Identity
- Trade Name
- DISPENSER for 5ml Dual Syringe FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
- Model / Reference
- L-22020P FDA UDI
Identifiers
- Catalog Number
- L-22020P FDA UDI
- Primary DI / UDI-DI
- D757L22020P1 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
DISPENSER for 5ml Dual Syringe by Bisco Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material cartridge-plunging applicator, two-component, manual.
- Henry Schein — HENRY SCHEIN, INC. · Class I
- 3M™ Aplicap™ — 3M Deutschland GmbH · Class I
- Ramitec™ — 3M Deutschland GmbH · Class I
- Imprint™ 4 Bite — 3M Deutschland GmbH · Class I
- 3M™ Maxicap™ — 3M Deutschland GmbH · Class I
- 3M™ Garant™ — 3M Deutschland GmbH · Class I
- Automix-Dispenser Type 50 1:1 — DMG Chemisch-Pharmazeutische Fabrik GmbH · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI a20651ae-c5c4-44a7-90c0-7dad0d607e2d 35 fields · synced May 30, 2026