FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
K Number: K903007
·
Decision Sep 19, 1990
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
5
Review Days
70
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
- MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
- K Number
- K903007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Habley Medical Technology Corp.
- Date Received
- July 11, 1990
- Decision Date
- September 19, 1990
- 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 Habley Medical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955164 | S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) | Mar 20, 1996 | Substantially Equivalent |
| K881980 | RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE | Jun 28, 1988 | Substantially Equivalent |
| K880594 | VACUGUARD(TM) | Apr 28, 1988 | Substantially Equivalent |
| K871007 | ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE | Apr 30, 1987 | Substantially Equivalent |