Identity
- Trade Name
- Large (White) Intraoral Tips FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Dental restorative material canula, single-use FDA UDI
- Model / Reference
- 032110 FDA UDI
- Description
- Dental restorative material canula, single-use FDA UDI
Identifiers
- Catalog Number
- 032110 FDA UDI
- Primary DI / UDI-DI
- 00359883002442 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Dental material injection cannula, single-use 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
Yes
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 injection cannula, single-use
Large (White) Intraoral Tips by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material injection cannula, single-use.
- PRIME|ONE — Akzenta International SA · Class I
- NaviTip Tips — ULTRADENT PRODUCTS, INC. · Class I
- CanalPro™ Color Syringes — Coltène/Whaledent AG · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- Avalon Biomed NeoSEALER 20 Flex Flo Tips — NUSMILE, LTD · Class I
- EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- PRIME|ONE — Akzenta International SA · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI e11b4111-280a-4983-b397-9cf016107ce4 35 fields · synced Jun 9, 2026