FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-PURPOSE DENTAL SYRINGE
K Number: K811831
·
Decision Sep 8, 1981
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
47
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MULTI-PURPOSE DENTAL SYRINGE
- K Number
- K811831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Centrix, Inc.
- Date Received
- June 29, 1981
- Decision Date
- September 8, 1981
- Product Code
- EJI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJI), ordered by most recent decision date.
LeEject 2 Dental Syringe and Needle System
FDA 510(k)
FDA Class 2
·Dental
Miltex N-Tralig Intraligamentary Syringe
FDA 510(k)
FDA Class 2
·Dental
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
FDA 510(k)
FDA Class 2
·Dental
ANESTHESIA INJECTION TOOL SET
FDA 510(k)
FDA Class 2
·Dental
MORPHEUS
FDA 510(k)
FDA Class 2
·Dental
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Centrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250714 | FluoroDose Varnish | Nov 21, 2025 | Substantially Equivalent |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Oct 27, 2023 | Substantially Equivalent |
| K152826 | NoCord | May 27, 2016 | Substantially Equivalent |
| K140144 | BENDA WEDGE | Jul 8, 2014 | Substantially Equivalent |
| K120176 | SENZZZZZ AWAY | Jul 25, 2012 | Substantially Equivalent |
| K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | Jul 22, 2011 | Substantially Equivalent |
| K092384 | LIQUICORD | Nov 4, 2009 | Substantially Equivalent |
| K091380 | CORDCAP | Jul 30, 2009 | Substantially Equivalent |
| K021131 | CHLORAPREP | Sep 26, 2002 | Substantially Equivalent |
| K021146 | D/SENSE 1-STEP | Jul 2, 2002 | Substantially Equivalent |