Identity
- Trade Name
- RC-PREP 3CC SYRINGE TIP REFILL (50) EUDAMEDRC-Prep FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- RC-Prep Tips EUDAMEDRC-PREP 3CC SYRINGE TIP REFILL (50) FDA UDI
- Model / Reference
- 9007139 EUDAMEDFDA UDI
- Description
- RC-PREP 3CC SYRINGE TIP REFILL (50) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783005141 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783RC-PrepTipsRC EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Dental material injection cannula, single-use
RC-Prep by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 9515daa0-880e-409a-8d10-96fa26350a97 33 fields · synced Jul 12, 2026
- EUDAMED 5be100a7-8b56-4849-b2b0-3d4095a14228 61 fields · synced Jul 12, 2026