Identity
- Trade Name
- UNIDOSE GUN EUDAMEDOrmco FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, single-component FDA UDI
- Device Name
- UNIDOSE GUN EUDAMEDFDA UDI
- Model / Reference
- 740-0200 EUDAMEDFDA UDI
- Description
- UNIDOSE GUN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989075267 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-Adh_UnidoseGun-5V EUDAMED
- Direct Marketing DI
- 00889989075267 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dental material cartridge-plunging applicator, single-component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dentine bonding agent/set
Unidose Gun by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-Adh_UnidoseGun-5V | Class I | Active |
| 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
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 30381bf7-db92-4472-bff4-8fda3bf5fa67 61 fields · synced Jul 9, 2026
- FDA UDI 9e5a0ae5-9355-4790-9d71-be3653243fff 34 fields · synced May 30, 2026