Identity
- Trade Name
- Mark II FDA UDI
- Generic Name
- Dental material injection cannula, reusable FDA UDI
- Device Name
- The Mark II CR Syringe is intended for use as a dispensing mechanism for adhesive tips. FDA UDI
- Model / Reference
- CRII FDA UDI
- Description
- The Mark II CR Syringe is intended for use as a dispensing mechanism for adhesive tips. FDA UDI
Identifiers
- Catalog Number
- CRII FDA UDI
- Primary DI / UDI-DI
- D798CRII0 FDA UDI
- FDA Product Code
- ECP FDA UDI
- GMDN Term
- Dental material injection cannula, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material injection cannula, reusable
Mark II by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material injection cannula, reusable.
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- Connect 4:1 Tips — Cosmedent, Inc. · Class I
- Impressiv 5:1 Putty Cartridge Tips — Cosmedent, Inc. · Class I
- BGMS 3/16 — QUALITY ASPIRATORS, INC. · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- LLSXN — QUALITY ASPIRATORS, INC. · Class I
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI dc0f1241-3bc1-4a62-822b-a867689a1eeb 36 fields · synced May 30, 2026