Identity
- Trade Name
- RelyX™ Unicem 2 Automix FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Starter Kit, 56850. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI
- Model / Reference
- 56850 FDA UDI
- Description
- 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Starter Kit, 56850. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI
Identifiers
- Catalog Number
- 56850 FDA UDI
- Primary DI / UDI-DI
- J001702011405660 FDA UDI
- FDA Product Code
- EID FDA UDIDZA FDA UDIELR FDA UDIEMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.4130 FDA UDI872.3810 FDA UDI872.3275 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental composite resinDental material injection cannula, single-useRoot canal post, preformedDental material mixing nozzle
RelyX™ Unicem 2 Automix by 3M Deutschland GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 3M Deutschland GmbH
Sources (1)
- FDA UDI bf10f824-dbc8-4ae5-9b1b-4ba24a1e838b 36 fields · synced May 30, 2026