Identity
- Trade Name
- EXEL Dental Needle FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- 25G SHORT, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
- Model / Reference
- 26559 FDA UDI
- Description
- 25G SHORT, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26559 FDA UDI
- Primary DI / UDI-DI
- 00020221265590 FDA UDI
- 510(k) Number
- K861150 FDA UDI
- FDA Product Code
- DZM FDA UDI
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental syringe needle, single-use
EXEL Dental Needle by Exel International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental syringe needle, single-use.
- EVOLUTION NEEDLES 30 G X-SHORT — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- SIRIO — TECNOFAR SPA · Class I
- ComfiJect — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- ULTRA SAFETY PLUS STER SINGLE USE HANDLE — SEPTODONT SAS SPECIALITES SEPTODONT · Class II
- Safco Shotgum Needles — Safco Dental Supply · Class I
- V-Ject — VERICOM CO., LTD. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- V-Ject — VERICOM CO., LTD. · Class I
Cleared under the same submission
K861150 also covers:
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
- Exel International
Sources (1)
- FDA UDI 8a92c7be-fb7e-42fa-a6a3-018e73abf211 36 fields · synced May 30, 2026