Identity
- Trade Name
- ASPIJECT WITH O-RING FDA UDI
- Generic Name
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
- Device Name
- Dental cartridge syringe FDA UDI
- Model / Reference
- 01N2030 FDA UDI
- Description
- Dental cartridge syringe FDA UDI
Identifiers
- Catalog Number
- 01N2030 FDA UDI
- Primary DI / UDI-DI
- 00303620000017 FDA UDI
- 510(k) Number
- K002168 FDA UDI
- FDA Product Code
- EJI FDA UDI
- GMDN Term
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1.8 Milliliter FDA UDI
Category: Syringe-loaded medication/vaccine injector, manual, professional
Aspiject With O-Ring by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Syringe-loaded medication/vaccine injector, manual, professional.
- ACE Surgical Supply — ACE SURGICAL SUPPLY CO., INC. · Class II
- NC606000-ENF — NEOCHILD, LLC · Class II
- Autoject 2 — OWEN MUMFORD LIMITED · Class II
- Inject-Ease — AMBI, INC. · Class II
- SyringePro — SLANTED ADAPTOR LLC · Class I
- NC600500 — NEOCHILD, LLC · Class II
- Burkhart Aspirating Syringe - Astra Style — BURKHART DENTAL SUPPLY CO., THE · Class II
- NC601000 — NEOCHILD, LLC · Class II
Cleared under the same submission
K002168 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Septodont
Sources (1)
- FDA UDI 5de47f17-1b61-4b1c-9be9-698722806f23 37 fields · synced May 30, 2026