Identity
- Trade Name
- PAROJECT FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Dental cartridge syringe FDA UDI
- Model / Reference
- 01N2040 FDA UDI
- Description
- Dental cartridge syringe FDA UDI
Identifiers
- Catalog Number
- 01N2040 FDA UDI
- Primary DI / UDI-DI
- 00303620000024 FDA UDI
- 510(k) Number
- K904279 FDA UDI
- FDA Product Code
- EGM FDA UDI
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4475 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
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
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: Dental anaesthesia syringe, reusable
Paroject by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental anaesthesia syringe, reusable.
- Septodont — A.Titan Instruments · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- A. Titan Instruments — A.Titan Instruments · Class II
- Dentapen Protective Sleeve — JUVAPLUS SA · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Dentapen Injector — JUVAPLUS SA · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K904279 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 ad353efc-a3da-42de-a7ec-32c4f9e0dd8b 37 fields · synced May 30, 2026