Cartridge Dispenser Gun, 1:1/2:1, 50ml FDA UDI
- Model / Reference
- IT8-50-11 FDA UDI
- Description
- Cartridge Dispenser Gun, 1:1/2:1, 50ml FDA UDI
Identifiers
- Catalog Number
- IT8-50-11 FDA UDI
- Primary DI / UDI-DI
- D832IT850110 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material cartridge-plunging applicator, two-component, manual
Plasdent by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental material cartridge-plunging applicator, two-component, manual.
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- Imprint™ 4 Bite — 3M Deutschland GmbH · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI fe1ed81c-55f4-443e-ae19-c5c536799f8a 34 fields · synced May 30, 2026